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GENOTROPIN (somatropin [rDNA origin] for injection)
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 [rDNA origin] for injection)
Initial U.S. Approval: 1987
RECENT MAJOR CHANGES
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Warnings and Precautions, Neoplasms (5.3) |
9/2014 |
INDICATIONS AND USAGE
GENOTROPIN is a recombinant human growth hormone indicated for:
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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)
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Adult: Treatment of adults with either adult onset or childhood onset GHD (1.2)
DOSAGE AND ADMINISTRATION
GENOTROPIN should be administered subcutaneously (2)
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Pediatric GHD: 0.16 to 0.24 mg/kg/week (2.1)
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Prader-Willi Syndrome: 0.24 mg/kg/week (2.1)
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Small for Gestational Age: Up to 0.48 mg/kg/week (2.1)
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Turner Syndrome: 0.33 mg/kg/week (2.1)
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Idiopathic Short Stature: up to 0.47 mg/kg/week (2.1)
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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)
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Non-weight based dosing: A starting dose of approximately 0.2mg/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)
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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)
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GENOTROPIN cartridges are color-coded to correspond to a specific GENOTROPIN PEN delivery device (2.3)
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Injection sites should always be rotated to avoid lipoatrophy (2.3)
DOSAGE FORMS AND STRENGTHS
GENOTROPIN lyophilized powder in a two-chamber color-coded cartridge (3):
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5 mg (green tip) and 12 mg (purple tip) (with preservative)
GENOTROPIN MINIQUICK Growth Hormone Delivery Device containing a two-chamber cartridge (without preservative):
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0.2 mg, 0.4 mg, 0.6 mg, 0.8 mg, 1.0 mg, 1.2 mg, 1.4 mg, 1.6 mg, 1.8 mg, and 2.0 mg
CONTRAINDICATIONS
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Acute Critical Illness (4.1, 5.1)
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Children with Prader-Willi syndrome who are severely obese or have severe respiratory impairment – reports of sudden death (4.2, 5.2)
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Active Malignancy (4.3)
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Active Proliferative or Severe Non-Proliferative Diabetic Retinopathy (4.4)
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Children with closed epiphyses (4.5)
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Known hypersensitivity to somatropin or m-cresol (4.6)
WARNINGS AND PRECAUTIONS
Acute Critical Illness: Potential benefit of treatment continuation should be weighed against the potential risk (5.1).
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Prader-Willi syndrome in Children: eva luate for signs of upper airway obstruction and sleep apnea before initiation of treatment.
Discontinue treatment if these signs occur (5.2).
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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).
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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).
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Intracranial Hypertension: Exclude preexisting papilledema. May develop and is usually reversible after discontinuation or dose reduction (5.5).
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Fluid Retention (i.e., edema, arthralgia, carpal tunnel syndrome – especially in adults): May occur frequently. Reduce dose as necessary (5.6).
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Hypopituitarism: Closely monitor other hormone replacement therapies (5.7).
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Hypothyroidism: May first become evident or worsen (5.8).
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Slipped Capital Femoral Epiphysis: May develop. eva luate children with the onset of a limp or hip/knee pain (5.9).
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Progression of Preexisting Scoliosis: May develop (5.10)
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Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain (5.14).
ADVERSE REACTIONS
Other common somatropin-related adverse reactions include injection site reactions/rashes and lipoatrophy (6.1) and headaches (6.3).
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).
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Glucocorticoid Replacement: Should be carefully adjusted (7.2)
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Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin (7.3)
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Oral Estrogen: Larger doses of somatropin may be required in women (7.4)
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Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment (7.5)
See 17 for PATIENT COUNSELING INFORMATION.
Revised: 5/2015
FULL PRESCRIBING INFORMATION: CONTENTS*
1 INDICATIONS AND USAGE
1.1 Pediatric Patients
GENOTROPIN (somatropin [rDNA origin] for injection) is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of endogenous growth hormone.
GENOTROPIN (somatropin [rDNA origin] for injection) is indicated for the treatment of pediatric patients who have growth failure due to Prader-Willi syndrome (PWS). The diagnosis of PWS should be confirmed by appropriate genetic testing (see CONTRAINDICATIONS).
GENOTROPIN (somatropin [rDNA origin] for injection) is indicated for the treatment of growth failure in children born small for gestational age (SGA) who fail to manifest catch-up growth by age 2 years.
GENOTROPIN (somatropin [rDNA origin] for injection) is indicated for the treatment of growth failure associated with Turner syndrome.
GENOTROPIN (somatropin [rDNA origin] for injection) is indicated for the treatment of idiopathic short stature (ISS), also called non-growth hormone-deficient short stature, defined by height standard deviation score (SDS) ≤-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients whose epiphyses are not closed and for whom diagnostic eva luation excludes other causes associated with short stature that should be observed or treated by other means.
1.2 Adult Patients
GENOTROPIN (somatropin [rDNA origin] for injection) is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
Adult Onset (AO): Patients who have growth hormone deficiency, either alone or associated with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
Childhood Onset (CO): Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes.
Patients who were treated with somatropin for growth hormone deficiency in childhood and whose epiphyses are closed should be reeva luated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.
2 DOSAGE AND ADMINISTRATION
The weekly dose should be divided into 6 or 7 subcutaneous injections. GENOTROPIN must not be injected intravenously.
Therapy with GENOTROPIN should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Prader-Willi syndrome (PWS), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.
2.1 Dosing of Pediatric Patients
General Pediatric Dosing Information
The GENOTROPIN dosage and administration schedule should be individualized based on the growth response of each patient.
Response to somatropin therapy in pediatric patients tends to decrease with time. However, in pediatric patients, the failure to increase growth rate, particularly during the first year of therapy, indicates the need for close assessment of compliance and eva luation for other causes of growth failure, such as hypothyroidism, undernutrition, advanced bone age and antibodies to recombinant human GH (rhGH).
Treatment with GENOTROPIN for short stature should be discontinued when the epiphyses are fused.
Pediatric Growth Hormone Deficiency (GHD)
Generally, a dose of 0.16 to 0.24 mg/kg body weight/week is recommended.
Prader-Willi Syndrome
Generally, a dose of 0.24 mg/kg body weight/week is recommended.
Turner Syndrome
Generally, a dose of 0.33 mg/kg body weight/week is recommended.
Idiopathic Short Stature
Generally, a dose up to 0.47 mg/kg body weight/week is recommended.
Small for Gestational Age1
Generally, a dose of up to 0.48 mg/kg body weight/week is recommended.
2.2 Dosing of Adult Patients
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