SKYRIZI ® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy. SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults and pediatric patients 6 years of age and older. SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adu...
For the treatment of moderately to severely active Crohn’s disease and ulcerative colitis, obtain liver enzymes and bilirubin levels prior to initiating treatment with SKYRIZI [see Warnings and Precautions ( 5.4 )] . Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI [see Warnings and Precautions ( 5.3 )] . Complete all age-appropriate vaccinations as recommended by curre...
How Supplied SKYRIZI (risankizumab-rzaa) injection is supplied in the following strengths and packaging units: Strength Packaging Unit NDC Subcutaneous Injection 150 mg/mL single-dose pen Carton of 1 0074-2100-01 55 mg/0.37 mL single-dose prefilled syringe Carton of 1 0074-4059-01 90 mg/mL single-dose prefilled syringe Carton of 2 0074-7040-02 Carton of 4 0074-7042-04 180 mg/1.2 mL (150 mg/mL) single-dose prefille...
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www.SKYRIZI.comwww.fda.gov/safesharpsdisposalwww.skyrizi.comwww.Skyrizi.comSKYRIZI® is indicated for the treatment of moderate-to-severe plaque psoriasis in adults and pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy.
SKYRIZI is indicated for the treatment of active psoriatic arthritis in adults and pediatric patients 6 years of age and older.
SKYRIZI is indicated for the treatment of moderately to severely active Crohn's disease in adults.
SKYRIZI is indicated for the treatment of moderately to severely active ulcerative colitis in adults.
• Visually inspect SKYRIZI for particulate matter and discoloration prior to administration. The solution may contain a few translucent to white particles.
○ SKYRIZI 55 mg/0.37 mL prefilled syringe, 150 mg/mL prefilled pen or prefilled syringe, 180 mg/1.2 mL prefilled syringe or prefilled cartridge, and 360 mg/2.4 mL prefilled cartridge: a colorless to yellow, and clear to slightly opalescent solution.
○ SKYRIZI 90 mg/mL prefilled syringe and 600 mg/10 mL vial: a colorless to slightly yellow, and clear to slightly opalescent solution.
○ Do not use if the solution contains large particles or is cloudy or discolored.
• Discard after use. Do not reuse.
Adults
The recommended dosage for adults is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
Pediatric Patients 6 Years of Age and Older
The recommended dosage for pediatric patients 6 years of age and older is based on body weight (see Table 1) and administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
| Body Weight | Recommended Dose |
| less than 40 kg | 55 mg |
| 40 kg or greater | 150 mg |
Adults
The recommended dosage for adult patients is 150 mg administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
SKYRIZI may be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).
Pediatric Patients 6 Years of Age and Older
The recommended dosage for pediatric patients 6 years of age and older is based on body weight (see Table 2) and administered by subcutaneous injection at Week 0, Week 4, and every 12 weeks thereafter.
| Body Weight | Recommended Dose |
| less than 40 kg | 55 mg |
| 40 kg or greater | 150 mg |
SKYRIZI may be administered alone or in combination with non-biologic disease-modifying antirheumatic drugs (DMARDs).
• Administer SKYRIZI 55 mg/0.37 mL prefilled syringe, 150 mg/mL prefilled pen or prefilled syringe subcutaneously.
• Provide proper training to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI. After proper training:
Adults
○ Adults may self-inject SKYRIZI.
Pediatric Patients 6 Years of Age and Older
○ For pediatric patients 10 years of age and older, it is recommended that SKYRIZI be administered by or under the supervision of an adult.
○ For pediatric patients 6 to less than 10 years of age, SKYRIZI should be administered by an adult.
The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation and administration of SKYRIZI [see Instructions for Use ]. Instruct the patient to read the Instructions for Use before administration.
Adult Patients: Induction
The recommended induction dosage of SKYRIZI is 600 mg administered by intravenous infusion over a period of at least one hour at Week 0, Week 4, and Week 8.
Adult Patients: Maintenance
The recommended maintenance dosage of SKYRIZI is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage needed to maintain therapeutic response.
Adult Patients: Induction
The recommended induction dosage of SKYRIZI is 1,200 mg administered by intravenous infusion over a period of at least two hours at Week 0, Week 4, and Week 8.
Adult Patients: Maintenance
The recommended maintenance dosage of SKYRIZI is 180 mg or 360 mg administered by subcutaneous injection at Week 12, and every 8 weeks thereafter. Use the lowest effective dosage needed to maintain therapeutic response.
Intravenous Induction Dosing Regimen:
1. SKYRIZI vial for intravenous administration is intended for administration by a healthcare provider using aseptic technique.
2. Prior to intravenous administration, determine the dose and number of SKYRIZI vials needed based on the patient’s indication (see table below). Withdraw 10 mL of SKYRIZI solution from a vial (600 mg/10 mL) and inject into an intravenous infusion bag or glass bottle containing 5% Dextrose Injection or 0.9% Sodium Chloride Injection (see Table 3 below) for a final concentration of approximately 1.2 mg/mL to 6 mg/mL. Discard any remaining solution in the vial.
Indication | Intravenous Induction Dose | Number of SKYRIZI 600 mg/10 mL Vials | Total Volume of 5% Dextrose or 0.9% Sodium Chloride Injection |
| Crohn’s disease | 600 mg | 1 | 100 mL, or 250 mL, or 500 mL |
| Ulcerative colitis | 1,200 mg | 2 | 250 mL, or 500 mL |
3. Infuse the diluted solution intravenously over a period of at least one hour for the SKYRIZI 600 mg dose; at least two hours for the SKYRIZI 1,200 mg dose. If stored refrigerated, allow the diluted SKYRIZI solution in the infusion bag or glass bottle to warm to room temperature prior to the start of the intravenous infusion.
4. Do not administer SKYRIZI diluted solution concomitantly in the same intravenous line with other medicinal products.
Handling and Storage of the Vial and the Diluted Solution:
Subcutaneous Maintenance Dosing Regimen:
Using the single-dose 180 mg or 360 mg prefilled cartridge with On-Body Injector:
The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation and administration of SKYRIZI [see Instructions for Use ]. Instruct the patient to read the Instructions for Use before administration.
Using the 90 mg/mL or 180 mg/1.2 mL prefilled syringe:
• Administer each SKYRIZI 90 mg/mL or 180 mg/1.2 mL prefilled syringe subcutaneously.
• Patients may self-inject SKYRIZI after training in subcutaneous injection technique. Provide proper training to patients and/or caregivers on the subcutaneous injection technique of SKYRIZI.
• Before injecting, remove the carton from the refrigerator and without removing the prefilled syringes from the carton, allow SKYRIZI to reach room temperature out of direct sunlight (15 to 30 minutes).
• Use the 90 mg/mL or 180 mg/1.2 mL prefilled syringe(s) to administer SKYRIZI 180 mg or SKYRIZI 360 mg subcutaneously as follows:
○ 180 mg maintenance dose:
▪ SKYRIZI 90 mg/mL prefilled syringes: Two 90 mg prefilled syringes are required. Inject one prefilled syringe after the other in different anatomic locations (such as thighs or abdomen).
▪ SKYRIZI 180 mg/1.2 mL prefilled syringe: One 180 mg prefilled syringe is required.
○ 360 mg maintenance dose:
▪ SKYRIZI 90 mg/mL prefilled syringes: Four 90 mg prefilled syringes are required. Inject one prefilled syringe after the other in different anatomic locations (such as thighs or abdomen).
▪ SKYRIZI 180 mg/1.2 mL prefilled syringes: Two 180 mg prefilled syringes are required. Inject one prefilled syringe after the other in different anatomic locations (such as thighs or abdomen).
• Do not inject into areas where the skin is tender, bruised, erythematous, indurated or affected by any lesions. Administration of SKYRIZI in the upper, outer arm may only be performed by a healthcare professional or caregiver.
• If a dose is missed, administer the dose as soon as possible. Thereafter, resume dosing at the regular scheduled time.
The SKYRIZI “Instructions for Use” contains more detailed instructions on the preparation and administration of SKYRIZI [see Instructions for Use ]. Instruct the patient to read the Instructions for Use before administration.
Subcutaneous Injection
SKYRIZI Pen
SKYRIZI Prefilled Syringe
SKYRIZI Prefilled Cartridge with Supplied On-Body Injector
Intravenous Infusion
SKYRIZI Vial
SKYRIZI is contraindicated in patients with a history of serious hypersensitivity reaction to risankizumab-rzaa or any of the excipients [see Warnings and Precautions ( 5.1 )].
Serious hypersensitivity reactions, including anaphylaxis, have been reported with use of SKYRIZI. If a serious hypersensitivity reaction occurs, discontinue SKYRIZI and initiate appropriate therapy immediately [see Adverse Reactions ( 6.1 )].
SKYRIZI may increase the risk of infections [see Adverse Reactions ( 6.1 )].
Treatment with SKYRIZI should not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated.
In patients with a chronic infection or a history of recurrent infection, consider the risks and benefits prior to prescribing SKYRIZI. Instruct patients to seek medical advice if signs or symptoms of clinically important infection occur. If a patient develops such an infection or is not responding to standard therapy, monitor the patient closely and do not administer SKYRIZI until the infection resolves.
Evaluate patients for tuberculosis (TB) infection prior to initiating treatment with SKYRIZI. Across the Phase 3 psoriasis clinical studies, of the 72 subjects with latent TB who were concurrently treated with SKYRIZI and appropriate TB prophylaxis during the studies, none developed active TB during the mean follow-up of 61 weeks on SKYRIZI. Two subjects taking isoniazid for treatment of latent TB discontinued treatment due to liver injury. Of the 31 subjects from the PsO-3 study with latent TB who did not receive prophylaxis during the study, none developed active TB during the mean follow-up of 55 weeks on SKYRIZI. Consider anti-TB therapy prior to initiating SKYRIZI in patients with a past history of latent or active TB in whom an adequate course of treatment cannot be confirmed. Monitor patients for signs and symptoms of active TB during and after SKYRIZI treatment. Do not administer SKYRIZI to patients with active TB.
A serious adverse reaction of drug-induced liver injury in conjunction with a rash that required hospitalization was reported in a patient with Crohn’s disease (ALT 54x ULN, AST 30x ULN, and total bilirubin 2.2x ULN) following two 600 mg intravenous doses of SKYRIZI. The liver test abnormalities resolved following administration of steroids. SKYRIZI was subsequently discontinued.
For the treatment of Crohn’s disease and ulcerative colitis, evaluate liver enzymes and bilirubin at baseline, and during induction at least up to 12 weeks of treatment. Monitor thereafter according to routine patient management.
Consider other treatment options in patients with evidence of liver cirrhosis. Prompt investigation of the cause of liver enzyme elevation is recommended to identify potential cases of drug-induced liver injury. Interrupt treatment if drug-induced liver injury is suspected, until this diagnosis is excluded. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of hepatic dysfunction.
Avoid use of live vaccines in patients treated with SKYRIZI. Drugs that interact with the immune system may increase the risk of infection following administration of live vaccines. Prior to initiating therapy with SKYRIZI, complete all age-appropriate vaccinations according to current immunization guidelines. No data are available on the response to live or inactive vaccines.
The following adverse reactions are discussed in other sections of labeling:
Because clinical trials are conducted under widely varying conditions, adverse drug reaction rates observed in the clinical trials of a drug cannot be directly compared with rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Adverse Reactions in Adults with Plaque Psoriasis
A total of 2234 subjects were treated with SKYRIZI in clinical development trials in plaque psoriasis. Of these, 1208 subjects with psoriasis were exposed to SKYRIZI for at least one year.
Data from placebo- and active-controlled trials were pooled to evaluate the safety of SKYRIZI for up to 16 weeks. In total, 1306 subjects were evaluated in the SKYRIZI 150 mg group.
Table 4 summarizes the adverse reactions that occurred at a rate of at least 1% and at a higher rate in the SKYRIZI group than the placebo group during the 16-week controlled period of pooled clinical trials.
| Adverse Drug Reactions | SKYRIZI N = 1306 n (%) | Placebo N = 300 n (%) |
| Upper respiratory infectionsa | 170 (13) | 29 (9.7) |
| Headacheb | 46 (3.5) | 6 (2) |
| Fatiguec | 33 (2.5) | 3 (1) |
| Injection site reactionsd | 19 (1.5) | 3 (1) |
| Tinea infectionse | 15 (1.1) | 1 (0.3) |
| a Includes: respiratory tract infection (viral, bacterial or unspecified), sinusitis (including acute), rhinitis, nasopharyngitis, pharyngitis (including viral), tonsillitis b Includes: headache, tension headache, sinus headache, cervicogenic headache c Includes: fatigue, asthenia d Includes: injection site bruising, erythema, extravasation, hematoma, hemorrhage, infection, inflammation, irritation, pain, pruritus, reaction, swelling, warmth e Includes: tinea pedis, tinea cruris, body tinea, tinea versicolor, tinea manuum, tinea infection, onychomycosis | ||
Adverse reactions that occurred in < 1% but > 0.1% of subjects in the SKYRIZI group and at a higher rate than in the placebo group through Week 16 were folliculitis and urticaria.
Specific Adverse Reactions
Infections: In the first 16 weeks, infections occurred in 22.1% of the SKYRIZI group (90.8 events per 100 patient-years) compared with 14.7% of the placebo group (56.5 events per 100 patient-years) and did not lead to discontinuation of SKYRIZI. The rates of serious infections for the SKYRIZI group and the placebo group were ≤0.4%. Serious infections in the SKYRIZI group included cellulitis, osteomyelitis, sepsis, and herpes zoster. In Trials PsO-1 and PsO-2, through Week 52, the rate of infections (73.9 events per 100 patient-years) was similar to the rate observed during the first 16 weeks of treatment.
Safety Through Week 52
Through Week 52, no new adverse reactions were identified, and the rates of the adverse reactions were similar to those observed during the first 16 weeks of treatment. During this period, serious infections that led to trial discontinuation included pneumonia.
Plaque Psoriasis of the Scalp or Genital Area
The overall safety profile observed in clinical trials of subjects with moderate-to-severe plaque psoriasis of the scalp or genital area treated with SKYRIZI is generally consistent with the safety profile observed in previous clinical trials of subjects with moderate-to-severe plaque psoriasis [see Clinical Studies ( 14.1 )].
Adverse Reactions in Pediatric Subjects 6 Years of Age and Older with Plaque Psoriasis
The safety of SKYRIZI was evaluated in a four-part trial that included 137 pediatric subjects 6 years of age and older with moderate-to-severe plaque psoriasis [see Clinical Studies ( 14.1 )]. Overall, the safety profile observed in pediatric subjects 6 years of age and older treated with SKYRIZI for up to 52 weeks was consistent with the safety profile observed in adult subjects with moderate-to-severe plaque psoriasis.
Adverse Reactions in Adult Subjects with Psoriatic Arthritis
The overall safety profile observed in adult subjects with psoriatic arthritis treated with SKYRIZI is generally consistent with the safety profile in adult subjects with plaque psoriasis. Additionally, in the Phase 3 placebo-controlled trials the incidence of hepatic events was higher in the SKYRIZI group (5.4%, 16.7 events per 100 patient-years) compared to the placebo group (3.9%, 12.6 events per 100 patient-years). Of these, the most common events that were reported more frequently in both the placebo group and the SKYRIZI group were ALT increased (placebo: n=12 (1.7%); SKYRIZI: n=16 (2.3%)), AST increased (placebo: n=9 (1.3%); SKYRIZI: n=13 (1.8%)), and GGT increased (placebo: n=5 (0.7%); SKYRIZI: n=8 (1.1%)). There were no serious hepatic events reported. The incidence of hypersensitivity reactions was higher in the SKYRIZI group (n=16, 2.3%) compared to the placebo group (n=9, 1.3%). In the Phase 3 placebo-controlled trials, hypersensitivity reactions reported at a higher rate in the SKYRIZI group included rash (placebo: n=4 (0.6%); SKYRIZI: n=5 (0.7%)), allergic rhinitis (placebo: n=1 (0.1%); SKYRIZI: n=2 (0.3%)), and facial swelling (placebo: n=0 (0.0%); SKYRIZI n=1 (0.1%)). One case of anaphylaxis was reported in a subject who received SKYRIZI in the Phase 2 clinical trial.
