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PrOmnitrope® (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
Omnitrope® 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.
Omnitrope® treatment for ISS should be prescribed only for those patients whose
epiphyses are not closed.
Adults
Omnitrope® (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 re-evaluated before continuation of somatropin therapy at the reduced dose level recommended for growth hormone deficient adults.
Click here for additional safety information and for a link to the Product Monograph discussing: