Somatropin is indicated for:
Population group: only minors (0 - 18 years old)
Prader-Willi syndrome (PWS), for improvement of growth and body composition. The diagnosis of PWS should be confirmed by appropriate genetic testing.
For this indication, competent medicine agencies globally authorize below treatments (click for details):
Population group: only minors (0 - 18 years old)
Growth disturbance associated with Turner syndrome.
For this indication, competent medicine agencies globally authorize below treatments (click for details):
Population group: only minors (0 - 18 years old)
In chronic renal insufficiency, renal function should be below 50 percent of normal before institution of therapy. To verify growth disturbance, growth should be followed for a year preceding institution of therapy. During this period, conservative treatment for renal insufficiency (which includes control of acidosis, hyperparathyroidism and nutritional status) should have been established and should be maintained during treatment. The treatment should be discontinued at renal transplantation.
To date, no data on final height in patients with chronic renal insufficiency treated with somatropin are available.
For this indication, competent medicine agencies globally authorize below treatments (click for details):
Population group: only minors (0 - 18 years old)
Growth disturbance [current height standard deviation score (SDS) < -2.5 and parental adjusted height SDS < -1] in short children born small for gestational age (SGA), with a birth weight and/or length below -2 SD, who failed to show catch-up growth [height velocity (HV) SDS < 0 during the last year] by 4 years of age or later.
For this indication, competent medicine agencies globally authorize below treatments (click for details):
Population group: only minors (0 - 18 years old)
For this indication, competent medicine agencies globally authorize below treatments (click for details):
Population group: only adults (18 - 65 years old)
Replacement therapy in adults with pronounced growth hormone deficiency.
Adult Onset: Patients who have severe growth hormone deficiency associated with multiple hormone deficiencies as a result of known hypothalamic or pituitary pathology, and who have at least one known deficiency of a pituitary hormone not being prolactin. These patients should undergo an appropriate dynamic test in order to diagnose or exclude a growth hormone deficiency.
Childhood Onset: Patients who were growth hormone deficient during childhood as a result of congenital, genetic, acquired, or idiopathic causes. Patients with childhood onset GHD should be re-evaluated for growth hormone secretory capacity after completion of longitudinal growth. In patients with a high likelihood for persistent GHD, i.e. a congenital cause or GHD secondary to a pituitary/hypothalamic disease or insult, an insulin-like growth factor-I (IGF-I) SDS < - 2 off growth hormone treatment for at least 4 weeks should be considered sufficient evidence of profound GHD.
All other patients will require IGF-I assay and one growth hormone stimulation test.
For this indication, competent medicine agencies globally authorize below treatments (click for details):
Somatropin is contraindicated in the following cases:
Population group: only minors (0 - 18 years old)
© All content on this website, including data entry, data processing, decision support tools, "RxReasoner" logo and graphics, is the intellectual property of RxReasoner and is protected by copyright laws. Unauthorized reproduction or distribution of any part of this content without explicit written permission from RxReasoner is strictly prohibited. Any third-party content used on this site is acknowledged and utilized under fair use principles.
