Prader-Willi Syndrome in Children: Somatropin should not be used in pediatric patients with Prader-Willi syndrome 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 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 severe respiratory impairment.

Safety and Efficacy Data

Growth hormone (GH) deficiency in children
Growth hormone (GH) deficiency in adults
Idiopathic short stature (ISS)
Children born small for gestational age (SGA)
Short stature homeobox-containing gene (SHOX) deficiency
Short stature associated with Turner syndrome

Humatrope Is Indicated for:

Growth hormone (GH) deficiency in children

Humatrope was approved by the FDA in 1987 for the treatment of growth failure in children with GH deficiency.

Humatrope is indicated for the treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous GH. Humatrope therapy should not be used for growth promotion in pediatric patients with closed epiphyses.

Recommended dosage: 0.026 to 0.043 mg/kg/day (0.18 to 0.30 mg/kg/week)1

View safety data for GH Deficiency in Children >

Growth hormone (GH) deficiency in adults

Humatrope was approved by the FDA in 1996 for the treatment of adults with GH deficiency. Humatrope is approved for replacement of endogenous GH in adults with GH deficiency who meet either of the following two criteria:

  • Adult-onset (AO) GH deficiency—Patients who have GH deficiency, either alone or accompanied by multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma;

OR

  • Childhood-onset (CO) GH deficiency—Patients who were GH-deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients who were treated with somatropin for GH deficiency in childhood and whose epiphyses are closed should be reevaluated before continuation of somatropin therapy at the reduced dose level recommended for GH-deficient adults.

Recommended dosage:
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 can be increased gradually every 1-2 months by increments of approximately 0.1-0.2 mg/day.1

Weight-based dosing: The recommended initial daily dose is not more than 0.006 mg/kg (6 µg/kg); the dose may be increased to a maximum of 0.0125 mg/kg (12.5 µg/kg) daily.1

View safety and efficacy data for GH Deficiency in Adults >

Idiopathic short stature (ISS)

Humatrope was approved by the FDA in 2003 for the treatment of idiopathic short stature, also called non-GH-deficient short stature, defined by height SDS ≤-2.25, and associated with growth rates unlikely to permit attainment of adult height in the normal range, in pediatric patients for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means.

Recommended dosage: Up to 0.053 mg/kg/day (0.37 mg/kg/week)1

View safety and efficacy data for ISS >

Children born small for gestational age (SGA)

Humatrope was approved by the FDA in 2009 for the treatment of growth failure in children born small for gestational age (SGA) who fail to demonstrate catch-up growth by age 2–4 years.

Recommended dosage: Up to 0.067 mg/kg/day (0.47 mg/kg/week)1

View safety and efficacy data for SGA >

Short stature homeobox-containing gene (SHOX) deficiency

Humatrope was approved by the FDA in 2006 for the treatment of short stature or growth failure in children with SHOX deficiency (SHOX-D).

Recommended dosage: 0.050 mg/kg/day (0.35 mg/kg/week)1

View safety and efficacy data for SHOX-D >

Short stature associated with Turner syndrome

Humatrope was approved by the FDA in 1997 for the treatment of short stature associated with Turner syndrome.

Recommended dosage: Up to 0.054 mg/kg/day (0.375 mg/kg/week)1

View safety and efficacy data for Short Stature Associated with Turner Syndrome >

Indications for Humatrope

Humatrope is indicated for the treatment of pediatric patients who have short stature or growth failure as a result of:
  • Growth hormone (GH) deficiency.
  • Turner syndrome.
  • Idiopathic short stature, 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.
  • Short stature homeobox-containing gene (SHOX) deficiency.
  • Small for gestational age birth, and fail to show catch-up growth by 2–4 years of age.
Humatrope 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 for Humatrope

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 in Children: Somatropin should not be used in pediatric patients with Prader-Willi syndrome 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 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 severe respiratory impairment.
  • 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.
  • Diabetic Retinopathy: Somatropin is contraindicated in patients with active proliferative or severe non-proliferative diabetic retinopathy.
  • Closed Epiphyses: Somatropin should not be used for growth promotion in pediatric patients with closed epiphyses.
  • Hypersensitivity: Humatrope is contraindicated in patients with a known sensitivity to somatropin or the supplied diluent. Localized reactions are the most common hypersensitivity reactions. Patients with a known sensitivity to either metacresol or glycerin should not receive Humatrope reconstituted with the supplied diluent for Humatrope.

