Cytokine release syndrome (CRS), including serious or life-threatening reactions, can occur in patients receiving LYNOZYFIC. Initiate treatment with LYNOZYFIC step-up dosing to reduce the risk of CRS. Manage CRS, withhold LYNOZYFIC until CRS resolves, and modify the next dose or permanently discontinue based on severity [see Dosage and Administration (2.2 , 2.4 , 2.5) and Warnings and Precautions (5.1) ]. Neurolog...
LYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody. This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14) ] . Continued approval for...
Administer LYNOZYFIC intravenously according to the step-up schedule to reduce the incidence and severity of cytokine release syndrome (CRS) [see Dosage and Administration (2.2) ] . Administer only as an intravenous infusion after dilution in 0.9% Sodium Chloride Injection [see Dosage and Administration (2.6) ] . Administer pretreatment medications [see Dosage and Administration (2.3) ] . LYNOZYFIC should be admin...
LYNOZYFIC (linvoseltamab-gcpt) injection is a clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial. It is supplied as provided in Table 11. Table 11: Packaging Configurations Carton contents NDC One 5 mg/2.5 mL (2 mg/mL) single-dose vial 61755-054-01 One 200 mg/10 mL (20 mg/mL) single-dose vial 61755-056-01 Store unopened vial in a refrigerator at 2°C to 8°C (36°F to 46°F) in the o...
www.fda.gov/medwatch
www.LYNOZYFIC.comLYNOZYFIC is indicated for the treatment of adult patients with relapsed or refractory multiple myeloma who have received at least four prior lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody.
This indication is approved under accelerated approval based on response rate and durability of response [see Clinical Studies (14)]. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).
The recommended dosage for LYNOZYFIC is presented in Table 1. In patients who experience CRS, ICANS, or neurologic adverse reactions, refer to Tables 3, 4, and 5, respectively, for recommendations regarding administration of the next LYNOZYFIC dose. Continue treatment until disease progression or unacceptable toxicity. The recommended dosing schedule for LYNOZYFIC is provided in Table 1. The recommended dosage of LYNOZYFIC is step-up doses of 5 mg, 25 mg, and 200 mg, followed by 200 mg weekly for 10 doses, followed by 200 mg biweekly (every 2 weeks). In patients who have achieved and maintained VGPR or better at or after Week 24 and received at least 17 doses of 200 mg, decrease the dosing frequency to 200 mg every 4 weeks.
| Dosing Schedule | Day* | LYNOZYFIC Dose | Duration of Infusion | |
|---|---|---|---|---|
| Step-up Dosing Schedule | Day 1 | Step-up dose 1 | 5 mg | 4 hours |
| Day 8 | Step-up dose 2 | 25 mg | ||
| Day 15 | First treatment dose | 200 mg | ||
| Weekly Dosing Schedule | One week after Day 15 treatment dose and once weekly from Week 4 to Week 13 for 10 treatment doses | Second and subsequent treatment doses | 200 mg | 1 hour for the second treatment dose, and 30 minutes for subsequent doses† |
| Biweekly (Every 2 Weeks) Dosing Schedule | Week 14 and every 2 weeks thereafter | Subsequent treatment doses | 200 mg | 30 minutes |
| Patients who have achieved and maintained VGPR or better at or after Week 24 and received at least 17 doses of 200 mg | ||||
| Every 4 Weeks Dosing Schedule | At Week 24 or after and every 4 weeks thereafter | 200 mg | 30 minutes | |
* Weekly doses should be at least 5 days apart. Biweekly doses should be at least 10 days apart. Every 4-week doses should be at least 24 days apart.
† For patients who experienced CRS with the previous dose of LYNOZYFIC, the duration of infusion should be maintained at the duration of the previous infusion; reduce the duration of infusion sequentially in subsequent doses in patients who do not experience CRS (e.g., 4 hours, 1 hour, then 30 minutes).
Administer the following pre-treatment medications before each dose of the LYNOZYFIC step-up dosing schedule, which includes step-up dose 1, step-up dose 2, and the first treatment dose, the second treatment dose, and if indicated, subsequent treatment doses (see Tables 1, 2, and 3), to reduce the risk of CRS and/or IRR [see Warnings and Precautions (5.1)]:
Pre-treatment medications may be discontinued once a treatment dose of LYNOZYFIC is tolerated without CRS and/or IRR following pre-treatment with 10 mg dexamethasone (or equivalent), acetaminophen (or equivalent), and diphenhydramine (or equivalent) as described.
Table 2 provides recommendations for restarting therapy after a dose delay. Refer to Table 3, Table 4, and Table 5 for recommendations about management of CRS, ICANS, or other adverse reactions.
| Last Dose Administered | Time since the last dose administered* | Action for next dose. (For CRS/IRR or ICANS, refer to the dose modifications in Table 3, Table 4, and Table 5.) |
|---|---|---|
| NOTE: Administer pre-treatment medications prior to step-up dose 1, step-up dose 2, the first treatment dose, the second treatment dose, and if indicated, subsequent treatment doses [see Dosage and Administration (2.3)]. | ||
| 5 mg | 14 days or less | Administer 25 mg |
| Greater than 14 days | Restart step-up dosing from 5 mg | |
| 25 mg | 14 days or less | Administer 200 mg |
| Greater than 14 days and less than or equal to 28 days | Restart step-up dosing from 25 mg | |
| Greater than 28 days | Restart step-up dosing from 5 mg | |
| 200 mg | 49 days or less | Administer 200 mg |
| Greater than 49 days | Restart step-up dosing from 5 mg | |
* Consider benefit-risk of restarting LYNOZYFIC in patients who require a dose delay of more than 30 days.
Table 3 describes the management of CRS. Table 4 describes the management of ICANS. Table 5 describes the management of other adverse reactions.