Adverse Reactions in Adult Subjects with Crohn’s Disease
SKYRIZI was studied up to 12 weeks in subjects with moderately to severely active Crohn’s disease in two randomized, double-blind, placebo-controlled induction trials (CD-1, CD-2) and a randomized, double-blind, placebo-controlled, dose-finding trial (CD-4; NCT02031276). Long-term safety up to 52 weeks was evaluated in subjects who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance trial (CD-3) [see Clinical Studies ( 14.3 )].
In the two induction trials (CD-1, CD-2) and the dose finding trial (CD-4), 620 subjects received the SKYRIZI intravenous induction regimen at Weeks 0, 4 and 8. In the maintenance trial (CD-3), 297 subjects who achieved clinical response, defined as a reduction in CDAI of at least 100 points from baseline after 12 weeks of induction treatment with intravenous SKYRIZI in trials CD-1 and CD-2, received a maintenance regimen of SKYRIZI either 180 mg or 360 mg subcutaneously at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks.
Adverse reactions reported in > 3% of subjects in induction trials and at a higher rate than placebo are shown in Table 5.
| Adverse Drug Reactions | SKYRIZI 600 mg Intravenous Infusiona N = 620 n (%) | Placebo N = 432 n (%) |
| Upper respiratory infectionsb | 66 (10.6) | 40 (9.3) |
| Headachec | 41 (6.6) | 24 (5.6) |
| Arthralgia | 31 (5) | 19 (4.4) |
| a SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8. b Includes: influenza like illness, nasopharyngitis, influenza, pharyngitis, upper respiratory tract infection, viral upper respiratory tract infection, COVID-19, nasal congestion, respiratory tract infection viral, viral pharyngitis, tonsillitis, upper respiratory tract inflammation c Includes: headache, tension headache | ||
Adverse reactions reported in >3% of subjects in the maintenance trial and at a higher rate than placebo are shown in Table 6.
| Adverse Drug Reactions | SKYRIZI 180 mg Subcutaneous Injection N = 155 n (%) | SKYRIZI 360 mg Subcutaneous Injection N = 142 n (%) | Placebo N = 143 n (%) |
| Arthralgia | 13 (8.4) | 13 (9.2) | 12 (8.4) |
| Abdominal painb | 9 (5.8) | 12 (8.5) | 6 (4.2) |
| Injection site reactionsc,d | 7 (4.5) | 8 (5.6) | 4 (2.8) |
| Anemia | 7 (4.5) | 7 (4.9) | 6 (4.2) |
| Pyrexia | 4 (2.6) | 7 (4.9) | 4 (2.8) |
| Back pain | 3 (1.9) | 6 (4.2) | 3 (2.1) |
| Arthropathy | 1 (0.6) | 5 (3.5) | 2 (1.4) |
| Urinary tract infection | 1 (0.6) | 5 (3.5) | 4 (2.8) |
| a SKYRIZI 180 mg or 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks b Includes: abdominal pain, abdominal pain upper, abdominal pain lower c Includes: injection site rash, injection site erythema, injection site swelling, injection site urticaria, injection site warmth, injection site pain, injection site hypersensitivity, injection site reaction d Some subjects had multiple occurrences of injection site reactions. In this table, injection site reactions are counted only once per subject for the rate calculations. | |||
Specific Adverse Reactions
Adverse Reactions in Adult Subjects with Ulcerative Colitis
SKYRIZI was studied up to 12 weeks in subjects with moderately to severely active ulcerative colitis in a randomized, double-blind, placebo-controlled induction trial (UC-1) and a randomized, double-blind, placebo-controlled, dose-finding trial (UC-3). Long-term safety up to 52 weeks was evaluated in subjects who responded to induction therapy in a randomized, double-blind, placebo-controlled maintenance trial (UC-2) [see Clinical Studies ( 14.4 )].
In the induction trials (UC-1 and UC-3), 712 subjects received the SKYRIZI 1,200 mg intravenous induction regimen at Weeks 0, 4 and 8. In the maintenance trial (UC-2), 347 subjects who achieved clinical response, defined as a decrease in mMS of ≥2 points and ≥30% from baseline and a decrease in RBS ≥1 from baseline or an absolute RBS ≤1, received a maintenance regimen of SKYRIZI either 180 mg or 360 mg subcutaneously at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks.
The adverse reaction reported in ≥3% subjects treated with SKYRIZI in the ulcerative colitis induction trials (UC-1 and UC-3) and at a higher rate than placebo was arthralgia (3% SKYRIZI vs 1% placebo).
Adverse reactions reported in ≥3% of subjects treated with SKYRIZI in the maintenance trial (UC-2) and at a higher rate than placebo are shown in Table 7.
| Adverse Drug Reactions | SKYRIZI 180 mg Subcutaneous Injection N = 170 n (%) | SKYRIZI 360 mg Subcutaneous Injection N = 177 n (%) | Placebo N = 173 n (%) |
| Arthralgia | 9 (5.3) | 17 (9.6) | 8 (4.6) |
| Pyrexia | 8 (4.7) | 7 (4) | 6 (3.5) |
| Injection site reactionsb,c | 5 (2.9) | 5 (2.8) | 2 (1.2) |
| Rashd | 7 (4.1) | 1 (0.6) | 3 (1.7) |
| a SKYRIZI 180 mg or 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks b Includes: application site pain, injection site erythema, injection site pain, injection site pruritus, injection site reaction c Some subjects had multiple occurrences of injection site reactions. In this table, injection site reactions are counted only once per subject for the rate calculations. d Includes: rash and rash macular | |||
Specific Adverse Reactions
The rates of infections, serious infections, and lipid elevations in subjects with UC who received SKYRIZI compared to subjects who received placebo in the induction trials (UC-1 and UC-3) and maintenance trial (UC-2) were similar to the rates in subjects with CD who received SKYRIZI compared to subjects who received placebo in the induction trials (CD-1, CD-2, and CD-4) and maintenance trial (CD-3).
The following adverse reactions have been reported during post-approval of SKYRIZI. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to SKYRIZI exposure:
Pregnancy Exposure Registry
There is a pregnancy exposure registry that monitors outcomes in women who become pregnant while treated with SKYRIZI. Patients should be encouraged to enroll by calling 1-877-302-2161 or visiting glowpregnancyregistry.com.
Risk Summary
Available pharmacovigilance and clinical trial data with risankizumab use in pregnant women are insufficient to establish a drug-associated risk of major birth defects, miscarriage or other adverse maternal or fetal outcomes. Although there are no data on risankizumab-rzaa, monoclonal antibodies can be actively transported across the placenta, and SKYRIZI may cause immunosuppression in the in utero-exposed infant. There are adverse pregnancy outcomes in women with inflammatory bowel disease (see Clinical Considerations).
In an enhanced pre- and post-natal developmental toxicity study, pregnant cynomolgus monkeys were administered subcutaneous doses of 5 or 50 mg/kg risankizumab-rzaa once weekly during the period of organogenesis up to parturition. Increased fetal/infant loss was noted in pregnant monkeys at the 50 mg/kg dose (see Data). The 50 mg/kg dose in pregnant monkeys resulted in approximately 5 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 32 times the exposure (AUC) to the maximum recommended maintenance dose (360 mg). No risankizumab-rzaa-related effects on functional or immunological development were observed in infant monkeys from birth through 6 months of age. The clinical significance of these findings for humans is unknown.
All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. The background risk of major birth defects and miscarriage for the indicated population is unknown. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.
Clinical Considerations
Disease-associated maternal and embryo/fetal risk
Published data suggest that the risk of adverse pregnancy outcomes in women with inflammatory bowel disease is associated with increased disease activity. Adverse pregnancy outcomes include preterm delivery (before 37 weeks of gestation), low birth weight (less than 2,500 g) infants, and small for gestational age at birth.
Fetal/Neonatal adverse reactions
Transport of endogenous IgG antibodies across the placenta increases as pregnancy progresses, and peaks during the third trimester. Therefore, SKYRIZI may be present in infants exposed in utero. The potential clinical impact of risankizumab exposure in infants exposed in utero should be considered.
Data
Animal Data
An enhanced pre- and post-natal developmental toxicity study was conducted in cynomolgus monkeys. Pregnant cynomolgus monkeys were administered weekly subcutaneous doses of risankizumab-rzaa of 5 or 50 mg/kg from gestation day 20 to parturition, and the cynomolgus monkeys (mother and infants) were monitored for 6 months after delivery. No maternal toxicity was noted in this study. There were no treatment-related effects on growth and development, malformations, developmental immunotoxicology, or neurobehavioral development. However, a dose-dependent increase in fetal/infant loss was noted in the risankizumab-rzaa-treated groups (32% and 43% in the 5 mg/kg and 50 mg/kg groups, respectively) compared with the vehicle control group (19%). The increased fetal/infant loss in the 50 mg/kg group was considered to be related to risankizumab-rzaa treatment. The no-observed adverse effect level (NOAEL) for maternal toxicity was identified as 50 mg/kg, and the NOAEL for developmental toxicity was identified as 5 mg/kg. The 5 mg/kg dose in pregnant monkeys resulted in approximately 0.6 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 5 times the exposure (AUC) in humans administered the maximum recommended maintenance dose (360 mg). In the infants, mean serum concentrations increased in a dose-dependent manner and were approximately 17%-86% of the respective maternal concentrations. Following delivery, most adult female cynomolgus monkeys and all infants from the risankizumab-rzaa-treated groups had measurable serum concentrations of risankizumab-rzaa up to 91 days postpartum. Serum concentrations were below detectable levels at 180 days postpartum.
Risk Summary
There are no data on the presence of risankizumab-rzaa in human milk, the effects on the breastfed infant, or the effects on milk production. Endogenous maternal IgG and monoclonal antibodies are transferred in human milk. The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed infant to risankizumab-rzaa are unknown. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for SKYRIZI and any potential adverse effects on the breastfed infant from SKYRIZI or from the underlying maternal condition.
Moderate-to-Severe Plaque Psoriasis
The safety and effectiveness of SKYRIZI for the treatment of moderate-to-severe plaque psoriasis have been established in pediatric patients 6 years of age and older who are candidates for systemic therapy or phototherapy.
Use of SKYRIZI for this indication is supported by evidence from a four-part trial in a total of 137 pediatric subjects 6 years of age and older with moderate-to-severe plaque psoriasis. In addition to two lead-in pharmacokinetic cohorts, the trial also included a randomized, efficacy assessor-blinded, active treatment-controlled cohort that enrolled 82 pediatric subjects 12 years of age and older and a single-arm, open-label cohort that enrolled 30 pediatric subjects 6 to less than 12 years of age [see Adverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 ), and Clinical Studies ( 14.1 )].
The safety and effectiveness of SKYRIZI have not been established in pediatric patients younger than 6 years of age with moderate-to-severe plaque psoriasis.
Active Psoriatic Arthritis
The safety and effectiveness of SKYRIZI for the treatment of psoriatic arthritis have been established in pediatric patients 6 years of age and older.
Use of SKYRIZI for this indication is supported by evidence from well-controlled studies of SKYRIZI in adults with psoriatic arthritis, pharmacokinetic data from adult patients with psoriatic arthritis or plaque psoriasis, and pharmacokinetic, safety, and immunogenicity data from pediatric patients with moderate-to-severe plaque psoriasis [see A dverse Reactions ( 6.1 ), Clinical Pharmacology ( 12.3 , 12.6 ), and Clinical Studies ( 14.2 ) ]. Risankizumab exposures in pediatric patients with psoriatic arthritis at the recommended dosage are predicted to be comparable to those observed in adults with psoriatic arthritis based on population pharmacokinetic modeling and simulation.
The safety and effectiveness of SKYRIZI have not been established in pediatric patients younger than 6 years of age with psoriatic arthritis.
Crohn’s Disease and Ulcerative Colitis
The safety and effectiveness of SKYRIZI have not been established in pediatric patients with Crohn’s disease or ulcerative colitis.
Of the 6,862 subjects exposed to SKYRIZI, a total of 664 were 65 years and older (243 subjects with plaque psoriasis, 246 subjects with psoriatic arthritis, 72 subjects with Crohn’s disease and 103 subjects with ulcerative colitis), and 71 subjects were 75 years and older.
Clinical studies of SKYRIZI, within each indication, did not include sufficient numbers of subjects 65 years of age and older to determine whether they respond differently from younger adult subjects.
No clinically meaningful differences in the pharmacokinetics of risankizumab-rzaa were observed based on age [see Clinical Pharmacology ( 12.3 )].
Risankizumab-rzaa, an interleukin-23 (IL-23) antagonist, is a humanized immunoglobulin G1 (IgG1) monoclonal antibody. Risankizumab-rzaa is produced by recombinant DNA technology in Chinese hamster ovary cells and has an approximate molecular weight of 149 kDa.
SKYRIZI (risankizumab-rzaa) injection 55 mg/0.37 mL prefilled syringe for subcutaneous use
Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 55 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.02 mg), polysorbate 20 (0.07 mg), sodium acetate (0.28 mg), trehalose (23.4 mg), and Water for Injection, USP. The pH is 5.7.
SKYRIZI (risankizumab-rzaa) injection 90 mg/mL prefilled syringe for subcutaneous use
Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each syringe delivers 90 mg of risankizumab-rzaa, and inactive ingredients polysorbate 20 (0.2 mg), sodium succinate (0.63 mg), sorbitol (41 mg), succinic acid (0.059 mg), and Water for Injection, USP. The pH is 6.2.
SKYRIZI (risankizumab-rzaa) injection 150 mg/mL prefilled syringe or prefilled pen for subcutaneous use
Each SKYRIZI prefilled pen or prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe and pen delivers 150 mg of risankizumab-rzaa and the inactive ingredients glacial acetic acid (0.054 mg), polysorbate 20 (0.2 mg), sodium acetate (0.75 mg), trehalose (63.33 mg), and Water for Injection, USP. The pH is 5.7.
SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2 mL prefilled syringe for subcutaneous use
Each SKYRIZI prefilled syringe contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each syringe delivers 180 mg of risankizumab-rzaa, and inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.898 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7.
SKYRIZI (risankizumab-rzaa) injection 180 mg/1.2mL (150 mg/mL) prefilled cartridge for use with supplied on-body-injector for subcutaneous use
Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 180 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.065 mg), polysorbate 20 (0.24 mg), sodium acetate (0.9 mg), trehalose (76 mg), and Water for Injection, USP. The pH is 5.7.
SKYRIZI (risankizumab-rzaa) injection 360 mg/2.4 mL (150 mg/mL) prefilled cartridge for use with the supplied on-body injector for subcutaneous use
Each SKYRIZI prefilled cartridge contains a sterile, preservative-free, colorless to yellow, and clear to slightly opalescent solution. Each cartridge delivers 360 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.13 mg), polysorbate 20 (0.48 mg), sodium acetate (1.8 mg), trehalose (152 mg), and Water for Injection, USP. The pH is 5.7.
