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Contraindications

• Growth hormone (GH) should not be used for growth promotion in pediatric patients with closed epiphyses.
• GH should not be used in patients with active proliferative or severe non-proliferative diabetic retinopathy.
• GH should not be used in patients with active malignancy. Any pre-existing malignancy should be inactive and its treatment complete prior to instituting therapy with growth hormone. GH therapy should be discontinued if there is evidence of recurring activity. GH should not be used in patients with any evidence of progression or recurrence of an underlying intracranial tumor.
• GH 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.
• GH is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment (see WARNINGS in full prescribing information). Unless patients with Prader-Willi syndrome also have a diagnosis of GH deficiency, Nutropin AQ^® [somatropin (rDNA origin) injection] and Nutropin^® [somatropin (rDNA origin) for injection] are not indicated for the long-term treatment of pediatric patients who have growth failure due to genetically confirmed Prader-Willi syndrome.
• Nutropin, when reconstituted with Bacteriostatic Water for Injection, USP (benzyl alcohol preserved), should not be used in newborns or in patients with a known sensitivity to benzyl alcohol. Benzyl alcohol as a preservative in Bacteriostatic Water for Injection, USP, has been associated with toxicity in newborns. When administering Nutropin to newborns, reconstitute with Sterile Water for Injection, USP. USE ONLY ONE DOSE PER NUTROPIN VIAL AND DISCARD THE UNUSED PORTION.

Precautions

General

• Nutropin AQ and Nutropin should be prescribed by physicians experienced in the diagnosis and management of patients with pediatric GH deficiency, adult GH deficiency, Turner syndrome, or chronic renal insufficiency.
• GH may reduce insulin sensitivity, so patients should be monitored for signs of glucose intolerance. For patient with diabetes mellitus or impaired glucose tolerance, doses of antihyperglycemic agents may require adjustment when somatropin therapy is instituted.
• Patients with preexisting tumors or a history of an intracranial lesion should be examined frequently for progression or recurrence of the underlying disease.
  • In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with GH after the first neoplasm. Intracranial tumors, in particular meningiomas, in patients treated with radiation to the head for their first neoplasm, 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.
• Intracranial hypertension (IH) with papilledema, visual changes, headache, nausea, and/or vomiting has been reported in a small number of patients treated with GH products.
  • Symptoms usually occurred within the first 8 weeks of the initiation of GH therapy. IH-associated signs and symptoms resolved after termination of therapy or a reduction of the GH dose in all cases.
  • Funduscopic examination of patients is recommended at the initiation and periodically during the course of GH therapy. If papilledema is observed by funduscopy during GH treatment, treatment should be stopped.
  • If GH-induced IH is diagnosed, treatment with GH can be restarted at a lower dose after IH-associated signs and symptoms have resolved.
  • Patients with Turner syndrome (TS), Prader-Willi syndrome, and Chronic Renal Insufficiency (CRI) may be at increased risk for development of IH.
• In patients with hypopituitarism (multiple hormone deficiencies), standard hormonal replacement therapy should be monitored closely when GH therapy is administered. Special attention should be paid to the evaluation of the integrity of the hypothalamic-pituitary-adrenal axis.
• Patients with TS have an increased risk for developing autoimmune thyroid disease and primary hypothyroidism. Therefore, patients treated with GH should have periodic thyroid function tests, and thyroid replacement therapy should be initiated or appropriately adjusted when indicated.
• Patients should be monitored carefully for any malignant transformation of skin lesions.
• When GH is administered subcutaneously at the same site over a long period of time, tissue atrophy may result. This can be avoided by rotating the injection site.
• As with any protein, local or systemic allergic reactions may occur.

Pediatric Patients

• Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders or in patients undergoing rapid growth. Any pediatric patient with the onset of a limp or complaints of hip or knee pain during GH therapy should be carefully evaluated.
• Children with growth failure secondary to CRI should be examined periodically for evidence of progression of renal osteodystrophy.
  • Slipped capital femoral epiphysis or avascular necrosis of the femoral head may be seen in children with advanced renal osteodystrophy, and it is uncertain whether these problems are affected by GH therapy.
  • X-rays of the hip should be obtained prior to initiating GH therapy for CRI patients.
• Progression of scoliosis can occur in patients who experience rapid growth.
  • GH increases growth rate. Therefore, patients with a history of scoliosis who are treated with GH should be monitored for progression of scoliosis.
  • GH has not been shown to increase the incidence of scoliosis.
  • Skeletal abnormalities, including scoliosis, are commonly seen in untreated TS patients.
  • Scoliosis is also commonly seen in untreated patients with Prader-Willi syndrome. Physicians should be alert to these abnormalities, which may manifest during GH therapy.
• Patients with TS should be evaluated carefully for otitis media and other ear disorders, since these patients have an increased risk of ear or hearing disorders.
• Patients with TS should be monitored closely for cardiovascular disorders (e.g., stroke, aortic aneurysm/dissection, hypertension), as these patients are also at risk for these conditions.

Adult Patients

• Fluid retention during GH replacement therapy in adults may occur. Clinical manifestations of fluid retention are usually transient and dose dependent.
• Carpal tunnel syndrome, arthralgia, and other joint disorders have been reported in GH-treated patients.
• Experience with prolonged rhGH treatment in adults is limited.

Drug Interactions

• In patients treated with GH, previously undiagnosed central (secondary) hypoadrenalism may be unmasked, requiring glucocorticoid replacement therapy. In addition, patients treated with glucocorticoid replacement therapy for previously diagnosed hypoadrenalism may require an increase in their maintenance or stress doses; this may be especially true for patients treated with cortisone acetate and prednisone.
• Glucocorticoid replacement therapy should be carefully adjusted in children with concomitant GH and glucocorticoid deficiency to avoid both hypoadrenalism and an inhibitory effect on growth.
• The use of Nutropin AQ and Nutropin in patients with CRI receiving glucocorticoid therapy has not been evaluated. Concomitant glucocorticoid therapy may inhibit growth-promoting effect of Nutropin AQ or Nutropin.
• Careful monitoring is advisable when GH is given in any combination with agents metabolized by CP450 liver enzymes.

Additional Safety Information

• In women on oral estrogen replacement, a larger dose of somatropin may be required to achieve the defined treatment goal.
• Carcinogenicity, mutagenicity, and reproduction studies have not been conducted with Nutropin AQ or Nutropin.
• GH should be given to a pregnant woman only if clearly needed, and caution should be exercised when administered to a nursing mother.
• In a clinical study of pubertal patients who were treated on 2 doses of Nutropin (0.3 and 0.7 mg/kg/wk), the patients in the 0.7 mg/kg/wk group were more likely to have IGF-1 values above the normal range. The clinical significance of elevated IGF-I levels is unknown.
• In a study of childhood-onset AGHD patients treated with GH (0.025 mg/kg/d) for 2 years, 35% had supraphysiologic levels of IGF-I at some time during the study, which may carry unknown risks. Dosage should be decreased if required by the occurrence of side effects or excessive IGF-I levels.
• Other adverse drug reactions that have been reported in GH-treated patients include the following:
  • Mild, transient peripheral edema
  • Carpal tunnel syndrome
  • Arthralgias and other joint disorders, reported in adults
  • Rare increased growth of pre-existing nevi
  • Gynecomastia
  • Pancreatitis (rare)

Please see full Prescribing Information for additional Important Safety Information.

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