HUMATROPE is indicated for the treatment of pediatric patients with: growth failure due to inadequate secretion of endogenous growth hormone (GH), short stature associated with Turner syndrome, Idiopathic Short Stature (ISS), height standard deviation score (SDS) HUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency.
Therapy with HUMATROPE should be supervised by a physician who is experienced in the diagnosis and management of patients with the conditions for which HUMATROPE is indicated [see Indications and Usage ( 1 )] . Fundoscopic examination should be performed routinely before initiating treatment with HUMATROPE to exclude preexisting papilledema, and periodically thereafter [see Warnings and Precautions ( 5.5 )] . Leav...
Each single-patient-use HUMATROPE cartridge is designed for use only with the appropriate corresponding HumatroPen ® supplied separately. HUMATROPE (somatropin) for injection is a white lyophilized powder available in the following cartridge sizes in Table 15 : Table 15: Components of Humatrope Kits NDC Kit HUMATROPE Diluent NDC 0002-8147-01 Cartridge Kit 6 mg Single Patient-Use cartridge (gold) prefilled syringe ...
www.fda.gov/medwatch
www.humatrope.comwww.fda.gov/safesharpsdisposalwww.HUMATROPE.comHUMATROPE is indicated for the treatment of pediatric patients with:
HUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency.
| Cartridge | Somatropin Concentration | |
| 6 mg | 2.08 mg/mL | |
| 12 mg | 4.17 mg/mL | |
| 24 mg | 8.33 mg/mL | |
Each single-patient-use HUMATROPE cartridge is designed for use only with the appropriate corresponding HumatroPen® supplied separately.
HUMATROPE is a white lyophilized powder available as follows:
HUMATROPE is contraindicated in patients with:
Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic doses of somatropin [see Contraindications (4)]. Two placebo-controlled clinical studies in non-GH deficient adult patients (n=522) with these conditions in intensive care units revealed a significant increase in mortality (42% vs. 19%) among somatropin-treated patients (doses 5.3-8.0 mg/day) compared to those receiving placebo. The safety of continuing HUMATROPE treatment in patients receiving replacement doses for approved indications who concurrently develop these illnesses has not been established. HUMATROPE is not indicated for the treatment of non-GH deficient adults.
There have been reports of sudden death after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin. If, during treatment with somatropin, patients show signs of upper airway obstruction (including onset of, or increased, snoring) and/or new onset sleep apnea, treatment should be interrupted. All patients with Prader-Willi syndrome treated with somatropin should also have effective weight control and be monitored for signs of respiratory infection, which should be diagnosed as early as possible and treated aggressively [see Contraindications (4)]. HUMATROPE is not indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome.
Active Malignancy
There is an increased risk of malignancy progression with somatropin treatment in patients with active malignancy [see Contraindications (4)]. Any preexisting malignancy should be inactive and its treatment complete prior to instituting therapy with HUMATROPE. Discontinue HUMATROPE if there is evidence of recurrent activity.
Risk of Second Neoplasm in Pediatric Patients
An increased risk of a second neoplasm in pediatric cancer survivors who were treated with radiation to the brain/head and who developed subsequent GH deficiency and were treated with somatropin has been reported. Intracranial tumors, in particular meningiomas, were the most common of these second neoplasms. In adults, it is unknown whether there is any relationship between somatropin replacement therapy and CNS tumor recurrence. Monitor all patients receiving HUMATROPE who have a history of GH deficiency secondary to an intracranial neoplasm for progression or recurrence of the tumor.
New Malignancy During Treatment
Because pediatric patients with certain rare genetic causes of short stature have an increased risk of developing malignancies, thoroughly consider the risks and benefits of starting HUMATROPE in these patients. If HUMATROPE is initiated, carefully monitor patients for development of neoplasms.
Monitor all patients receiving HUMATROPE carefully for increased growth, or potential malignant changes, of preexisting nevi. Advise patients/caregivers to report marked changes in behavior, onset of headaches, vision disturbances and/or changes in skin pigmentation or changes in the appearance of pre-existing nevi.
Treatment with somatropin may decrease insulin sensitivity, particularly at higher doses. New onset type 2 diabetes mellitus has been reported in patients taking somatropin. Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked. Monitor glucose levels periodically in all patients receiving HUMATROPE, especially in those with risk factors for diabetes mellitus, such as obesity, Turner syndrome, or a family history of diabetes mellitus. Patients with preexisting type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely. The doses of antidiabetic agents may require adjustment when HUMATROPE is initiated.
Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with somatropins. Symptoms usually occurred within the first eight (8) weeks after the initiation of somatropin therapy. In all reported cases, IH-associated signs and symptoms rapidly resolved after cessation of therapy or a reduction of the somatropin dose. Fundoscopic examination should be performed routinely before initiating treatment with HUMATROPE to exclude preexisting papilledema, and periodically thereafter. If papilledema is observed by fundoscopy during somatropin treatment, treatment should be stopped. If somatropin-induced IH is diagnosed, treatment with HUMATROPE can be restarted at a lower dose after IH-associated signs and symptoms have resolved. Patients with Turner syndrome may be at increased risk for the development of IH.
Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins. Patients and caregivers should be informed that such reactions are possible and that prompt medical attention should be sought if an allergic reaction occurs. Do not use HUMATROPE in patients with known hypersensitivity to somatropin or any of the excipients in HUMATROPE. Do not use HUMATROPE cartridges in patients with known hypersensitivity to metacresol or glycerin [see Dosage and Administration (2.4), Contraindications (4)].
Fluid retention during somatropin replacement therapy may frequently occur. Clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paresthesia) are usually transient and dose dependent.
Patients receiving somatropin therapy who have or are at risk for pituitary hormone deficiency(s) may be at risk for reduced serum cortisol levels and/or unmasking of central (secondary) hypoadrenalism. In addition, patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses following initiation of HUMATROPE treatment. Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism [see Drug Interactions (7)].
Undiagnosed/untreated hypothyroidism may prevent an optimal response to HUMATROPE, in particular, the growth response in pediatric patients. Patients with Turner syndrome have an inherently increased risk of developing autoimmune thyroid disease and primary hypothyroidism. In patients with GH deficiency, central (secondary) hypothyroidism may first become evident or worsen during somatropin treatment. Therefore, patients treated with somatropin should have periodic thyroid function tests performed, and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.
Slipped capital femoral epiphysis may occur more frequently in patients undergoing rapid growth. Slipped capital femoral epiphysis may lead to osteonecrosis. Cases of slipped capital femoral epiphysis with or without osteonecrosis have been reported in pediatric patients with short stature receiving somatropin. Evaluate pediatric patients receiving HUMATROPE with the onset of a limp or complaints of hip or knee pain for slipped capital femoral epiphysis and osteonecrosis and manage accordingly.
Somatropin increases the growth rate, and progression of existing scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis. Monitor patients with a history of scoliosis for progression of scoliosis.
Cases of pancreatitis have been reported in pediatric patients and adults receiving somatropins. The risk may be greater risk in pediatric patients compared with adults. Published literature indicates that girls who have Turner syndrome may be at greater risk than other pediatric patients receiving somatropins. Pancreatitis should be considered in patients who develop abdominal pain.
When somatropins are administered subcutaneously at the same site over a long period of time, tissue atrophy may result. Rotate injection sites when administering HUMATROPE to reduce this risk [see Dosage and Administration (2.1)].
Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone and IGF-I may increase after HUMATROPE therapy.
The following important adverse reactions are also described elsewhere in the labeling:
Because clinical studies are conducted under varying conditions, adverse reaction rates observed during the clinical studies performed with one somatropin formulation cannot always be directly compared to the rates observed during the clinical studies performed with a different somatropin formulation, and may not reflect the adverse reaction rates observed in practice.
Pediatric Patients
Growth Failure Due to Inadequate Secretion of Endogenous Growth Hormone
In an uncontrolled open-label study, 314 treatment-naive children aged >2 years who had GH deficiency were treated with HUMATROPE (0.06 mg/kg 3 times per week) for up to 8 years. Adverse reactions of special interest are reported in Table 2.
| |
| |
| Adverse Reaction | HUMATROPEa (n=314) |
| Hypothyroidism | 25% |
| Allergic reaction | 11% |
| Arthralgia | 6% |
| Bone disorder | 4% |
| Edema | 4% |
| Injection site pain/reaction | 4% |
| Neoplasm/tumor | 2% |
| Cardiovascular disorders | 1% |
| Thyroid disorders | 1% |
| Intracranial hypertension | 0%b |
Short Stature Associated with Turner Syndrome
In a randomized, concurrent-controlled (untreated), open-label study until attainment of adult height, the adverse reactions of special interest occurring in 74 patients treated with Humatrope at dose 0.3 mg/kg/week (mean duration 4.1 years) and in 62 untreated patients (mean duration 3.7 years) are reported in Table 3. A similar increase in otitis media was observed in an 18-month placebo-controlled study.
| Untreated (n=62) | HUMATROPE (n=74) | |
| Surgical procedure | 27% | 45% |
| Otitis media | 26% | 43% |
| Ear disorders | 5% | 18% |
Idiopathic Short Stature
Adverse reactions occurring in a randomized, placebo-controlled study of HUMATROPE treatment (0.22 mg/kg/week) until attainment of adult height (mean duration of HUMATROPE treatment 3.7 years, mean duration of placebo treatment 3.3 years) are reported in Table 4. Mean fasting serum insulin concentration increased by 10% in the HUMATROPE treatment group at the end of treatment relative to baseline, but remained within the normal reference range.
| Placebo (n=31) | HUMATROPE (n=37) | |
| Scoliosis | 13% | 19% |
| Otitis media | 7% | 16% |
| Hyperlipidemia | 3% | 8% |
| Gynecomastia | 3% | 5% |
| Hip pain | 0 | 3% |
| Arthralgia | 3% | 11% |
| Arthrosis | 7% | 11% |
| Myalgia | 13% | 24% |
| Hypertension | 0 | 3% |
In a dose-response study (239 patients treated for 2 years), among HUMATROPE dose groups [0.24 mg/kg/week (n=78), 0.37 mg/kg/week (n=83), 0.24 mg/kg/week for the first year and 0.37 mg/kg/week thereafter (n=78)], mean fasting blood glucose, mean glycosylated hemoglobin, and the incidence of elevated fasting blood glucose concentrations were similar. One patient developed glucose intolerance and high serum HbA1c.
