Side Effect Reporting

You may report side effects to the FDA at (800) FDA-1088 or www.fda.gov/medwatch.

You may also report side effects to Genentech at (888) 835-2555.

Indication

Nutropin therapy is indicated for the treatment of pediatric patients who have short stature or growth failure as a result of:

  • Growth hormone deficiency (GHD)
  • Idiopathic short stature (ISS), defined by height standard deviation score ≤ -2.25, associated with growth rates unlikely to result in normal adult height, in whom other causes of short stature have been excluded
  • Turner syndrome (TS)
  • Chronic kidney disease (CKD) up to the time of renal transplantation

Nutropin therapy is indicated for the replacement of endogenous GH in adults with GH deficiency, either:

  • Adult-onset, as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma; or
  • Childhood-onset. Patients treated for GH deficiency in childhood who have closed epiphyses should be reevaluated

Important Safety Information

CONTRAINDICATIONS

Acute Critical Illness: Somatropin should not be used to treat patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure. A significant increase in mortality has been reported in such cases.

Prader-Willi Syndrome (PWS) in Children: Somatropin is contraindicated in pediatric patients with PWS who are severely obese, have a history of upper airway obstruction or sleep apnea, or have severe respiratory impairment. There have been reports of sudden death after initiation of somatropin treatment in such patients. Nutropin AQ is not indicated for the treatment of pediatric patients who have growth failure due to genetically confirmed PWS.

Active Malignancy: Somatropin is contraindicated in patients with any evidence of active malignancy. Growth hormone deficiency may be an early sign of a pituitary tumor or other intracranial tumor; the presence of such a tumor should be excluded before initiation of somatropin treatment.

Hypersensitivity: Nutropin AQ is contraindicated in patients with a known hypersensitivity to somatropin or any of its excipients.

Diabetic Retinopathy: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.

Closed Epiphysis: Somatropin should not be used for growth promotion in pediatric patients with closed epiphysis.

WARNINGS AND PRECAUTIONS

Acute Critical Illness: Evaluate potential benefit of treatment continuation against potential risk.

Prader-Willi Syndrome (PWS) in Children: Evaluate for signs of upper airway obstruction and sleep apnea before initiating therapy. Discontinue treatment if these signs occur.

Neoplasms: Patients with a history of GHD secondary to an intracranial neoplasm should be monitored routinely while on somatropin therapy for progression or recurrence of the tumor. Because children with certain rare genetic causes of short stature have an increased risk of developing malignancies, these patients should be carefully monitored for development of neoplasms, if treatment with somatropin is initiated. Patients on somatropin therapy should be monitored carefully for increased growth, or potential malignant changes, of preexisting nevi.

Impaired Glucose Tolerance (IGT) and Diabetes Mellitus (DM): Periodically monitor glucose levels in all patients as IGT and DM may be unmasked during somatropin therapy. Patients with pre-existing type 1 or type 2 DMor IGT should be monitored closely during somatropin treatment. Doses of concurrent antihyperglycemic drugs in patients with DM may require adjustment.

Intracranial Hypertension (IH): Funduscopic examination should be performed routinely before initiating treatment with somatropin to exclude preexisting papilledema, and periodically during the course of somatropin therapy. In all reported cases, IH-associated signs and symptoms resolved after somatropin discontinuation or dose reduction. Patients with TS, CKD, and PWS may be at increased risk for the development of IH.

Severe Hypersensitivity: Serious systemic hypersensitivity reactions may occur. Patients and caregivers should be informed of such reactions and prompt medical attention should be sought when an allergic reaction occurs.

Fluid Retention: Clinical manifestations of fluid retention are usually transient and dose dependent.

Hypoadrenalism: Monitor patients for reduced serum cortisol levels and/or need for glucocorticosteroid dose increase in those with known hypoadrenalism.

Hypothyroidism: Thyroid function should be tested periodically and thyroid hormone replacement therapy should be initiatied or adjusted when indicated.

Slipped Capital Femoral Epiphysis in Pediatric Patients (SCFE): Any pediatric patient with the onset of a limp or complaints of hip or knee pain during somatropin therapy should be carefully evaluated.

Progression of Pre-existing Scoliosis in Pediatric Patients: Monitor any child with scoliosis for progression of the curve.

Otitis Media and Cardiovascular Disorders in Patients with Turner Syndrome: Patients with TS should be evaluated carefully for otitis media, other ear disorders, and cardiovascular disorders.

Osteodystrophy in Pediatric Patients with Chronic Kidney Disease: Children with growth failure secondary to CKD should be examined periodically for evidence of progression of renal osteodystrophy.

Lipoatrophy: Injection site should be rotated to avoid tissue atrophy

Laboratory Tests: Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone and IGF-I may increase during somatropin therapy.

Pancreatitis: Consider pancreatitis in patients with persistent severe abdominal pain.

DRUG INTERACTIONS

Somatropin inhibits 11ß-hydroxysteroid dehydrogenase type 1 (11ßHSD-1) in adipose/hepatic tissue and may significantly impact the metabolism of cortisol and cortisone. As a consequence, in patients treated with somatropin, previously undiagnosed central (secondary) hypoadrenalism may be unmasked, requiring glucocorticoid replacement therapy.

Careful monitoring is advisable when somatropin is administered in combination with insulin and/or other hypoglycemic agents, other drugs metabolized by CYP450 liver enzymes (eg, hydrocortisone or other corticosteroids, sex steroids, anticonvulsants, cyclosporine), or other hormone replacement therapy.

USE IN SPECIFIC POPULATIONS

Pregnancy/Nursing Mothers: Somatropin should be used during pregnancy only if clearly needed and with caution in nursing mothers because it is not known whether somatropin is excreted in human milk.

Geriatric Use: Clinical studies of somatropin did not include sufficient numbers of subjects aged 65 years and over to determine whether they respond differently from younger patients.

ADVERSE REACTIONS

Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions. Additional common adverse reactions in adults include edema, arthralgia, and carpal tunnel syndrome.

You may report side effects to FDA at (800) FDA-1088 or www.fda.gov/medwatch. You may also report side effects to Genentech at (888) 835-2555.

Please click here for Nutropin full Prescribing Information for additional Important Safety Information.