SKYRIZI 600 mg/10 mL (60 mg/mL) in a vial for intravenous infusion
SKYRIZI (risankizumab-rzaa) injection 600 mg/10 mL (60 mg/mL) is a sterile, preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution in a 10 mL single-dose vial.
Each 10 mL single-dose vial contains 600 mg of risankizumab-rzaa, and the inactive ingredients glacial acetic acid (0.54 mg), polysorbate 20 (2 mg), sodium acetate (7.5 mg), trehalose (633.3 mg), and Water for Injection, USP. The pH is 5.7.
Risankizumab-rzaa is a humanized IgG1 monoclonal antibody that selectively binds to the p19 subunit of human IL-23 cytokine and inhibits its interaction with the IL-23 receptor. IL-23 is a naturally occurring cytokine that is involved in inflammatory and immune responses.
Risankizumab-rzaa inhibits the release of pro-inflammatory cytokines and chemokines.
No formal pharmacodynamics studies have been conducted with risankizumab-rzaa.
Risankizumab-rzaa plasma concentrations, after single dose administration increased dose proportionally from 18 mg to 360 mg when administered subcutaneously (0.12 to 2.4 times the lowest recommended dose and 0.05 to 1 times the highest recommended dose) and from 200 mg to 1,800 mg when administered as an up to 3-hour intravenous infusion (0.2 to 3 times the recommended dose) in healthy subjects.
In subjects with plaque psoriasis treated with 150 mg subcutaneously at Weeks 0, 4, and every 12 weeks thereafter, steady-state peak concentration (Cmax) and trough concentration (Ctrough) are estimated to be 12 mcg/mL and 2 mcg/mL, respectively.
With the same subcutaneous dosing regimen, the pharmacokinetics of risankizumab-rzaa in subjects with psoriatic arthritis were similar to that in subjects with plaque psoriasis.
In subjects with Crohn’s disease treated with 600 mg intravenous induction dose at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneous maintenance dose at Week 12 and every 8 weeks thereafter, the median Cmax and Ctrough are estimated to be 156 mcg/mL and 38.8 mcg/mL, respectively, during Weeks 8-12; and the steady state median Cmax and Ctrough are estimated to be 14 mcg/mL and 4.1 mcg/mL, respectively for 180 mg or 28 mcg/mL and 8.1 mcg/mL, respectively, for 360 mg, during Weeks 40-48.
In subjects with ulcerative colitis treated with 1,200 mg intravenous induction dose at Weeks 0, 4, and 8, followed by 180 mg or 360 mg subcutaneous maintenance dose at Week 12 and every 8 weeks thereafter, the median Cmax and Ctrough are estimated to be 350 and 87.7 mcg/mL, respectively, during the induction period (Weeks 8-12); and the steady state median Cmax and Ctrough are estimated to be 19.6 and 4.64 µg/mL, respectively, for 180 mg or 39.2 mcg/mL and 9.29 mcg/mL, respectively, for 360 mg, during the maintenance period (Weeks 40-48).
Based on population pharmacokinetic analyses, the pharmacokinetics of risankizumab-rzaa in subjects with ulcerative colitis was generally similar to that in subjects with Crohn’s disease.
Absorption
The absolute bioavailability of risankizumab-rzaa was estimated to be 74 to 89% following subcutaneous injection. In healthy subjects, following administration of a single subcutaneous dose, Cmax was reached by 3 to 14 days.
Distribution
The estimated steady-state volume of distribution (inter-subject CV%) was 11.2 L (34%) in subjects with plaque psoriasis, and 7.68 L (64%) in subjects with Crohn’s disease.
Elimination
The estimated systemic clearance (inter-subject CV%) was 0.31 L/day (24%) and 0.30 L/day (34%) and terminal elimination half-life was approximately 28 days and 21 days in subjects with plaque psoriasis and Crohn’s disease, respectively.
Metabolism
The metabolic pathway of risankizumab-rzaa has not been characterized. As a humanized IgG1 monoclonal antibody, risankizumab-rzaa is expected to be degraded into small peptides and amino acids via catabolic pathways in a manner similar to endogenous IgG.
Specific Populations
Pediatric Patients
Geriatric Patients
Risankizumab-rzaa exposures (Ctrough) in geriatric patients (≥65 years) are comparable to those in younger adult patients within each indication. No studies have been conducted to determine the effect of renal or hepatic impairment on the pharmacokinetics of risankizumab-rzaa.
Body Weight
Risankizumab-rzaa clearance and volume of distribution increase and plasma concentrations decrease as body weight increases; however, no dose adjustment is recommended based on body weight in adult patients.
Drug Interaction Studies
Cytochrome P450 Substrates
No clinically significant changes in exposure of caffeine (CYP1A2 substrate), warfarin (CYP2C9 substrate), omeprazole (CYP2C19 substrate), metoprolol (CYP2D6 substrate), or midazolam (CYP3A substrate) were observed when used concomitantly with risankizumab-rzaa in subjects with plaque psoriasis (risankizumab-rzaa 150 mg administered subcutaneously at Weeks 0, 4, 8, and 12) and subjects with Crohn’s disease or ulcerative colitis (risankizumab-rzaa 1,800 mg administered intravenously at Weeks 0, 4, and 8, i.e., 3 times and 1.5 times the recommended dose for Crohn’s disease and ulcerative colitis, respectively).
The observed incidence of anti-drug antibodies is highly dependent on the sensitivity and specificity of the assay. Differences in assay methods preclude meaningful comparisons of the incidence of anti-drug antibodies (ADA) in the trials described below with the incidence of ADA in other trials, including those of SKYRIZI or other risankizumab products.
Moderate-to-Severe Plaque Psoriasis
By Week 52, approximately 24% (263/1079) of adults treated with SKYRIZI at the recommended dosage developed antibodies to risankizumab-rzaa. Of the subjects who developed antibodies to risankizumab-rzaa, approximately 57% (14% of all subjects treated with SKYRIZI) had antibodies that were classified as neutralizing. Higher antibody titers in approximately 1% of subjects treated with SKYRIZI were associated with lower risankizumab-rzaa concentrations and reduced clinical response.
In pediatric subjects 6 years of age and older, approximately 15% (13/88) of subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumab-rzaa by Week 52. Of the 13 subjects who developed antibodies to risankizumab-rzaa, approximately 15% (2.3% of all subjects treated with SKYRIZI) had antibodies that were classified as neutralizing. Due to the small number of subjects who developed antibodies to risankizumab-rzaa, it is difficult to determine the impact of the antibodies on pharmacokinetics, pharmacodynamics, safety, and/or effectiveness.
Active Psoriatic Arthritis
By Week 28, approximately 12.1% (79/652) of adult subjects treated with SKYRIZI at the recommended dose developed antibodies to risankizumab-rzaa. None of the subjects who developed antibodies to risankizumab-rzaa had antibodies that were classified as neutralizing. Antibodies to risankizumab-rzaa were not associated with changes in clinical response for psoriatic arthritis. A higher proportion of subjects with anti-drug antibodies experienced hypersensitivity reactions (6.3% (5/79)) and injection site reactions (2.5% (2/79)) compared to subjects without anti-drug antibodies (3.8% (22/574) with hypersensitivity reactions and 0.7% (4/574) with injection site reactions). None of these hypersensitivity and injection site reactions led to discontinuation of risankizumab-rzaa.
Moderately to Severely Active Crohn’s Disease
By Week 64, antibodies to risankizumab-rzaa developed in approximately 3.4% (2/58) of subjects treated with SKYRIZI induction followed by 360 mg maintenance regimen. No subjects (0/57) treated with SKYRIZI induction followed by 180 mg maintenance regimen developed antibodies to risankizumab-rzaa. None of the subjects who developed antibodies to risankizumab-rzaa had antibodies that were classified as neutralizing.
Moderately to Severely Active Ulcerative Colitis
By Week 64, antibodies to risankizumab-rzaa developed in approximately 8.9% (8/90) or 4.4% (4/91) of subjects treated with SKYRIZI induction followed by the 180 mg or 360 mg maintenance regimen, respectively. Of the subjects who developed antibodies to risankizumab-rzaa, 75% (6.7% of all subjects treated with SKYRIZI induction followed by the 180 mg maintenance regimen) or 50% (2.2% of all subjects treated with SKYRIZI induction followed by the 360 mg maintenance regimen), respectively, had antibodies that were classified as neutralizing.
Carcinogenicity and mutagenicity studies have not been conducted with SKYRIZI.
No effects on male fertility parameters were observed in sexually mature male cynomolgus monkeys dosed weekly for 26 weeks with 50 mg/kg risankizumab-rzaa at 4 times the exposure (AUC) in humans administered the maximum recommended induction dose (1,200 mg) and 39 times the exposure in humans administered the maximum recommended maintenance dose (360 mg).
Adults with Moderate-to-Severe Plaque Psoriasis
Four multicenter, randomized, double-blind trials [PsO-1 (NCT02684370), PsO-2 (NCT02684357), PsO-3 (NCT02672852), and PsO-4 (NCT02694523)] enrolled 2,109 subjects 18 years of age and older with moderate-to-severe plaque psoriasis who had a body surface area (BSA) involvement of ≥10%, a static Physician’s Global Assessment (sPGA) score of ≥3 (“moderate”) in the overall assessment (plaque thickness/induration, erythema, and scaling) of psoriasis on a severity scale of 0 to 4, and a Psoriasis Area and Severity Index (PASI) score ≥12.
Overall, subjects had a median baseline PASI score of 17.8 and a median BSA of 20%. Baseline sPGA score was 4 (“severe”) in 19% of subjects. A total of 10% of trial subjects had a history of diagnosed psoriatic arthritis.
Across all trials, 38% of subjects had received prior phototherapy, 48% had received prior non-biologic systemic therapy, and 42% had received prior biologic therapy for the treatment of psoriasis.
Trials PsO-1 and PsO-2
In trials PsO-1 and PsO-2, 997 subjects were enrolled (including 598 subjects randomized to the SKYRIZI 150 mg group, 200 subjects randomized to the placebo group, and 199 to the biologic active control group). Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter.
Both trials assessed the responses at Week 16 compared with placebo for the two co-primary endpoints:
Secondary endpoints included the proportion of subjects who achieved PASI 100, sPGA 0, and Psoriasis Symptom Scale (PSS) 0 at Week 16.
The results are presented in Table 8.
| PsO-1 | PsO-2 | |||
| SKYRIZI (N=304) n (%) | Placebo (N=102) n (%) | SKYRIZI (N=294) n (%) | Placebo (N=98) n (%) | |
| sPGA 0 or 1 (“clear or almost clear”)a | 267 (88) | 8 (8) | 246 (84) | 5 (5) |
| PASI 90a | 229 (75) | 5 (5) | 220 (75) | 2 (2) |
| sPGA 0 (“clear”) | 112 (37) | 2 (2) | 150 (51) | 3 (3) |
| PASI 100 | 109 (36) | 0 (0) | 149 (51) | 2 (2) |
| a Co-primary endpoints | ||||
Examination of age, gender, race, body weight, baseline PASI score and previous treatment with systemic or biologic agents did not identify differences in response to SKYRIZI among these subgroups at Week 16.
In PsO-1 and PsO-2 at Week 52, subjects receiving SKYRIZI achieved sPGA 0 (58% and 60%, respectively), PASI 90 (82% and 81%, respectively), and PASI 100 (56% and 60%, respectively).
Patient Reported Outcomes
Improvements in signs and symptoms related to pain, redness, itching and burning at Week 16 compared to placebo were observed in both trials as assessed by the PSS. In PsO-1 and PsO-2, about 30% of the subjects who received SKYRIZI achieved PSS 0 (“none”) at Week 16 compared to 1% of the subjects who received placebo.
Trial PsO-3
Trial PsO-3 enrolled 507 subjects (407 randomized to SKYRIZI 150 mg and 100 to placebo). Subjects received treatment at Weeks 0, 4, and every 12 weeks thereafter.
At Week 16, SKYRIZI was superior to placebo on the co-primary endpoints of sPGA 0 or 1 (84% SKYRIZI and 7% placebo) and PASI 90 (73% SKYRIZI and 2% placebo). The respective response rates for SKYRIZI and placebo at Week 16 were: sPGA 0 (46% SKYRIZI and 1% placebo); PASI 100 (47% SKYRIZI and 1% placebo); and PASI 75 (89% SKYRIZI and 8% placebo).
Maintenance and Durability of Response
In PsO-1 and PsO-2, among the subjects who received SKYRIZI and had PASI 100 at Week 16, 80% (206/258) of the subjects who continued on SKYRIZI had PASI 100 at Week 52. For PASI 90 responders at Week 16, 88% (398/450) of the subjects had PASI 90 at Week 52.
In PsO-3, subjects who were originally on SKYRIZI and had sPGA 0 or 1 at Week 28 were re-randomized to continue SKYRIZI every 12 weeks or withdrawal of therapy. At Week 52, 87% (97/111) of the subjects re-randomized to continue treatment with SKYRIZI had sPGA 0 or 1 compared to 61% (138/225) who were re-randomized to withdrawal of SKYRIZI.
Moderate-to-Severe Plaque Psoriasis of the Scalp or Genital Area (Trial PsO-5)
The efficacy of SKYRIZI was assessed in a multicenter, randomized, double-blind, placebo-controlled trial [PsO-5 (NCT05969223)] that enrolled subjects 18 years of age and older with moderate-to-severe plaque psoriasis of the scalp (Trial S), defined as Psoriasis Scalp Severity Index (PSSI) ≥12, scalp Investigator Global Assessment (scalp IGA) ≥3 (“moderate”), and ≥30% of the scalp affected, or moderate-to-severe plaque psoriasis of the genital area (Trial G), defined as static Physician’s Global Assessment of Genitalia (sPGA-G) ≥3 (“moderate”) at baseline. All subjects had BSA ≥1% and sPGA ≥3 (“moderate”) at baseline.
In trial PsO-5, subjects were randomized to receive either SKYRIZI 150 mg or placebo subcutaneously at Weeks 0 and 4. Starting at Week 16, all subjects received SKYRIZI 150 mg every 12 weeks until the last dose at Week 40.
Plaque Psoriasis of the Scalp
PsO-5 Trial S enrolled 105 subjects with moderate-to-severe plaque psoriasis of the scalp. The median age of enrolled subjects at baseline was 44 years (range 20 to 83 years) and 10% of the subjects were 65 years of age and older. Fifty-six (56)% of the subjects were male, 83% were White, 8% were Black or African American, and 5% were Asian; for ethnicity, 36% of the subjects identified as Hispanic or Latino. At baseline, 74% of the subjects had moderate plaque psoriasis of the scalp (scalp IGA of 3) and 26% had severe plaque psoriasis of the scalp (scalp IGA of 4). Median baseline PSSI was 32. Baseline BSA involvement was ≥10% for 62% of the subjects and <10% for the remaining subjects. Median baseline BSA involvement was 11%. Baseline sPGA score was 4 (“severe”) in 24% of the subjects.
At baseline, 54% of subjects were naïve to both non-biologic systemic and biologic therapy, 0% of subjects had received prior phototherapy, 15% had received prior non-biologic systemic therapy, and 37% had received prior biologic therapy.