Short Stature or Growth Failure in SHOX Deficiency
Adverse reactions of special interest from a 2-year randomized, open-label study with HUMATROPE (0.35 mg/kg/wk) compared to no treatment are presented in Table 5. During the 2-year study period, the proportion of patients who had at least one IGF-I concentration greater than 2.0 SD above the age- and gender-appropriate mean was 10 of 27 (37%) for the HUMATROPE-treated group vs. 0 of 24 patients (0%) for the untreated group. The proportion of patients who had at least one IGFBP-3 concentration greater than 2.0 SD above the age and gender appropriate mean was 16 of 27 (59%) for the HUMATROPE treated group vs. 7 of 24 (29%) for the untreated group.
| ||
| Untreated (n=25) | HUMATROPE (n=27) | |
| Arthralgia | 8% | 11% |
| Gynecomastiaa | 0% | 8% |
| Excessive number of cutaneous nevi | 0% | 7% |
| Scoliosis | 0% | 47% |
Small for Gestational Age (SGA) with No Catch-up Growth by Age 2-4 Years
In a 2-year, multicenter, randomized study, 193 pediatric patients were treated with 2 different HUMATROPE treatment regimens: a fixed dose of 0.067 mg/kg/day (FHD group) or an individually adjusted dose regimen (IAD group; starting dose 0.035 mg/kg/day which could be increased as early as Month 3 to 0.067 mg/kg/day based on a validated growth prediction model). Reported adverse reactions included: common childhood infectious diseases, otitis media, headaches, and slipped capital femoral epiphysis (n=1. Six patients (4 in the FHD group and 2 in the IAD group whose dose was increased from 0.035 mg/kg/day to 0.067 mg/kg/day [one at Month 3 and one at Year 1]) had impaired fasting glucose at Year 2. Two of 6 had impaired fasting glucose during the study, and one discontinued HUMATROPE at month 15 as a consequence. At study completion, 20-25% of patients had serum IGF-I SDS values > +2.
The following adverse reactions were reported from an observational study of 340 pediatric patients who received HUMATROPE with an average dosage of 0.041 mg/kg/day (maximum dose: 0.084 mg/kg/day) for an average of 3.0 years: type 2 diabetes mellitus (n=1), carpal tunnel syndrome (n=1) and an exacerbation of preexisting scoliosis (n=1).
Adult Patients with GH deficiency
Adult-Onset GH Deficiency
In the first 6 months of controlled blinded studies during which patients received either HUMATROPE or placebo, patients who received HUMATROPE experienced an increase in edema (17% vs. 4%) and peripheral edema (12% vs. 0%). Edema, muscle pain, joint pain, and joint disorder were reported early in therapy and tended to be transient or responsive to dosage titration.
Two of 113 patients developed carpal tunnel syndrome after beginning maintenance therapy without a low dose (0.00625 mg/kg/day) lead-in phase. Symptoms abated in these patients after dosage reduction.
Adverse reactions with ≥5% overall occurrence rate during 12 or 18 months of replacement therapy with HUMATROPE are shown in Table 6 (adult-onset patients) and in Table 7 (childhood-onset patients).
| Adverse Reaction | 18 Months Exposure [Placebo (6 Months)/Humatrope (12 Months)] (n=44) | 18 Months Humatrope Exposure (n=52) |
| Edema | 11% | 21% |
| Arthralgia | 14% | 17% |
| Paresthesia | 14% | 17% |
| Myalgia | 9% | 14% |
| Pain | 14% | 14% |
| Peripheral edema | 18% | 12% |
| Headache | 7% | 8% |
| Hypertension | 5% | 8% |
| Joint disorder | 2% | 6% |
| Rhinitis | 11% | 13% |
| Back pain | 9% | 10% |
| Acne | 0% | 6% |
| Surgical procedure | 2% | 6% |
| Flu syndrome | 7% | 4% |
Childhood-Onset GH Deficiency
Two double-blind, placebo-controlled studies were conducted in 67 adult patients who had received previous somatropin treatment during childhood. Patients were randomized to receive either placebo injections or HUMATROPE (0.00625 mg/kg/day for the first 4 weeks, then 0.0125 mg/kg/day thereafter) for the first 6 months, followed by open-label use of HUMATROPE for the next 12 months for all patients. During the placebo-controlled phase (first 6 months) of the study, elevations of serum glutamic oxaloacetic transferase were reported more for HUMATROPE-treated (13% vs. 0%) than placebo-treated patients.
| ||
| Adverse Reaction | 18 Months Exposure [Placebo (6 Months)/Humatrope (12 Months)] (n=30) | 18 Months Humatrope Exposure (n=32) |
| AST a increased | 7% | 13% |
| Headache | 7% | 9% |
| Asthenia | 3% | 6% |
| Edema | 10% | 6% |
| Myalgia | 7% | 6% |
| Pain | 10% | 6% |
| ALT a increased | 7% | 6% |
| Flu syndrome | 10% | 16% |
| Cough increased | 0% | 6% |
| Hypesthesia | 0% | 6% |
| Rhinitis | 7% | 6% |
| Respiratory disorder | 7% | 3% |
| Gastritis | 7% | 0% |
| Pharyngitis | 7% | 3% |
The following adverse reactions have been identified during post-approval use of somatropin or HUMATROPE. Because these adverse events 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 drug exposure.
Severe Hypersensitivity Reactions — Serious systemic hypersensitivity reactions including anaphylactic reactions and angioedema have been reported with postmarketing use of somatropins
Neurologic — Headaches (common in pediatric patients and occasional in adults)
Skin — Increase in size or number of cutaneous nevi
Endocrine — Gynecomastia
Gastrointestinal — Pancreatitis
Metabolic — New-onset type 2 diabetes mellitus
Musculoskeletal and connective tissue disorders — Osteonecrosis in pediatric patients
Neoplasia — Leukemia has been reported in a small number of GH deficient pediatric patients treated with somatropin
Table 8 includes a list of drugs with clinically important drug interactions when administered concomitantly with HUMATROPE and instructions for preventing or managing them.
| Replacement Glucocorticoid Treatment | |
| Clinical Impact: | Microsomal enzyme 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-1) is required for conversion of cortisone to its active metabolite, cortisol, in hepatic and adipose tissue. HUMATROPE inhibits 11βHSD-1. Consequently, individuals with untreated GH deficiency have relative increases in 11βHSD-1 and serum cortisol. Initiation of HUMATROPE may result in inhibition of 11βHSD-1 and reduced serum cortisol concentrations. |
| Intervention: | Patients treated with glucocorticoid replacement for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of HUMATROPE [see Warnings and Precautions (5.8)]. |
| Examples: | Cortisone acetate and prednisone may be effected more than others since conversion of these drugs to their biologically active metabolites is dependent on the activity of 11βHSD-1. |
| Non-Replacement Glucocorticoid Treatment in Pediatric Patients | |
| Clinical Impact: | Non-replacement glucocorticoid treatment, including supraphysiologic glucocorticoid treatment, may attenuate the growth promoting effects of HUMATROPE in pediatric patients. |
| Intervention: | Carefully adjust glucocorticoid dosing in pediatric patients receiving glucocorticoid treatments to avoid both hypoadrenalism and an inhibitory effect on growth. |
| Cytochrome P450-Metabolized Drugs | |
| Clinical Impact: | Limited published data indicate that somatropin treatment increases cytochrome P450 (CP450)-mediated antipyrine clearance. HUMATROPE may alter the clearance of compounds known to be metabolized by CP450 liver enzymes. |
| Intervention: | Careful monitoring is advisable when HUMATROPE is administered in combination with drugs metabolized by CP450 liver enzymes. |
| Oral Estrogen | |
| Clinical Impact: | Oral estrogens may reduce the serum IGF-1 response to HUMATROPE. |
| Intervention: | Patients receiving oral estrogen may require greater HUMATROPE dosages [see Dosage and Administration (2.3)]. |
| Insulin and/or Other Hypoglycemic Agents | |
| Clinical Impact: | Treatment with HUMATROPE may decrease insulin sensitivity, particularly at higher doses. |
| Intervention: | Patients with diabetes mellitus may require adjustment of their doses of insulin and/or other hypoglycemic agents [see Warnings and Precautions (5.4)]. |
Risk Summary
Limited available data with somatropin use in pregnant women are insufficient to determine a drug-associated risk of adverse developmental outcomes. Animal reproduction studies have not been conducted with HUMATROPE.
