Humatrope® (somatropin [rDNA origin] for injection) is a synthetic form of human growth hormone and is approved for: Growth Hormone Deficiency (GHD) for adults and children, Turner Syndrome, Idiopathic Short Stature, SHOX deficiency, Small for Gestational Age and Hypopituitarism in Adults

Important Safety Information

Patients with a known sensitivity to either metacresol or glycerin should not receive Humatrope reconstituted with the supplied diluent for Humatrope.

Somatropin is contraindicated in pediatric patients with closed epiphyses, in patients with proliferative or preproliferative diabetic retinopathy or if there is any evidence of active malignancy. Any pre-existing skin lesions should be monitored carefully for malignant transformation.

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. Fatalities have been reported in such cases.

Somatropin should not be used in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. There have been reports of fatalities after initiation of somatropin treatment in pediatric patients with Prader-Willi syndrome who had one or more of the following: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection.

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. Patients with pre-existing tumors or growth hormone deficiency secondary to an intracranial lesion should be examined routinely for progression or recurrence of the underlying disease.

Blood glucose concentrations should be monitored periodically in all patients taking somatropin, especially in those with risk factors for diabetes, pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance.

In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm.

Somatropin inhibits 11β-hydroxysteroid dehydrogenase type 1 (11βHSD-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 growth hormone is administered in combination with insulin, other drugs metabolized by CP450 liver enzymes (e.g., hydrocortisone or other corticosteroids, sex steroids, anticonvulsants, cyclosporin), or other hormone replacement therapy.

Fundoscopic examination is recommended at the initiation of and periodically during therapy as intracranial hypertension with papilledema, visual changes, headache, nausea, and/or vomiting have been reported in a small number of pediatric patients treated with somatropin.

Patients treated with somatropin should have periodic thyroid function tests and thyroid hormone replacement therapy should be initiated or appropriately adjusted when indicated.

In patients with hypopituitarism, standard hormone replacement therapy should be monitored closely when somatropin therapy is administered.

Slipped capital femoral epiphysis may occur more frequently in patients with endocrine disorders and in patients undergoing rapid growth. 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 scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis.

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.

The safety and effectiveness of somatropin in patients aged 65 and over has not been evaluated in clinical studies. Elderly patients may be more sensitive to the action of somatropin and may be more prone to adverse reactions.

In clinical studies of children with growth hormone deficiency, injection site pain was rarely reported. Mild and transient edema was reported early in the course of treatment. Leukemia has been reported in a small number of children who have received growth hormone therapy. The relationship, if any, between leukemia and growth hormone therapy is uncertain.

In a clinical study of patients with Turner syndrome, the following adverse events were reported more frequently in patients taking Humatrope than those taking placebo: otitis media, ear disorders, and surgical procedures, bone disorders including scoliosis, hypothyroidism, increased nevi, and peripheral edema.

In clinical studies in children with idiopathic short stature, in children with SHOX deficiency, and in children born small for gestational age, adverse events reported for children treated with Humatrope were similar to those reported in other studies of Humatrope treatment in children.

The most commonly reported adverse events in adult-onset growth hormone-deficient patients were edema, arthralgia, paresthesia, myalgia, pain, rhinitis, peripheral edema, back pain, headache, hypertension, and joint disorder.

The most commonly reported adverse events in childhood-onset growth hormone-deficient patients were flu syndrome, increased concentrations of liver enzymes, headache, edema, myalgia, and pain.

Prescribing Information | Important Safety Information
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