The results are presented in Table 9.
| Endpoint | SKYRIZI (N=51) n (%) | Placebo (N=54) n (%) | Treatment Difference (95% CI) |
| scalp IGA of 0 or 1 (“clear or almost clear”)a | 31 (61) | 7 (13) | 47 (31, 63) |
| PSSI 90b | 27 (53) | 7 (13) | 40 (24, 55) |
| PSSI 100c | 23 (45) | 7 (13) | 31 (15, 47) |
| a Primary endpoint b Achievement of ≥90% improvement from baseline in PSSI c Achievement of 100% improvement from baseline in PSSI | |||
Plaque Psoriasis of the Genital Area
PsO-5 Trial G enrolled 109 subjects with moderate-to-severe plaque psoriasis of the genital area. The median age of enrolled subjects at baseline was 45 years (range 19 to 77 years) and 15% of the subjects were 65 years of age and older. Sixty-five (65)% of the subjects were male, 90% were White, 4% were Asian, and 2% were Black or African American; for ethnicity, 29% of the subjects identified as Hispanic or Latino. At baseline, 62% of the subjects had moderate plaque psoriasis of the genital area (sPGA-G of 3) and 38% had severe or very severe plaque psoriasis of the genital area (sPGA-G of 4 or 5). Baseline BSA involvement was ≥10% for 63% of the subjects and <10% for the remaining subjects. Median baseline BSA involvement was 11%. Baseline sPGA score was 4 (“severe”) in 19% of the subjects.
At baseline, 61% of subjects were naïve to both non-biologic systemic and biologic therapy, 3% of subjects had received prior phototherapy, 17% had received prior non-biologic systemic therapy, and 26% had received prior biologic therapy.
The results are presented in Table 10.
| Endpoint | SKYRIZI (N=55) n (%) | Placebo (N=54) n (%) | Treatment Difference (95% CI) |
| sPGA-G of 0 or 1 (“clear or minimal”)a | 38 (69) | 7 (13) | 57 (42, 72) |
| sPGA-G of 0 (“clear”) | 28 (51) | 3 (6) | 47 (33, 61) |
| GPI-NRS reduction of ≥4-point from baselineb | N=41 20 (49) | N=45 3 (7) | 43 (27, 59) |
| GenPs-SFQ item 2 score of 0 (never) or 1 (rarely)c,d | N=31 22 (71) | N=32 7 (22) | 46 (27, 66) |
| a Primary endpoint b Improvement of genital itch severity as measured by a reduction of at least 4 points in the 11-point Genital Psoriasis Itch (GPI) Numeric Rating Scale (NRS) from the Genital Psoriasis Symptom Scale (GPSS) among subjects with baseline score ≥4 c Genital Psoriasis Sexual Frequency Questionnaire (GenPs-SFQ) Item 2 (In the past week, how often did your genital psoriasis limit the frequency of your sexual activity?) score ranges from 0 to 4 (0 = never, 1 = rarely, 2 = sometimes, 3 = often, 4 = always); where higher scores indicate greater limitations on the frequency of sexual activity in the past week d Among subjects with baseline score ≥2 | |||
Pediatric Subjects with Moderate-to-Severe Plaque Psoriasis
The safety and efficacy of SKYRIZI were assessed in a four-part trial [PsO-6 (NCT04435600)] [see Use in Specific Populations ( 8.4 ) ]. The trial included a randomized, efficacy assessor-blinded, active treatment-controlled cohort of 82 pediatric subjects 12 years of age and older with moderate-to-severe plaque psoriasis defined as BSA involvement of ≥10% with sPGA score of ≥3 or a PASI score ≥12.
Subjects were randomized 2:1 to receive SKYRIZI (N = 54) or ustekinumab (N = 28). Subjects weighing 40 kg or greater received SKYRIZI 150 mg and subjects weighing less than 40 kg received SKYRIZI 55 mg at Week 0, Week 4, and every 12 weeks thereafter.
Fifty-six (56)% of subjects were female, 83% were White, 10% were Asian, and 5% were Black or African American; for ethnicity, 17% of subjects identified as Hispanic or Latino. At baseline, 82% of subjects had a sPGA score of 3 (“moderate”) and 9% of subjects had a sPGA score of 4 (“severe”). Subjects had a median baseline PASI score of 15.7, and a median baseline BSA of 18%. A total of 4% of subjects had received prior biologic therapy.
The co-primary endpoints were sPGA score of 0 (“clear”) or 1 (“almost clear”) and at least a 2-point improvement from baseline, and PASI 75 at Week 16. The duration of treatment was up to 68 weeks.
The efficacy results are presented below (see Table 11).
| SKYRIZI (N = 54) n (%) | |
| sPGA 0 or 1 (“clear or almost clear”)a,b | 37 (69) |
| PASI 75a | 46 (85) |
| PASI 90 | 35 (65) |
| PASI 100 | 22 (41) |
| sPGA 0 (“clear”) | 22 (41) |
| aco-primary endpoints band at least a 2-point improvement from baseline at Week 16 | |
Maintenance of Response
Subjects originally treated with SKYRIZI who achieved sPGA of 0 or 1 at Week 16 were re-randomized to continue SKYRIZI every 12 weeks through Week 52 or were withdrawn from treatment. For subjects who were re-randomized and also had at least a 2-point improvement in sPGA from baseline at Week 16, 95% (18/19) of the subjects continuing SKYRIZI had sPGA of 0 or 1 and at least a 2-point improvement from baseline at Week 52 compared with 39% (7/18) for those withdrawn from SKYRIZI.
The safety and efficacy of SKYRIZI were assessed in 1407 subjects in 2 randomized, double-blind, placebo-controlled trials (964 in PsA-1 [NCT03675308] and 443 in PsA-2 [NCT03671148]) in subjects 18 years and older with active psoriatic arthritis (PsA).
Subjects in these trials had a diagnosis of PsA for at least 6 months based on the Classification Criteria for Psoriatic Arthritis (CASPAR), a median duration of PsA of 4.9 years at baseline, ≥ 5 tender joints and ≥5 swollen joints, and active plaque psoriasis or psoriatic nail disease at baseline. Regarding baseline clinical presentation, 55.9% of subjects had ≥3% BSA with active plaque psoriasis; 63.4% and 27.9% of subjects had enthesitis and dactylitis, respectively. In PsA-1 where psoriatic nail disease was further assessed, 67.3% had psoriatic nail disease.
In PsA-1, all subjects had a previous inadequate response or intolerance to non-biologic DMARD therapy and were biologic naïve. In PsA-2, 53.5% of subjects had a previous inadequate response or intolerance to non-biologic DMARD therapy, and 46.5% of subjects had a previous inadequate response or intolerance to biologic therapy.
In both trials, subjects were randomized to receive SKYRIZI 150 mg or placebo at Weeks 0, 4, and 16. Starting from Week 28, all subjects received SKYRIZI every 12 weeks. Both trials included a long-term extension for up to an additional 204 weeks. Regarding use of concomitant medications, 59.6% of subjects were receiving concomitant methotrexate (MTX), 11.6% were receiving concomitant non-biologic DMARDs other than MTX, and 28.9% were receiving SKYRIZI monotherapy.
For both trials, the primary endpoint was the proportion of subjects who achieved an American College of Rheumatology (ACR) 20 response at Week 24.
Clinical Response
In both trials, treatment with SKYRIZI resulted in significant improvement in measures of disease activity compared with placebo at Week 24. See Tables 12 and 13 for key efficacy results.
In both trials, similar responses were seen regardless of concomitant non-biologic DMARD use, number of prior non-biologic DMARDs, age, gender, race, and BMI. In PsA-2, responses were seen regardless of prior biologic therapy.
| Endpoint | Placebo N=481 Response Rate | SKYRIZI N=483 Response Rate | Difference from Placebo (95% CI) |
| ACR20 Response* | |||
| Week 16 | 33.4% | 56.3%a | 23.1% (16.8, 29.4) |
| Week 24 | 33.5% | 57.3%a | 24% (18, 30) |
| ACR50 Response* | |||
| Week 16 | 11.1% | 26.4% | 15.4% (10.6, 20.2) |
| Week 24 | 11.3% | 33.4 % | 22.2% (17.3, 27.2) |
| ACR70 Response* | |||
| Week 16 | 2.7% | 11.8% | 9.2% (6.1, 12.4) |
| Week 24 | 4.7% | 15.3% | 10.5% (6.9, 14.2) |
| a. multiplicity-controlled p≤0.001, SKYRIZI vs. placebo comparison. *A Subject was considered as a non-responder after initiation of rescue medication or concomitant medications for PsA that could meaningfully impact efficacy assessment. | |||
| Endpoint | Placebo N=219 Response Rate | SKYRIZI N=224 Response Rate | Difference from Placebo (95% CI) |
| ACR20 Response* | |||
| Week 16 | 25.3% | 48.3% a | 22.6% (13.9, 31.2) |
| Week 24 | 26.5% | 51.3% a | 24.5% (15.9, 33) |
| ACR50 Response* | |||
| Week 16 | 6.8% | 20.3% | 13.5% (7.3, 19.7) |
| Week 24 | 9.3% | 26.3% | 16.6% (9.7, 23.6) |
| ACR70 Response* | |||
| Week 16 | 3.4% | 11.2% | 7.8% (3, 12.6) |
| Week 24 | 5.9% | 12% | 6% (0.8, 11.3) |
| a. multiplicity-controlled p≤0.001, SKYRIZI vs. placebo comparison. *A Subject was considered as a non-responder after initiation of rescue medication or concomitant medications for PsA that could meaningfully impact efficacy assessment. | |||
The percent of subjects achieving ACR20 responses in trial PsA-1 through Week 24 is shown in Figure 1.
Figure 1. Percent of Adult Subjects with Active Psoriatic Arthritis Achieving ACR20 Responses in Trial PsA-1 through Week 24
The results of the components of the ACR response criteria for both trials are shown in Table 14.
| PsA-1 | PsA-2 | |||
| Placebo (N=481) Mean (SD) | SKYRIZI (N=483) Mean (SD) | Placebo (N=219) Mean (SD) | SKYRIZI (N=224) Mean (SD) | |
| Number of Swollen Joints (0-66) | ||||
| Baseline | 12.2 (8) | 12.1 (7.8) | 13.6 (9) | 13 (8.7) |
| Mean change at Week 16 | -5.5 (7) | -7.7 (7.2) | -5.4 (8.5) | -8 (7.4) |
| Mean change at Week 24 | -6.7 (7.2) | -8.7 (7.2) | -6.5 (7.8) | -9.1 (7.6) |
| Number of Tender Joints (0-68) | ||||
| Baseline | 20.5 (12.8) | 20.8 (14) | 22.3 (13.8) | 22.8 (14.9) |
| Mean change at Week 16 | -6.3 (11.1) | -10.7 (11.4) | -6 (13.1) | -11.3 (13) |
| Mean change at Week 24 | -7.9 (10.7) | -12 (12.3) | -8.3 (11.3) | -13 (12.5) |
| Patient’s Assessment of Paina | ||||
| Baseline | 57.1 (22.6) | 57.1 (22.6) | 57 (23.1) | 55 (23.5) |
| Mean change at Week 16 | -8.6 (23.7) | -18.4 (26.3) | -5.7 (22.7) | -14.4 (26.4) |
| Mean change at Week 24 | -10.9 (25.4) | -21.4 (26.5) | -8.7 (25.3) | -15.3 (26.5) |
| Patient’s Global Assessmenta | ||||
| Baseline | 57.4 (22.1) | 57.9 (21.7) | 56.2 (23) | 56.2 (21.8) |
| Mean change at Week 16 | -10.2 (23.9) | -19.4 (25.7) | -4.9 (23.6) | -17 (27.1) |
| Mean change at Week 24 | -11.1 (25.1) | -22.6 (26.9) | -8.7 (25.4) | -17.7 (27.7) |
| Physician Global Assessmenta | ||||
| Baseline | 62.4 (17) | 61.3 (17.6) | 60.7 (16.4) | 63 (17) |
| Mean change at Week 16 | -18.3 (22.5) | -31.1 (23.4) | -19 (23.3) | -32.7 (24.7) |
| Mean change at Week 24 | -22.2 (22.8) | -34.8 (23.2) | -21.3 (25.2) | -35.5 (25.6) |
| Health Assessment Questionnaire - Disability Index (HAQ-DI)b | ||||
| Baseline | 1.2 (0.7) | 1.2 (0.7) | 1.1 (0.6) | 1.1 (0.6) |
| Mean change at Week 16 | -0.1 (0.5) | -0.3 (0.5) | -0.1 (0.5) | -0.2 (0.5) |
| Mean change at Week 24 | -0.1 (0.5) | -0.3 (0.5) | -0.1 (0.4) | -0.2 (0.5) |
| High sensitivity C-reactive protein (hs-CRP) mg/L | ||||
| Baseline | 11.3 (14.1) | 11.9 (15.9) | 8.2 (17.1) | 7.4 (10.9) |
| Mean change at Week 16 | -0.3 (14.7) | -4.8 (14.2) | -0.1 (6.8) | -2.1 (7.5) |
| Mean change at Week 24 | -0.2 (11.7) | -4.3 (12.8) | -0.5 (14.5) | -1.8 (13.4) |
| SD= Standard Deviation. a. Assessment based on Visual Analog Scale (100 mm) with the left end indicating “no pain” (for patient’s assessment of pain), “very well” (for patient global assessment), or “no arthritis activity” (for physician global assessment) and the right end indicating “the worst possible pain” (for patient assessment of pain), “poor” (for patient global assessment), or “extremely active arthritis” (for physician global assessment). b. Disability Index of the Health Assessment Questionnaire; 0 = no difficulty to 3 = inability to perform, measures the patient’s ability to perform the following: dressing, arising, eating, walking, hygiene, reaching, gripping, and activities of daily living. | ||||
Treatment with SKYRIZI resulted in improvement in dactylitis and enthesitis in subjects with pre-existing dactylitis or enthesitis.
In patients with coexistent plaque psoriasis receiving SKYRIZI, the skin lesions of psoriasis improved with treatment, relative to placebo, as measured by the Psoriasis Area Severity Index (PASI 90) at Week 24.
Physical Function
In both trials, patients treated with SKYRIZI showed statistically significant improvement from baseline in physical function compared with placebo as assessed by HAQ-DI at Week 24 (Table 14). The mean difference (95% CI) from placebo in HAQ-DI change from baseline at Week 24 was -0.20 (-0.26, -0.14) in trial PsA-1 and -0.16 (-0.26, -0.07) in trial PsA-2.
In both trials, a greater proportion of subjects achieved a reduction of at least 0.35 in HAQ-DI score from baseline in the SKYRIZI group compared with placebo at Week 24.
Other Health Related Outcomes
In both trials, general health status was assessed by the 36-Item Short Form Health Survey (SF-36 V2). Fatigue was assessed by Functional Assessment of Chronic Illness Therapy Fatigue Scale (FACIT-Fatigue).
In both trials at Week 24, subjects treated with SKYRIZI showed improvements in the SF-36 physical component summary scores compared with subjects who received placebo. There were also numerical improvements in subjects treated with SKYRIZI in physical functioning, role physical, bodily pain, general health, vitality, social functioning, mental health, role emotional domain scores and mental component summary scores in both trials at week 24 compared to placebo. In both trials at Week 24, subjects treated with SKYRIZI showed improvements in FACIT-Fatigue scores compared with subjects who received placebo.
Induction Trials (Trials CD-1 and CD-2)
In two 12-week induction trials (CD-1; NCT03105128 and CD-2; NCT03104413), subjects with moderately to severely active Crohn’s disease were randomized to receive SKYRIZI 600 mg, SKYRIZI 1,200 mg, or placebo as an intravenous infusion at Week 0, Week 4, and Week 8. Moderately to severely active CD was defined as a Crohn’s Disease Activity Index (CDAI) of 220 to 450 and Simple Endoscopic Score for Crohn’s disease (SES-CD) ≥6 (or ≥4 for isolated ileal disease). Subjects with inadequate response, loss of response, or intolerance to oral aminosalicylates, corticosteroids, immunosuppressants, and/or biologic therapy were enrolled.