The estimated 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 2-4% and 15-20%, respectively.
Risk Summary
There is no information regarding the presence of somatropin in human milk. Limited published data indicate that exogenous somatropin does not increase normal breastmilk concentrations of growth hormone. No adverse effects related to somatropin in the breastfed infant have been reported. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for HUMATROPE and any potential adverse effects on the breastfed infant from HUMATROPE or from the underlying maternal condition.
Safety and effectiveness of HUMATROPE in pediatric patients have been established in growth failure due to inadequate secretion of endogenous growth hormone, short stature associated with Turner syndrome, idiopathic short stature (ISS), short stature or growth failure in SHOX deficiency, and short stature in children born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.
Growth Failure due to Inadequate Secretion of Endogenous Growth Hormone
Safety and effectiveness of HUMATROPE have been established in pediatric patients with growth failure due to growth hormone deficiency based on data from an open-label, uncontrolled, multicenter study with HUMATROPE in 314 pediatric patients conducted for up to 8 years [see Clinical Studies (14.1)].
Short Stature Associated with Turner Syndrome
Safety and effectiveness of HUMATROPE have been established in pediatric patients with short stature associated with Turner syndrome based on data from one long-term, randomized, open-label, multicenter, concurrently controlled study; two long-term, open-label multicenter, historically controlled US studies; and one long-term, randomized, US dose-response study with HUMATROPE in 181 pediatric patients [see Clinical Studies (14.2)].
Idiopathic Short Stature (ISS)
Safety and effectiveness of HUMATROPE have been established in pediatric patients with ISS based on data from two randomized, multicenter studies, one placebo-controlled study and one dose-response study with HUMATROPE in 310 pediatric patients [see Clinical Studies (14.3)].
Short Stature or Growth Failure in SHOX Deficiency
Safety and effectiveness of HUMATROPE have been established in pediatric patients with short stature or growth failure in SHOX deficiency based on data from a randomized, controlled, two-year, three-arm, open-label study with HUMATROPE in 52 pediatric patients [see Clinical Studies (14.4)].
Short Stature in Children Born Small for Gestational Age (SGA) with No Catch-up Growth by 2 Years to 4 Years of Age
Safety and effectiveness of HUMATROPE have been established in pediatric patients with short stature born SGA with no catch-up growth based on data from two clinical studies with HUMATROPE in 214 pediatric patients [see Clinical Studies (14.5)].
The safety and effectiveness of HUMATROPE in patients aged 65 years and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin, and therefore may be more prone to development of adverse reactions. A lower starting dose and smaller dose increments should be considered for older patients [see Dosage and Administration (2.3)].
HUMATROPE contains somatropin, which is not a controlled substance.
Inappropriate use of somatropin may result in significant negative health consequences.
Somatropin is not associated with drug related withdrawal adverse reactions.
Acute overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Overdose with somatropin is likely to cause fluid retention. Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess endogenous growth hormone.
Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and has a molecular weight of about 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin.
HUMATROPE (somatropin) for injection is a sterile, white, lyophilized powder intended for subcutaneous injection after reconstitution supplied in a cartridge. Phosphoric acid and/or sodium hydroxide may have been added to adjust the pH. Reconstituted solutions have a pH of approximately 7.5. This product is oxygen sensitive.
Cartridge — Each single-patient-use cartridge of HUMATROPE contains either 6 mg (18 IU), 12 mg (36 IU), or 24 mg (72 IU) of somatropin. Each HUMATROPE cartridge contains the following components (see Table 9):
| Component | Cartridge | ||
| 6 mg (gold) | 12 mg (teal) | 24 mg (purple) | |
| Somatropin | 6 mg | 12 mg | 24 mg |
| Dibasic sodium phosphate | 1.36 mg | 2.72 mg | 5.43 mg |
| Glycine | 6 mg | 12 mg | 24 mg |
| Mannitol | 18 mg | 36 mg | 72 mg |
Each cartridge is co-packaged with an accompanying syringe containing approximately 3 mL of diluent containing Water for Injection with 0.3% metacresol as a preservative and 1.7%, 0.29%, and 0.29% glycerin in the 6, 12, and 24 mg cartridges, respectively.
Somatropin binds to dimeric GH receptors located within the cell membranes of target tissue cells. This interaction results in intracellular signal transduction and subsequent induction of transcription and translation of GH-dependent proteins including IGF-1, IGF BP-3 and acid-labile subunit. Somatropin has direct tissue and metabolic effects or mediated indirectly by IGF-1, including stimulation of chondrocyte differentiation, and proliferation, stimulation of hepatic glucose output, protein synthesis and lipolysis.
Somatropin stimulates skeletal growth in pediatric patients with GHD as a result of effects on the growth plates (epiphyses) of long bones. The stimulation of skeletal growth increases linear growth rate (height velocity) in most somatropin-treated pediatric patients. Linear growth is facilitated in part by increased cellular protein synthesis.
Subcutaneous administration of a single dose of Humatrope (0.033 mg/kg body weight) in healthy volunteers (10 males, 10 females) resulted in an increased median IGF-1 level from 202 ng/mL (men) and 107 ng/mL (women) predose to maximal level of 362 ng/mL (men) and 234 ng/mL (women) after a median of 21 hours (men) and 14 hours (women).
Absorption
HUMATROPE has been studied following intramuscular, subcutaneous, and intravenous administration in healthy adult subjects. A single subcutaneous dose administration of HUMATROPE 0.1 mg/kg (0.27 IU/kg) in healthy subjects (n= 8) resulted in a mean (SD) Cmax of 63.3 (18.2) ng/mL at median Tmax of 4.0 (range 3 to 8) hours. The absolute bioavailability of somatropin is 75% after subcutaneous administration.
Distribution
The mean (SD) volume of distribution of somatropin after single dose subcutaneous injection of 0.1 mg/kg (0.27 IU/kg) in healthy subjects is about 0.96 (0.3) L/kg.
Elimination
Metabolism — Extensive metabolism studies have not been conducted. The metabolic fate of somatropin involves classical protein catabolism in both the liver and kidneys. In renal cells, at least a portion of the breakdown products of somatropin is returned to the systemic circulation.
Excretion — In healthy subjects, mean somatropin clearance is 0.18 (0.03) L/hr/kg following subcutaneous administration. The mean half-life of subcutaneous somatropin is 3.8 (1.4) hours. The long half-life observed after subcutaneous administration is due to slow absorption from the injection site. Urinary excretion of intact HUMATROPE has not been measured. Small amounts of somatropin have been detected in the urine of pediatric patients following replacement therapy.
Specific Populations
Geriatric patients — The pharmacokinetics of HUMATROPE have not been studied in patients greater than 65 years of age.
Pediatric patients — The pharmacokinetics of HUMATROPE in pediatric patients are similar to those of adults.
Male and Female Patients — No gender-specific pharmacokinetic studies have been performed with HUMATROPE. The available literature indicates that the pharmacokinetics of somatropin are similar in men and women.
Patients with Renal or hepatic impairment — No studies have been performed with HUMATROPE.
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 studies described below with the incidence of anti-drug antibodies in other studies, including those of HUMATROPE or other somatropins.
In a clinical study with HUMATROPE during the first 6 months of HUMATROPE therapy in 314 naive patients, 1.6% developed specific antibodies to HUMATROPE (binding capacity ≥0.02 mg/L). None had antibody concentrations which exceeded 2 mg/L. Throughout 8 years of this same study, two patients (0.6%) had binding capacity >2 mg/L. Neither patient demonstrated a decrease in growth velocity at or near the time of increased antibody production. It has been reported that growth attenuation from pituitary-derived GH may occur when antibody concentrations are >1.5 mg/L.
Carcinogenicity, mutagenicity and impairment of fertility studies have not been conducted with HUMATROPE.
An open-label, uncontrolled, multicenter study with Humatrope was conducted in, 314 treatment-naive children aged >2 years who had GH deficiency. Patients were treated with HUMATROPE (0.06 mg/kg 3 times per week) for up to 8 years. The efficacy of HUMTROPE was assessed by evaluating height velocity. Mean increase in height velocity from baseline of 3.6 ± 1.9 cm/year to 8.8 ± 2.3 cm/year was achieved by 1 year of treatment. Height velocity remained increased above baseline for a small subset of patients (n=12) who remained on-study up to 8 years during the long-term extension phase (6.3 ± 2.5 cm/year at year 8 of treatment).
One long-term, randomized, open-label, Canadian multicenter, concurrently controlled study, two long-term, open-label multicenter, historically controlled US studies and one long-term, randomized, US dose-response study were conducted to evaluate the efficacy of HUMATROPE for treatment of short stature due to Turner syndrome.
The randomized, open-label, Canadian study (NCT00191113) compared near-adult height outcomes for HUMATROPE-treated patients to those of a concurrent control group who received no injections. The HUMATROPE-treated patients received a dosage of 0.3 mg/kg/week given in divided doses 6 times per week from a mean age of 11.7 years for a mean duration of 4.7 years. Puberty was induced with a standardized estrogen regimen initiated at 13 years of age for both treatment groups.
