May alter response to insulin and/or oral hypoglycemic agents, dose adjustment may be necessary.
Adult Growth Hormone Deficiency
SC (Adults) 0.04 mg/kg/wk divided into equal doses given 7 days per wk initially; may be ↑ at 4–8 wk intervals to a maximum of 0.08 mg/kg/wk.
Pediatric Growth Hormone Deficiency
SC Children 0.16–0.24 mg/kg/wk divided into equal doses given 6–7 times per wk.
Growth Failure Associated with Prader-Willi or Turner Syndrome
SC Children Prader-Willi syndrome–0.24 mg/kg/wk divided into equal doses given 6–7 times per wk; Turner syndrome–0.33 mg/kg/wk divided into equal doses given 6–7 times per wk.
Short Stature Born Small for Gestational Age
SC Children up to 0.48 mg/kg/wk divided into equal doses given 6–7 times per wk.
Idiopathic Short Stature
SC Children Up to 0.47 mg/kg/wk divided into equal doses given 6–7 times per wk.
Solution for subcutaneous injection (cartridges for use with pen device): 5 mg/1.5 mL, 10 mg/1.5 mL
Powder for subcutaneous injection: 5.8 mg/vial
Monitor bone age annually and growth rate determinations, height, and weight every 3–6 mo during therapy.
Lab Test Considerations:
Monitor thyroid function prior to and during therapy. May decrease T4, radioactive iodine uptake, and thyroxine-binding capacity. Hypothyroidism necessitates concurrent thyroid replacement for growth hormone to be effective. Serum inorganic phosphorus, alkaline phosphatase, and parathyroid hormone may ↑ with somatropin therapy.
Monitor blood glucose periodically during therapy. Diabetic patients may require ↑ insulin dose.
Monitor for development of neutralizing antibodies if growth rate does not exceed 2.5 cm/6 mo.
Monitor alkaline phosphatase closely in patients with adult growth hormone deficiency.
After initial injection, use within 4 wk (3 wk for 5.8 mg vial) if stored in refrigerator.
Instruct patient and parents on correct procedure for reconstituting medication, site selection, technique for subcut injection, and disposal of needles and syringes. Review dose schedule. Parents should report persistent pain or edema at injection site.
Explain rationale for prohibition of use for increasing athletic performance. Administration to persons without growth hormone deficiency or after epiphyseal closure may result in acromegaly (coarsening of facial features; enlarged hands, feet, and internal organs; increased blood glucose; hypertension).
Assure parents and child that these dose forms are synthetic and therefore not capable of transmitting Creutzfeldt-Jakob disease, as was the original somatropin, which was extracted from human cadavers.
Advise parents to monitor blood glucose closely in children with diabetes mellitus. Parents should also be advised to report persistent severe abdominal pain; may be a symptom of pancreatitis, and signs and symptoms of hypersensitivity reactions (rash, facial swelling, difficulty breathing) immediately to health care professional.
Emphasize need for regular follow-up with endocrinologist to ensure appropriate growth rate, to evaluate lab work, and to determine bone age by x-ray exam.
Child's attainment of adult height in growth failure secondary to pituitary growth hormone deficiency. Therapy is limited to period before closure of epiphyseal plates (approximately up to 14–15 yr in girls, 15–16 yr in boys).
Replacement of growth hormone in deficient adults.
somatropin (recombinant) (Omnitrope) is a sample topic from the Davis's Drug Guide.
Pediatrics Central™ is an all-in-one application that puts valuable medical information, via your mobile device or the web, in the hands of clinicians treating infants, children, and adolescents. Complete Product Information.