At baseline, the median CDAI was 307 (range: 76 – 634) and 307 (range: 72 – 651), and the median SES-CD was 12 (range: 4 – 45) and 13 (range 4 – 40), in CD-1 and CD-2, respectively. In CD-1, 58% (491/850) of subjects had failed or were intolerant to treatment with one or more biologic therapies (prior biologic failure). All subjects in CD-2 had prior biologic failure. At baseline, 30% and 34% of patients were receiving corticosteroids, 24% and 23% of patients were receiving immunomodulators (azathioprine, 6-mercaptopurine, methotrexate), and 31% and 19% of patients were receiving aminosalicylates in CD-1 and CD-2, respectively. In CD-1 and CD-2 combined, the median age was 36 years (ranging from 16 to 80 years), 81% (1145/1419) of subjects were white, and 53% (753/1419) were male.
In CD-1 and CD-2, the co-primary endpoints were clinical remission and endoscopic response at Week 12. Secondary endpoints included clinical response and endoscopic remission (see Table 15 and Table 16). The SKYRIZI 1,200 mg dosage did not demonstrate additional treatment benefit over the 600 mg dosage and is not a recommended regimen [see Dosage and Administration ( 2.6 )].
| Endpoint | Placebo | SKYRIZI 600 mg Intravenous Infusiona | Treatment Differenceb (95% CI) |
| Clinical Remissionc,d | |||
| Total Population | N=175 25% | N=336 45% | 21%e
(12%, 29%) |
| Prior biologic failuref | N=97 26% | N=195 42% | |
| Without prior biologic failure | N=78 23% | N=141 49% | |
| Endoscopic Responsec,g | |||
| Total Population | N=175 12% | N=336 40% | 28%e
(21%, 35%) |
| Prior biologic failuref | N=97 11% | N=195 33% | |
| Without prior biologic failure | N=78 13% | N=141 50% | |
| Clinical Responseh | |||
| Total Population | N=175 37% | N=336 60% | 23%e
(14%, 32%) |
| Prior biologic failuref | N=97 34% | N=195 58% | |
| Without prior biologic failure | N=78 40% | N=141 62% | |
| Endoscopic Remissioni | |||
| Total Population | N=175 9% | N=336 24% | 15%e
(9%, 21%) |
| Prior biologic failuref | N=97 5% | N=195 18% | |
| Without prior biologic failure | N=78 14% | N=141 32% | |
| a. SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8 b. Adjusted treatment difference (95% CI) based on Cochran-Mantel-Haenszel method adjusted for randomization stratification factors c. Co-primary endpoints d. CDAI <150 e. p <0.001 f. Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologic treatments for CD g. A decrease in SES-CD > 50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading h. A reduction of CDAI ≥ 100 points from baseline i. SES-CD ≤ 4 and at least a 2-point reduction from baseline, with no individual subscore greater than 1, based on central reading | |||
| Endpoint | Placebo N=187 | SKYRIZI 600 mg Intravenous Infusionb N=191 | Treatment Differencec (95% CI) |
| Clinical Remissiond,e | 20% | 42% | 22%f
(13%, 31%) |
| Endoscopic Responsed,g | 11% | 29% | 18%f
(10%, 25%) |
| Clinical Responseh | 30% | 60% | 29%f
(20%, 39%) |
| Endoscopic Remissioni | 4% | 19% | 15%f
(9%, 21%) |
| a. All subjects enrolled in CD-2 had prior biologic failure. Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologic treatments for CD b. SKYRIZI 600 mg as an intravenous infusion at Week 0, Week 4, and Week 8 c. Adjusted treatment difference (95% CI) based on Cochran-Mantel-Haenszel method adjusted for randomization stratification factors d. Co-primary endpoints e. CDAI score <150 f. p < 0.001 g. A decrease in SES-CD > 50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading h. A reduction of CDAI ≥ 100 points from baseline i. SES-CD ≤ 4 and at least a 2-point reduction versus from baseline, with and no individual subscore greater than 1, based on central reading | |||
Onset of clinical response and clinical remission based on CDAI occurred as early as Week 4 in a greater proportion of subjects treated with the SKYRIZI 600 mg induction regimen compared to placebo.
Reductions in stool frequency and abdominal pain were observed in a greater proportion of subjects treated with the SKYRIZI 600 mg induction regimen compared to placebo at Week 12.
Trial CD-3
The maintenance trial CD-3 evaluated 382 subjects who achieved clinical response defined as a reduction in CDAI of at least 100 points from baseline after 12 weeks of induction treatment with intravenous SKYRIZI in trials CD-1 and CD-2. Subjects were randomized to receive a maintenance regimen of SKYRIZI 180 mg or SKYRIZI 360 mg or placebo at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks.
The co-primary endpoints in CD-3 were clinical remission and endoscopic response at Week 52 (see Table 17).
| Endpoint | Placeboa | SKYRIZI 180 mg Subcutaneous Injectionb | SKYRIZI 360 mg Subcutaneous Injectionc | Treatment Difference vs Placebod (95% CI) | ||
| SKYRIZI 180 mg | SKYRIZI 360 mg | |||||
| Clinical Remissione,f | ||||||
| Total Population | N=130 46% | N=135 61% | N=117 57% | 17%g
(6%, 28%) | 14%g
(3%, 26%) | |
| Prior biologic failureh | N=99 40% | N=95 56% | N=83 51% | |||
| Without prior biologic failure | N=31 65% | N=40 75% | N=34 71% | |||
| Endoscopic Responsee,i | ||||||
| Total Population | N=130 22% | N=135 50% | N=117 48% | 30%g
(20%, 39%) | 31%g
(21%, 41%) | |
| Prior biologic failureh | N=99 21% | N=95 44% | N=83 44% | |||
| Without prior biologic failure | N=31 23% | N=40 65% | N=34 59% | |||
| a. The placebo group consisted of patients who were in response to SKYRIZI and were randomized to receive placebo at the start of maintenance therapy. b. SKYRIZI 180 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks c. SKYRIZI 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks d. Adjusted treatment difference and 95% CI computed using Cochran-Mantel-Haenszel method adjusted for randomization stratification factors e. Co-primary endpoints f. CDAI <150 g. p <0.05 h. Prior biologic failure includes inadequate response, loss of response, or intolerance to one or more biologic treatments for CD i. A decrease in SES-CD > 50% from baseline, or a decrease of at least 2 points for subjects with a baseline score of 4 and isolated ileal disease, based on central reading | ||||||
Endoscopic remission was observed at Week 52 in 33% (44/135) of subjects treated with the SKYRIZI 180 mg maintenance regimen and 41% (48/117) of subjects treated with the SKYRIZI 360 mg maintenance regimen, compared to 13% (17/130) of subjects treated with placebo. This endpoint was not statistically significant under the prespecified multiple testing procedure.
Induction Trial (Trial UC-1)
In the 12-week induction trial (UC-1; NCT03398148), 966 subjects with moderately to severely active ulcerative colitis were randomized and received SKYRIZI 1,200 mg or placebo as an intravenous infusion at Week 0, Week 4, and Week 8. Disease activity was assessed by the modified Mayo score (mMS), a 3-component Mayo score (0-9) which consists of the following subscores (0 to 3 for each subscore): stool frequency (SFS), rectal bleeding (RBS), and findings on centrally read endoscopy score (ES). An ES of 2 was defined by marked erythema, lack of vascular pattern, any friability, and/or erosions; an ES of 3 was defined by spontaneous bleeding and ulceration. Enrolled subjects had a mMS between 5 and 9, with an ES of 2 or 3. Subjects with inadequate response, or intolerance to oral aminosalicylates, corticosteroids, immunomodulators, biologics, Janus Kinase inhibitors (JAKi), and/or sphingosine-1-phosphate receptor modulators (S1PRM) were enrolled.
At baseline in UC-1, the median mMS was 7; 37% had severely active disease (mMS >7); 69% had an ES of 3. In UC-1, 52% (499/966) of subjects had failed (inadequate response or intolerance) treatment with one or more biologics, JAKi or S1PRM. Of these 499 subjects, 484 (97%) failed biologics and 90 (18%) failed JAK inhibitors. Enrolled subjects were permitted to use a stable dose of oral corticosteroids (up to 20 mg/day prednisone or equivalent), immunomodulators, and aminosalicylates. At baseline, 36% of subjects were receiving corticosteroids, 16% of subjects were receiving immunomodulators (including azathioprine, 6-mercaptopurine, methotrexate), and 73% of subjects were receiving aminosalicylates in UC-1.
In UC-1, the primary endpoint was clinical remission defined using the mMS at Week 12 (see Table 18). Key secondary endpoints included clinical response, endoscopic improvement, and histologic endoscopic mucosal improvement (see Table 18).
| Endpoint | Placebo | SKYRIZI 1,200 mg Intravenous Infusiona | Treatment Difference (95% CI)b |
| Clinical Remissionc | |||
| Total Population | N=320 8% | N=646 24% | 16%h
(12%, 20%) |
| Prior biologic, JAKi, or S1PRM failured | N=168 6% | N=331 14% | |
| Without prior biologic, JAKi, or S1PRM failure | N=152 9% | N=315 33% | |
| Clinical Responsee | |||
| Total Population | N=320 36% | N=646 65% | 29%h
(23%, 35%) |
| Prior biologic, JAKi, or S1PRM failured | N=168 32% | N=331 56% | |
| Without prior biologic, JAKi, or S1PRM failure | N=152 41% | N=315 75% | |
| Endoscopic Improvementf | |||
| Total Population | N=320 12% | N=646 36% | 25%h
(20%, 30%) |
| Prior biologic, JAKi, or S1PRM failured | N=168 10% | N=331 26% | |
| Without prior biologic, JAKi, or S1PRM failure | N=152 14% | N=315 47% | |
| Histologic Endoscopic Mucosal Improvement (HEMI)g | |||
| Total Population | N=320 7% | N=646 24% | 17%h
(13%, 21%) |
| Prior biologic, JAKi, or S1PRM failured | N=168 7% | N=331 16% | |
| Without prior biologic, JAKi, or S1PRM failure | N=152 8% | N=315 33% | |
| a SKYRIZI 1,200 mg as an intravenous infusion at Week 0, Week 4, and Week 8 b Adjusted treatment difference (95% CI) based on Cochran-Mantel-Haenszel method adjusted for stratification factors c Per mMS: SFS ≤ 1 and not greater than baseline, RBS = 0, and ES ≤ 1 without friability d Prior failure includes inadequate response or intolerance to treatment with one or more of the following: biologic therapies, Janus Kinase inhibitors (JAKi), and/or sphingosine-1-phosphate receptor modulators (S1PRM) e Per mMS: decrease ≥ 2 points and ≥ 30% from baseline, and a decrease in RBS ≥ 1 from baseline or an absolute RBS ≤ 1 f ES ≤ 1 without the evidence of friability g ES ≤ 1 without the evidence of friability and Geboes score ≤ 3.1 (indicating neutrophil infiltration in <5% of crypts, no crypt destruction and no erosions, ulcerations or granulation tissue) h p < 0.001 | |||
UC-1 was not designed to evaluate the relationship of histologic endoscopic mucosal improvement at week 12 to disease progression and long-term outcomes.
Rectal Bleeding and Stool Frequency Subscores
Decreases in rectal bleeding and stool frequency subscores in subjects treated with SKYRIZI compared to placebo were observed as early as 4 weeks.
Endoscopic Assessment
Endoscopic remission was defined as ES of 0. At Week 12, a greater proportion of subjects treated with SKYRIZI compared to placebo achieved endoscopic remission (11% vs 3%).
Bowel Urgency
A greater proportion of subjects treated with the SKYRIZI 1,200 mg induction regimen compared to placebo had no bowel urgency (44% vs 27%) at Week 12.
Fatigue
In UC-1, subjects treated with SKYRIZI experienced a clinically meaningful improvement in fatigue, assessed by change from baseline in FACIT-F score, at Week 12, compared to placebo-treated subjects. The effect of SKYRIZI to improve fatigue after 12 weeks of induction has not been established.
Other UC Symptoms
The proportion of subjects who had no nocturnal bowel movements was greater in subjects treated with SKYRIZI compared to placebo at Week 12 (67% vs 43%).
Maintenance Trial UC-2
The maintenance trial (UC-2; NCT03398135) evaluated 547 subjects who received one of three SKYRIZI induction regimens, including the 1,200 mg regimen, for 12 weeks in Trials UC-1 or UC-3 and demonstrated clinical response per mMS after 12 weeks. Subjects were randomized to receive a maintenance regimen of subcutaneous (SC) SKYRIZI 180 mg or SKYRIZI 360 mg or placebo at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks.
In UC-2, 75% (411/547) of subjects had failed (inadequate response or intolerance) treatment with one or more biologics, JAKi, or S1PRM. Of these 411 subjects, 407 (99%) failed biologics and 78 (19%) failed JAK inhibitors.
The primary endpoint in UC-2 was clinical remission using mMS at Week 52 (see Table 19). Key secondary endpoints included corticosteroid-free clinical remission, endoscopic improvement, and histologic endoscopic mucosal improvement (see Table 19).
| Endpoint | Placeboa | SKYRIZI 180 mg SC Injectionb | SKYRIZI 360 mg SC Injectionc |
| Clinical remissiond | |||
| Total Population | N=182 26% | N=179 45% | N=186 41% |
| Treatment Difference vs Placeboe (95% CI) | 20%
j
[11%, 29%] | 16% j
[7%, 25%] | |
| Prior biologic, JAKi, or S1PRM failuref | N=138 24% | N=134 41% | N=139 32% |
| Without prior biologic, JAKi, or S1PRM failure | N=44 32% | N=45 58% | N=47 67% |
| Corticosteroid-free clinical remissiong | |||
| Total Population | N=182 26% | N=179 45% | N=186 40% |
| Treatment Difference vs Placeboe (95% CI) | 20% j
[11%, 29%] | 16%j
[7%, 25%] | |
| Prior biologic, JAKi, or S1PRM failuref | N=138 24% | N=134 40% | N=139 32% |
| Without prior biologic, JAKi, or S1PRM failure | N=44 32% | N=45 58% | N=47 64% |
| Endoscopic improvementh | |||
| Total Population | N=182 31% | N=179 51% | N=186 48% |
| Treatment Difference vs Placeboe (95% CI) | 20%
j
[11%, 30%] | 18%
j
[8%, 27%] | |
| Prior biologic, JAKi, or S1PRM failuref | N=138 30% | N=134 48% | N=139 39% |
| Without prior biologic, JAKi, or S1PRM failure | N=44 34% | N=45 60% | N=47 76% |
| Histologic Endoscopic Mucosal Improvementi | |||
| Total Population | N=182 24% | N=179 43% | N=186 42% |
| Treatment Difference vs Placeboe (95% CI) | 20% j
[11%, 29%] | 20% j
[11%, 29%] | |
| Prior biologic, JAKi, or S1PRM failuref | N=138 22% | N=134 39% | N=139 33% |
| Without prior biologic, JAKi, or S1PRM failure | N=44 30% | N=45 55% | N=47 69% |
| a The placebo group consisted of subjects who were in response to 12 weeks of SKYRIZI induction and were randomized to receive placebo at the start of maintenance therapy. b SKYRIZI 180 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks c SKYRIZI 360 mg at Week 12 and every 8 weeks thereafter for up to an additional 52 weeks d Per mMS: SFS ≤ 1 and not greater than baseline, RBS = 0, and ES ≤ 1 without friability e Adjusted treatment difference (95% CI) based on Cochran-Mantel-Haenszel method adjusted for stratification factors f Prior failure includes inadequate response or intolerance to treatment with one or more of the following: biologic therapies, Janus Kinase inhibitors (JAKi), and/or sphingosine-1-phosphate receptor modulators (S1PRM) g Clinical remission per mMS at Week 52 and corticosteroid-free for ≥90 days h ES ≤ 1 without the evidence of friability i ES ≤ 1without the evidence of friability and Geboes score ≤ 3.1 (indicating neutrophil infiltration in <5% of crypts, no crypt destruction and no erosions, ulcerations or granulation tissue) j p < 0.001 | |||
Endoscopic Assessment
Endoscopic remission was defined as ES of 0. In UC-2, a greater proportion of subjects treated with SKYRIZI 180 mg and SKYRIZI 360 mg compared to placebo achieved endoscopic remission at Week 52 (23% and 24% vs 15%).