In two of the US studies the effect of long-term treatment with Humatrope (0.375 mg/kg/week given in divided doses either 3 times per week or daily) on adult height was determined by comparing adult heights in the treated patients with those of age-matched historical controls with Turner syndrome who received no growth-promoting therapy. Puberty was induced with a standardized estrogen regimen initiated after 14 years of age in one study; in the second study patients treated early (before 11 years of age) were randomized to begin pubertal induction at either age 12 (n=26) or 15 (n=29) years (conjugated estrogens, 0.3 mg escalating to 0.625 mg daily); those whose treatment was initiated after 11 years of age began estrogen replacement after 1 year of treatment with HUMATROPE.
In the third US study, a randomized, blinded dose-response study, patients were treated from a mean age of 10.9 years for a mean duration of 5.5 years with a weekly HUMATROPE dosage of either 0.27 mg/kg or 0.36 mg/kg administered in divided doses 3 or 6 times weekly.
In summary, patients with Turner syndrome (total n=249 from the 4 studies above) treated to adult height achieved average height gains ranging from 5.0 to 8.3 cm. See Table 10.
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| Study | Group | Study Designb | Somatropin Treated Number at Adult Height | GH Age (yr) | Estrogen Age (yr) | GH Duration (yr) | Adult Height Gain (cm)c |
| Canadian | RCT | 27 | 11.7 | 13 | 4.7 | 5.4 | |
| US 1 | MHT | 17 | 9.1 | 15.2 | 7.6 | 7.4 | |
| US 2 | Ad | MHT | 29 | 9.4 | 15 | 6.1 | 8.3 |
| Be | MHT | 26 | 9.6 | 12.3 | 5.6 | 5.9 | |
| Cf | MHT | 51 | 12.7 | 13.7 | 3.8 | 5 | |
| US 3 | RDT | 99 | 10.9 | 8-13.5 | 5.5 | 5.7 | |
Two randomized, multicenter studies, one placebo-controlled and one dose-response, were conducted in pediatric patients with idiopathic short stature. The diagnosis of idiopathic short stature was made after excluding other known causes of short stature, as well as GH deficiency. The placebo-controlled study enrolled 71 pediatric patients (55 males, 16 females) 9 to 15 years old (mean age 12.4 ± 1.5 years), with short stature, 68 of whom received placebo (n=31) or HUMATROPE (n=37); NCT00191074. Patients were predominately prepubertal (Tanner I, 45%) or in early puberty (Tanner II, 47%) at baseline. In this double-blind study, patients received subcutaneous injections of either HUMATROPE 0.222 mg/kg/week, or placebo given in divided doses 3 times per week until height velocity decreased to ≤1.5 cm/year (“final height”). Final height measurements were available for 33 subjects (22 treated with HUMATROPE, 11 treated with placebo) after a mean treatment duration of 4.4 years (range 0.1-9.1 years).
Results are presented in Table 11. The number of patients whose final height was above the 5th percentile of the general population height standard for age and sex was significantly greater in the HUMATROPE group than the placebo group (41% vs. 0%), as was the number of patients who gained at least 1 SDS unit in height across the duration of the study (50% vs. 0%).
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| Placebo (n=11) Mean (SD) | HUMATROPE (n=22) Mean (SD) | Treatment Effect Mean (95%CIb) | p-value | |
| Baseline height SDS | -2.8 (0.6) | -2.7 (0.6) | NAb | 0.77c |
| BPH SDS | -2.3 (0.8) | -2.1 (0.7) | NA | 0.53c,d |
| Final height SDS | -2.3 (0.6) | -1.8 (0.8) | 0.51 (0.10, 0.92) | 0.017e |
| FHb SDS - baseline height SDS | 0.4 (0.2) | 0.9 (0.7) | 0.51 (0.04, 0.97) | 0.034e |
| FH SDS - BPH SDS | -0.1 (0.6) | 0.3 (0.6) | 0.46 (0.02, 0.89) | 0.043d,e |
The dose-response study included 239 pediatric patients (158 males, 81 females), 5 to 15 years old, (mean age 9.8 ± 2.3 years). Mean ± SD baseline characteristics included: height SDS -3.21 ± 0.70, predicted adult height SDS -2.63 ± 1.08, and height velocity SDS -1.09 ± 1.15. All but 3 patients were prepubertal. Patients were randomized to one of three HUMATROPE treatment groups: 0.24 mg/kg/week (n=78); 0.24 mg/kg/week for 1 year, followed by 0.37 mg/kg/week (n=78); and 0.37 mg/kg/week (n=83). Height velocity was assessed in each treatment group during the first 2 years of therapy. After completing the initial 2-year dose-response phase of the study, 50 patients were followed to final height.
After 2 years of treatment, patients who received the HUMATROPE dosage of 0.37 mg/kg/week (n=71) had a significantly greater increase in mean height velocity than patients who received 0.24 mg/kg/week (n=68), (4.04 vs. 3.27 cm/year respectively (ANOVA p=0.003). A total of 12 patients who received 0.37 mg/kg/week and 10 patients who received 0.24 mg/kg/week treatment had missing 2 year treatment data. The mean difference between final height and baseline predicted height was 7.2 cm for patients who received Humatrope 0.37 mg/kg/week and 5.4 cm for patients who received 0.24 mg/kg/week. The results are presented in Table 12. While no patient had height above the 5th percentile in any dosage group at baseline, 82% (n=14) of the 17 patients who received 0.37 mg/kg/week and 47% (n=8) of the 17 patients who received 0.24 mg/kg/week achieved final heights above the 5th percentile of the general population height standards.
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| Placebo-controlled Study 3x per week dosing | Dose Response Study 6x per week dosing | ||||
| Placebo (n=10) | HUMATROPE 0.22 mg/kg (n=22) | HUMATROPE 0.24 mg/kg (n=13) | HUMATROPE 0.24/0.37 mg/kg (n=13) | HUMATROPE 0.37 mg/kg (n=13) | |
| FH - Baseline PH Mean (95% CI), cm | -0.7 (-3.6, 2.3) | +2.2 (0.4, 3.9) | +5.4 (2.8, 7.9) | +6.7 (4.1, 9.2) | +7.2 (4.6, 9.8) |
A randomized, controlled, two-year, three-arm, open-label study was conducted to evaluate the efficacy of HUMATROPE for treatment of short stature in pediatric patients with SHOX deficiency who were not GH–deficient; NCT00190658. A total of 52 patients (24 male, 28 female) with SHOX deficiency, 3 to 12.3 years of age, were randomized to either a HUMATROPE-treated arm (27 patients; mean age 7.3 ± 2.1 years) or an untreated control arm (25 patients; mean age 7.5 ± 2.7 years). To determine the comparability of treatment effect between patients with SHOX deficiency and patients with Turner syndrome, the third study arm enrolled 26 patients with Turner syndrome, 4.5 to 11.8 years of age (mean age 7.5 ± 1.9 years) who received HUMATROPE treatment. All patients were prepubertal at study entry. Patients in the HUMATROPE-treated group(s) received daily subcutaneous injections of 0.05 mg/kg of HUMATROPE, equivalent to 0.35 mg/kg/week. Patients in the untreated group received no injections. One untreated patient discontinued the study during the first year. The results are presented in Table 13; the mean first-year height velocity of treated patients with SHOX deficiency was significantly greater than that of the untreated patients (mean between-group difference = 3.5 [95% CI: 2.8 – 4.2] cm/year, p<0.001).
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| SHOX Deficiency | Turner Syndrome | |||
| Untreated (n=24) Mean (SD) | HUMATROPE (n=27) Mean (SD) | Treatment Differencea Mean (95% CI) | HUMATROPE (n=26) Mean (SD) | |
| Height Velocity (cm/yr) | ||||
| 1st Year | 5.2 (1.1) | 8.7 (1.6)b | +3.5 (2.8, 4.2) | 8.9 (2.0) |
| 2nd Year | 5.4 (1.2) | 7.3 (1.1)b | +2.0 (1.3, 2.6) | 7.0 (1.1) |
| Height Gain (cm) | ||||
| Baseline to 1st Year | 5.4 (1.2) | 9.1 (1.5)c | +3.7 (2.9, 4.5) | 8.9 (1.9) |
| Baseline to 2nd Year | 10.5 (1.9) | 16.4 (2.0)c | +5.8 (4.6, 7.1) | 15.7 (2.7) |
| Height SDS Gain | ||||
| Baseline to 1st Year | 0.1 (0.5) | 0.7 (0.5)d | +0.5 (0.3, 0.8) | 0.8 (0.5) |
| Baseline to 2nd Year | 0.2 (0.5) | 1.2 (0.7)d | +1.0 (0.7, 1.3) | 1.2 (0.7) |
| Patients with height SDS > -2.0 at 2 years | 1 (4%) | 11 (41%)e | -- | 8 (31%) |
The height increases would be considered similar if the lower bound of the 95% confidence interval (CI) for the mean difference between the groups (IAD – FHD) was greater than -0.5 height SDS. A 2-year, open-label, multicenter, European study enrolled 193 prepubertal, non-GH deficient children with mean chronological age 6.8 ± 2.4 years (range: 3 to 12.3); NCT00191529. Study entry criteria included birth weight <10th percentile and/or birth length SDS <-2 for gestational age, and height SDS for chronological age ≤-3. Exclusion criteria included syndromal conditions (e.g., Turner syndrome), chronic disease (e.g., diabetes mellitus), and active tumors. The primary objective was to compare the increase from baseline in height SDS after 1 year of treatment when HUMATROPE is administered according to an individually adjusted dose (IAD) regimen with a fixed high dose (FHD) regimen. Patients were randomized to either a FHD (0.067 mg/kg/day [0.47 mg/kg/week]; n=99) or an IAD treatment group (n=94). The initial HUMATROPE dosage in the IAD treatment group was 0.035 mg/kg/day (0.25 mg/kg/week). The dosage was increased to 0.067 mg/kg/day in those patients in the IAD group whose 1-year height gain predicted at Month 3 was <0.75 height SDS (n=40) or whose actual height gain measured at Year 1 was <0.75 height SDS (n=11).
