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GENOTROPIN (somatropin [rDNA origin] for injection) Indications And Clinical Use

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Indications And Clinical Use

GENOTROPIN (somatropin for injection) is indicated for:

Children

The long‑term treatment of children who have growth failure due to an inadequate secretion of endogenous growth hormone (growth hormone deficiency (GHD)).  Other causes of short stature should be excluded.

SGA Indication

GENOTROPIN is indicated for the treatment of growth failure (current height standard deviation score [SDS] < - 2) in short children born SGA (birth weight and/or length below -2 SD) and who fail to achieve catch-up growth (height velocity SDS < 0 during the last year) by 2 to 4 years or later.

TS Indication

The treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed. 

ISS Indication

The long-term 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 for whom diagnostic evaluation excludes other causes associated with short stature that should be observed or treated by other means. Genotropin treatment for ISS should be prescribed only for those patients whose epiphyses are not closed. 

Adults

GENOTROPIN (somatropin [rDNA origin] for injection) is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:

Adult Onset (AO): Patients who have growth hormone deficiency, 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 growth hormone 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. According to current standards, confirmation of the diagnosis of adult growth hormone deficiency in both groups involves an appropriate growth hormone provocative test with two exceptions: (1) patients with multiple other pituitary hormone deficiencies due to organic disease; and (2) patients with congenital/genetic growth hormone deficiency.

Geriatrics

The safety and effectiveness of GENOTROPIN in patients aged 65 and over have not been evaluated in clinical studies. (see WARNINGS AND PRECAUTIONS, Special Populations, Geriatrics).

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