GENOTROPIN® Highlights

(somatropin)

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GENOTROPIN safely and effectively. See full prescribing information for GENOTROPIN

GENOTROPIN (somatropin) for injection, for subcutaneous use
Initial U.S. Approval: 1987

INDICATIONS AND USAGE

GENOTROPIN is a recombinant human growth hormone indicated for:

Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1)
Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2)

DOSAGE AND ADMINISTRATION

GENOTROPIN should be administered subcutaneously (2)

Pediatric GHD: 0.16 to 0.24 mg/kg/week (2.1)
Prader-Willi Syndrome: 0.24 mg/kg/week (2.1)
Small for Gestational Age: Up to 0.48 mg/kg/week (2.1)
Turner Syndrome: 0.33 mg/kg/week (2.1)
Idiopathic Short Stature: up to 0.47 mg/kg/week (2.1)
Adult GHD: Either a non-weight based or a weight based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-I concentrations (2.2)
Non-weight based dosing: A starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight, and increased gradually every 1–2 months by increments of approximately 0.1–0.2 mg/day. (2.2)
Weight based dosing: The recommended initial dose is not more than 0.04 mg/kg/week; the dose may be increased as tolerated to not more than 0.08 mg/kg/week at 4–8 week intervals. (2.2)
GENOTROPIN cartridges are color-coded to correspond to a specific GENOTROPIN PEN delivery device (2.3)
Injection sites should always be rotated to avoid lipoatrophy (2.3)

DOSAGE FORMS AND STRENGTHS

For injection: 5 mg or 12 mg lyophilized powder in a single‑patient‑use two‑chamber cartridge (3)

For injection: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg lyophilized powder in a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge (GENOTROPIN MINIQUICK) (3)

CONTRAINDICATIONS

Acute Critical Illness (4)
Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death (4)
Active Malignancy (4)
Hypersensitivity to somatropin or excipients (4)
Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy (4)
Children with closed epiphyses (4)

WARNINGS AND PRECAUTIONS

Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk (5.1)
Prader-Willi Syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment
Discontinue treatment if these signs occur (5.2)
Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin in particular meningiomas in patients treated with radiation to the head for their first neoplasm (5.3)
Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked
Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment (5.4)
Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction (5.5)
Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention (5.6)
Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome – especially in adults): May occur frequently. Reduce dose as necessary (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: May first become evident or worsen. Monitor thyroid function periodically (5.9)
Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain (5.10)
Progression of Preexisting Scoliosis: Monitor any child with scoliosis for progression of the curve (5.11)
Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain (5.15)

ADVERSE REACTIONS

Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.2).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses (7.1, 7.2).

Glucocorticoid Replacement: Should be carefully adjusted (7.2)
Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin (7.3)
Oral Estrogen: Larger doses of somatropin may be required in women (7.4)
Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment (7.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2024

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Highlights

HIGHLIGHTS OF PRESCRIBING INFORMATION

These highlights do not include all the information needed to use GENOTROPIN safely and effectively. See full prescribing information for GENOTROPIN

GENOTROPIN (somatropin) for injection, for subcutaneous use
Initial U.S. Approval: 1987

INDICATIONS AND USAGE

GENOTROPIN is a recombinant human growth hormone indicated for:

Pediatric: Treatment of children with growth failure due to growth hormone deficiency (GHD), Prader-Willi syndrome, Small for Gestational Age, Turner syndrome, and Idiopathic Short Stature (1.1)
Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2)

DOSAGE AND ADMINISTRATION

GENOTROPIN should be administered subcutaneously (2)

Pediatric GHD: 0.16 to 0.24 mg/kg/week (2.1)
Prader-Willi Syndrome: 0.24 mg/kg/week (2.1)
Small for Gestational Age: Up to 0.48 mg/kg/week (2.1)
Turner Syndrome: 0.33 mg/kg/week (2.1)
Idiopathic Short Stature: up to 0.47 mg/kg/week (2.1)
Adult GHD: Either a non-weight based or a weight based dosing regimen may be followed, with doses adjusted based on treatment response and IGF-I concentrations (2.2)
Non-weight based dosing: A starting dose of approximately 0.2 mg/day (range, 0.15–0.30 mg/day) may be used without consideration of body weight, and increased gradually every 1–2 months by increments of approximately 0.1–0.2 mg/day. (2.2)
Weight based dosing: The recommended initial dose is not more than 0.04 mg/kg/week; the dose may be increased as tolerated to not more than 0.08 mg/kg/week at 4–8 week intervals. (2.2)
GENOTROPIN cartridges are color-coded to correspond to a specific GENOTROPIN PEN delivery device (2.3)
Injection sites should always be rotated to avoid lipoatrophy (2.3)

DOSAGE FORMS AND STRENGTHS

For injection: 5 mg or 12 mg lyophilized powder in a single‑patient‑use two‑chamber cartridge (3)

For injection: 0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, or 2 mg lyophilized powder in a single-dose Growth Hormone Delivery Device containing a two-chamber cartridge (GENOTROPIN MINIQUICK) (3)

CONTRAINDICATIONS

Acute Critical Illness (4)
Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death (4)
Active Malignancy (4)
Hypersensitivity to somatropin or excipients (4)
Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy (4)
Children with closed epiphyses (4)

WARNINGS AND PRECAUTIONS

Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk (5.1)
Prader-Willi Syndrome in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiation of treatment
Discontinue treatment if these signs occur (5.2)
Neoplasm: Monitor patients with preexisting tumors for progression or recurrence. Increased risk of a second neoplasm in childhood cancer survivors treated with somatropin in particular meningiomas in patients treated with radiation to the head for their first neoplasm (5.3)
Impaired Glucose Tolerance and Diabetes Mellitus: May be unmasked
Periodically monitor glucose levels in all patients. Doses of concurrent antihyperglycemic drugs in diabetics may require adjustment (5.4)
Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction (5.5)
Hypersensitivity: Serious hypersensitivity reactions may occur. In the event of an allergic reaction, seek prompt medical attention (5.6)
Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome – especially in adults): May occur frequently. Reduce dose as necessary (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: May first become evident or worsen. Monitor thyroid function periodically (5.9)
Slipped Capital Femoral Epiphysis: May develop. Evaluate children with the onset of a limp or hip/knee pain (5.10)
Progression of Preexisting Scoliosis: Monitor any child with scoliosis for progression of the curve (5.11)
Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain (5.15)

ADVERSE REACTIONS

Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.2).

To report SUSPECTED ADVERSE REACTIONS, contact Pfizer Inc. at 1-800-438-1985 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

DRUG INTERACTIONS

Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses (7.1, 7.2).

Glucocorticoid Replacement: Should be carefully adjusted (7.2)
Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin (7.3)
Oral Estrogen: Larger doses of somatropin may be required in women (7.4)
Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment (7.5)

See 17 for PATIENT COUNSELING INFORMATION.

Revised: 8/2024

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