How Supplied
SKYRIZI (risankizumab-rzaa) injection is supplied in the following strengths and packaging units:
| Strength | Packaging Unit | NDC |
| Subcutaneous Injection | ||
| 150 mg/mL single-dose pen | Carton of 1 | 0074-2100-01 |
| 55 mg/0.37 mL single-dose prefilled syringe | Carton of 1 | 0074-4059-01 |
| 90 mg/mL single-dose prefilled syringe | Carton of 2 | 0074-7040-02 |
| Carton of 4 | 0074-7042-04 | |
| 180 mg/1.2 mL (150 mg/mL) single-dose prefilled syringe | Carton of 1 | 0074-8300-01 |
| Carton of 2 | 0074-8350-01 | |
| 150 mg/mL single-dose prefilled syringe | Carton of 1 | 0074-1050-01 |
| 180 mg/1.2 mL (150 mg/mL) single-dose prefilled cartridge with on-body injector | Kit | 0074-1065-01 |
| 360 mg/2.4 mL (150 mg/mL) single-dose prefilled cartridge with on-body injector | Kit | 0074-1070-01 |
| Intravenous Infusion | ||
| 600 mg/10 mL (60 mg/mL) single-dose vial | Carton of 1 | 0074-5015-01 |
Subcutaneous Injection
Intravenous Infusion
SKYRIZI 600 mg/10 mL (60 mg/mL) vial contains a sterile and preservative-free, colorless to slightly yellow, and clear to slightly opalescent solution. Each glass vial is closed with a stopper and blue flip cap.
Storage and Handling
Advise patients and/or caregivers to read the FDA-approved patient labeling (Medication Guide and Instructions for Use).
Hypersensitivity Reactions
Advise patients to discontinue SKYRIZI and seek immediate medical attention if they experience any symptoms of serious hypersensitivity reactions [see Warnings and Precautions ( 5.1 )].
Infections
Inform patients that SKYRIZI may lower the ability of their immune system to fight infections. Instruct patients of the importance of communicating any history of infections to the healthcare provider and contacting their healthcare provider if they develop any symptoms of an infection [see Warnings and Precautions ( 5.2 )].
Hepatotoxicity
Inform patients that SKYRIZI may cause liver injury, especially during the initial 12 weeks of treatment. Instruct patients to seek immediate medical attention if they experience symptoms suggestive of liver dysfunction (e.g., unexplained rash, nausea, vomiting, abdominal pain, fatigue, anorexia, or jaundice and/or dark urine) [see Warnings and Precautions ( 5.4 )] .
Immunizations
Advise patients that vaccination with live vaccines is not recommended during SKYRIZI treatment and immediately prior to or after SKYRIZI treatment. Medications that interact with the immune system may increase the risk of infection following administration of live vaccines. Instruct patients to inform the healthcare practitioner that they are taking SKYRIZI prior to a potential vaccination [see Warnings and Precautions ( 5.5 ) ].
Administration Instruction
Instruct patients or caregivers to perform the first self-injected dose under the supervision and guidance of a qualified healthcare professional for training in preparation and administration of SKYRIZI, including choosing anatomical sites for administration, and proper subcutaneous injection technique [see Dosage and Administration ( 2.5 )].
For pediatric patients, inform patients and caregivers that for pediatric patients 10 years of age and older, it is recommended that SKYRIZI be administered by or under supervision of an adult. For pediatric patients 6 to less than 10 years of age, SKYRIZI should be administered by an adult [see Dosage and Administration ( 2.5 )].
If using SKYRIZI 90 mg/mL, instruct patients or caregivers to administer two 90 mg single-dose syringes to achieve the full 180 mg maintenance dose or four 90 mg single-dose syringes to achieve the full 360 mg maintenance dose of SKYRIZI for Crohn’s disease or ulcerative colitis [see Instructions for Use ].
If using SKYRIZI 180 mg/1.2 mL, instruct patients or caregivers to administer one 180 mg single-dose syringe to achieve the full 180 mg maintenance dose or two 180 mg single-dose syringes to achieve the full 360 mg maintenance dose of SKYRIZI for Crohn’s disease or ulcerative colitis [see Instructions for Use ].
Instruct patients or caregivers in the technique of pen or syringe disposal [see Instructions for Use ].
Pregnancy
Advise patients that there is a pregnancy registry that monitors pregnancy outcomes in women exposed to SKYRIZI during pregnancy [see Use in Specific Populations ( 8.1 ) ].
Manufactured by:
AbbVie Inc.
North Chicago, IL 60064, USA
US License Number 1889
SKYRIZI and its design are trademarks of AbbVie Biotechnology Ltd.
© 2026 AbbVie. All rights reserved.
20101630 6/2026
| Medication Guide SKYRIZI® (sky-RIZZ-ee) (risankizumab-rzaa) injection, for subcutaneous or intravenous use | |||||||
| What is the most important information I should know about SKYRIZI? SKYRIZI may cause serious side effects, including: Serious allergic reactions. Stop using SKYRIZI and get emergency medical help right away if you get any of the following symptoms of a serious allergic reaction: | |||||||
| ● fainting, dizziness, feeling lightheaded (low blood pressure) | ● chest tightness | ||||||
| ● swelling of your face, eyelids, lips, mouth, tongue, or throat | ● skin rash, hives | ||||||
| ● trouble breathing or throat tightness | ● itching | ||||||
| Infections. SKYRIZI may lower the ability of your immune system to fight infections and may increase your risk of infections. Your healthcare provider should check you for infections and tuberculosis (TB) before starting treatment with SKYRIZI and may treat you for TB before you begin treatment with SKYRIZI if you have a history of TB or have active TB. Your healthcare provider should watch you closely for signs and symptoms of TB during and after treatment with SKYRIZI. Tell your healthcare provider right away if you have an infection or have symptoms of an infection, including: | |||||||
| ● fever, sweats, or chills | ● muscle aches | ● weight loss | |||||
| ● cough | ● warm, red, or painful skin or sores on your body different from your psoriasis | ● diarrhea or stomach pain | |||||
| ● shortness of breath | ● burning when you urinate or urinating more often than normal | ||||||
| ● blood in your mucus (phlegm) | |||||||
| See “What are the possible side effects of SKYRIZI?” for more information about side effects. | |||||||
| What is SKYRIZI? SKYRIZI is a prescription medicine used to treat:
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| Who should not use SKYRIZI? Do not use SKYRIZI if you are allergic to risankizumab-rzaa or any of the ingredients in SKYRIZI. See the end of this Medication Guide for a complete list of ingredients in SKYRIZI. | |||||||
Before using SKYRIZI, tell your healthcare provider about all of your medical conditions, including if you:
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| How should I use SKYRIZI? See the detailed “Instructions for Use” that comes with SKYRIZI for information on how to prepare and inject a dose of SKYRIZI, and how to properly throw away (dispose of) a used SKYRIZI prefilled pen, prefilled syringe, or prefilled cartridge with on-body injector.
Adults with moderately to severely active Crohn’s disease or moderately to severely active ulcerative colitis will receive their starter doses with SKYRIZI through a vein in the arm (intravenous infusion) in a healthcare facility by a healthcare provider. After completing the starter doses, patients will receive SKYRIZI as 1 or more injections under the skin (subcutaneous injection) using the prefilled cartridge with on-body injector or prefilled syringe. | |||||||
| What are the possible side effects of SKYRIZI? SKYRIZI may cause serious side effects including:
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| The most common side effects of SKYRIZI in people treated for Crohn’s disease and ulcerative colitis include: | |||||||
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| The most common side effects of SKYRIZI in people treated for plaque psoriasis and psoriatic arthritis include: | |||||||
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| These are not all the possible side effects of SKYRIZI. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | |||||||
How should I store SKYRIZI?
| |||||||
| General information about the safe and effective use of SKYRIZI. Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use SKYRIZI for a condition for which it was not prescribed. Do not give SKYRIZI to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about SKYRIZI that is written for health professionals. | |||||||
| What are the ingredients in SKYRIZI? Active ingredient: risankizumab-rzaa. SKYRIZI 90 mg/mL prefilled syringe inactive ingredient s: polysorbate 20, sodium succinate, sorbitol, succinic acid, and Water for Injection, USP. SKYRIZI 55 mg/0.37 mL prefilled syringe, 150 mg/mL prefilled pen or prefilled syringe , 180 mg/1.2 mL prefilled syringe or prefilled cartridge , 360 mg/2.4 mL prefilled cartridge , and 600 mg/ 10 mL vial i nactive ingredients: glacial acetic acid, polysorbate 20, sodium acetate, trehalose, and Water for Injection, USP. Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A. US License Number 1889 SKYRIZI and its design are trademarks of AbbVie Biotechnology Ltd. © 2026 AbbVie. All rights reserved. For more information, call 1-866-SKYRIZI (1-866-759-7494) or go to www.SKYRIZI.com. | |||||||
| This Medication Guide has been approved by the U.S. Food and Drug Administration 20101630 | Revised: 6/2026 | ||||||
INSTRUCTIONS FOR USE
SKYRIZI® (sky-RIZZ-ee) Pen
(risankizumab-rzaa)
injection, for subcutaneous use
single-dose prefilled pen
150 mg/mL
Read Before First Use
Refer to the Medication Guide for product information.
Read complete Instructions for Use before using SKYRIZI Pen (risankizumab-rzaa) injection.
Before using SKYRIZI, you should receive training from your healthcare provider on how to inject SKYRIZI Pen.
In children 10 years of age and older, it is recommended that SKYRIZI Pen be given by an adult or with an adult watching (supervision).
In children 6 years to less than 10 years of age, SKYRIZI should be given by an adult.
SKYRIZI Pen
Important Information You Need to Know Before Injecting SKYRIZI Pen
Prepare SKYRIZI Pen injection  | Take the SKYRIZI Pen carton out of the refrigerator. Leave the carton at room temperature and out of direct sunlight for 30 to 90 minutes before injecting.
|
 | Check expiration date (EXP). Do not use the SKYRIZI Pen if expiration date has passed. Gather and Place the following on a clean, flat surface:
|
 | Choose an injection site:
|
 | Hold the SKYRIZI Pen with the dark gray cap pointing up.
|
Give SKYRIZI
Pen
injection
 | Hold the SKYRIZI Pen with your fingers on the gray hand grips. Turn the SKYRIZI Pen so that the white needle sleeve points toward the injection site and you can see the green activator button. Pinch the skin at your injection site to make a raised area and hold it firmly. Place the white needle sleeve straight (90-degree angle) against the raised injection site. |
 | Hold the SKYRIZI Pen so that you can see the green activator button and inspection window. Push and keep pressing the SKYRIZI Pen down firmly against the raised injection site.
|
 | Keep pressing the SKYRIZI Pen down
firmly against the injection site until the injection is complete. This takes up to 15 seconds. The injection is complete when:
|
After SKYRIZI Pen injection | When the injection is complete, slowly pull the SKYRIZI Pen straight out from the skin. The white needle sleeve will cover the needle tip and make another “click.” After completing the injection, place a cotton ball or gauze pad on the skin at the injection site.
|
 | Throw away (dispose of) the used SKYRIZI Pen in a sharps disposal container right away after use.
● Do not dispose of used SKYRIZI Pens in your household trash unless your community guidelines permit this. ● Do not recycle your sharps disposal container. The dark gray cap, alcohol swab, cotton ball or gauze pad, and packaging may be placed in your household trash. For more information see “Used SKYRIZI Pen Disposal” section located on the other side of the instructions. |
Important Information You Need to Know Before Injecting SKYRIZI Pen
Storage Information
Keep the SKYRIZI Pen and sharps disposal container out of the reach of children.
Call your healthcare provider or (866) SKYRIZI or (866)
759-7494 or go to
www.SKYRIZI.com
if you need help or do not know how to proceed.
Questions About Using the SKYRIZI Pen
Q. What if I need help on how to inject SKYRIZI Pen ?
A. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help.
Q. I have removed the dark gray cap and pressed the green activator button. Why is my injection not starting?
A. The green activator button will not start the injection unless the white needle sleeve is pressed firmly against the injection site.
Q. How do I know when the injection is complete?
A. The injection is complete if the SKYRIZI Pen makes a second “click” or the yellow indicator fills the inspection window. This takes up to 15 seconds.
Q. What should I do if there are more than a few drops of liquid on the injection site?
A. Call (866) SKYRIZI or (866) 759-7494 for help.
Q. What should I do with the used SKYRIZI Pen after my injection?
A. Throw away (dispose of) the used SKYRIZI Pen in a sharps disposal container right after use. Do not throw away in your household trash.
For more information, see “Used SKYRIZI Pen Disposal” section.
Call (866) SKYRIZI or (866) 759-7494 or go to www.SKYRIZI.com for help with your injection.
 | To help remember when to inject, mark your calendar with the date you give your SKYRIZI injection. |
Keep the SKYRIZI Pen and sharps disposal container out of the reach of children.
Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help or have questions about the use of SKYRIZI.
Used SKYRIZI Pen Disposal
If you do not have a sharps disposal container, you may use a household container that is:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used SKYRIZI Pens.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI and its design are trademarks of AbbVie Biotechnology Ltd.
© 2026 AbbVie. All rights reserved.
20101613
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 6/2026
INSTRUCTIONS FOR USE
SKYRIZI® (sky-RIZZ-ee)
(risankizumab-rzaa)
injection, for subcutaneous use
55 mg/0.37 mL single-dose prefilled syringe,
150 mg/mL single-dose prefilled syringe
Read Before First Use
Refer to the Medication Guide for product information.
Read complete Instructions for Use before using SKYRIZI prefilled syringe.
Before using SKYRIZI, you should receive training from your healthcare provider on how to inject SKYRIZI prefilled syringe.
In children 10 years of age and older, it is recommended that SKYRIZI prefilled syringe be given by an adult or with an adult watching (supervision).
In children 6 years to less than 10 years of age, SKYRIZI should be given by an adult.
SKYRIZI Prefilled Syringe
Important Information You Need to Know Before Injecting SKYRIZI Prefilled Syringe
Keep SKYRIZI prefilled syringe and all medicines out of the reach of children.
Before Injecting
Important Information You Need to Know Before Injecting SKYRIZI Prefilled Syringe
Storage Information
Keep SKYRIZI prefilled syringe and all medicines out of the reach of children.
