HUMATROPE Somatropin Kit
🆔 Identity & classification
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🏷️ RxNorm drug class
This medicine belongs to the Recombinant Human Growth Hormone class.
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🏭 Manufacturer & labeler
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🩺 Clinical
Somatropin injection is used to treat growth failure caused by growth hormone deficiency and certain other conditions to increase body weight and endurance in certain people with human immunodeficiency virus (HIV) infection to treat short bowel syndrome in adults who need special nutrition therapy Somatropin is a human growth hormone (hGH) analog. It works by replacing growth hormones that are normally produced in the body, which may result in increased growth, body weight, and improved absorption of nutrients and fluids from the intestines.
Read the full MedlinePlus article ↗- Somatropin is a lab-made version of the growth hormone your body naturally produces. Your doctor has likely prescribed it because your body — or your child's body — isn't making en...
- What exactly is somatropin and why has my doctor prescribed it?
- You'll inject it just under the skin — not into a vein or deep muscle. Common spots are the belly, thigh, upper arm, or buttock. The most important habit to get into is rotating yo...
- How do I give the injection, and does it hurt?
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🧪 Inactive Ingredients / Excipients
Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.
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💲 Pricing
A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.
| Price system | Per each | Per package |
|---|---|---|
| Retail pharmacies payNADAC · weekly | Not in the retail survey — common for institutional, discontinued, or low-volume packs. | |
| Medicaid paysCMS SDUD · 12 mo | $1,768.29 | — |
| Medicare drug plans payPart D · Q2 2026 | $1,764.42 | — |
| Medicare Part B allowsASP · J2941 | No ASP payment limit on file for J2941 this quarter. | |
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🧾 Billing & reimbursement
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🔁 Therapeutic equivalents
| Product | Labeler | Pack | NADAC/unit | TE | Status | Price vs. this |
|---|---|---|---|---|---|---|
| Humatropethis 00002-8148-01 | Eli | 1 kit | — | — | FDA listed | — |
| Humatrope 00002-8147-01 | Eli | 1 kit | — | — | FDA listed | — |
| Humatrope 00002-8149-01 | Eli | 1 kit | — | — | FDA listed | — |
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⏳ Availability & biosimilar status
Biologics have no small-molecule generics; biosimilar competition is tracked in the FDA Purple Book.
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🗺️ Medicaid utilization & spend
📊 Medicare Part D spend CMS · PART D · 2026 (Q1)
🔬 Reported adverse events (FAERS)
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📦 Packaging — all sizes for this product
| Package NDC | Description | Marketing start | Status |
|---|---|---|---|
| 00002-8148-01 You're viewing this | 1 TRAY in 1 CARTON (0002-8148-01) / 1 KIT in 1 TRAY * 2.88 mL in 1 CARTRIDGE (0002-7555-01) * 2.88 mL in 1 SYRINGE (0002-7619-01) | 2006-01-27 | Active |
🧭 About this NDC listing & data coverage
Kit / multi-component package
This NDC identifies a kit — a package containing more than one component. Structured data (pricing, ingredients, equivalents) is often reported per component rather than for the kit NDC itself, which can make this page look thinner than the components' own pages.
What data is (and isn’t) available for this NDC — tap to expand
| NDC identity (package / product / labeler codes) | ✓ Available |
| Labeler | ✓ Available |
| Product & package description | ✓ Available |
| Marketing category & status | ✓ Available |
| Active ingredient / dosage form / route | ✓ Available |
| FDA label (SPL via DailyMed) | ✓ Available |
| Package photos | ✓ Available |
| Inactive ingredients (structured) | — Not published for this NDC The labeler did not submit a structured excipient list, or no SPL is available. |
| NADAC pharmacy acquisition price (CMS) | — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey. |
| Orange Book / therapeutic-equivalence data | — Not published for this NDC Applies only to products approved under an NDA/ANDA; many listings are out of scope. |
| HCPCS J-code billing crosswalk | ✓ Available |
| Medicaid utilization (CMS SDUD) | ✓ Available |
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📄 Full prescribing information FDA SPL
🎯 Indications and Usage ▾
1 INDICATIONS AND USAGE HUMATROPE is a recombinant human growth hormone indicated for: Pediatric Patients: 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) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range; short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency; short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.
( 1.1 ) Adult Patients: replacement of endogenous GH in adults with GH deficiency. ( 1.2 )
1.1Pediatric Patients 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) <-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, short stature or growth failure in short stature homeobox-containing gene (SHOX) deficiency, short stature born small for gestational age (SGA) with no catch-up growth by 2 years to 4 years of age.