The results are presented in Table 14, The increase from baseline in height SDS in the IAD group was non-inferior to that in the FHD group at Year 1 (mean between-group difference = -0.3 SDS [95% CI: -0.4, -0.2 SDS]). The results were similar when children who entered puberty during the study were removed from the analysis. Data is shown for the efficacy analysis population that included all patients who received at least 1 dose of HUMATROPE and had at least 1 post randomization height measurement. Approximately 85% of the randomized patients completed 2 years of therapy.
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| IAD Group 0.035 to 0.067 mg/kg/day Mean (SD) | FHD Group 0.067 mg/kg/day Mean (SD) | IAD – FHD Group Difference ± SE (95% CI) b | |
| Baseline | (n=86) -3.9 (0.6) | (n=93) -3.9 (0.7) | -0.0 ± 0.1 (-0.2, 0.2) |
| Year 1 Height SDS Change from baseline | (n=86)c
-3.0 (0.7) 0.9 (0.4) | (n=93)c
-2.7 (0.7) 1.1 (0.4) | -0.3 ± 0.1 (-0.4, -0.2) p-value <0.001 |
| Year 2 Height SDS Change from baseline | (n=82)c
-2.5 (0.8) 1.4 (0.5) | (n=88)c
-2.2 (0.7) 1.6 (0.5) | -0.3 ± 0.1 (-0.4, -0.1) |
An open-label, multicenter, single arm study was conducted in France, during which 35 prepubertal, non-GH deficient children were treated for 2 years with HUMATROPE 0.067 mg/kg/day (0.47 mg/kg/week). Mean chronological age at baseline was 9.3 ± 0.9 years (range: 6.7 to 10.8). Additional study entry criteria included birth length SDS <-2 or <3rd percentile for gestational age, and height SDS for chronological age <-2. Exclusion criteria included syndromal conditions (e.g., Turner syndrome), and chronic disease (e.g., diabetes mellitus). All 35 patients completed the study. Mean height SDS increased from a baseline value of -2.7 (SD 0.5) to -1.5 (SD 0.6) after 2 years of HUMATROPE treatment.
Two multicenter studies in patients with adult-onset GH deficiency (n=98) and two studies in patients with childhood-onset GH deficiency (n=67) were designed to assess the effects of replacement therapy with HUMATROPE. Adult-onset patients and childhood-onset patients differed by diagnosis (organic vs. idiopathic pituitary disease), body size (average vs. small [mean height (171 cm vs 161 cm) and weight (85 kg vs 64 kg)]), and age (mean 44 vs. 29 years).Each study included a 6-month randomized, blinded, placebo-controlled phase, during which approximately half of the patients received placebo injections, while the other half received HUMATROPE injections. The HUMATROPE dosages for all studies were identical: 1 month of treatment at 0.00625 mg/kg/day followed by 0.0125 mg/kg/day for the next 5 months. The 6-month, double-blind phase was followed by 12 months of open-label HUMATROPE treatment for all patients. The primary efficacy measures were body composition (lean body mass and fat mass) and lipid parameters [Total cholesterol, high-density lipoprotein (HDL) and low-density lipoprotein (LDL)]. Lean body mass was determined by bioelectrical impedance analysis (BIA), validated with potassium 40. Body fat was assessed by BIA and sum of skinfold thickness. Lipid subfractions were analyzed by standard assay methods in a central laboratory.
In a study with patients with adult-onset GH deficiency, HUMATROPE treatment (vs. placebo) resulted in an increase in mean lean body mass (2.59 vs. -0.22 kg, p<0.001) and a decrease in body fat (-3.27 vs. 0.56 kg, p<0.001). Similar changes were seen in childhood-onset GH deficient patients. These changes in lean body mass persisted throughout the 18-month period for both the adult-onset and childhood-onset groups; the changes in fat mass persisted in the childhood-onset group. Serum concentrations of HDL cholesterol which were low at baseline (mean, 31.0 mg/dL and 33.9 mg/dL in adult-onset (n=46) and childhood-onset (n=30) patients, respectively) had increased by the end of 18 months of HUMATROPE treatment (mean change of 13.7 and 11.1 mg/dL for the adult-onset (n=40) and childhood-onset (n=21) groups, respectively p<0.001; there was no adjustment for missing data). Total cholesterol and LDL did not show significant difference from baseline results by the end of 18 months of HUMATROPE treatment.
In an additional 2-year, open-label, randomized study 149 patients with childhood-onset GH deficiency who had completed pediatric somatropin therapy, had attained final height (height velocity <1 cm/yr) and were confirmed to be GH-deficient as young adults, were randomized to receive HUMATROPE 0.0125 mg/kg/day (n=59), HUMATROPE 0.025 mg/kg/day (n=58), or no treatment (control) (n=32). Total bone mineral content (BMC) increased by 5.2% ± 3.9% in the control group (n=28 for those with BMC measurements), 7.0% ± 7.2% in the HUMATROPE 0.025 mg/kg/day group (n=51) and 8.0% ± 8.9% in the HUMATROPE 0.0125 mg/kg/day group (n=51). For the treatment effect versus control group, p=0.012 (ANOVA); there was no statistically significant difference between the 2 HUMATROPE dose groups. A significant overall treatment effect (ANOVA, p=0.037) was seen for the percentage change in lumbar spine BMC, but not for femoral neck or hip.
Each single-patient-use HUMATROPE cartridge is designed for use only with the appropriate corresponding HumatroPen® supplied separately.
HUMATROPE (somatropin) for injection is a white lyophilized powder available in the following cartridge sizes in Table 15:
| NDC | Kit | HUMATROPE | Diluent |
| NDC 0002-8147-01 | Cartridge Kit | 6 mg Single Patient-Use cartridge (gold) | prefilled syringe of Diluent for HUMATROPE |
| NDC 0002-8148-01 | Cartridge Kit | 12 mg Single Patient-Use cartridge (teal) | prefilled syringe of Diluent for HUMATROPE |
| NDC 0002-8149-01 | Cartridge Kit | 24 mg Single Patient-Use cartridge (purple) | prefilled syringe of Diluent for HUMATROPE |
Cartridges
Refrigerate cartridges of HUMATROPE and Diluent for HUMATROPE at 36° to 46°F (2° to 8°C). Avoid freezing Diluent for HUMATROPE. Store in the original carton to protect HUMATROPE from light.
Each single-patient-use HUMATROPE cartridge is designed for use only with the appropriate corresponding HumatroPen® supplied separately.
Advise the patient to read the FDA-approved patient labeling (Instructions for Use).
Eli Lilly and Company, Indianapolis, IN 46285, USA
US License Number 1891
Copyright ©, 1987, 2025, Eli Lilly and Company. All rights reserved.
HTR-0007-USPI-20251125
Instructions for Use
HUMATROPE® (HU-ma-trope)
(somatropin)
For injection, for subcutaneous use
Single-Patient-Use Cartridge Kit
HUMATROPE cartridges are only to be used with the appropriate corresponding HumatroPen® injection devices supplied separately.
Read this Instructions for Use before you start using HUMATROPE Cartridge Kit 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 or your child's medical condition or treatment.
Your healthcare provider should show you how to prepare, mix, measure, and inject HUMATROPE the right way before you use it for the first time. Ask your healthcare provider if you have any questions.
How should I store HUMATROPE?
Important:
HUMATROPE Cartridge Kit (See Figure A)
Note: There are 3 strengths of HUMATROPE Cartridges that have different amounts of HUMATROPE (6 mg, 12 mg, or 24 mg). Make sure that you have the Cartridge that your healthcare provider prescribed.
Mixing the HUMATROPE in the Cartridge
Only use the prefilled Diluent Syringe that comes with your HUMATROPE Cartridge Kit to mix the HUMATROPE in the Cartridge. Do not use the diluent that comes in the HUMATROPE vial box, or any other liquid.
HUMATROPE Cartridge Kit mixing Instructions
Parts (Figure A) |
 |
Only use a HUMATROPE Cartridge Kit to prepare the HUMATROPE Cartridge.