Call your healthcare provider or (866) SKYRIZI or (866) 759-7494
or go to www.SKYRIZI.com if you need help or do not know how to proceed.
 | Gather and Place the supplies for the injection.
| |
 | Remove SKYRIZI prefilled syringe from cardboard sleeve by holding the finger grip. | |
 | Pick from the 3 injectable areas:
| |
 | Hold the SKYRIZI prefilled syringe with covered needle facing down, as shown. Check the liquid in the SKYRIZI prefilled syringe.
| |
 | Remove the needle cover.
| |
 | Hold the body of the SKYRIZI prefilled syringe in 1 hand between the thumb and index fingers. P inch the area of cleaned skin with your other hand and hold it firmly. Insert the needle into the skin at about a 45-degree angle using a quick, short movement. Hold angle steady. | |
 | Slowly push the plunger rod all the way in until all of the liquid is injected, and the SKYRIZI prefilled syringe is empty. Pull the needle out of the skin while keeping the SKYRIZI prefilled syringe at the same angle. Release the plunger rod.
| |
 | Put your used SKYRIZI prefilled syringe in a sharps disposal container right away after use.
|
Questions About Using SKYRIZI Prefilled Syringe
| Q. What if I need help on how to inject SKYRIZI prefilled syringe ? |
| A. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help. |
| Q. What should I do with the used SKYRIZI prefilled syringe after my injection? |
| A. Throw away (dispose of) the used SKYRIZI prefilled syringe in a sharps disposal container. Do not throw away in your household trash. For more information, see “Used SKYRIZI Prefilled Syringe Disposal” section. |
|
Q. How do I know when the injection is complete? |
| A. The injection is complete when the SKYRIZI prefilled syringe is empty, the plunger rod is pushed all the way in, and the syringe needle guard is activated. |
Used SKYRIZI Prefilled Syringe Disposal
If you do not have a sharps disposal container, you may use a household container that is:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI and its design are trademarks of AbbVie Biotechnology Ltd.
© 2026 AbbVie. All rights reserved.
20092742
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 6/2026
Instructions for Use
SKYRIZI® (sky-RIZZ-ee)
(risankizumab-rzaa)
injection, for subcutaneous use
2 x 90 mg/mL single-dose prefilled syringes for a total 180 mg/2 mL dose
Read Before First Use
Refer to the Medication Guide for product information.
SKYRIZI Single-Dose Prefilled Syringe
Keep SKYRIZI and all medicines out of the reach of children.
Important Information:
Please Read Complete Instructions for Use Before Using SKYRIZI Prefilled Syringe
Before Injecting:
Important Information:
Storage Information:
Keep SKYRIZI and all medicines out of the reach of children.
Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help or do not know how to proceed.
 |  Gather the supplies for the injections and place the following on a clean, flat surface:
Start with 1 prefilled syringe for first injection. |
 | Pick from the 3 injectable areas:
 Wipe the injection site in a circular motion with the alcohol swab (before both injections)
|
 | Hold the prefilled syringe with covered needle facing down, as shown. Check the liquid in the prefilled syringe.
|
 | Remove the needle cover.
|
 | Hold the body of the prefilled syringe in 1 hand between the thumb and index finger. Gently pinch the area of cleaned skin with your other hand and hold it firmly. Insert the needle into the skin at about a 45-degree angle using a quick, short movement. Hold angle steady. |
 | Slowly push the plunger rod all the way in until all of the liquid is injected and the syringe is empty. Pull the needle out of the skin while keeping the syringe at the same angle. Release the plunger rod.
|
 | Repeat Steps 2 through 6 with the 2nd prefilled syringe for a full dose.
|
 | Put your used prefilled syringes in an FDA-cleared sharps disposal container right away after use.
|
Questions About Using the SKYRIZI Syringe
Q. What if I have not received in-person training from a healthcare professional?
A. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help. Receive training on how to inject SKYRIZI before giving injections.
Q. What should I do with both used prefilled syringes after my injections?
A. Throw away (dispose of) both used prefilled syringes in a sharps disposal container. Do not put in household trash. For more information, see “Used SKYRIZI Prefilled Syringe Disposal” section.
You can sign up to receive sharps containers for SKYRIZI prefilled syringe disposal at no additional cost by going to www.SKYRIZI.com or calling (866) 759-7494
Q. How do I know when the injection is complete?
A. The injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way in, and the syringe needle guard is activated.
Used SKYRIZI Prefilled Syringe Disposal
Throw away (dispose of) both used prefilled syringes in a sharps disposal container. Do not put in household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI® is a trademark of AbbVie Biotechnology Ltd.
© 2019-2024 AbbVie Inc.
20078139
This Instructions for Use have been approved by the U.S. Food and Drug Administration.
Revised: 3/2024
Instructions for Use
SKYRIZI® (sky-RIZZ-ee)
(risankizumab-rzaa)
injection, for subcutaneous use
4 x 90 mg/mL single-dose prefilled syringes for a total 360 mg/4 mL dose
Read Before First Use
Refer to the Medication Guide for product information.
SKYRIZI Single-Dose Prefilled Syringe
Keep SKYRIZI and all medicines out of the reach of children.
Important Information:
Please Read Complete Instructions for Use Before Using SKYRIZI Prefilled Syringe
Before Injecting:
Important Information:
Storage Information:
Keep SKYRIZI and all medicines out of the reach of children.
Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help or do not know how to proceed.
 |  Gather the supplies for the injections and place the following on a clean, flat surface:
Start with 1 prefilled syringe for first injection. |
 | Pick from the 3 injectable areas:
 Wipe the injection site in a circular motion with the alcohol swab (before all four injections)
|
 | Hold the prefilled syringe with covered needle facing down, as shown. Check the liquid in the prefilled syringe.
|
 | Remove the needle cover.
|
 | Hold the body of the prefilled syringe in 1 hand between the thumb and index finger. Gently pinch the area of cleaned skin with your other hand and hold it firmly. Insert the needle into the skin at about a 45-degree angle using a quick, short movement. Hold angle steady. |
 | Slowly push the plunger rod all the way in until all of the liquid is injected and the syringe is empty. Pull the needle out of the skin while keeping the syringe at the same angle. Release the plunger rod.
|
 | Repeat Steps 2 through 6 with the 2nd, 3rd, and 4th prefilled syringe for a full dose.
 |
 | Put your used prefilled syringes in an FDA-cleared sharps disposal container right away after use.
|
Questions About Using the SKYRIZI Syringe
Q. What if I have not received in-person training from a healthcare professional?
A. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help. Receive training on how to inject SKYRIZI before giving injections.
Q. What should I do with all four used prefilled syringes after my injections?
A. Throw away (dispose of) all 4 used prefilled syringes in a sharps disposal container. Do not put in household trash. For more information, see “Used SKYRIZI Prefilled Syringe Disposal” section.
You can sign up to receive sharps containers for SKYRIZI prefilled syringe disposal at no additional cost by going to www.SKYRIZI.com or calling (866) 759-7494
Q. How do I know when the injection is complete?
A. The injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way in, and the syringe needle guard is activated.
Used SKYRIZI Prefilled Syringe Disposal
Throw away (dispose of) all four used prefilled syringes in a sharps disposal container. Do not put in household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about sharps disposal in the state that you live in, go to the FDA's website at: www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI® is a trademark of AbbVie Biotechnology Ltd.
© 2019-2024 AbbVie Inc.
This Instructions for Use have been approved by the U.S. Food and Drug Administration.
Revised: 3/2024
Instructions for Use
SKYRIZI® (sky-RIZZ-ee)
(risankizumab-rzaa)
injection, for subcutaneous use
180 mg/1.2 mL (150 mg/mL) single-dose prefilled syringe for a total 180 mg/1.2 mL dose
Read Before First Use
Refer to the Medication Guide for product information.
SKYRIZI Single-Dose Prefilled Syringe
Keep SKYRIZI and all medicines out of the reach of children.
Important Information:
Please Read Complete Instructions for Use Before Using SKYRIZI Prefilled Syringe
Before Injecting:
Important Information:
Storage Information:
Keep SKYRIZI and all medicines out of the reach of children.
Call your healthcare provider or ( 866 ) SKYRIZI or ( 866 ) 759 - 7494. if you need help or do not know how to proceed.
 | Gather the supplies for the injection and place the following on a clean, flat surface:
|
 | Remove prefilled syringe from blue and white cardboard sleeve by holding the finger grip |
 | Pick from the 3 injectable areas:
|
 | Hold the prefilled syringe with covered needle facing down, as shown. Check the liquid in the prefilled syringe.
|
 | Remove the needle cover.
|
 | Hold the body of the prefilled syringe in 1 hand between the thumb and index finger. Gently pinch the area of cleaned skin with your other hand and hold it firmly. Insert the needle into the skin at about a 45-degree angle using a quick, short movement. Hold angle steady. |
 | Slowly push the plunger rod all the way in until all of the liquid is injected and the prefilled syringe is empty. Pull the needle out of the skin while keeping the prefilled syringe at the same angle. Release the plunger rod .
|
 | Put your used prefilled syringe in an FDA-cleared sharps disposal container right away after use.
|
Questions About Using the SKYRIZI Syringe
Q. What if I have not received in-person training from a healthcare professional?
A. Call your healthcare provider or ( 866 ) SKYRIZI or ( 866 ) 759 - 7494 if you need help. Receive training on how to inject SKYRIZI before giving injections.
Q. What should I do with the used prefilled syringe after my injection?
A. Throw away (dispose of) the used prefilled syringe in a sharps disposal container. Do not put in household trash. For more information, see “Used SKYRIZI Prefilled Syringe Disposal” section.
You can sign up to receive sharps containers for SKYRIZI syringe disposal at no additional cost by going to www.SKYRIZI.com or calling (866) 759-7494
Q. How do I know when the injection is complete?
A. The injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way in, and the syringe needle guard is activated.
Used SKYRIZI Prefilled Syringe Disposal
Throw away (dispose of) the used prefilled syringe in a sharps disposal container. Do not put in household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about shams disposal in the state that you live in, go to the FDA's website at: www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI® is a trademark of AbbVie Biotechnology Ltd.
© 2019-2025 AbbVie Inc.
20087559
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
Revised: 9/2025
Instructions for Use
SKYRIZI® (sky-RIZZ-ee)
(risankizumab-rzaa)
injection, for subcutaneous use
2 x 180 mg/1.2 mL (150 mg/mL) single-dose prefilled syringe for a total 360 mg/2.4 mL dose
Read Before First Use
Refer to the Medication Guide for product information.
SKYRIZI Single-Dose Prefilled Syringe
Keep SKYRIZI and all medicines out of the reach of children.
Important Information:
Please Read Complete Instructions for Use Before Using SKYRIZI Prefilled Syringe
Before Injecting:
Important Information:
Storage Information:
Keep SKYRIZI and all medicines out of the reach of children.
Call your healthcare provider or ( 866 ) SKYRIZI or ( 866 ) 759 - 7494. if you need help or do not know how to proceed.
 | Gather the supplies for the injections and place the following on a clean, flat surface:
Start with 1 prefilled syringe for first injection. |
 | Pick from the 3 injectable areas:
Wipe the injection site in a circular motion with the alcohol swab (before both injections)
|
 | Hold the prefilled syringe with covered needle facing down, as shown. Check the liquid in the prefilled syringe.
|
 | Remove the needle cover.
|
 | Hold the body of the prefilled syringe in 1 hand between the thumb and index finger. Gently pinch the area of cleaned skin with your other hand and hold it firmly. Insert the needle into the skin at about a 45-degree angle using a quick, short movement. Hold angle steady. |
 | Slowly push the plunger rod all the way in until all of the liquid is injected and the prefilled syringe is empty. Pull the needle out of the skin while keeping the prefilled syringe at the same angle. Release the plunger rod.
|
 | Repeat Steps 2 through 6 with the 2nd prefilled syringe for a full dose.
|
 | Put your used prefilled syringes in an FDA-cleared sharps disposal container right away after use.
|
Questions About Using the SKYRIZI Syringe
Q. What if I have not received in-person training from a healthcare professional?
A. Call your healthcare provider or ( 866 ) SKYRIZI or ( 866 ) 759 - 7494 if you need help. Receive training on how to inject SKYRIZI before giving injections.
Q. What should I do with both used prefilled syringes after my injections?
A. Throw away (dispose of) both used prefilled syringes in a sharps disposal container. Do not put in household trash. For more information, see “Used SKYRIZI Prefilled Syringe Disposal” section.
You can sign up to receive sharps containers for SKYRIZI syringe disposal at no additional cost by going to www.SKYRIZI.com or calling (866) 759-7494
Q. How do I know when the injection is complete?
A. The injection is complete when the prefilled syringe is empty, the plunger rod is pushed all the way in, and the syringe needle guard is activated.
Used SKYRIZI Prefilled Syringe Disposal
Throw away (dispose of) both used prefilled syringes in a sharps disposal container. Do not put in household trash.
If you do not have an FDA-cleared sharps disposal container, you may use a household container that:
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal, and for specific information about shams disposal in the state that you live in, go to the FDA's website at: www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Manufactured by: AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI® is a trademark of AbbVie Biotechnology Ltd.
© 2019-2025 AbbVie Inc.
20087560
These Instructions for Use have been approved by the U.S. Food and Drug Administration.
Revised: 9/2025
Instructions for Use
SKYRIZI® (sky-RIZZ-ee) On-Body Injector
risankizumab-rzaa
injection, for subcutaneous use only
On-Body Injector and 180 mg/1.2 mL Prefilled Cartridge,
On-Body Injector and 360 mg/2.4 mL Prefilled Cartridge
Read this Instructions for Use before you start using SKYRIZI and each time you get a refill. There may be new information. This information does not take the place of talking to your healthcare provider about your medical condition or treatment.
Refer to the Medication Guide for SKYRIZI product information. Call your healthcare provider, call (866) SKYRIZI or (866) 759-7494 or go to SKYRIZI.com if you need help.
Important information you need to know before injecting SKYRIZI
Storage and preparation for use
Get to know your SKYRIZI On-Body Injector and prefilled cartridge
Please read complete Instructions for Use before using SKYRIZI. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 or go to www.SKYRIZI.com if you need help or if you do not know how to proceed.
| Step 1 Get ready | ||
| Before using SKYRIZI, you should receive training on how to inject SKYRIZI. | ||
 | Check expiration date
| |
 | Wait at least 45 minutes
| |
 | Open the carton and remove the plastic tray
| |
 | Gather all supplies and wash hands
| |
 | Remove the white paper tray seal
| |
 | Lift the plastic cover
 | |
 | Inspect the On-Body Injector
| |
| Step 2 Set up On-Body Injector | ||
 | Fully open the gray door | |
 | Inspect the prefilled cartridge
| |
 | Clean the smaller bottom tip of the prefilled cartridge
| |
 | Load the cleaned prefilled cartridge into the On-Body Injector  | |
 | Make sure that you start the injection within 5 minutes after inserting the prefilled cartridge into the On-Body Injector. Waiting will dry out the medicine and the On-Body Injector will not work afterwards. | |
 | Confirm cartridge is inserted and close the gray door  | |
| Step 3 Prepare to inject | ||
| Keep electronic devices including cell phones at least 12 inches (30 cm) from On-Body Injector until injection is complete | ||
 | Pick your injection area Locate a firm and flat area on your bare skin. Make sure the area is clear of clothing:
| |
 | Clean the injection area
| |
 | Peel both tabs to expose adhesive  | |
 | ||
 | Prepare the On-Body Injector for placement
| |
 | Place the On-Body Injector on your skin
| |
| Step 4 Inject medicine | ||
 | Start injection 
| |
 | Wait for the injection to finish
◦ the status light will continue to flash green. ◦ you will hear pumping sounds as the On-Body Injector continues delivering the medicine. ◦ moderate physical activities can be done, such as walking, reaching and bending.
| |
 | Injection is finished
| |
 | Remove the On-Body Injector
| |
| Step 5 Confirm and dispose | ||
 | Check the On-Body Injector
 | |
 | Put the used On-Body Injector in an FDA-cleared sharps disposal container right away after use
| |
Please read complete Instructions for Use before using SKYRIZI. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 or go to www.SKYRIZI.com if you need help or if you do not know how to proceed.