Cytokine Release Syndrome
Identify CRS based on clinical presentation [see Warnings and Precautions (5.1)]. Evaluate and treat other causes of fever, hypoxia, and hypotension. If CRS is suspected, withhold LYNOZYFIC until CRS resolves. CRS should be managed according to the recommendations in Table 3 and per current practice guidelines. Supportive therapy for CRS should be administered, which may include intensive care for severe or life-threatening CRS.
| Grade* | Presenting Symptoms | Recommendations |
|---|---|---|
| Grade 1 | Fever ≥100.4ºF (38ºC)† | |
| Grade 2 | Fever ≥100.4°F (38°C)† with: Hypotension responsive to fluids and not requiring vasopressors and/or hypoxia requiring low-flow oxygen¶ by nasal cannula or blow-by |
|
| Grade 3 | Fever ≥100.4°F (38°C)† with: Hypotension requiring a vasopressor (with or without vasopressin) and/or hypoxia requiring high-flow oxygen¶ by nasal cannula, face mask, non-rebreather mask, or Venturi mask. |
|
| Grade 4 | Fever ≥100.4°F (38°C) † with: Hypotension requiring multiple vasopressors (excluding vasopressin) and/or hypoxia requiring oxygen by positive pressure (e.g., continuous positive airway pressure (CPAP), bilevel positive airway pressure (BiPAP), intubation, and mechanical ventilation). |
|
| Other | AST/ALT greater than 5 times ULN associated with CRS Grade 3 or less |
|
* Based on American Society for Transplantation and Cellular Therapy (ASTCT) criteria for grading CRS (2019).
† Attributed to CRS. Fever may not always be present concurrently with hypotension or hypoxia as it may be masked by interventions such as steroids, antipyretics, or anticytokine therapy.
‡ Administer pretreatment medications prior to next dose [see Dosage and Administration (2.3)].
§ Follow the recommendations in Table 2 for restarting dosing.
¶ Low-flow oxygen defined as oxygen delivered at less than 6 L/minute: high-flow oxygen defined as oxygen delivered at greater than or equal to 6 L/minute.
# If the last dose administered was 5 mg, administer 2.5 mg. If the last dose administered was 25 mg, restart step-up dosing from 5 mg. If the last dose administered was 200 mg, refer to Table 2 for recommendations regarding restarting therapy based on time since the last dose.
Neurologic Toxicity, including ICANS
Management recommendations for ICANS and neurologic toxicity are summarized in Table 4 and Table 5. At the first sign of suspected neurologic toxicity, including ICANS, withhold LYNOZYFIC and consider consultation with neurologist and other specialists for further evaluation and management. Rule out other causes of neurologic symptoms. Provide supportive therapy, which may include intensive care for severe or life-threatening ICANS. Manage per current practice guidelines.
| Grade* | Presenting Symptoms† | Recommendations |
|---|---|---|
| Grade 1 | ICE‡ score 7-9, or depressed level of consciousness§: awakens spontaneously. |
|
| Grade 2 | ICE‡ score 3-6, or depressed level of consciousness§: awakens to voice. |
|
| Grade 3 | ICE‡ score 0-2, or depressed level of consciousness§: awakens only to tactile stimulus, or seizures, either:
|
|
| Grade 4 | ICE‡ score 0, or depressed level of consciousness§: either:
|
|
* Based on American Society for Transplantation and Cellular Therapy (ASTCT) 2019 grading for ICANS.
† Management is determined by the most severe event, not attributable to any other cause.
‡ If patient is arousable and able to perform Immune Effector Cell-Associated Encephalopathy (ICE) Assessment, assess: Orientation (oriented to year, month, city, hospital=4 points); Naming (name 3 objects, e.g., point to clock, pen, button=3 points); Following Commands (e.g., "show me 2 fingers" or "close your eyes and stick out your tongue"=1 point); Writing (ability to write a standard sentence=1 point); and Attention (count backwards from 100 by ten=1 point). If patient is unarousable and unable to perform ICE Assessment (Grade 4 ICANS)=0 points.
§ Not attributable to any other cause.
¶ Follow the recommendations in Table 2 for restarting dosing.
# All references to dexamethasone administration are dexamethasone or equivalent.
♠ If the last dose administered was 5 mg, administer 2.5 mg. If the last dose administered was 25 mg, restart step-up dosing from 5 mg. If the last dose administered was 200 mg, refer to Table 2 for recommendations regarding restarting therapy based on time since the last dose.
Other Adverse Reactions
Management recommendations for other adverse reactions are summarized in Table 5.
| Adverse Reaction | Severity* | Recommendations |
|---|---|---|
| Infusion-Related Reactions | Grade 2 |
|
| Grade 3 |
| |
| Grade 4 |
| |
| Neurologic Adverse Reactions (excluding ICANS) | Grade 2 |
|
| Grade 3 (First occurrence) |
| |
| Grade 3 (Recurrent) Grade 4 |
| |
| Infections | Grades 2 or 3 |
|
| Grade 4 |
| |
| Other Non-hematologic Adverse Reactions | Grade 3 |
|
| Grade 4 |
| |
| Hematologic Adverse Reactions | Platelet count less than 50,000/mcL with bleeding OR less than 25,000/mcL |
|
| Absolute neutrophil count less than 1 × 109/L with Grade 2 or higher infection OR less than 0.5 × 109/L |
| |
| Febrile neutropenia |
| |
| Hemoglobin less than 8 g/dL |
|
* Based on National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE), Version 5.0
† If the last dose administered was 5 mg, administer 2.5 mg. If the last dose administered was 25 mg, restart step-up dosing from 5 mg. If the last dose administered was 200 mg, refer to Table 2 for recommendations regarding restarting therapy based on time since the last dose.
‡ Follow the recommendations in Table 2 for restarting dosing.
Preparation
Dilution
| LYNOZYFIC dose | LYNOZYFIC vial strength | Volume of LYNOZYFIC to be added to the infusion bag | Size of 0.9% Sodium Chloride Injection Infusion Bag (PVC or PO) |
|---|---|---|---|
| 2.5 mg* | 5 mg/2.5 mL | 1.25 mL | 50 mL |
| 5 mg | 5 mg/2.5 mL | 2.5 mL | 50 mL or 100 mL |
| 25 mg | 5 mg/2.5 mL | 12.5 mL | 50 mL or 100 mL |
| 200 mg | 200 mg/10 mL | 10 mL | 50 mL or 100 mL |
* Modified dose due to adverse reaction. For instructions on when to use the modified dose refer to Table 3, Table 4, and Table 5.
Diluted LYNOZYFIC Storage
Use diluted LYNOZYFIC immediately. If not used immediately, store the solution:
Do not freeze.
Do not shake.
Administration
LYNOZYFIC is a clear to slightly opalescent, colorless to pale yellow solution, available as:
None.