*Note: The liquid (Diluent) should be clear, colorless, and free of particles and is shown as blue in the figure
(See Figure A).
| Preparing Your New HUMATROPE Cartridge | |||
 |  |  | |
| Start by thoroughly washing your hands. Remove all contents from the tray. Note: The HUMATROPE Cartridge is made for left or right handed use so you may handle it the way that is most comfortable for you. | Hold the gray needle cover at the bottom of the Diluent Syringe. | Pull the needle cover straight down to remove from the Diluent Syringe and throw it away. Do not push the plunger yet. It is okay if a drop of Diluent is seen. You do not have to release air from the Diluent Syringe. | |
 |  |  | |
| Hold the Cartridge, with the black triangles up toward the Diluent Syringe. Make sure the Cartridge and Diluent Syringe are facing each other in a straight line. Do not insert the Cartridge at an angle. | Push the Cartridge straight into the Diluent Syringe until it stops and the black triangles are covered inside the Diluent Syringe. You may hear or feel a click. Do not twist the Cartridge. | Hold the Diluent Syringe and the Cartridge together with both hands. Push and release the plunger 2 or 3 times until the Diluent is in the Cartridge. | |
 |  |  | |
| Remove your thumb from the plunger and check that the Diluent Syringe is empty. It is normal for small drops of Diluent to remain in the Diluent Syringe. | With your thumb off the plunger, pull the Cartridge away from the Diluent Syringe. | Place the end cap on a hard, flat surface. Push the Diluent Syringe onto the end cap and throw away the Diluent Syringe right away as instructed by your healthcare provider. | |
 |  | ||
| Mix the medicine in the Cartridge by gently moving it in an up and down motion 10 times. Then let the Cartridge sit for 3 minutes. Do not shake. | Check the HUMATROPE liquid, it should be clear. If the liquid is clear, your Cartridge is now prepared and ready to be attached to your HumatroPen (See the Instructions for Use for HumatroPen 6 mg, 12 mg or 24 mg). If the liquid is cloudy or contains particles, gently mix the medicine in the Cartridge 10 more times. Let the Cartridge sit for 5 more minutes. If the liquid still remains cloudy or contains particles, do not use the Cartridge. Contact your healthcare provider or call Lilly at 1-800-545-5979 or go to www.humatrope.com.If you have questions about preparing your HUMATROPE Cartridge, you should contact your healthcare provider. | ||
Talk to your healthcare provider about the right way to use your HUMATROPE Cartridge Kit and HumatroPen injection device, the right sites to inject HUMATROPE, and how to rotate your injection sites.
Disposing of used Diluent Syringes:
www.fda.gov/safesharpsdisposal.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
HUMATROPE® and HumatroPen® are registered trademarks of Eli Lilly and Company.
Copyright © 2019, 2025 Eli Lilly and Company. All rights reserved.
Revised: November 2025
Manufactured by: Eli Lilly and Company, Indianapolis, IN 46285, USA
US License Number 1891
HTRCART-0003-IFU-20251125
Instructions for Use
HumatroPen® 6 mg
(HU-ma-tro-Pen 6 mg)
HUMATROPE® Delivery System Device for use only with HUMATROPE® (somatropin) 6 mg Cartridges
 | 6 mg |
|
Section 1: Read Section 1 completely before you move on to Section 2.
What you need to know about HumatroPen® 6 mg
Read this Instructions for Use including the “Commonly asked questions” section, at the end of this Instructions for Use, before you start using HumatroPen 6 mg and each time you get a new Pen. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.
Your healthcare provider should show you how to use HumatroPen (Pen) the right way before you use it for the first time. Ask your healthcare provider if you have any questions.
www.humatrope.com.
Introduction
Intended Use:
Contraindications:
There are no known contraindications for HumatroPen 6 mg.
Important information about HumatroPen 6 mg:
Information about Needles used with HumatroPen 6 mg:
How do I care for HumatroPen 6 mg?
How do I store HumatroPen 6 mg with an attached cartridge?
When do I need to replace and dispose my HumatroPen?
Do not use your Pen for more than 3 years after first use or past the Use-by date on the carton, whichever comes first.
The expired Pen may be discarded in your household trash after you have removed the Needle.
Record the date the Pen was first used here: __ / __ / __.
Record the Use-by date from your carton here: __ / __ / __.
Contact your healthcare provider if you need a new HumatroPen 6 mg, or when the Pen has been used for 3 years.
For more information, call Lilly at 1-800-545-5979 or go to www.humatrope.com.
| HumatroPen 6 mg Parts |
    |
Section 2: Read Section 2 only after you have read Section 1.
Getting Started
New Cartridge Set-up
| Step 2A – Check the Pen and Cartridge | ||
  |  |  |
Important Notes:
|
|
|
| Step 2B – Attach the Cartridge | ||
 |  | |
|
If the Cartridge is not completely attached, the screw may not move, and cause you to inject the wrong dose. | |
| Step 2C – Attach the Needle | ||
 |  |  |
|
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|
| Step 2D – Remove air from new Cartridge | |
 |  |
|
|
Important Notes:
Step 2E – Continue on to Daily Use
Section 3: Now that you have done the 1 time only New Cartridge Set-up, follow Section 3 for each of your daily injections.
| Daily Use Before your injection: Take the Pen out of the refrigerator and let it sit for 10 minutes before injecting to allow it to reach room temperature. Injecting medicine that is cold can cause discomfort. |
| Step 3A – Check the Pen | ||
 |  | |
Do not use the Pen if any part of the Pen or Cartridge appears broken or damaged. Contact your healthcare provider. |
Important Note: |
|
| Step 3B – Attach a new disposable Pen Needle for each injection. | ||
|  | |
|
|
|
Important Note: Talk to your healthcare provider about the right way to use the Pen, and the optional Hidden Needle Cover, the right sites to inject HUMATROPE, and how to rotate your injection sites. When using the Hidden Needle Cover with your HumatroPen, you must use a Needle length of 5 mm or longer. Read the Hidden Needle Cover Instructions for Use.
Step 3C – Dial and inject the dose
 |  |  |  |
Confirm the dose dialed matches the prescribed dose. Your dose may be different than the dose shown in the figure above.
|
|
| Important Note: It is possible to set a dose larger than the amount of HUMATROPE left in the Cartridge.
|
Step 3D – Remove and dispose of the Needle
 |  |  |
•
|
| • Replace the Pen Cap. |
Important Note: Do not remove this Cartridge from the Pen until the Cartridge is empty or needs to be replaced to help prevent you from giving the wrong dose.
Step 3E – Store Pen and Cartridge for next use
Commonly asked questions:
www.humatrope.com.
If you have any questions or problems with your HumatroPen 6 mg, contact Lilly at 1-800-545-5979 or your healthcare professional for assistance.
Report all MEDICAL DEVICE COMPLAINTS or UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS, to Eli Lilly and Company, by contacting them at 1-800-545-5979.
You are also encouraged to report all UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS, to the U.S. FOOD & DRUG Administration (US FDA) by:
www.fda.gov/safety/reporting-serious-problems-fda/how-consumers-can-report-adverse-event-or-serious-problem-fda) orDisposing of used Needles:
www.fda.gov/safesharpsdisposal.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Eli Lilly and Company
Pharmaceutical Delivery Systems
Lilly Corporate Center
Indianapolis, IN 46285, USA
US License Number 1891
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ UTRECHT
The Netherlands
HUMATROPE® and HumatroPen® 6 mg are registered trademarks of Eli Lilly and Company.
| The HumatroPen® 6 mg meets the current dose accuracy and functional requirements of ISO 11608-1 and is for use with HUMATROPE® 6 mg Cartridges only. |
Copyright © 2009, 2025, Eli Lilly and Company. All rights reserved.
Revised: November 2025
Non-harmonized Symbol Glossary1
1 Glossary includes non-harmonized symbols used in the labeling.
2 Symbol used only on the carton.
HTRPEN6-0006-IFU-20251125
Instructions for Use
HumatroPen® 12 mg
(HU-ma-tro-Pen 12 mg)
HUMATROPE® Delivery System Device for use only with HUMATROPE® (somatropin) 12 mg Cartridges
 | 12 mg |
|
Section 1: Read Section 1 completely before you move on to Section 2.
What you need to know about HumatroPen® 12 mg
Read this Instructions for Use including the “Commonly asked questions” section, at the end of this Instructions for Use before you start using HumatroPen 12 mg and each time you get a new Pen. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.
Your healthcare provider should show you how to use HumatroPen (Pen) the right way before you use it for the first time. Ask your healthcare provider if you have any questions.
www.humatrope.com.
Introduction
Intended Use:
Contraindications:
There are no known contraindications for HumatroPen 12 mg.
Important information about HumatroPen 12 mg:
Information about Needles used with HumatroPen 12 mg:
How do I care for HumatroPen 12 mg?
How do I store HumatroPen 12 mg with an attached cartridge?
When do I need to replace and dispose my HumatroPen?
Do not use your pen for more than 3 years after the first use or past the Use-by date on the carton, whichever comes first.
The expired Pen may be discarded in your household trash after you have removed the Needle.
Record the date the Pen was first used here: __ / __ / __.
Record the Use-by date from your carton here: __ / __ / __.
Contact your healthcare provider if you need a new HumatroPen 12 mg, or when the Pen has been used for 3 years.
For more information, call Lilly at 1-800-545-5979 or go to www.humatrope.com.
| HumatroPen 12 mg Parts |
 |
|
Section 2: Read Section 2 only after you have read Section 1.
