SCITROPIN A

What it is

SciTropin A contains somatropin (rbe), recombinant human growth hormone (r-hGH) . It is produced using recombinant DNA technology, with the active substance somatropin produced in cell culture by Escherichia coli cells bearing the gene for human growth hormone . SciTropin A is available in three strengths: 5 mg/1.5 mL solution for injection containing 3.33 mg/mL somatropin, 10 mg/1.5 mL solution for injection containing 6.67 mg/mL somatropin, and 15 mg/1.5 mL solution for injection containing 10 mg/mL somatropin .

Approved indications

SciTropin A is intended for the long term treatment of children above three years of age with: — <cite index="1-7">growth disturbance due to insufficient secretion of pituitary growth hormone — growth disturbance associated with gonadal dysgenesis (Turner syndrome) — growth disturbance associated with chronic renal insufficiency

Dosing overview

The dose is based on body weight and must always be adjusted individually in accordance with the response to therapy . Daily administration by subcutaneous injection in the evening is recommended .

Treatment is to be discontinued when the patient has reached a satisfactory final height, when the epiphyses are closed or when the patient no longer responds to growth hormone therapy .

Key safety warnings

Somatropin may induce a state of insulin resistance and in some patients hyperglycaemia, therefore patients should be observed for evidence of glucose intolerance during SciTropin A treatment . Hypothyroidism may develop during therapy with somatropin, and thyroid hormone levels must be checked periodically during SciTropin A therapy and patients should be treated with thyroid hormone when indicated . In cases of severe or recurrent headache, visual problems, nausea and/or vomiting, a fundoscopy for papilloedema is recommended as some rare cases of benign intracranial hypertension have been reported during somatropin treatment, and if papilloedema is confirmed SciTropin A treatment should be interrupted . Progression of scoliosis can occur in patients who experience rapid growth, and signs of scoliosis should be monitored during treatment . Patients with endocrine disorders may have an increased incidence of slipped capital femoral epiphyses, and any child who develops a limp or complains of hip or knee pain during SciTropin A treatment should be evaluated . Increased mortality has been demonstrated in patients suffering from acute critical illness due to complications following open heart surgery, abdominal surgery, multiple accidental trauma or acute respiratory failure who were treated with somatropin in high doses, and these types of patients should not be treated with somatropin .

Contraindications

Treatment with SciTropin A is contraindicated in patients with evidence of malignancies; intracranial lesions have to be inactive and anti-tumour therapy has to be completed prior to treatment, and treatment should be discontinued if there is any evidence of recurrent tumour activity . SciTropin A should not be used for growth promotion in paediatric patients with closed epiphyses . Treatment is contraindicated in patients with known hypersensitivity to somatropin or to any of the excipients . SciTropin A is contraindicated in patients with acute critical illness due to complications following open heart surgery or abdominal surgery, multiple accident trauma, excessive burns or in patients having acute respiratory failure . SciTropin A is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment .

PBS listing

SciTropin A 5 mg/1.5 mL and 10 mg/1.5 mL solutions for injection are listed on the PBS with authority required restrictions at ex-manufacturer prices of A$156.36 and A$312.72 respectively .

Regulatory history

SciTropin A 5 mg/1.5 mL injection cartridge was first listed on the ARTG on 31 October 2007 . SciTropin A 10 mg/1.5 mL solution for injection cartridge was first listed on the ARTG on 29 September 2010 . SciTropin A 15 mg/1.5 mL solution for injection cartridge was first listed on the ARTG on 20 May 2025 . In July 2018, the PBAC recommended re-listing of the 5 mg/1.5 mL form under the Growth Hormone Programme under the same conditions as Omnitrope .