WARNINGS AND PRECAUTIONS

  • Acute Critical Illness: Increased mortality in patients with acute critical illness due to complications following open heart surgery, abdominal surgery or multiple accidental trauma, or those with acute respiratory failure has been reported after treatment with pharmacologic doses of somatropin.
  • Prader-Willi Syndrome in Children: There have been reports of fatalities after initiating therapy with somatropin in pediatric patients with Prader-Willi syndrome who had one or more of the following risk factors: severe obesity, history of upper airway obstruction or sleep apnea, or unidentified respiratory infection. Male patients with one or more of these factors may be at greater risk than females. Patients with Prader-Willi syndrome should be evaluated for signs of upper airway obstruction and sleep apnea before initiation of treatment with somatropin.
  • Neoplasms: 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. In childhood cancer survivors, an increased risk of a second neoplasm has been reported in patients treated with somatropin after their first neoplasm. Any pre-existing skin lesions should be monitored carefully for malignant transformation.
  • Glucose Intolerance and Diabetes Mellitus: Previously undiagnosed impaired glucose tolerance and overt diabetes mellitus may be unmasked during somatropin treatment. New-onset type 2 diabetes mellitus has been reported. As a result, blood glucose concentrations should be monitored periodically in all patients taking somatropin, especially in those with risk factors for diabetes mellitus. Patients with pre-existing type 1 or type 2 diabetes mellitus or impaired glucose tolerance should be monitored closely during somatropin treatment.
  • Intracranial Hypertension: Funduscopic 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 patients treated with somatropin. If papilledema is observed by funduscopy during treatment with somatropin, treatment should be stopped and the patient’s condition should be reassessed before treatment is resumed.
  • Fluid Retention: Transient and dose-dependent fluid retention during somatropin replacement in adults may frequently occur.
  • Hypopituitarism: In patients with hypopituitarism, standard hormone replacement therapy should be monitored closely when somatropin therapy is administered.
  • Hypothyroidism: Patients treated with somatropin should have periodic thyroid function tests, and thyroid hormone replacement therapy should be initiated or appropriately adjusted in cases of unmasked or worsening hypothyroidism.
  • Slipped Capital Femoral Epiphysis in Pediatric Patients: 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 in Pediatric Patients: Progression of scoliosis can occur in patients who experience rapid growth. Somatropin has not been shown to increase the occurrence of scoliosis.
  • Otitis Media and Cardiovascular Disorders in Patients with Turner Syndrome: Patients with Turner syndrome should be evaluated carefully for otitis media and other ear disorders as somatropin treatment may increase the occurrence of otitis media in these susceptible patients. In addition, patients with Turner syndrome should be monitored closely for cardiovascular disorders (e.g., hypertension, aortic aneurysm or dissection, stroke) as they are at increased risk for these conditions.
  • Pancreatitis: Cases of pancreatitis have been reported rarely in children and adults receiving somatropin. Pancreatitis should be considered in any somatropin-treated patient, especially a child, who develops abdominal pain. Girls who have Turner syndrome may be at greater risk than other somatropin-treated children.
  • Local and Systemic Reactions: Injection site should be rotated to avoid tissue atrophy. Patients should be informed that local or systemic allergic reactions may occur and that prompt medical attention should be sought in such cases.
  • Laboratory Tests: Serum levels of inorganic phosphorus, alkaline phosphatase, parathyroid hormone and IGF-I may increase after somatropin therapy.
  • 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.
  • Special Populations: The safety and effectiveness of somatropin in patients aged 65 years and over have 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.
  • Potential 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 growth hormone is administered in combination with insulin and/or other hypoglycemic agents, other drugs metabolized by CYP450 liver enzymes (e.g., hydrocortisone or other corticosteroids, sex steroids, anticonvulsants, cyclosporine), or other hormone replacement therapy.