LYNOZYFIC can cause cytokine release syndrome (CRS), which can be serious or life-threatening.
In LINKER-MM1, CRS occurred in 46% (54/117) of patients who received LYNOZYFIC at the recommended dose, with Grade 1 CRS occurring in 35% (41/117) of patients, Grade 2 in 10% (12/117), and Grade 3 in 0.9% (1/117) [see Adverse Reactions (6.1)]. Thirty-eight percent (45/117) of patients had CRS following step-up dose 1, including 1 patient who experienced Grade 3 CRS; 8% (9/117) had an initial CRS event following a subsequent dose. Seventeen percent (19/113) of patients developed CRS after step-up dose 2, 10% (11/111) developed CRS after the first full 200 mg dose of LYNOZYFIC, and 3.6% (4/110) developed CRS after the second full dose. Recurrent CRS occurred in 20% (23/117) of patients. The median time to onset of CRS from the end of infusion was 11 (range: -1 to 184) hours after the most recent dose with a median duration of 15 (range: 1 to 76) hours.
Clinical signs and symptoms of CRS included, but were not limited to pyrexia, chills, hypoxia, tachycardia, and hypotension.
Administer pretreatment medications and initiate therapy according to LYNOZYFIC step-up dosing to reduce the incidence and severity of CRS [see Dosage and Administration (2.2) and Dosage and Administration (2.3)].
Monitor patients for signs and symptoms of CRS after infusion. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur.
At the first sign of CRS, immediately evaluate patients for hospitalization, manage per current practice guidelines, and administer supportive care; withhold LYNOZYFIC until CRS resolves and modify the next dose or permanently discontinue LYNOZYFIC based on severity [see Dosage and Administration (2.5)].
Infusion Related Reactions
Infusion-related reactions (IRR) may be clinically indistinguishable from manifestations of CRS. In the patients who were treated with the recommended step-up dosing regimen and pretreatment medications [see Dosage and Administration (2.2) and Dosage and Administration (2.3)], the rate of IRR was 9% [11/117 including Grade 2 IRR (4.3%) and Grade 3 IRR (1.7%)]. For IRR, interrupt or slow the rate of infusion or permanently discontinue LYNOZYFIC based on severity of reaction [see Dosage and Administration (2.5)].
LYNOZYFIC is available only through a restricted program under a REMS [see Warnings and Precautions (5.3)].
LYNOZYFIC can cause serious or life-threatening neurologic toxicity, including immune effector cell-associated neurotoxicity syndrome (ICANS) [see Adverse Reactions (6.1)].
In LINKER-MM1, neurologic toxicity occurred in 54% of patients, with Grade 3 or 4 neurologic toxicity occurring in 8%, at the recommended dose [see Adverse Reactions (6.1)]. Neurologic toxicities included ICANS, depressed level of consciousness, encephalopathy, and toxic encephalopathy.
ICANS occurred in 8% of patients who received LYNOZYFIC with the recommended dosing regimen, including Grade 3 events in 2.6%. Most patients experienced ICANS following step-up dose 1 (5%). Two patients (1.8%) experienced initial ICANS following step-up dose 2 and one patient developed the first occurrence of ICANS following a subsequent full dose of LYNOZYFIC. Recurrent ICANS occurred in one patient. The median time to onset of ICANS was 1 (range: 1 to 4) day after the most recent dose with a median duration of 2 (range: 1 to 11) days. The onset of ICANS can be concurrent with CRS, following resolution of CRS, or in the absence of CRS.
The most common clinical signs and symptoms of ICANS are confusion, depressed level of consciousness, and lethargy. Monitor patients for signs and symptoms of neurologic toxicity during treatment. At the first sign of neurologic toxicity, including ICANS, immediately evaluate the patient; provide supportive therapy and consider further management per current practice guidelines. Withhold LYNOZYFIC until ICANS resolves and modify the next dose or permanently discontinue LYNOZYFIC based on severity [see Dosage and Administration (2.5)]. Counsel patients to seek immediate medical attention should signs or symptoms of neurologic toxicity occur at any time.
Due to the potential for neurologic toxicity, including ICANS, patients receiving LYNOZYFIC are at risk of confusion and depressed consciousness. Advise patients to refrain from driving, or operating heavy or potentially dangerous machinery, for 48 hours after completion of each of the step-up doses [see Dosage and Administration (2.2)] and in the event of new onset of any neurological symptoms, until symptoms resolve.
LYNOZYFIC is available only through a restricted program under a REMS [see Warnings and Precautions (5.3)].
LYNOZYFIC is available only through a restricted program under a REMS called the LYNOZYFIC REMS because of the risks of CRS and neurologic toxicity, including ICANS [see Warnings and Precautions (5.1, 5.2)].
Notable requirements of the LYNOZYFIC REMS include the following:
Further information about the LYNOZYFIC REMS program is available at lynozyficREMS.com or by telephone at 1-855-212-6391.
LYNOZYFIC can cause serious, life-threatening, or fatal infections.
In patients who received LYNOZYFIC at the recommended dose in LINKER-MM1, serious infections, including opportunistic infections, occurred in 42% of patients, with Grade 3 or 4 infections in 38% and fatal infections in 4% [see Adverse Reactions (6.1)]. The most common serious infection reported (≥10%) were pneumonia and sepsis. Two cases of progressive multifocal leukoencephalopathy (PML) occurred in patients receiving LYNOZYFIC.
Monitor patients for signs and symptoms of infection and immunoglobulin levels prior to and during treatment with LYNOZYFIC and treat appropriately. Administer prophylactic antimicrobials, antibiotics, antifungals, antivirals, vaccines, and subcutaneous or intravenous immunoglobulin (IVIG) according to guidelines, including prophylaxis for PJP and herpesviruses [see Dosage and Administration (2.3)].
Withhold LYNOZYFIC or consider permanent discontinuation of LYNOZYFIC based on severity of the infection [see Dosage and Administration (2.5)].
LYNOZYFIC can cause neutropenia and febrile neutropenia.
In patients who received LYNOZYFIC at the recommended dose in LINKER-MM1, decreased neutrophil count occurred in 62% of patients with Grade 3 or 4 decreased neutrophil count in 47%. Febrile neutropenia occurred in 8% of patients [see Adverse Reactions (6.1)].
