Saizen

Somatropin

Growth failure in childn caused by decreased or absent secretion of endogenous growth hormone (GH). Growth failure in girls w/ gonadal dysgenesis (Turner Syndrome) confirmed by chromosomal analysis. Growth disturbance (current height SDS <-2.5 & parental adjusted height SDS <-1) in short childn born small for gestational age (SGA) w/ a birth wt &/or length below -2 SD, who failed to show catch-up growth (HV SDS <0 during the last yr) by ≥4 yr. Replacement therapy in adults w/ pronounced GH deficiency as diagnosed by a single dynamic test for GH deficiency. Growth failure in prepubertal childn due to chronic renal failure (CRF). Growth disturbance due to idiopathic short stature (ISS).

SC Individualised dosage. Growth failure due to inadequate endogenous GH secretion 0.7-1 mg/m² daily or 0.025-0.035 mg/kg daily. Growth failure in girls due to gonadal dysgenesis (Turner syndrome) 1.4 mg/m² daily or 0.045-0.05 mg/kg daily. May enhance growth response in concomitant therapy w/ non-androgenic anabolic steroids. Growth failure in short childn born SGA 1 mg/m² daily or 0.035 mg/kg daily. Discontinue treatment when patient has reached a satisfactory adult height or the epiphyses are fused. Growth failure in prepubertal childn due to CRF 1.4 mg/m² daily or 0.045-0.05 mg/kg daily. Growth disturbance due to ISS 0.067 mg/kg daily, 6 times wkly. GH deficiency in adult Initially 0.15-0.3 mg daily. Adjust dose stepwise, controlled by insulin-like growth factor 1 (IGF-1) values. Recommended final GH dose seldom exceeds 1 mg daily.

Hypersensitivity. Patients w/ active neoplasia; any anti-tumor therapy must be completed prior to starting treatment. Cases w/ evidence of any progression or recurrence of underlying intracranial lesion. Patients w/ acute critical illness suffering complications following open heart surgery, abdominal surgery, multiple accidental trauma, acute resp failure or similar conditions; proliferative or pre-proliferative diabetic retinopathy. Pregnancy & lactation. Childn in whom epiphyseal fusion occurred, & w/ chronic renal disease; discontinue treatment at renal transplantation.

Carefully examine patients w/ intra- or extracranial neoplasia in remission who are receiving treatment w/ GH at regular intervals. Frequently examine patients w/ GH deficiency secondary to an intracranial tumour for progression or recurrence of the underlying disease process. Carefully monitor risk of malignancies. Possible increased risk of 2nd neoplasm in childhood cancer survivors treated w/ somatropin after their 1st neoplasm. Possibly slight increased incidence of leukemia. May induce a state of insulin resistance which can result in hyperinsulinism & in some patients in hyperglycemia; monitor patients for evidence of glucose intolerance. Patients w/ DM or w/ family history of DM. Discontinue treatment if preproliferative changes & presence of proliferative retinopathy develop. Patients w/ central subclinical hypothyroidism; correct hypothyroidism if diagnosed in the course of therapy. Test thyroid function after starting treatment & after dose adjustments. Decrease dosage in case of persistent oedema or severe paraesthesia. Discontinue treatment & consider a diagnosis of benign intracranial HTN if papilloedema is confirmed. Carefully monitor intracranial HTN symptoms; discontinue treatment if it recurs. Routinely perform fundoscopic exam before initiating treatment to exclude preexistent papilloedema. Consider pancreatitis especially in childn who develop abdominal pain. Monitor for signs of scoliosis during treatment. Patients who fail to respond to therapy should be tested for Ab to somatropin. Slipped capital femoral epiphysis is often associated w/ endocrine disorders eg, GH deficiency & hypothyroidism, & w/ growth spurts. Periodically examine evidence of renal osteodystrophy progression in patients w/ growth failure due to CRF; possible slipped capital femoral epiphysis or avascular necrosis of the femoral head in childn w/ advanced renal osteodystrophy. Patient must obtain hip X-rays prior to treatment initiation. Decreased renal function to <50% of normal in childn w/ CRF before therapy is instituted; establish & maintain a conservative treatment for renal insufficiency during treatment (which includes control of acidosis, hyperparathyroidism & nutritional status for 1 yr prior to treatment). Rule out other medical reasons or treatments that could explain growth disturbance in short childn born SGA before starting treatment. Measure fasting insulin & blood glucose before start of treatment & annually thereafter; IGF-1 level before start of treatment & twice yrly thereafter in SGA patients. Not recommended to initiate treatment near onset of puberty. SGA patients w/ Silver-Russel syndrome. Inj site should be varied to prevent lipoatrophy. Patients w/ acute critical illness. Not indicated for long-term treatment of ped patients w/ Prader-Willi syndrome. Concomitant use w/ glucocorticoids; oral oestrogen therapy. Renal & hepatic impairment.

Inj site reactions (localized lipoatrophy); fluid retention, peripheral oedema, stiffness, arthralgia, myalgia, paresthesia; isolated headache, carpal tunnel syndrome (adult).

Concomitant corticosteroid therapy may inhibit response to Saizen; monitor serum cortisol levels in patients on corticosteroid replacement therapy in whom somatropin therapy is started & adjust corticosteroid dose if necessary. May unmask previously undiscovered central hypoadrenalism or render low glucocorticoid replacement doses ineffective. May require higher GH dose in women on oral oestrogen replacement. Co-administration w/ drugs known to be metabolised by CYP450 3A4 hepatic enzymes.

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.

POM