ADVERSE REACTIONS

  • Common adverse reactions reported in adult and pediatric patients taking somatropin include injection site reactions, hypersensitivity to the diluent, and hypothyroidism. Additional common adverse reactions in adults include edema, arthralgia, myalgia, carpal tunnel syndrome, paresthesias, and hyperglycemia.

For more safety information, please see the Full Prescribing Information, Patient Information-Cartridge, and Patient Information-Vial.

See Full Pen User Manual that accompanies the HumatroPen 6 mg, 12 mg, and 24 mg.

HG HCP ISI Mar152011

Reference:
1. Humatrope [package insert]. Indianapolis, IN: Eli Lilly and Company; 2011. 1. Takahashi Y, Kipnis DM, Daughaday WH. Growth hormone secretion during sleep. J Clin Invest. 1968;47(9):2079-2090.

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This document includes the following pages:

  • Statement of Medical Necessity  (page 1)
    Important Safety Information  (page 2)
    Prescribing Information  (pages 3–20)
    Patient Information  (pages 21–27)
Download and Print Document

This document includes the following pages:

  • Instructions for Use  (pages 1–6)
    Important Safety Information  (pages 7–9)
    Prescribing Information  (pages 10–27)
    Patient Information  (pages 28–34)
Download and Print Document
  • Iversen S, Iversen L, Saper CB. The autonomic nervous system and the hypothalamus. In: Kandel ER, Schwartz JH, eds. Principles of Neural Science. 4th ed. Norwalk, CT: Appleton & Lange; 1991:961-981.
  • Melmed S. The pituitary. In: Ulijaszek SJ, Johnston FE, Preece MA, eds. The Cambridge Encyclopedia of Human Growth and Development. New York, NY: Cambridge University Press, 1995.
  • Casanueva FF, Dieguez C. Ghrelin a new hormone implicated in the regulation of growth hormone secretion and body energy homeostasis. Growth, Genetics and Hormones. 2004;20:1-16.
  • Mehls O, Tönshoff B. Growth hormone in renal transplantation—the mode of action, animal studies, and clinical use. J Am Soc Nephrol. 1992;2(suppl 12):S284-S289.
  • Hansen TK, Gravholt CH, Ørskov H, Rasmussen MH, Christiansen JS, Jørgensen JO. Dose dependency of the pharmacokinetics and acute lipolytic actions of growth hormone. J Clin Endocrinol Metab. 2002;87(10):4691-4698.
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  • López-Bermejo A, Buckway CK, Rosenfeld RG. Genetic defects of the growth hormone-insulin-like growth factor axis. Trends Endocrinol Metab. 2000;11(2):39-49.
  • Trivedi B, Daughaday WH. Release of growth hormone binding protein from IM-9 lymphocytes by endopeptidase is dependent on sulfhydryl group inactivation. Endocrinology. 1988;123(5):2201-2206.
  • Kofoed EM, Hwa V, Little B, Woods KA, Buckway CK, Tsubaki J, et al. Growth hormone insensitivity associated with a STAT5b mutation. N Engl J Med. 2003;349(12):1139-1147.
  • Eugster EA, Pescovitz OH. New revelations about the role of STATs in stature. New Engl J Med. 2003;349(12):1110-1112.
  • Robson H, Siebler T, Shalet SM, Williams GR. Interactions between GH, IGF-I, glucocorticoids, and thyroid hormones during skeletal growth. Pediatr Res. 2002;52(2):137-147.
  • Chin E, Zhou J, Dai J, Baxter RC, Bondy CA. Cellular localization and regulation of gene expression for components of the insulin-like growth factor ternary binding protein complex. Endocrinology. 1994;134(6):2498-2504.
  • Scharf J, Ramadori G, Braulke T, Hartmann H. Synthesis of insulinlike growth factor binding proteins and of the acid-labile subunit in primary cultures of rat hepatocytes, of Kupffer cells, and in cocultures: regulation by insulin, insulinlike growth factor, and growth hormone. Hepatology. 1996;23(4):818-827.
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