Monitor complete blood cell counts at baseline and periodically during treatment and provide supportive care per local guidelines. Monitor patients with neutropenia for signs of infection. Withhold LYNOZYFIC based on severity [see Dosage and Administration (2.5)].
LYNOZYFIC can cause hepatotoxicity.
In LINKER-MM1, elevated ALT occurred in 46% of patients, with Grade 3 or 4 ALT elevation occurring in 6%; elevated AST occurred in 61% of patients, with Grade 3 or 4 AST elevation occurring in 10% of patients who received the recommended dose. Grade 3 or 4 total bilirubin elevations occurred in 1.7% of patients [see Adverse Reactions (6.1)]. Liver enzyme elevation can occur with or without concurrent CRS.
Monitor liver enzymes and bilirubin at baseline and during treatment as clinically indicated. Withhold LYNOZYFIC or consider permanent discontinuation of LYNOZYFIC based on severity [see Dosage and Administration (2.5)].
Based on its mechanism of action, LYNOZYFIC may cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to the fetus. Advise females of reproductive potential to use effective contraception during treatment with LYNOZYFIC and for 3 months after the last dose [see Use in Specific Populations (8.1, 8.3)].
The following clinically significant adverse reactions are described elsewhere in the labeling:
Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice.
Relapsed or Refractory Multiple Myeloma
The safety of LYNOZYFIC was evaluated in LINKER-MM1 [see Clinical Studies (14)]. Patients (n=117) received LYNOZYFIC as step-up doses of 5 mg on Day 1 and 25 mg on Day 8, and the first treatment dose of 200 mg on Day 15. Patients then received 200 mg intravenously once weekly from Week 4 to Week 13, followed by 200 mg every 2 weeks from Week 14. In the Phase 2 portion of the study, patients who achieved and maintained VGPR or better at or after Week 24 and received at least 17 doses of 200 mg were able to receive every 4-week dosing. The median duration of treatment was 47 weeks (range 1, 151); 55% of patients were exposed for 9 months or longer and 36% were exposed for 1 year or longer.
The median age of patients who received LYNOZYFIC was 70 years (range: 37 to 91 years); 55% were male; 71% were White, 17% were Black or African American, and 9% were Asian.
Serious adverse reactions occurred in 74% of patients who received LYNOZYFIC. Serious adverse reactions that occurred in >5% of patients included cytokine release syndrome (27%), pneumonia (13%), COVID-19 (7%), and acute kidney injury (5%). Fatal adverse reactions occurred in 7% of patients, and included sepsis (3.4%), chronic kidney disease (0.9%), pneumonia (0.9%), tumor lysis syndrome (0.9%), and encephalopathy (0.9%).
Permanent discontinuation of LYNOZYFIC due to adverse reactions occurred in 16% of patients. Adverse reactions leading to discontinuation that occurred in at least 2 patients included sepsis, pneumonia, and encephalopathy.
Dosage interruptions or delays of LYNOZYFIC due to adverse reactions occurred in 74% of patients. Adverse reactions which required a dosage interruption or delay in >10% of patients included neutropenia (29%), upper respiratory tract infection (18%), pneumonia (15%), and COVID-19 infection (11%).
The most common adverse reactions (≥20%) were musculoskeletal pain, cytokine release syndrome, cough, upper respiratory tract infection, diarrhea, fatigue, pneumonia, nausea, headache, and dyspnea. The most common Grade 3 to 4 laboratory abnormalities (≥30%) were decreased lymphocyte count, decreased neutrophil count, decreased hemoglobin, and decreased white blood cell count.
Table 7 summarizes the adverse reactions in LINKER-MM1.
| Adverse Reaction | LYNOZYFIC (N=117) | |
|---|---|---|
| All Grades (%) | Grade 3 or 4 (%) | |
| Musculoskeletal and connective tissue disorders | ||
| Musculoskeletal pain* | 53 | 3.4† |
| Immune system disorders | ||
| Cytokine release syndrome | 46 | 0.9† |
| Hypogammaglobulinemia | 13 | 0.9† |
| Respiratory, thoracic and mediastinal disorders | ||
| Cough* | 39 | 0 |
| Dyspnea* | 21 | 0.9† |
| Nasal congestion | 16 | 0 |
| Infections and infestations | ||
| Upper respiratory tract infection* | 35 | 6† |
| Pneumonia‡ , § | 28 | 21 |
| COVID-19 | 17 | 5 |
| Urinary tract infections* | 16 | 8† |
| Sepsis | 10 | 6 |
| Gastrointestinal disorders | ||
| Diarrhea | 35 | 1.7† |
| Nausea | 23 | 0 |
| Vomiting | 19 | 0 |
| Constipation | 17 | 0 |
| General disorders and administration site conditions | ||
| Fatigue* | 34 | 0 |
| Edema* | 19 | 0.9† |
| Pyrexia | 17 | 0 |
| Nervous system disorders | ||
| Headache* | 22 | 0.9† |
| Encephalopathy§ , ¶ | 18 | 3.4 |
| Sensory Neuropathy* | 13 | 0.9 |
| Metabolism and nutrition disorders | ||
| Decreased appetite | 15 | 0.9† |
| Skin and subcutaneous tissue disorders | ||
| Rash# | 15 | 1.7† |
| Psychiatric disorders | ||
| Insomnia | 13 | 0 |
| Vascular disorders | ||
| Hypertension | 10 | 4.3† |
* Includes other related terms.
† Only Grade 3 adverse reactions occurred.
‡ Pneumonia includes atypical pneumonia, COVID-19 pneumonia, PJP, pneumonia, pneumonia cytomegaloviral, pneumonia fungal, pneumonia influenzal, and pneumonia viral.
§ Includes fatal outcome.
¶ Encephalopathy includes agitation, amnesia, cognitive disorder, confusional state, delirium, depressed level of consciousness, encephalopathy (including hyperammonemic and toxic encephalopathy), irritability, lethargy, memory impairment, mental status changes, somnolence, and excludes ICANS.
# Rash includes dermatitis acneiform, dermatitis contact, drug eruption, erythema, rash, rash erythematous, rash maculo-papular, rash pruritic, and stasis dermatitis.
Clinically significant adverse reactions that occurred in <10% of patients treated with LYNOZYFIC included IRR, motor dysfunction, febrile neutropenia, ICANS, CMV infection, and PML.