1.2Adult Patients HUMATROPE is indicated for the replacement of endogenous GH in adults with GH deficiency.
⏱️ Dosage and Administration ▾
2 DOSAGE AND ADMINISTRATION Administer by subcutaneous injection to the back of upper arm, abdomen, buttock, or thigh with regular rotation of injection sites. ( 2.1 ) Pediatric Dosage - divide the calculated weekly dosage into equal doses given either 6, or 7 days per week. GHD: 0.18 mg/kg/week to 0.3 mg/kg/week.
( 2.2 ) Turner Syndrome: Up to 0.375 mg/kg/week. ( 2.2 ) ISS: Up to 0.37 mg/kg/week. ( 2.2 ) SHOX Deficiency: 0.35 mg/kg/week.
( 2.2 ) SGA: Up to 0.47 mg/kg/week. ( 2.2 ) Adult Dosage - Either of the following two dosing regimens may be used: Non-weight based dosing: Initiate with a dose of approximately 0.2 mg/day (range: 0.15 mg/day-0.3 mg/day) and increase the dose every 1-2 months by increments of approximately 0.1 mg/day-0.2 mg/day, according to individual patient requirements ( 2.3 ) Weight-based dosing (Not recommended for obese patients): Initiate at 0.006 mg/kg daily and increase the dose according to individual patient requirements to a maximum of 0.0125 mg/kg daily ( 2.3 ) See Full Prescribing Information for reconstitution instructions.
( 2.4 )
2.1Administration and Use Instructions 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 )] . Leave HUMATROPE at room temperature for 10 minutes prior to administration.
Administer HUMATROPE by subcutaneous injection to the back of the upper arm, abdomen, buttock, or thigh with regular rotation of injection sites to avoid lipoatrophy.
2.2Pediatric Dosage Individualize dosage for each patient based on the growth response. Divide the calculated weekly HUMATROPE dosage into equal doses given either 6 or 7 days per week. The recommended weekly dose in milligrams (mg) per kilogram (kg) of body weight for pediatric patients is: Pediatric GH Deficiency: 0.18 mg/kg/week to 0.3 mg/kg/week (0.026 to 0.043 mg/kg/day) Turner Syndrome: Up to 0.375 mg/kg/week (up to.054 mg/kg/day) Idiopathic Short Stature: Up to 0.37 mg/kg/week (up to 0.053 mg/kg/day) SHOX Deficiency: 0.35 mg/kg/week (0.05 mg/kg/day) Small for Gestational Age (SGA): Up to 0.47 mg/kg/week (up to 0.067 mg/kg/day) In very short pediatric patients, height SDS less than -3, and older pubertal pediatric patients consider initiating treatment with a larger dose of HUMATROPE (up to 0.067 mg/kg/day).
Consider a gradual reduction in dosage if substantial catch-up growth is observed during the first few years of therapy. In pediatric patients less than 4 years of age with less severe short stature, baseline height SDS values between -2 and -3, consider initiating treatment at 0.033 mg/kg/day and titrate the dose as needed. Assess compliance and evaluate other causes of poor growth such as hypothyroidism, under-nutrition, advanced bone age and antibodies to recombinant human GH if patients experience failure to increase height velocity, particularly during the first year of treatment.
Discontinue HUMATROPE for stimulation of linear growth once epiphyseal fusion has occurred [see Contraindications ( 4 )] .
2.3Adult Dosage Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin for GH deficient adults. Consider using a lower starting dose and smaller dose increment increases for geriatric patients as they may be at increased risk for adverse reactions with HUMATROPE than younger individuals [see Use in Specific Populations ( 8.5 )] . Women may require higher doses and patients receiving oral estrogen may require higher doses [see Drug Interactions ( 7 )] .
Administer the prescribed dose daily. Either of two HUMATROPE dosing regimens may be used: Non-weight based: Initia…
💊 Dosage Forms and Strengths ▾
3 DOSAGE FORMS AND STRENGTHS 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: For injection: 6 mg in a single-patient-use cartridge (gold) For injection: 12 mg in a single-patient-use cartridge (teal) For injection: 24 mg in a single-patient-use cartridge (purple) For injection: 6 mg, 12 mg, or 24 mg lyophilized powder in a single-patient-use cartridge for reconstitution.
( 3 )
⛔ Contraindications ▾
4 CONTRAINDICATIONS HUMATROPE is contraindicated in patients with: Acute critical illness after open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure due to the risk of increased mortality with use of pharmacologic doses of somatropin [see Warnings and Precautions ( 5.1 )] . Pediatric patients with Prader-Willi syndrome who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to the risk of sudden death [see Warnings and Precautions ( 5.2 )] .