Getting Started
New Cartridge Set-up
| Step 2A – Check the Pen and Cartridge | ||
  |  |  |
Important Notes:
|
|
| |
| Step 2B – Attach the Cartridge | ||
 |  | |
|
If the Cartridge is not completely attached, the screw may not move, and cause you to inject the wrong dose. | |
| Step 2C – Attach the Needle | ||
|  |  |
|
|
|
| Step 2D – Remove air from new Cartridge | |
 |  |
|
|
Important Notes:
Step 2E – Continue on to Daily Use
Section 3: Now that you have done the 1 time only New Cartridge Set-up, follow Section 3 for each of your daily injections.
| Daily Use Before your injection: Take the Pen out of the refrigerator and let it sit for 10 minutes before injecting to allow it to reach room temperature. Injecting medicine that is cold can cause discomfort. |
| Step 3A – Check the Pen | ||
 |  | |
Do not use the Pen if any part of the Pen or Cartridge appears broken or damaged. Contact your healthcare provider. |
Do not use the Cartridge past the expiration date. |
|
| Step 3B – Attach a new disposable Pen Needle for each injection. | |||
|  | |
|
|
| |
Important Note: Talk to your healthcare provider about the right way to use the Pen, and the optional Hidden Needle Cover, the right sites to inject HUMATROPE, and how to rotate your injection sites. When using the Hidden Needle Cover with your HumatroPen, you must use a Needle length of 5 mm or longer. Read the Hidden Needle Cover Instructions for Use.
Step 3C – Dial and inject the dose
 | |  |  | |
Confirm the dose dialed matches the prescribed dose. Your dose may be different than the dose shown in the figure above.
|
|
| Important Note: It is possible to set a dose larger than the amount of HUMATROPE left in the Cartridge.
|
Step 3D – Remove and dispose of the Needle
 |  |  |
|
|
|
Important Note: Do not remove this Cartridge from the Pen until the Cartridge is empty or needs to be replaced to help prevent you from giving the wrong dose.
Step 3E – Store Pen and Cartridge for next use
Commonly asked questions:
www.humatrope.com.
If you have any questions or problems with your HumatroPen 12 mg, contact Lilly at 1-800-545-5979 or your healthcare professional for assistance.
Report all MEDICAL DEVICE COMPLAINTS or UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS, to Eli Lilly and Company, by contacting them at 1-800-545-5979.
You are also encouraged to report all UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS, to the U.S. FOOD & DRUG Administration (US FDA) by:
www.fda.gov/safety/reporting-serious-problems-fda/how-consumers-can-report-adverse-event-or-serious-problem-fda) orDisposing of used Needles:
www.fda.gov/safesharpsdisposal.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Eli Lilly and Company
Pharmaceutical Delivery Systems
Lilly Corporate Center
Indianapolis, IN 46285, USA
US License Number 1891
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ UTRECHT
The Netherlands
HUMATROPE® and HumatroPen® 12 mg are registered trademarks of Eli Lilly and Company.
| The HumatroPen® 12 mg meets the current dose accuracy and functional requirements of ISO 11608-1 and is for use with HUMATROPE® 12 mg Cartridges only. |
Copyright © 2009, 2025, Eli Lilly and Company. All rights reserved.
Revised: November 2025
Non-harmonized Symbol Glossary1
1 Glossary includes non-harmonized symbols used in the labeling.
2 Symbol used only on the carton.
HTRPEN12-0006-IFU-20251125
Instructions for Use
HumatroPen® 24 mg
(HU-ma-tro-Pen 24 mg)
HUMATROPE® Delivery System Device for use only with HUMATROPE® (somatropin) 24 mg Cartridges
 | 24 mg |
|
Section 1: Read Section 1 completely before you move on to Section 2.
What you need to know about HumatroPen® 24 mg
Read this Instructions for Use including the “Commonly asked questions” section, at the end of this Instructions for Use, before you start using HumatroPen 24 mg and each time you get a new Pen. There may be new information. This information does not take the place of talking to your healthcare provider about your or your child's medical condition or treatment.
Your healthcare provider should show you how to use HumatroPen (Pen) the right way before you use it for the first time. Ask your healthcare provider if you have any questions.
www.humatrope.com.
Introduction
Intended Use:
Contraindications:
There are no known contraindications for HumatroPen 24 mg.
Important information about HumatroPen 24 mg:
Information about Needles used with HumatroPen 24 mg:
How do I care for HumatroPen 24 mg?
How do I store HumatroPen 24 mg with an attached cartridge?
When do I need to replace and dispose my HumatroPen?
Do not use your pen for more than 3 years after the first use or past the Use-by date on the carton, whichever comes first.
The expired Pen may be discarded in your household trash after you have removed the Needle.
Record the date the Pen was first used here: __ / __ / __.
Record the Use-by date from your carton here: __ / __ / __.
Contact your healthcare provider if you need a new HumatroPen 24 mg, or when the Pen has been used for 3 years.
For more information, call Lilly at 1-800-545-5979 or go to www.humatrope.com.
| HumatroPen 24 mg Parts |
 |
|
Section 2: Read Section 2 only after you have read Section 1.
Getting Started
New Cartridge Set-up
| Step 2A – Check the Pen and Cartridge | ||
  |  |  |
|
|
|
| Step 2B – Attach the Cartridge | ||
 |  | |
|
If the Cartridge is not completely attached, the screw may not move, and cause you to inject the wrong dose. | |
| Step 2C – Attach the Needle | ||
|  |  |
|
|
|
| Step 2D – Remove air from new Cartridge | |
 |  |
|
|
Important Notes:
Step 2E – Continue on to Daily Use
Section 3: Now that you have done the 1 time only New Cartridge Set-up, follow Section 3 for each of your daily injections.
| Daily Use |
| Before your injection: Take the Pen out of the refrigerator and let it sit for 10 minutes before injecting to allow it to reach room temperature. Injecting medicine that is cold can cause discomfort. Step 3A – Check the Pen | ||
 |  | | |
Do not use the Pen if any part of the Pen or Cartridge appears broken or damaged. Contact your healthcare provider. |
Do not use the Cartridge past the expiration date. |
|
| Step 3B – Attach a new disposable Pen Needle for each injection. | |||
|  | |
|
|
| |
Important Note: Talk to your healthcare provider about the right way to use the Pen, and the optional Hidden Needle Cover, the right sites to inject HUMATROPE, and how to rotate your injection sites. When using the Hidden Needle Cover with your HumatroPen, you must use a Needle length of 5 mm or longer. Read the Hidden Needle Cover Instructions for Use.
Step 3C – Dial and inject the dose
 | |  |  |
Confirm the dose dialed matches the prescribed dose. Your dose may be different than the dose shown in the figure above.
|
|
| Important Note: It is possible to set a dose larger than the amount of HUMATROPE left in the Cartridge.
|
Step 3D – Remove and dispose of the Needle
 |  |  |
|
|
|
Important Note: Do not remove this Cartridge from the Pen until the Cartridge is empty or needs to be replaced to help prevent you from giving the wrong dose.
Step 3E – Store Pen and Cartridge for next use
Commonly asked questions:
www.humatrope.com.
If you have any questions or problems with your HumatroPen 24 mg, contact Lilly at 1-800-545-5979 or your healthcare professional for assistance.
Report all MEDICAL DEVICE COMPLAINTS or UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS, to Eli Lilly and Company, by contacting them at 1-800-545-5979.
You are also encouraged to report all UNDESIRABLE SIDE EFFECTS, including SUSPECTED SERIOUS INCIDENTS, to the U.S. FOOD & DRUG Administration (US FDA) by:
www.fda.gov/safety/reporting-serious-problems-fda/how-consumers-can-report-adverse-event-or-serious-problem-fda) orDisposing of used Needles:
www.fda.gov/safesharpsdisposal.
This Instructions for Use has been approved by the U.S. Food and Drug Administration.
Eli Lilly and Company
Pharmaceutical Delivery Systems
Lilly Corporate Center
Indianapolis, IN 46285, USA
US License Number 1891
Eli Lilly Nederland B.V.
Papendorpseweg 83
3528 BJ UTRECHT
The Netherlands
HUMATROPE® and HumatroPen® 24 mg are registered trademarks of Eli Lilly and Company.
| The HumatroPen® 24 mg meets the current dose accuracy and functional requirements of ISO 11608-1 and is for use with HUMATROPE® 24 mg Cartridges only. |
Copyright © 2009, 2025, Eli Lilly and Company. All rights reserved.