Table 8 summarizes the laboratory abnormalities in LINKER-MM1.
| Laboratory Abnormality* | LYNOZYFIC (N=117)† | |
|---|---|---|
| All Grades (%) | Grades 3 or 4 (%) | |
| Hematology | ||
| Lymphocyte count decreased | 97 | 92 |
| Hemoglobin decreased | 72 | 42 |
| Platelet count decreased | 64 | 19 |
| White blood cell count decreased | 63 | 31 |
| Neutrophil count decreased | 62 | 47 |
| Chemistry | ||
| Aspartate aminotransferase increased | 61 | 10 |
| Phosphorus decreased | 55 | 24 |
| Creatinine increased | 47 | 7 |
| Alanine aminotransferase increased | 46 | 6 |
* Laboratory tests were graded according to NCI-CTCAE (National Cancer Institute Common Terminology Criteria for Adverse Events) Version 5.0.
† The denominator used to calculate the rate varied from 106 to 117 based on the number of patients with a baseline value and at least one post-treatment value.
Certain CYP substrates
Monitor for toxicity unless otherwise recommended in the Prescribing Information of certain CYP substrates where minimal changes in the concentration may lead to serious adverse reactions when used concomitantly with LYNOZYFIC.
Linvoseltamab-gcpt causes the release of cytokines [see Clinical Pharmacology (12.2)] that may suppress cytochrome P450 (CYP) enzyme activity. Concomitant use with LYNOZYFIC increases CYP substrate exposure which may increase the risk of adverse reactions related to these substrates. Increased CYP substrate exposure is more likely to occur from initiation of the LYNOZYFIC step-up dosing schedule up to 14 days after the first 200 mg dose, and during and after CRS [see Warnings and Precautions (5.1)].
Risk Summary
Based on the mechanism of action, LYNOZYFIC may cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on the use of LYNOZYFIC in pregnant women to evaluate for a drug associated risk. No animal reproductive or developmental toxicity studies have been conducted with LYNOZYFIC.
Linvoseltamab-gcpt causes T-cell activation and cytokine release; immune activation may compromise pregnancy maintenance. In addition, based on the finding of B-cell depletion in non-pregnant animals, linvoseltamab-gcpt can cause B-cell lymphocytopenia in infants exposed to linvoseltamab-gcpt in-utero. Human immunoglobulin (IgG) is known to cross the placenta after the first trimester of pregnancy; therefore, linvoseltamab-gcpt has the potential to be transmitted from the mother to the developing fetus. Advise women of the potential risk to the fetus.
LYNOZYFIC is associated with hypogammaglobulinemia, therefore, assessment of immunoglobulin levels in newborns of mothers treated with LYNOZYFIC should be considered.
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.
Risk Summary
There are no data on the presence of linvoseltamab-gcpt in human milk, the effects on the breastfed child, or the effects on milk production. Maternal IgG is known to be present in human milk.
Because of the potential for serious adverse reactions in a breastfed child, advise women not to breastfeed during treatment with LYNOZYFIC and for 3 months after the last dose.
LYNOZYFIC may cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1)].
Pregnancy Testing
Verify the pregnancy status of females of reproductive potential prior to initiating treatment with LYNOZYFIC.
Contraception
Females
Advise females of reproductive potential to use effective contraception during treatment and for 3 months after the last dose of LYNOZYFIC.
The safety and effectiveness of LYNOZYFIC have not been established in pediatric patients.
Of the 117 patients with relapsed or refractory multiple myeloma who received LYNOZYFIC, 42 (36%) of patients were 65 to 74 years of age and 31 (26%) were 75 years of age and older [see Clinical Studies (14)]. No overall differences in safety or effectiveness were observed in patients 65 years of age and older, including patients 75 years of age and older, when compared with younger patients.
Linvoseltamab-gcpt, a bispecific B-cell maturation antigen (BCMA)-directed CD3 T-cell engager, is a recombinant human immunoglobulin (Ig)G4 antibody. Linvoseltamab-gcpt is produced by recombinant DNA technology in Chinese hamster ovary (CHO) cell suspension culture. The molecular weight of linvoseltamab-gcpt is approximately 146 kDa.
LYNOZYFIC (linvoseltamab-gcpt) injection for intravenous use is a sterile, preservative-free, clear to slightly opalescent, colorless to pale yellow solution with a pH 6.0.
Each LYNOZYFIC 5 mg/2.5 mL vial contains 5 mg of linvoseltamab-gcpt. Each mL contains 2 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP.
Each LYNOZYFIC 200 mg/10 mL vial contains 200 mg of linvoseltamab-gcpt. Each mL contains 20 mg of linvoseltamab-gcpt, histidine (0.7 mg), L-histidine hydrochloride monohydrate (1.1 mg), polysorbate 80 (1 mg), sucrose (100 mg), and Water for Injection, USP.
Linvoseltamab-gcpt is a bispecific T-cell engaging antibody that binds to the CD3 receptor expressed on the surface of T-cells and B-cell maturation antigen (BCMA) expressed on the surface of multiple myeloma cells and some healthy B-lineage cells.
In vitro, linvoseltamab-gcpt activated T-cells, caused the release of various proinflammatory cytokines, and resulted in the lysis of multiple myeloma cells. Linvoseltamab-gcpt had anti-tumor activity in mouse models of multiple myeloma.
The 200 mg once weekly dosing regimen was associated with better objective response rate and complete response rate when compared to the 50 mg once weekly (0.25 times the recommended dosage) dosing regimen in patients with relapsed or refractory multiple myeloma.
Linvoseltamab-gcpt exposure-response relationships have not been fully characterized.
Effect on Circulating Cytokines
Transient elevation of circulating cytokines (IL-2, IL-6, and IFN-γ) was primarily observed during the step-up dose regimen and the first full 200 mg dose. The highest elevation of cytokines was generally observed 4 hours after each infusion and generally returned to baseline prior to the next dose. Limited cytokine release was observed following subsequent doses.
Pharmacokinetic (PK) parameters were evaluated at the recommended dosage in patients with relapsed or refractory multiple myeloma and are presented as geometric mean (CV%) unless otherwise specified.