Active malignancy [see Warnings and Precautions ( 5.3 )] . Known hypersensitivity to somatropin or any of the excipients in HUMATROPE. Systemic hypersensitivity reactions have been reported with postmarketing use of somatropins [see Warnings and Precautions ( 5.6 )] .
Active proliferative or severe non-proliferative diabetic retinopathy. Pediatric patients with closed epiphyses. Acute critical illness.
( 4 ) Pediatric patients with Prader-Willi syndrome who are severely obese, have history of upper airway obstruction or sleep apnea, or have severe respiratory impairment due to risk of sudden death. ( 4 ) Active malignancy. ( 4 ) Hypersensitivity to somatropin or excipients.
( 4 ) Active proliferative or severe non-proliferative diabetic retinopathy. ( 4 ) Pediatric patients with closed epiphyses. ( 4 )
⚠️ Warnings and Cautions ▾
5 WARNINGS AND PRECAUTIONS Increased Risk of Neoplasm: Second neoplasms have occurred in childhood cancer survivors. Monitor patients with preexisting tumors for progression or recurrence. ( 5.3 ) Glucose Intolerance and Diabetes Mellitus: HUMATROPE may decrease insulin sensitivity, particularly at higher doses.
Monitor glucose levels periodically in all patients receiving HUMATROPE, especially in patients with existing diabetes mellitus or at risk for development. ( 5.4 ) Intracranial Hypertension (IH): Has been reported usually within 8 weeks of initiation. Perform fundoscopic examinations prior to initiation and periodically thereafter.
If papilledema occurs, stop treatment. ( 5.5 ) Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention.
( 5.6 ) Fluid Retention: May occur in adults and may be dose dependent. ( 5.7 ) Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticoid dose increases in those with known hypoadrenalism. ( 5.8 ) Hypothyroidism: Monitor thyroid function periodically as hypothyroidism may occur or worsen after initiation of somatropin.
( 5.9 ) Slipped Capital Femoral Epiphysis in Pediatric Patients: May occur; evaluate patients with onset of a limp or hip/knee pain. ( 5.10 ) Progression of Preexisting Scoliosis in Pediatric Patients: Monitor patients with scoliosis for progression. ( 5.11 ) Pancreatitis: Has been reported; consider pancreatitis in patients with abdominal pain, especially pediatric patients.
( 5.12 )
5.1Acute Critical Illness 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.
5.2Sudden Death in Pediatric Patients with Prader-Willi Syndrome 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.
5.3Increased Risk of Neoplasms 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 o…
🤒 Adverse Reactions ▾
6 ADVERSE REACTIONS The following important adverse reactions are also described elsewhere in the labeling: Increased mortality in patients with acute critical illness [see Warnings and Precautions ( 5.1 )] Fatalities in children with Prader-Willi syndrome [see Warnings and Precautions ( 5.2 )] Neoplasms [see Warnings and Precautions ( 5.3 )] Glucose intolerance and diabetes mellitus [see Warnings and Precautions ( 5.4 )] Intracranial hypertension [see Warnings and Precautions ( 5.5 )] Severe hypersensitivity [see Warnings and Precautions ( 5.6 )] Fluid retention [see Warnings and Precautions ( 5.7 )] Hypoadrenalism [see Warnings and Precautions ( 5.8 )] Hypothyroidism [see Warnings and Precautions ( 5.9 )] Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions ( 5.10 )] Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions ( 5.11 )] Pancreatitis [see Warnings and Precautions ( 5.12 )] Lipoatrophy [see Warnings and Precautions ( 5.13 )] Common adverse reactions reported in adult and pediatric patients include: upper respiratory infection, fever, pharyngitis, headache, otitis media, edema, arthralgia, paresthesia, myalgia, carpal tunnel syndrome, peripheral edema, flu syndrome, hypothyroidism, hyperglycemia, and impaired glucose tolerance.
( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Eli Lilly and Company at 1-800-LillyRx (1-800-545-5979) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch .
6.1Clinical Studies Experience 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 . Table 2: Adverse Reactions of Special Interest Occurring in Humatrope-Treated Patients with Growth Failure Due to Inadequate Secretion of Endogenous Growth Hormone in an Open-label Study for Up to 8 Years a Dose=0.06 mg/kg 3 times per week for up to 8 years. b n=1 Adverse Reaction HUMATROPE a (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. Table 3: Adverse Reactions of Special Interest Occurring in Patients with Turner Syndrome in an Open-label Study Until Attainment of Adult Height 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. Table 4: Adverse Reactions Occurring in Patients with Idiopathic Short Stature Tre…
🔄 Drug Interactions ▾
7 DRUG INTERACTIONS Table 8 includes a list of drugs with clinically important drug interactions when administered concomitantly with HUMATROPE and instructions for preventing or managing them. Table 8: Clinically Important Drug Interactions with HUMATROPE 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 )]. Replacement Glucocorticoid Treatment: Patients treated with glucocorticoids for hypoadrenalism may require an increase in their maintenance or stress doses following initiation of HUMATROPE. ( 7 ) Non-Replacement Glucocorticoid Treatment in Pediatric Patients: Adjust glucocorticoid dosing in pediatric patients receiving glucocorticoid treatment to avoid both hypoadrenalism and an inhibitory effect on growth.
( 7 ) Cytochrome P450-Metabolized Drugs: HUMATROPE may alter the clearance. Monitor carefully if used with HUMATROPE. ( 7 ) Oral Estrogen: Patients may require larger doses of HUMATROPE.
( 7 ) Insulin and/or Other Hypoglycemic Agents: Dose adjustment of insulin or hypoglycemic agent may be required. ( 5.4 , 7 )
👥 Use in Specific Populations ▾
8 USE IN SPECIFIC POPULATIONS
8.1Pregnancy 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.
8.2Lactation 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.
8.4Pediatric Use 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 )] .
8.5Geriatric Use 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 )] .
🤰 Pregnancy ▾
8.1Pregnancy 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.
🧒 Pediatric Use ▾
8.4Pediatric Use 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 )] .
🧓 Geriatric Use ▾
8.5Geriatric Use 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 )] .
🆘 Overdosage ▾
10 OVERDOSAGE 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.
🧬 Clinical Pharmacology ▾
12 CLINICAL PHARMACOLOGY
12.1Mechanism of Action 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.
12.2Pharmacodynamics 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).
12.3Pharmacokinetics 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) C max of 63.3 (18.2) ng/mL at median T max 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.
12.6Immunogenicity 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 nea…
🧬 Mechanism of Action ▾
12.1Mechanism of Action 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.
📦 How Supplied / Storage and Handling ▾
16 HOW SUPPLIED/STORAGE AND HANDLING Each single-patient-use HUMATROPE cartridge is designed for use only with the appropriate corresponding HumatroPen ® supplied separately.
16.1How Supplied 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 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
16.2Storage and Handling 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.
16.1How Supplied 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 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
📦 Storage and Handling ▾
16.2Storage and Handling 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.
📋 Description ▾
11 DESCRIPTION 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 ): Table 9: Contents of HUMATROPE 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.
💬 Information for Patients ▾
17 PATIENT COUNSELING INFORMATION 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). Neoplasms – Advise childhood cancer survivors/caregivers that individuals treated with brain/head radiation are at increased risk of secondary neoplasms and as a precaution need to be monitored for recurrence.
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. Fluid Retention - Advise patients that fluid retention during HUMATROPE replacement therapy in adults may frequently occur. Inform patients of the clinical manifestations of fluid retention (e.g. edema, arthralgia, myalgia, nerve compression syndromes including carpal tunnel syndrome/paraesthesias) and to report to their healthcare provider any of these signs or symptoms that occur during treatment with HUMATROPE.
Pancreatitis - Advise patients/caregivers that pancreatitis may develop and to report to their healthcare provider any new onset of abdominal pain. Hypoadrenalism - Advise patients/caregivers who have or who are at risk for pituitary hormone deficiency(s) that hypoadrenalism may develop and to report to their healthcare provider if they experience hyperpigmentation, extreme fatigue, dizziness, weakness, or weight loss. Hypothyroidism - Advise patients/caregivers that undiagnosed/untreated hypothyroidism may prevent an optimal response to HUMATROPE.
Advise patients/caregivers they may require periodic thyroid function tests. Intracranial Hypertension - Advise patients/caregivers to report to their healthcare provider any visual changes, headache, and nausea and/or vomiting. Hypersensitivity Reactions – Advise patients/caregivers that serious systemic hypersensitivity reactions (anaphylaxis and angioedema) are possible and that prompt medical attention should be sought if an allergic reaction occurs.
Glucose Intolerance/ Diabetes Mellitus – Advise patients/caregivers that new onset impaired glucose intolerance/diabetes mellitus or exacerbation of preexisting diabetes mellitus can occur and monitoring of blood glucose during treatment with HUMATROPE may be needed. Administration – Counsel patients and parents that they should never share a HumatroPen with another person, even if the needle is changed. Sharing of the pen between patients may pose a risk of transmission of infection.
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