HUMATROPE SUMMARY
Humatrope® (Somatropin, rDNA Origin, for Injection) is a polypeptide hormone of recombinant DNA origin.
INDICATIONS AND USAGE
Pediatric Patients -- Humatrope is indicated for the long-term treatment of pediatric patients who have growth failure due to an inadequate secretion of normal endogenous growth hormone.
Humatrope is indicated for the treatment of short stature associated with Turner syndrome in patients whose epiphyses are not closed.
Humatrope is indicated for the long-term treatment of idiopathic short stature, also called non-growth hormone-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 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. Adult Patients -- Humatrope is indicated for replacement of endogenous growth hormone in adults with growth hormone deficiency who meet either of the following two criteria:
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Adult Onset: Patients who have growth hormone deficiency either alone, or with multiple hormone deficiencies (hypopituitarism), as a result of pituitary disease, hypothalamic disease, surgery, radiation therapy, or trauma;
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Childhood Onset: Patients who were growth hormone-deficient during childhood who have growth hormone deficiency confirmed as an adult before replacement therapy with Humatrope is started.
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