Linvoseltamab-gcpt PK exposures following use of the recommended dosing schedule are presented in Table 9. Linvoseltamab-gcpt Ctrough increased more than proportionally over a dose range of 96 mg to 800 mg (0.48 to 4 times the recommended full dose). Linvoseltamab-gcpt maximum concentration (127 mg/L [51%]) is achieved after the first dose of the every-2-weeks dosing regimen (i.e., the 12th dose of 200 mg).
| Dosing Period | Cmax (mg/L) | Ctrough (mg/L) | Cavg (mg /L) |
|---|---|---|---|
| First 200 mg weekly dose | 52.7 (37.2) | 15.5 (64.8) | 27.4 (34.2) |
| End of 200 mg weekly dosing (11th dose of 200 mg) | 124 (50.4) | 61.8 (123) | 84.6 (74.6) |
| End of 200 mg every 2 weeks dosing (16th dose of 200 mg) | 97.9 (52.7) | 30.2 (213) | 51.9 (95.3) |
| Steady state* with 200 mg every 4 weeks dosing | 64.8 (45.1) | 6.3 (362) | 20.5 (84.6) |
* Steady state values are approximated at Week 28.
Distribution
Linvoseltamab-gcpt volume of distribution (Vd) is 7.05 L (33.6%).
Elimination
Linvoseltamab-gcpt clearance is 0.68 L/day (52.2%) at baseline and 0.43 L/day (83.8%) at steady state.
Linvoseltamab-gcpt clearance decreases over time because its elimination is mediated by two parallel processes: a linear, non-saturable catabolic process and a nonlinear, saturable target-mediated pathway. Patients who discontinue linvoseltamab-gcpt are expected to have a 97% reduction from Cmax at a median (5th to 95th percentile) time of 77.7 (18 to 154) days after last dose.
Metabolism
Linvoseltamab-gcpt is expected to be metabolized into small peptides by catabolic pathways.
Specific Populations
No clinically significant differences in the pharmacokinetics of linvoseltamab-gcpt were observed based on age (37 to 91 years), weight (44 to 172 kg), sex, race (White, Asian, or Black), ethnicity (Hispanic/Latino or not Hispanic/Latino), mild to moderate renal impairment (creatinine clearance [CrCL] 30 to 89 mL/min, by Cockcroft-Gault [C-G] equation), or mild hepatic impairment (total bilirubin less than or equal to upper limit of normal [ULN] with AST greater than ULN or total bilirubin greater than 1 to 1.5 times ULN with any AST).
The effect of severe renal impairment (CrCL 15 to 29 mL/min), end-stage renal disease (CrCL less than 15 mL/min), and moderate to severe hepatic impairment (total bilirubin greater than 1.5 times ULN with any AST) on the pharmacokinetics of linvoseltamab-gcpt is unknown.
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 in the study described below with the incidence of anti-drug antibodies in other studies, including those of linvoseltamab-gcpt.
During treatment in LINKER-MM1 (evaluated through 30 months) [see Clinical Studies (14)], 1% (2/192) of LYNOZYFIC-treated patients developed anti-linvoseltamab-gcpt antibodies. Because of the low occurrence of anti-drug antibodies, the effect of these antibodies on the pharmacokinetics, pharmacodynamics, safety, and/or effectiveness of linvoseltamab products is unknown.
No carcinogenicity or genotoxicity studies have been conducted with linvoseltamab-gcpt.
No animal studies have been performed to evaluate the effects of linvoseltamab-gcpt on fertility.
The efficacy of LYNOZYFIC was evaluated in patients with relapsed or refractory multiple myeloma in an open-label, multi-center, multi-cohort study: LINKER-MM1 (NCT03761108). The study included patients who had previously received at least 3 prior therapies, including a proteasome inhibitor (PI), an immunomodulatory agent (IMiD), and an anti-CD38 antibody. The study included patients with Eastern Cooperative Oncology Group (ECOG) score of 0 or 1 and adequate baseline hematologic (absolute neutrophil count > 1 × 109/L, platelet count > 50 × 109/L, hemoglobin level >8 g/dL), renal (CrCL > 30 mL/min), and hepatic (AST and ALT ≤ 2.5 × ULN, total bilirubin ≤ 1.5 × ULN, alkaline phosphatase ≤ 2.5 × ULN) function.
The study excluded patients with known multiple myeloma brain lesions or meningeal involvement, history of a neurodegenerative condition, history of seizure within 12 months prior to study enrollment, active infection, a history of an allogeneic or autologous stem cell transplantation within 12 weeks, prior BCMA-directed bispecific antibody therapy, prior bispecific T-cell engaging therapy, or prior BCMA CAR-T cell therapy.
Patients received a step-up dose of 5 mg on Day 1, 25 mg on Day 8, and the first treatment dose of 200 mg on Day 15 of LYNOZYFIC by intravenous infusion. Then, patients received 200 mg of LYNOZYFIC weekly from Week 4 to Week 13, followed by 200 mg every other week thereafter. After at least 24 weeks, the Phase 2 patients who achieved a very good partial response (VGPR) or greater received 200 mg of LYNOZYFIC every 4 weeks. Patients were treated until disease progression or unacceptable toxicity.
The efficacy population included 80 patients who had received at least four prior lines of therapy. The median age was 71 (range: 37 to 83) years with 30% of patients 75 years or older; 64% were male and 36% were female; 69% were White, 14% were Black or African American, 13% were Asian, and 2.5% were Hispanic/Latino.
The International Staging System (ISS) at study entry was Stage I in 39%, Stage II in 36%, and Stage III in 19%. High-risk cytogenetics (presence of del(17p), t(4;14) and t(14;16)) were present in 40% of patients. Eighteen percent of patients had extramedullary disease at baseline.
The median number of prior lines of therapy was 5 (range: 4 to 13); 83% of patients were refractory to the last line of therapy. Sixty-five percent of patients received prior stem cell transplantation. Seventy-nine percent of patients were triple-class refractory (refractory to a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody). Thirteen percent of patients were previously treated with a BCMA antibody-drug conjugate.
