Children’s growth disorders, Chronic renal failure, Growth hormone deficiency, HIV-associated wasting or cachexia, Intrauterine growth retardation, Prader Willi syndrome, Severe idiopathic short stature, Short bowel syndrome, Sjogren’s syndrome
Synthetic Human Growth Hormone
Somatropin (as well as endogenous GH) binds to a dimeric GH receptor in the cell membrane of target cells resulting in intracellular signal transduction and a host of pharmacodynamic effects. Some of these pharmacodynamic effects are primarily mediated by IGF-I produced in the liver and also locally (e.g., skeletal growth, protein synthesis), while others are primarily a consequence of the direct effects of somatropin (e.g., lipolysis).
Children with short stature homeobox-containing (SHOX) deficiency: Child: 50 mcg/kg/day may be used. Growth retardation due to chronic renal insufficiency, Turner's syndrome: Child: 45-50 mcg/kg or 1.4 mg/m2 daily. Growth retardation in children who were born small for gestational age, Prader-Will syndrome: Child: 35 mcg/kg or 1 mg/m2 daily. Max: 2.7 mg daily. Growth hormone deficiency: Adult: Initially, 6 mcg/kg daily. May increase gradually according to patient response. Max: 12.5 mcg/kg/day. Reassess 9 mth after starting treatment. Child: 25-35 mcg/kg daily. Reassess 9 mth after starting treatment. Elderly: Lower doses may be required. Short bowel syndrome: Adult: 100 mcg/kg/day for 4 wk. Max: 8 mg/day. HIV-associated wasting or cachexia: Adult: 0.1 mg/kg daily at bedtime. May be taken on alternate days for patients at increased risk of adverse effects. Max: 6 mg/day.
Inhibition of 11ß-Hydroxysteroid Dehydrogenase Type 1: May require the initiation of glucocorticoid replacement therapy. Patients treated with glucocorticoid replacement for previously diagnosed hypoadrenalism may require an increase in their maintenance doses.
Glucocorticoid Replacement: Should be carefully adjusted.
Cytochrome P450-Metabolized Drugs: Monitor carefully if used with somatropin.
Oral Estrogen: Larger doses of somatropin may be required in women.
Insulin and/or Oral/Injectable Hypoglycemic Agents: May require adjustment.
Acute critical illness due to heart or abdominal surgery, multiple accidental trauma or respiratory failure; active neoplasms, proliferative or preproliferative diabetic retinopathy; lactation; patients with closed epiphyses. Intracranial lesions. Patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. Monitor thyroid function; benign intracranial hypertension. DM; may require dose reduction in insulin. Pregnancy. Discontinue treatment if there is evidence of tumour growth. Monitoring in patients with scoliosis is recommended due to risk of progression of scoliosis.
Hypothyroidism, peripheral oedema; headache; muscle and joint pain; benign intracranial hypertension. Loss of glycaemic control in diabetics.
Pregnancy Category B: Either animal-reproduction studies have not demonstrated a foetal risk but there are no controlled studies in pregnant women or animal-reproduction studies have shown an adverse effect (other than a decrease in fertility) that was not confirmed in controlled studies in women in the 1st trimester (and there is no evidence of a risk in later trimesters).
Store at 2-8°C. Do not freeze. Avoid direct light. Keep out of reach of children.
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