Revised: November 2025
Non-harmonized Symbol Glossary1
1 Glossary includes non-harmonized symbols used in the labeling.
2 Symbol used only on the carton.
HTRPEN24-0006-IFU-20251125
6 mg
Cartridge Kit
NDC 0002-8147-01
MS 8147
Humatrope®
(somatropin) for injection
6 mg
Cartridge Kit
Single-Patient-Use
For use ONLY with the Humatrope® 6 mg injection device supplied separately
Rx only
Refrigerate
Do Not Freeze
Do Not Shake
Kit contains:
One Humatrope Cartridge 6 mg
One Prefilled Diluent Syringe
Lilly
12 mg
Cartridge Kit
NDC 0002-8148-01
MS 8148
Humatrope®
(somatropin) for injection
12 mg
Cartridge Kit
Single-Patient-Use
For use ONLY with the Humatrope® 12 mg injection device
Rx only
Refrigerate
Do Not Freeze
Do Not Shake
Kit contains:
One Humatrope Cartridge 12 mg
One Prefilled Diluent Syringe
Lilly
24 mg
Cartridge Kit
NDC 0002-8149-01
MS 8149
Humatrope®
(somatropin) for injection
24 mg
Cartridge Kit
Single-Patient-Use
For use ONLY with the Humatrope® 24 mg injection device
Rx only
Refrigerate
Do Not Freeze
Do Not Shake
Kit contains:
One Humatrope Cartridge 24 mg
One Prefilled Diluent Syringe
Lilly
Humatrope®
(somatropin) for injection
HumatroPen® 6 mg
Growth Hormone Delivery System
Injection Device for Use with Humatrope® (somatropin) 6 mg Cartridges
HumatroPen® 6 mg is recommended for use with Becton, Dickinson and Company pen needles
Not included: Humatrope® cartridge and Becton, Dickinson and Company pen needles.
Contents
HumatroPen® 6 mg
Pen Case
HumatroPen® 6 mg User Manual
Hidden Needle Cover
Hidden Needle Cover User Manual
REF MS9560
Lilly
Humatrope®
(somatropin) for injection
HumatroPen® 12 mg
Growth Hormone Delivery System
Injection Device for Use with Humatrope® (somatropin) 12 mg Cartridges
HumatroPen® 12 mg is recommended for use with Becton, Dickinson and Company pen needles
Not included: Humatrope® cartridge and Becton, Dickinson and Company pen needles.
Contents
HumatroPen® 12 mg
Pen Case
HumatroPen® 12 mg User Manual
Hidden Needle Cover
Hidden Needle Cover User Manual
REF MS9561
Lilly
Humatrope®
(somatropin) for injection
HumatroPen® 24 mg
Growth Hormone Delivery System
Injection Device for Use with Humatrope® (somatropin) 24 mg Cartridges
HumatroPen® 24 mg is recommended for use with Becton, Dickinson and Company pen needles
Not included: Humatrope® cartridge and Becton, Dickinson and Company pen needles.
Contents
HumatroPen® 24 mg
Pen Case
HumatroPen® 24 mg User Manual
Hidden Needle Cover
Hidden Needle Cover User Manual
REF MS9562
Lilly
| Product concept | Relation | Version | Effective |
|---|---|---|---|
| 79c101e4-e5e3-43d7-be20-f7477d1e7556 | Product name | 1 | 20241230 |
| 34b7b043-6d89-4d95-9bed-7f5f2b49e6ef | Product name | 2 | 20200325 |
| 37e0ae3d-ccb0-0ec8-fae8-e1f0917a8a04 | Product name | 2 | 20200325 |
| 739a54c2-5f56-495a-aa67-4295fbc1cc86 | Product name | 2 | 20200325 |
| 0ca1d589-929b-4b33-bc5b-1d84abdafa6a | Product name | 1 | 20150324 |
| fc363c46-397b-4476-ac0f-70e43e8e4592 | Product name | 1 | 20150324 |
| Package NDC | Billing unit | Product NDC | DailyMed indexing SPL | SPL version | Effective |
|---|---|---|---|---|---|
| 0002-8147-01 | EA - Each | 0002-8147 | cabb52b8-bea9-4e6d-bce8-67dc3b21ad18 | 1 | 2012-07-24 |
| 0002-8148-01 | EA - Each | 0002-8148 | c2698c4b-a07a-4e2b-aa0c-1a93f6af4ad4 | 1 | 2012-07-24 |
| 0002-8149-01 | EA - Each | 0002-8149 | 3c1bd126-2fe5-45c7-bb23-ea0fc5272ba1 | 1 | 2012-07-24 |
| Ingredient | Type | UNII | SPL version | Uploaded |
|---|---|---|---|---|
| Somatropin | ACTIVE INGREDIENT | NQX9KB6PCL | 24 | |
| Somatropin | ACTIVE MOIETY | NQX9KB6PCL | 24 | |
| glycine | INACTIVE INGREDIENT | TE7660XO1C | 24 | |
| mannitol | INACTIVE INGREDIENT | 3OWL53L36A | 24 | |
| phosphoric acid | INACTIVE INGREDIENT | E4GA8884NN | 24 | |
| sodium hydroxide | INACTIVE INGREDIENT | 55X04QC32I | 24 | |
| sodium phosphate, dibasic | INACTIVE INGREDIENT | GR686LBA74 | 24 |
Every source-derived product name is available through these pages.
| Product NDC | Package NDC |
|---|---|
| 0002-8147 | 0002-8147-01 |
| 0002-7554 | 0002-7554-01 |
| 0002-7618 | 0002-7618-01 |
| 0002-8148 | 0002-8148-01 |
| 0002-7555 | 0002-7555-01 |
| 0002-7619 | 0002-7619-01 |
| 0002-8149 | 0002-8149-01 |
| 0002-7556 | 0002-7556-01 |
| BLA | Proprietary name | Proper name | License type | Status | Latest source |
|---|---|---|---|---|---|
| 019640 | Humatrope | somatropin | 351(a) | Disc | 2026-09-01 |
Every source-derived ingredient row is available through these pages.
| Version | Effective date | Source | Hydrated |
|---|---|---|---|
| 44 | 2025-11-25 | full-release | 2026-05-31 21:49:27 |
Inactive Ingredient Database values describe FDA-listed use contexts. The match method and ambiguity count are shown because ingredient names, routes, and dosage forms are not always unique. Browse recovered IID releases and source provenance.
| DailyMed ingredient | IID ingredient | UNII | Dosage form / route | Potency | Maximum daily exposure | Match |
|---|---|---|---|---|---|---|
| glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 40 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| sodium phosphate, dibasic | SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | INJECTION / INTRAMUSCULAR | 40 mg | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| glycine | GLYCINE | TE7660XO1C | INJECTION / INTRAMUSCULAR | 68 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBCUTANEOUS | 99 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAMUSCULAR | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | POWDER, FOR SUSPENSION / INTRAMUSCULAR | 6.75 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAMUSCULAR | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION / SUBCUTANEOUS | 675 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 35 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / SUBCUTANEOUS | 1 %w/v | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 27 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / INTRAMUSCULAR | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION / SUBCUTANEOUS | 4.54 %w/v | ||
| glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 10 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | NA | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 164 mg | ||
| glycine | GLYCINE | TE7660XO1C | INJECTION / INTRAMUSCULAR | 68 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION / SUBCUTANEOUS | 675 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 300 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 0.5 mg | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION / INTRAMUSCULAR | ADJ PH | ||
| glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 40 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAMUSCULAR | 71 mg | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | ADJ PH | ||
| glycine | GLYCINE | TE7660XO1C | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 40 mg | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / SUBCUTANEOUS | 658 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / INTRAMUSCULAR | 164 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 5.4 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SOLUTION / SUBCUTANEOUS | 35 mg | ||
| sodium phosphate, dibasic | SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | INJECTION / INTRAMUSCULAR | 40 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, LYOPHILIZED, FOR SOLUTION / INTRAMUSCULAR | 113 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 105 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 27 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION / INTRAMUSCULAR | 106.6 mg | ||
| sodium phosphate, dibasic | SODIUM PHOSPHATE, DIBASIC | GR686LBA74 | INJECTION / INTRAMUSCULAR | 40 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION / SUBCUTANEOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | 7.01 mg | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SOLUTION / SUBCUTANEOUS | 99 mg | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION / INTRAMUSCULAR | ADJ PH | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION, POWDER, FOR SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION, EXTENDED RELEASE / INTRAMUSCULAR | 105 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAMUSCULAR | 78 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | INJECTION, SOLUTION / INTRAMUSCULAR | 78 mg | ||
| phosphoric acid | PHOSPHORIC ACID | E4GA8884NN | INJECTION / SUBCUTANEOUS | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SUSPENSION, EXTENDED RELEASE / SUBCUTANEOUS | NA | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, POWDER, FOR SUSPENSION / SUBCUTANEOUS | 180 mg | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | LIQUID / INTRAMUSCULAR | ADJ PH | ||
| sodium hydroxide | SODIUM HYDROXIDE | 55X04QC32I | SOLUTION / INTRAMUSCULAR | ADJ PH | ||
| mannitol | MANNITOL | 3OWL53L36A | SOLUTION / SUBCUTANEOUS | 4.54 %w/v | ||
| mannitol | MANNITOL | 3OWL53L36A | INJECTION, SUSPENSION / INTRAMUSCULAR | 71 mg |
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 |
|---|---|---|---|---|---|---|
| HUMATROPE | SOMATROPIN | Eli Lilly and Company | a774e1ae-3997-49ee-8b0e-99a2b315d409 | 2026-08-20 | Warnings, Adverse reactions | 0002-7618-01 0002-7554-01 0002-7556-01 0002-7619-01 0002-7555-01 0002-8147-01 0002-8148-01 0002-8149-01 0002-8149 0002-8148 0002-8147 00002814701 00002755601 00002755401 00002761801 00002755501 00002761901 00002814901 00002814801 32f865e2-68df-47bc-b392-21b696a9f845 a774e1ae-3997-49ee-8b0e-99a2b315d409 |
Adverse event summaries are temporarily unavailable. Other product information remains available.