Efficacy was established based on objective response rate (ORR) as determined by blinded independent review committee (IRC), as measured using the International Myeloma Working Group (IMWG) criteria (see Table 10). The median time to first response was 0.95 months (range: 0.5 to 6 months). With a median follow-up of 11.3 months among responders, the estimated duration of response (DOR) rate was 89% (95% CI: 77, 95) at 9 months and 72% (95% CI: 54, 84) at 12 months.
| Efficacy Endpoints | LYNOZYFIC N=80 |
|---|---|
| CI=confidence interval; NE=not estimable | |
| Objective Response Rate (ORR) % (n) | 70% (56) |
| (95% CI) | (59,80) |
| Complete response (CR) or better, % (n) | 45% (36) |
| (95% CI) | (34,57) |
| Stringent complete response (sCR), % (n) | 39% (31) |
| Complete response (CR), % (n) | 6% (5) |
| Very good partial response (VGPR) % (n) | 19% (15) |
| Partial response (PR), % (n) | 6% (5) |
| Duration of Response (DOR)* | |
| Median, months (95% CI) | NR (12, NE) |
* Based on Kaplan-Meier estimation.
LYNOZYFIC (linvoseltamab-gcpt) injection is a clear to slightly opalescent, colorless to pale yellow solution in a single-dose vial. It is supplied as provided in Table 11.
| Carton contents | NDC |
|---|---|
| One 5 mg/2.5 mL (2 mg/mL) single-dose vial | 61755-054-01 |
| One 200 mg/10 mL (20 mg/mL) single-dose vial | 61755-056-01 |
Store unopened vial in a refrigerator at 2°C to 8°C (36°F to 46°F) in the original carton to protect from light. Do not freeze or shake.
Advise the patient to read the FDA-approved patient labeling (Medication Guide).
Cytokine Release Syndrome (CRS)
Advise patients that they should be hospitalized for 24 hours after administration of the first and second step-up doses of LYNOZYFIC [see Dosage and Administration (2.2)]. Inform patients of the risk of CRS, and discuss the signs and symptoms associated with CRS, including fever, chills, hypoxia, tachycardia, and hypotension. Counsel patients to seek immediate medical attention should signs or symptoms of CRS occur at any time [see Warnings and Precautions (5.1)].
Neurologic Toxicity, including Immune Effector Cell-Associated Neurotoxicity Syndrome
Discuss the signs and symptoms associated with neurologic toxicity, including ICANS, including confusion, depressed level of consciousness, and lethargy. Advise patients to immediately contact their healthcare provider if they experience any signs or symptoms of neurologic toxicity. Advise patients to refrain from driving, or operating heavy or potentially dangerous machinery, for 48 hours after completion of each of the step-up doses or if they experience new onset of neurologic toxicity symptoms until the symptoms resolve [see Warnings and Precautions (5.2)].
LYNOZYFIC REMS
LYNOZYFIC is available only through a restricted program called the LYNOZYFIC REMS. Inform patients that they will be given a Patient Wallet Card that they should carry with them at all times and show to all of their healthcare providers. This card describes symptoms of CRS and neurologic toxicity, including ICANS which, if experienced, should prompt the patient to seek immediate medical attention [see Warnings and Precautions (5.3)].
Infections
Advise patients of the risk of serious infections. Instruct patients to immediately report infection-related signs or symptoms of infection (e.g., fever, chills, weakness) [see Warnings and Precautions (5.4)].
Neutropenia
Discuss the signs and symptoms associated with neutropenia and febrile neutropenia [see Warnings and Precautions (5.5)].
Hepatotoxicity
Advise patients that liver enzymes elevations may occur and that they should report symptoms that may indicate liver toxicity, including fatigue, anorexia, right upper abdominal discomfort, dark urine, or jaundice [see Warnings and Precautions (5.6)].
Embryo-Fetal Toxicity
Advise pregnant women and females of reproductive potential of the potential risk to a fetus. Advise females of reproductive potential to inform their healthcare provider if they are pregnant or become pregnant. Advise females of reproductive potential to use effective contraception during treatment with LYNOZYFIC and for 3 months after the last dose [see Warnings and Precautions (5.7), Use in Specific Populations (8.1, 8.3)].
Lactation
Advise women not to breastfeed during treatment with LYNOZYFIC and for 3 months after the last dose [see Use in Specific Populations (8.2)].
Manufactured by:
Regeneron Pharmaceuticals, Inc.
777 Old Saw Mill River Road
Tarrytown, NY 10591-6707
U.S. License No. 1760
LYNOZYFIC is a trademark of Regeneron Pharmaceuticals, Inc.
©2025 Regeneron Pharmaceuticals, Inc.
All rights reserved.
| MEDICATION GUIDE LYNOZYFIC™ (lin-oh-ZI-fik) (linvoseltamab-gcpt) injection, for intravenous use | ||
|---|---|---|
| This Medication Guide has been approved by the U.S. Food and Drug Administration. | Issued: July 2025 | |
| What is the most important information I should know about LYNOZYFIC? LYNOZYFIC may cause serious or life-threatening side effects, including:
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| Due to the risk of CRS and neurologic problems, you will receive LYNOZYFIC on a "step-up dosing schedule" and should be hospitalized for 24 hours after the first and second "step-up" doses. | ||
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If you have any questions about LYNOZYFIC, ask your healthcare provider. See "What are the possible side effects of LYNOZYFIC?" below for more information about side effects. | ||
| What is LYNOZYFIC? LYNOZYFIC is a prescription medicine used to treat adults with multiple myeloma who:
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Before receiving LYNOZYFIC, tell your healthcare provider about all of your medical conditions, including if you:
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How will I receive LYNOZYFIC? | ||
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| What should I avoid while receiving LYNOZYFIC? Do not drive, or operate heavy or potentially dangerous machinery, or do other dangerous activities for 48 hours after completing each of your "step-up" doses or at any time during treatment with LYNOZYFIC if you develop new neurologic symptoms, until the symptoms go away. See "What is the most important information I should know about LYNOZYFIC?" for more information about signs and symptoms of neurologic problems. | ||
| What are the possible side effects of LYNOZYFIC? LYNOZYFIC may cause serious side effects, including:
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| The most common side effects of LYNOZYFIC include: | ||
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| The most common severe abnormal blood test results with LYNOZYFIC include: low white blood cell counts and low red blood cell counts. These are not all of the possible side effects of LYNOZYFIC. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. | ||
| General information about safe and effective use of LYNOZYFIC Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about LYNOZYFIC that is written for health professionals. | ||
| What are the ingredients in LYNOZYFIC? Active ingredient: linvoseltamab-gcpt Inactive ingredients: histidine, L-histidine hydrochloride monohydrate, polysorbate 80, sucrose, and Water for Injection. | ||
| Manufactured by: Regeneron Pharmaceuticals, Inc., Tarrytown, NY 10591 U.S. License No. 1760 For more information about LYNOZYFIC, go to www.LYNOZYFIC.com or call 1-844-746-4363.LYNOZYFIC is a trademark of Regeneron Pharmaceuticals, Inc. © 2025 Regeneron Pharmaceuticals, Inc. All rights reserved. | ||
NDC 61755-054-01
Rx only
LYNOZYFIC™
(linvoseltamab-gcpt)
Injection
5 mg / 2.5 mL (2 mg/mL)
For Intravenous Infusion after Dilution
Single-Dose Vial. Discard unused portion.
