Somatropin (17 brand names, 1 dosage form, 2 routes)
Available dosage forms: INJECTABLE.
Routes of administration: INJECTION, SUBCUTANEOUS.
Brand Names
- ACCRETROPIN
- BIO-TROPIN
- GENOTROPIN
- GENOTROPIN PRESERVATIVE FREE
- HUMATROPE
- NORDITROPIN
- NORDITROPIN FLEXPRO
- NORDITROPIN NORDIFLEX
- NUTROPIN
- NUTROPIN AQ
- NUTROPIN AQ NUSPIN
- NUTROPIN AQ PEN
- OMNITROPE
- SAIZEN
- SEROSTIM
- SEROSTIM LQ
- ZOMACTON
Dosage and Administration
The weekly dose should be divided into 6 or 7 subcutaneous injections. GENOTROPIN must not be injected intravenously. Therapy with GENOTROPIN should be supervised by a physician who is experienced in the diagnosis and management of pediatric patients with growth failure associated with growth hormone deficiency (GHD), Prader-Willi syndrome (PWS), Turner syndrome (TS), those who were born small for gestational age (SGA) or Idiopathic Short Stature (ISS), and adult patients with either childhood onset or adult onset GHD.
Adverse Reactions
The following important adverse reactions are also described elsewhere in the labeling: •Increased mortality in patients with acute critical illness [see Warnings and Precautions (5.1)] •Fatalities in children with Prader-Willi syndrome [see Warnings and Precautions (5.2)] •Neoplasms [see Warnings and Precautions (5.3)] •Glucose intolerance and diabetes mellitus [see Warnings and Precautions (5.4)] •Intracranial hypertension [see Warnings and Precautions (5.5)] •Severe hypersensitivity [see Warnings and Precautions (5.6)] •Fluid retention [see Warnings and Precautions (5.7)] •Hypoadrenalism [see Warnings and Precautions (5.8)] •Hypothyroidism [see Warnings and Precautions (5.9)] •Slipped capital femoral epiphysis in pediatric patients [see Warnings and Precautions (5.10)] •Progression of preexisting scoliosis in pediatric patients [see Warnings and Precautions (5.11)] •Otitis media and cardiovascular disorders in patients with Turner syndrome [see Warnings and Precautions (5.12)] •Lipoatrophy [see Warnings and Precautions (5.13)] •Pancreatitis [see Warnings and Precautions (5.15)]
Mechanism of Action
In vitro, preclinical, and clinical tests have demonstrated that GENOTROPIN lyophilized powder is therapeutically equivalent to human growth hormone of pituitary origin and achieves similar pharmacokinetic profiles in normal adults. In pediatric patients who have growth hormone deficiency (GHD), have Prader-Willi syndrome (PWS), were born small for gestational age (SGA), have Turner syndrome (TS), or have Idiopathic short stature (ISS), treatment with GENOTROPIN stimulates linear growth. In patients with GHD or PWS, treatment with GENOTROPIN also normalizes concentrations of IGF-I (Insulin-like Growth Factor-I/Somatomedin C). In adults with GHD, treatment with GENOTROPIN results in reduced fat mass, increased lean body mass, metabolic alterations that include beneficial changes in lipid metabolism, and normalization of IGF-I concentrations. In addition, the following actions have been demonstrated for GENOTROPIN and/or somatropin.
Overdosage
Short-Term Short-term overdosage could lead initially to hypoglycemia and subsequently to hyperglycemia. Furthermore, overdose with somatropin is likely to cause fluid retention. Long-Term Long-term overdosage could result in signs and symptoms of gigantism and/or acromegaly consistent with the known effects of excess growth hormone [see Dosage and Administration (2)].