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Somatropin

Adult: Replacement therapy in adults w/ pronounced growth hormone deficiency (GHD) (adult or childhood onset). Childn: Growth disturbance due to insufficient secretion of growth hormone (GHD); associated w/ Turner syndrome or chronic renal insufficiency; in short childn born small for gestational age (SGA), w/ birth wt &/or length below -2 SD, who failed to show catch-up growth by ≥4 yr. Prader-Willi syndrome (PWS), for improvement of growth & body composition.

SC Adult Continued growth hormone therapy after childhood GHD Restart dose at 0.2-0.5 mg daily. Gradually increase or decrease dose according to the patient requirements as determined by the insulin-like growth factor-I (IGF-I) conc. Adult-onset GHD Initially 0.15-0.3 mg daily. Gradually increase dose according to the patient requirements as determined by the IGF-I conc. Maintenance: 1 mg daily. Childn GHD 0.025-0.035 mg/kg daily or 0.7-1 mg/m² daily. Continue treatment to achieve full somatic development if childhood onset GHD persists into adolescence. PWS 0.035 mg/kg daily or 1 mg/m² daily. Max: 2.7 mg daily. Turner syndrome & chronic renal insufficiency 0.045-0.05 mg/kg daily or 1.4 mg/m² daily. SGA 0.035 mg/kg daily or 1 mg/m² daily until final height is reached. Discontinue if height velocity SDS is <+1 after 1st yr of treatment or if <2 cm/yr, & if bone age is >14 yr (girls) or >16 yr (boys) corresponding to closure of the epiphyseal growth plates. Patient >60 yr Initially 0.1-0.2 mg daily & slowly increased according to patient requirements. Maintenance: 0.5 mg daily.

Hypersensitivity. Not to be used when there is any evidence of activity or growth of a tumour. Intracranial tumours must be inactive & antitumour therapy must be completed prior to starting therapy. Not to be used to treat patients w/ acute critical illness suffering complications following open heart & abdominal surgery, multiple accidental trauma, acute resp failure or similar conditions. Not to be used for growth promotion in childn w/ closed epiphyses.

Consider myositis in case of myalgia or disproportionate pain at inj site & if confirmed, presentation w/o metacresol should be used. May require insulin dose adjustment for patients w/ DM after therapy is instituted. Hypothyroidism may develop in subjects w/ subclinical hypothyroidism. Closely monitor the potential effect of treatment on thyroid function in patients w/ hypopituitarism on standard replacement therapy. May unmask previously undiagnosed central (secondary) hypoadrenalism in treated patients & glucocorticoid replacement therapy may be required; may also require an increase in the maintenance or stress doses following initiation of treatment in patients treated w/ glucocorticoid replacement therapy for previously diagnosed hypoadrenalism. Malignancy relapse in patients w/ GHD secondary to treatment of malignant disease. Slipped epiphyses of the hip may occur frequently in patients w/ endocrine disorders. Consider diagnosis of benign intracranial HTN if papilloedema is confirmed &, if appropriate, discontinue treatment. Leukemia. Carry out Abs testing in any patient w/ unexplained lack of response to treatment. Consider pancreatitis especially in childn who develop abdominal pain. Monitor patients w/ diabetes, glucose intolerance, or additional risk factors for diabetes; thyroid function; for symptoms of intracranial HTN if treatment is restarted. Patients on a controlled Na diet. Concomitant use w/ oral oestrogen therapy. Not recommended during pregnancy & in women of childbearing potential not using contraception. Lactation. Childn limping during treatment should be examined. Elderly >80 yr. Prader-Willi syndrome: Should always be in combination w/ a calorie-restricted diet. Assess for signs of upper airway obstruction, sleep apnoea, or resp infections before initiation of treatment. Monitor for signs of scoliosis during treatment. SGA: Measure fasting insulin & blood glucose before starting treatment & annually thereafter; IGF-I level before starting treatment & twice a yr thereafter. Perform oral glucose tolerance testing in patients w/ increased risk for DM (eg, familial history of diabetes, obesity, severe insulin resistance, acanthosis nigricans). Not to be administered if overt diabetes occur. Not recommended to initiate treatment near onset of puberty. May lost some of the height gain obtained if treatment is stopped before final height is reached. Chronic renal insufficiency: Discontinue treatment at renal transplantation.

Arthralgia. Adult: Peripheral oedema. Paraesthesia, carpal tunnel syndrome; myalgia, musculoskeletal stiffness. Childn w/ GHD: Inj site reactions.

Inhibited growth-promoting effects w/ glucocorticoids. Decreased conversion of cortisone to cortisol & may unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective. May increase clearance of cytochrome P 450 3A4-metabolised compd eg, sex steroids, corticosteroids, anticonvulsants & ciclosporin.

Trophic Hormones & Related Synthetic Drugs

H01AC01 - somatropin ; Belongs to the class of somatropin and somatropin agonists. Used in anterior pituitary lobe hormone and analogue preparations.

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