Commonly asked questions
Q. What if I cannot open the On-Body Injector door to insert the prefilled cartridge?
A. To open the On-Body Injector door, press in firmly on the left side of the door to release the door latch. If you are still unable to open the door, call (866) SKYRIZI or (866) 759-7494.
Q. What if I push the gray start button before I place the On-Body Injector on my skin?
A. The gray start button may be pressed just 1 time only. If the gray start button is pressed before placing it on your body, it can no longer be used. Call (866) SKYRIZI or (866) 759-7494.
Q. What if the On-Body Injector does not beep and the blue status light does not flash when I remove the green pull tabs?
A. Peeling off the small green pull tab will remove the clear plastic strip, activating the On-Body Injector. If all of the adhesive backing has been removed and the On-Body Injector still does not turn on, call (866) SKYRIZI or (866) 759-7494.
Q. What if I push the start button as instructed after placing the On-Body Injector on the skin and the light remains blue?
A. Firmly press the gray start button again. If the status light remains blue or flashes red, remove the On-Body Injector by carefully peeling it away from your skin. Do not re-apply the On-Body Injector. Call (866) SKYRIZI or (866) 759-7494.
Q. What if the status light flashes red and beeps while wearing the On-Body Injector?
A. If the status light continuously flashes red and beeps, do not use the On-Body Injector. If it is attached to your body, carefully remove it. Call (866) SKYRIZI or (866) 759-7494.
Q. What should I do if the On-Body Injector comes off my body during the injection?
A. The loaded On-Body Injector can no longer be used. Do not re-apply it to your body. Call (866) SKYRIZI or (866) 759-7494.
Q. How do I know when the injection is complete?
A. The injection is complete when the On-Body Injector beeps, the white plunger has completely filled the medicine window, and the status light turns from flashing green to solid green.
Q. What should I do if there are more than a few drops of liquid on the injection area?
A. Call (866) SKYRIZI or (866) 759-7494 for help.
Q. What should I do with the used On-Body Injector after my injection?
A. Throw away (dispose of) used On-Body Injector in a FDA-cleared sharps disposal container and not your household trash. You can receive a sharps container for SKYRIZI disposal at no additional cost by going to www.SKYRIZI.com or by calling (866) SKYRIZI or (866) 759-7494.
Q. What if I have not received in-person training from a healthcare professional?
A. Call your healthcare provider or (866) SKYRIZI or (866) 759-7494 if you need help.
Receive training on how to inject SKYRIZI before giving injections.
Disposing of SKYRIZI
When your sharps disposal container is almost full, you will need to follow your community guidelines for the right way to dispose of your sharps disposal container. There may be state or local laws about how you should throw away used needles and syringes.
For more information about safe sharps disposal in the state that you live in, go to the FDA’s website at: www.fda.gov/safesharpsdisposal.
Do not recycle your used sharps disposal container.
Additional information
● Type BF applied part.
● 
● Altitude range is -1,312 feet to 10,499 feet (-400 meters to 3,200 meters).
Electromagnetic Compatibility (EMC) of the On-Body Injector
The On-Body Injector is intended for home use or use in a professional healthcare environment and complies with ISO 11608-1:2014 and IEC 60601-1-2:2014.
Care should be taken to use the On-Body Injector within the following specific limits and environments to avoid adversely impacting the performance (missed or incomplete SKYRIZI dose).
Emissions
| Emissions test name | Test levels |
| Radiated Radio frequency electromagnetic fields | Per CISPR 11, class B |
Electromagnetic Immunity
| Test Name | Test Levels |
| Electrostatic discharge (ESD) | ± 8 kV contact ± 2 kV, ± 4 kV, ± 8 kV, ± 15 kV air |
| Radio frequency electromagnetic field | 10 V/m 80 MHz – 2.7 GHz |
| Power frequency 50 Hz magnetic field | 30 A/m |
The enclosure port immunity to RF wireless communications equipment complies with IEC 60601-1-2:2014.
Glossary of symbols
| Symbol | Description of Symbol |
 | Keep dry |
 | Sterilized using ethylene oxide |
 | Do not re-use |
 | Do not use if package is damaged and consult instructions for use |
 | Date of manufacture |
 | Batch code |
 | Catalogue number |
 | Serial number |
 | Refer to instruction manual / booklet |
 | Type BF Applied Part |
 | MR Unsafe |
Manufactured by:
AbbVie Inc., North Chicago, IL 60064, U.S.A.
US License Number 1889
SKYRIZI® is a registered trademark of AbbVie Biotechnology Ltd.
©2026 AbbVie Inc.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Revised: 3/2026
20096311
NDC 0074-2100-01
One 1 mL Single-Dose Prefilled Pen
Skyrizi® PEN 150 mg/mL
risankizumab-rzaa Injection
FOR SUBCUTANEOUS USE ONLY
Return to pharmacy if carton perforations are broken.
ATTENTION PHARMACIST:
Each patient is required to receive
the enclosed Medication Guide.
The entire carton is to be dispensed as a unit.
Rx only
abbvie
NDC 0074-1050-01
One 1 mL Single-Dose Prefilled Syringe
Skyrizi® 150 mg/mL
risankizumab-rzaa
injection
FOR SUBCUTANEOUS USE ONLY
AREA FOR PHARMACY LABEL
Rx only
Abbvie
NDC 0074-1070-01
1 x 2.4 mL Prefilled Cartridge
1 On-Body Injector
Skyrizi®
risankizumab-rzaa Injection
360 mg/2.4 mL
(150 mg/mL)
FOR SUBCUTANEOUS USE ONLY
Single-Dose
SKYRIZI.com
Rx only
abbvie
NDC 0074-5015-01
Skyrizi®
risankizumab-rzaa Injection
600 mg/10 mL
(60 mg/mL)
FOR INTRAVENOUS USE ONLY
Must be diluted prior to use
One 10 mL Single-Dose Vial-
Discard Unused Portion
ATTENTION: Dispense the enclosed Medication Guide to each patient.
Rx only
abbvie
NDC 0074-1069-01
Skyrizi®
risankizumab-rzaa
Injection
360 mg/2.4 mL
(150 mg/mL)
FOR SUBCUTANEOUS USE ONLY
Single-Dose
Rx Only
NDC 0074-1069-02
NOT FOR SALE
Skyrizi®
risankizumab-rzaa
Injection
360 mg/2.4 mL
(150 mg/mL)
FOR SUBCUTANEOUS USE ONLY
Single-Dose
Rx Only
NDC 0074-1065-01
1 x 1.2 mL Prefilled Cartridge
1 On-Body Injector
Skyrizi®
risankizumab-rzaa Injection
180 mg/1.2 mL
(150 mg/mL)
FOR SUBCUTANEOUS USE ONLY
Single-Dose
SKYRIZI.com
Rx only
abbvie
NDC 0074-1066-01
Skyrizi®
risankizumab-rzaa
Injection
180 mg/1.2 mL
(150 mg/mL)
FOR SUBCUTANEOUS USE ONLY
Single-Dose
Rx Only
NDC 0074-1066-02
NOT FOR SALE
Skyrizi®
risankizumab-rzaa
Injection
180 mg/1.2 mL
(150 mg/mL)
FOR SUBCUTANEOUS USE ONLY
Single-Dose
Rx Only
NDC 0074-7034-02
2 x 1 mL Prefilled Syringes
Skyrizi®
risankizumab-rzaa Injection
90 mg/mL per syringe
2 x 90 mg/mL. Single-Dose Prefilled
Syringes for a total 180 mg/2 mL dose
FOR SUBCUTANEOUS USE ONLY
FOR HEALTHCARE PROVIDER ADMINISTRATION ONLY
www. SKYRIZI.com
Rx Only
abbvie
NDC 0074-7032-90
One 1 mL Single-Dose Prefilled Syringe
Skyrizi®
risankizumab-rzaa Injection
90 mg/mL
FOR SUBCUTANEOUS USE ONLY
FOR HEALTHCARE PROVIDER ADMINISTRATION ONLY
www. SKYRIZI.com
Rx Only
abbvie
NDC 0074-7036-04
4 x 1 mL Prefilled Syringes
Skyrizi®
risankizumab-rzaa Injection
90 mg/mL per syringe
4 x 90 mg/mL Single-Dose Prefilled
Syringes for a total 360 mg/4 mL dose
FOR SUBCUTANEOUS USE ONLY
FOR HEALTHCARE PROVIDER ADMINISTRATION ONLY
ATTENTION PHARMACIST:
Each patient is required to receive the enclosed Medication Guide.
The entire carton is to be dispensed as a unit.
Return to Pharmacy if carton seal is broken or missing.
www. SKYRIZI.com
Rx Only
Abbvie
NDC 0074-7032-01
Skyrizi® 90 mg/mL
risankizumab-rzaa
Injection
For Subcutaneous Use Only
FOR HEALTHCARE PROVIDER ADMINISTRATION ONLY
FOR A 350 MG DOES,
FOUR 90 MG SYRINGES ARE REQUIRED,
INJECT ALL 4 SYRINGES FOR A FULL DOSE
Rx Only
abbvie
NDC 0074-7040-02
2 x 90 mg/mL Single Dose Prefilled Syringes
Skyrizi®
90 mg/mL per syringe
2 x 90 mg/mL Single-Dose Prefilled
Syringes for a total 180 mg/2 mL dose
risankizumab-rzaa
Injection
FOR SUBCUTANEOUS USE ONLY
Return to pharmacy if carton
perforations are broken.
ATTENTION PHARMACIST:
Each patient is required to receive
the enclosed Medication Guide.
The entire carton is to be
dispensed as a unit.
FOR A 180 MG DOSE,
TWO 90 MG SYRINGES ARE REQUIRED.
INJECT 2 SYRINGES FOR A FULL DOSE.
Rx only
abbvie
NDC 0074-7042-04
4 x 90 mg/mL Single Dose Prefilled Syringes
Skyrizi®
90 mg/mL per syringe
4 x 90 mg/mL Single-Dose Prefilled
Syringes for a total 360 mg/4 mL dose
risankizumab-rzaa
Injection
FOR SUBCUTANEOUS USE ONLY
Return to pharmacy if carton perforations are broken.
ATTENTION PHARMACIST:
Each patient is required to receive the
enclosed Medication Guide.
The entire carton is to be dispensed as a unit.
FOR A 360 MG DOSE,
FOUR 90 MG SYRINGES ARE REQUIRED.
INJECT ALL 4 SYRINGES FOR A FULL DOSE.
Rx only
abbvie
NDC 0074-8300-01
One 1.2 mL Single -Dose Prefilled Syringe
Skyrizi®
180 mg/1.2 mL
(150 mg/mL)
risankizumab-rzaa
Injection
FOR SUBCUTANEOUS USE ONLY
Return to pharmacy if carton perforations are broken.
ATTENTION PHARMACIST:
Each patient is required to receive the
enclosed Medication Guide.
The entire carton is to be dispensed as a unit.
Rx only
abbvie
NDC 0074-8350-01
Two 1.2 mL Single -Dose Prefilled Syringes
Skyrizi®
180 mg/1.2 mL (150 mg/mL) per syringe
2 x 180 mg/1.2 mL Single Dose Prefilled Syringes for a total 360 mg/2.4 mL
risankizumab-rzaa
Injection
FOR SUBCUTANEOUS USE ONLY
FOR A 360 MG DOSE, TWO 180 MG SYRINGES ARE REQUIRED.
INJECT 2 SYRINGES FOR A FULL DOSE.
Return to pharmacy if carton perforations are broken.
ATTENTION PHARMACIST:
Each patient is required to receive the
enclosed Medication Guide.
The entire carton is to be dispensed as a unit.
Rx only
abbvie
NDC 0074-4059-01
One 0.37 mL Single-Dose Prefilled Syringe
Skyrizi® 55mg mg/0.37 mL
risankizumab-rzaa
Injection
FOR SUBCUTANEOUS USE ONLY
For children and adolescents less than 40kg (88lb)
Return to pharmacy if carton perforations are broken.
ATTENTION PHARMACIST:
Each patient is required to receive the enclosed Medication Guide.
The entire carton is to be dispensed as a unit.
Rx only
abbvie
| Resource | Code type | Value | Equivalent identifiers | Source image |
|---|---|---|---|---|
| Barcode | DataBar Limited | (01)10300741066011 | GTIN-14: 10300741066011 GTIN storage (14 digits): 10300741066011 | skyrizi-77.jpg |
| Barcode | DataBar Limited | (01)10300741069012 | GTIN-14: 10300741069012 GTIN storage (14 digits): 10300741069012 | skyrizi-74.jpg |
| Data code | Data Matrix | 20069431 | skyrizi-74.jpg | |
| Data code | Data Matrix | 20071098 | skyrizi-77.jpg | |
| Data code | Data Matrix | 20072279 | skyrizi-78.jpg |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 47a46f9e-58f7-4803-b9d3-2d36444a6c49 | Product name | 3 | 20250122 |
| 6bd95106-a412-1dad-b9cc-4cb74bfb27ce | Product name | 2 | 20230315 |
| 48747306-602a-42cc-957b-5b0c69158eee | Product name | 1 | 20180604 |
| d5e51f11-ad28-caa4-4b49-4143974782ad | Product name | 1 | 20150831 |
| 290f523a-f9db-9774-b5a9-e1f908ac1782 | Product name | 1 | 20150828 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| c6b65c52-69c7-df49-550a-a50c137f6218 | Product name | 1 | 20140508 |
| db5ebcdb-b6ae-21cd-4dc5-76cd84b5578b | Product name | 1 | 20140508 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0074-2042-02 | EA - Each | 0074-2042 | ad6742df-2188-4c3b-a2fa-3d4df4688085 | 1 | 2019-06-19 |
| 0074-1050-01 | ML - Milliliter | 0074-1050 | e0d6af44-0e13-4346-b5a5-68c6cf0181e6 | 1 | 2021-06-02 |
| 0074-2100-01 | ML - Milliliter | 0074-2100 | fd7e7672-9eb0-4e60-a623-1a1791a3573c | 1 | 2021-06-02 |
| 0074-1070-01 | ML - Milliliter | 0074-1070 | b2360042-ce49-4f26-9615-1c0a2dfebddb | 1 | 2022-07-06 |
| 0074-5015-01 | ML - Milliliter | 0074-5015 | 241ff588-f9ab-4a06-9a22-447427ac7b0a | 1 | 2022-07-06 |
| 0074-1065-01 | ML - Milliliter | 0074-1065 | 718965fb-7dd8-45c7-912e-4abb8e77b2fa | 1 | 2023-01-09 |
Every source-derived product name is available through these pages.
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 179 | 2026-06-15 | daily-update | 2026-08-01 05:10:35 |
| 176 | 2026-06-12 | monthly-update | 2026-07-17 21:38:37 |
| 173 | 2026-03-19 | full-release | 2026-05-31 22:11:51 |
OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Adverse event summaries are temporarily unavailable. Other product information remains available.