ATTENTION: Dispense the enclosed Medication Guide
to each patient.
One 2.5 mL Vial
REGENERON
NDC 61755-056-01
Rx only
LYNOZYFIC™
(linvoseltamab-gcpt)
Injection
200 mg / 10 mL (20 mg/mL)
For Intravenous Infusion after Dilution
Single-Dose Vial. Discard unused portion.
ATTENTION: Dispense the enclosed Medication Guide
to each patient.
One 10 mL Vial
REGENERON
| RxCUI | RxNorm string | TTY | SPL version |
|---|---|---|---|
| 2719483 | linvoseltamab-gcpt 200 MG in 10 ML Injection | PSN | 6 |
| 2719494 | linvoseltamab-gcpt 5 MG in 2.5 ML Injection | PSN | 6 |
| 2719490 | LYNOZYFIC 200 MG in 10 ML Injection | PSN | 6 |
| 2719497 | LYNOZYFIC 5 MG in 2.5 ML Injection | PSN | 6 |
| 2719490 | 10 ML linvoseltamab-gcpt 20 MG/ML Injection [Lynozyfic] | SBD | 6 |
| 2719497 | 2.5 ML linvoseltamab-gcpt 2 MG/ML Injection [Lynozyfic] | SBD | 6 |
| 2719483 | 10 ML linvoseltamab-gcpt 20 MG/ML Injection | SCD | 6 |
| 2719494 | 2.5 ML linvoseltamab-gcpt 2 MG/ML Injection | SCD | 6 |
| 2719490 | 10 ML Lynozyfic 20 MG/ML Injection | SY | 6 |
| 2719497 | 2.5 ML Lynozyfic 2 MG/ML Injection | SY | 6 |
| 2719483 | linvoseltamab-gcpt 200 MG per 10 ML Injection | SY | 6 |
| 2719494 | linvoseltamab-gcpt 5 MG per 2.5 ML Injection | SY | 6 |
| 2719490 | Lynozyfic 200 MG per 10 ML Injection | SY | 6 |
| 2719497 | Lynozyfic 5 MG per 2.5 ML Injection | SY | 6 |
| Class | Version | Type | Effective |
|---|---|---|---|
| LINVOSELTAMAB Pharmacologic Class Indexing | 1 | Indexing - Pharmacologic Class | 20260410 |
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| REMS document | Relation | Version | Effective | Sponsor | Source |
|---|---|---|---|---|---|
| Risk Evaluation and Mitigation Strategy (REMS) Document LYNOZYFIC (linvoseltamab-gcpt) REMS | SPL related document | 3 | 2025-07-14 | Regeneron Pharmaceuticals, Inc. | 20250907_8425ddd3-28d0-421c-bb57-bdabde2bd7ff.zip!ed438285-5806-4240-8019-9cbda319d96a.xml |
| Package NDC | Product | Description | Form | Quantity | Strength | SPL version |
|---|---|---|---|---|---|---|
| 61755-054-00 | LYNOZYFIC | 2.5 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 2.5 | 6 | |
| 61755-054-01 | LYNOZYFIC | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | 6 | |
| 61755-056-00 | LYNOZYFIC | 10 mL in 1 VIAL, SINGLE-DOSE | INJECTION, SOLUTION, CONCENTRATE | 10 | 6 | |
| 61755-056-01 | LYNOZYFIC | 1 in 1 CARTON | INJECTION, SOLUTION, CONCENTRATE | 1 | 6 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 61755-054-00 | ML - Milliliter | 61755-054 | db8a9aa5-1ec1-4b92-ae2c-034861e05169 | 1 | 2025-08-11 |
| 61755-054-01 | ML - Milliliter | 61755-054 | b5622ed0-2373-474c-96a9-c3ef07c8480b | 1 | 2025-08-11 |
| 61755-056-00 | ML - Milliliter | 61755-056 | d2fa0629-49e5-49c9-910f-4a316d455405 | 1 | 2025-08-11 |
| 61755-056-01 | ML - Milliliter | 61755-056 | a0461f41-ddbf-4eb6-9602-6b1407eb892a | 1 | 2025-08-11 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 61755-054 | 61755-054-00, 61755-054-01 |
| 61755-056 | 61755-056-00, 61755-056-01 |
Every source-derived ingredient row is available through these pages.
| Name | UNII | Kind |
|---|---|---|
| LINVOSELTAMAB | M3CPC50MZS | ACTIB |
| HISTIDINE | 4QD397987E | IACT |
| HISTIDINE HYDROCHLORIDE MONOHYDRATE | X573657P6P | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SUCROSE | C151H8M554 | IACT |
| WATER | 059QF0KO0R | IACT |
| LINVOSELTAMAB | M3CPC50MZS | ACTIB |
| HISTIDINE | 4QD397987E | IACT |
| HISTIDINE HYDROCHLORIDE MONOHYDRATE | X573657P6P | IACT |
| POLYSORBATE 80 | 6OZP39ZG8H | IACT |
| SUCROSE | C151H8M554 | IACT |
| WATER | 059QF0KO0R | IACT |
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.
| Brand | Generic | Manufacturer | SPL set ID | Effective date | Available safety fields | Join |
|---|---|---|---|---|---|---|
| d82c287f-a94e-4831-9991-4742cdd17348 | e9fd0739-1b3f-4b8b-824a-1f0a902384d3 | 2025-07-02 | Boxed warning, Warnings, Adverse reactions | d82c287f-a94e-4831-9991-4742cdd17348 e9fd0739-1b3f-4b8b-824a-1f0a902384d3 |
Adverse event summaries are temporarily unavailable. Other product information remains available.