Manufacturer
Pfizer Manufacturing Belgium NV
Contents
Recombinant somatropin
Indication
Replacement therapy in adults w/ pronounced growth hormone deficiency (GHD). Growth disturbance due to insufficient secretion of growth hormone or associated w/ Turner syndrome or chronic renal insufficiency in childn. Growth disturbance in short childn born small for gestational age (SGA) w/ a birth wt &/or length <2 SD, who failed to show catch-up growth by ≥4 yr. Prader-Willi syndrome (PWS) for improvement of growth & body composition.
Instruction
Growth hormone deficiency Adult Restart w/ 0.2-0.5 mg daily. Childn 0.025-0.035 mg/kg daily or 0.7-1 mg/m2 daily. Short childn born SGA 0.035 mg/kg or 1 mg/m2 daily until final height is reached. Chronic renal insufficiency 0.045-0.05 mg/kg daily or 1.4 mg/m2 daily. Onset GHD Adult Start w/ 0.15-0.3 mg daily. Prader-Willi syndrome 0.035 mg/kg or 1 mg/m2 daily. Max: 2.7 mg. Turner syndrome 0.045-0.05 mg/kg daily or 1.4 mg/m2 daily.
Drug interaction
Inhibited growth-promoting effects w/ glucocorticoids. Increased clearance of compd metabolized by CYP450 3A4 (eg, sex steroids, corticosteroids, anticonvulsants & ciclosporin).
Malaysia
