Generic Name and Formulations:
Somatropin (rDNA origin) 5mg, 8.8mg; per vial; lyophilized pwd for SC inj after reconstitution; diluent contains benzyl alcohol.
EMD Serono, Inc.
Indications for SAIZEN:
Treatment of children with growth failure due to GH deficiency. Adults with childhood-onset or adult-onset GH deficiency.
Individualize. Rotate inj site. Give by SC inj. Weight-based regimen: initial max 0.005mg/kg per day; may increase after 4 weeks to max 0.01mg/kg per day. Non weight-based regimen: intially 0.2mg/day (range 0.15–0.3mg/day); may increase gradually every 1–2 months by increments of 0.1–0.2mg/day. Elderly or obese: may need lower dose.
Individualize. Rotate inj site. Give by SC inj. 0.18mg/kg per week divided into equal doses either on 3 alternate days, 6 times a week, or daily.
Acute critical illness. Active malignancy. Diabetic retinopathy. Children with closed epiphyses. Prader-Willi syndrome (severely obese or w. respiratory impairment); see full labeling.
Diabetes. Obesity. Turner syndrome. Monitor thyroid function, glucose tolerance, bone age, gait. Monitor for hip or knee pain, intracranial hypertension (do baseline and periodic funduscopic exams), and progression of scoliosis. Prader-Willi syndrome: evaluate baseline respiratory function; monitor weight and for respiratory infection. Discontinue if signs of upper airway obstruction or sleep apnea occur. Monitor for progression or recurrence in preexisting tumors. Hypopituitarism. Discontinue when epiphyses are fused. Elderly. Pregnancy (Cat.B). Nursing mothers.
Growth hormone (GH).
May be antagonized by glucocorticoids. Concomitant oral estrogens: may require larger somatotropin doses. Antidiabetic medications may need to be adjusted. May affect CYP3A4 substrates. May increase phosphorus, alkaline phosphatase, PTH, IGF-1 serum levels.
Inj site reactions, fluid retention, peripheral edema, arthralgia, myalgia, paresthesia, headache; hypersensitivity (may be severe), hypoadrenalism, hypothyroidism; rare: pancreatitis. Long-term overdose may cause gigantism and/or acromegaly.
May be given using click.easy, a needle-free delivery device (see full labeling for instructions).
Vial—1 (w. diluent); click.easy device—1 (8.8mg vial + diluent)