Somatropindrug info

somatropin 5 MG/ML Injectable Solution [Omnitrope]

What it is used for

OMNITROPE is a recombinant human growth hormone indicated for:

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

Adult: Treatment of adults with either adult onset or childhood onset GHD

1.1 Pediatric

Patients OMNITROPE is indicated for the treatment of children with growth failure due to inadequate secretion of endogenous growth hormone (GH). OMNITROPE 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. OMNITROPE 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. OMNITROPE is indicated for the treatment of growth failure associated with Turner Syndrome. OMNITROPE 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 evaluation excludes other causes associated with short stature that should be observed or treated by other means. 1.2 Adult Patients OMNITROPE is indicated for the replacement of endogenous GH in adults with growth hormone deficiency (GHD) who meet either of the following two criteria:

Adult Onset (AO): Patients who have GHD, 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 GH 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 reevaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults. Confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: patients with multiple other pituitary hormone deficiencies due to organic disease; and patients with congenital/genetic growth hormone deficiency.

Text above is quoted in full from the FDA-approved drug label published by openFDA, effective July 10, 2025. Matched to this product by RxNorm code. Cross-references to other sections of the full prescribing information have been removed, since they point to a document not shown here. Nothing else is changed: no sentence is shortened, reworded or summarised.

Description

Somatropin is a human growth hormone (GH) produced by recombinant DNA technology using Escherichia coli. The protein is comprised of 191 amino acid residues and a molecular weight of approximately 22,125 daltons. The amino acid sequence is identical to that of human GH of pituitary origin. OMNITROPE (somatropin) injection is a clear, colorless, sterile solution for subcutaneous injection supplied in a cartridge for use with OMNITROPE Pen delivery system. Sodium hydroxide and/or phosphoric acid may be added during manufacture to adjust pH. OMNITROPE (somatropin) for injection is a white to off-white lyophilized powder supplied in a vial for subcutaneous injection after reconstitution. Sodium hydroxide and/or hydrochloric acid may be added during manufacture to adjust pH. Vials are co-packaged with accompanying 1.14 mL vials of a diluent containing Bacteriostatic Water for Injection with 1.5% benzyl alcohol as a preservative. After reconstitution, the concentration is 5 mg/mL. Each OMNITROPE cartridge or vial contains the following (see Table 4 ): Table 4. Contents of OMNITROPE Cartridges and Vial Product Cartridge 5 mg/ 1.5 mL Cartridge 10 mg/ 1.5 mL For Injection 5.8 mg/ vial Component Somatropin 5 mg 10 mg 5.8 mg Dibasic sodium phosphate 0.609 mg 0.71 mg 0.996 mg Monobasic sodium phosphate 1.28 mg 1.2 mg 0.52 mg Poloxamer 3 mg 3 mg - Mannitol 52.5 mg - - Glycine - 27.75 mg 27.6 mg Benzyl alcohol 13.5 mg - - Phenol - 4.5 mg - Water for Injection to make 1.5 mL to make 1.5 mL - Diluent (vials only) Bacteriostatic Water for Injection Water for injection to make 1.14 mL Benzyl alcohol 17 mg

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