OMNITROPE

What it is

Omnitrope is somatropin (rbe), a recombinant human growth hormone. 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. Omnitrope solution for injection is a clear, colourless solution. The medicine is available in three strengths: 5 mg/1.5 mL, 10 mg/1.5 mL, and 15 mg/1.5 mL. Omnitrope is a ready-to-use solution filled in glass cartridges intended for multiple use with a pen device.

Approved indications

Omnitrope is intended for the long-term treatment of children above three years of age with: — 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. Injection sites have to be rotated to minimise the risk of local lipoatrophy. 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, and patients should be observed for evidence of glucose intolerance during Omnitrope treatment. Omnitrope should be used with caution in patients with diabetes mellitus or a family history of diabetes mellitus, and in patients with already manifested diabetes mellitus, the anti-diabetic therapy might require adjustment. Hypothyroidism may develop during therapy with somatropin, and thyroid hormone levels must be checked periodically during Omnitrope therapy with patients 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, Omnitrope treatment should be interrupted. Progression of scoliosis can occur in patients who experience rapid growth, and physicians should be alert to this abnormality which may become apparent during growth hormone therapy, with signs of scoliosis monitored during treatment. Patients with endocrine disorders, including growth hormone deficiency, hypopituitarism and renal osteodystrophy, 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 Omnitrope treatment should be evaluated.

Contraindications

Treatment with Omnitrope is contraindicated in patients with evidence of malignancies, as intracranial lesions must be inactive and anti-tumour therapy must be completed prior to treatment, and treatment should be discontinued if there is any evidence of recurrent tumour activity. Treatment is contraindicated for growth promotion in paediatric patients with closed epiphyses. Omnitrope is contraindicated in patients with known hypersensitivity to somatropin or to any of the excipients. Treatment is contraindicated in patients with acute critical illness due to complications following open heart surgery or abdominal surgery, multiple accident trauma, excessive burns or to patients having acute respiratory failure. Omnitrope is contraindicated in patients with Prader-Willi syndrome who are severely obese or have severe respiratory impairment. In newborns, Omnitrope 5 mg/1.5 mL should not be used because of the presence of the preservative benzyl alcohol.

PBS listing

Omnitrope 5 mg in 1.5 mL cartridge is listed on the PBS with three items, authority required restriction, and ex-manufacturer price of A$156.36. The 10 mg strength in 1.5 mL cartridge is listed with three items, authority required restriction, and ex-manufacturer price of A$312.72. The 15 mg strength in 1.5 mL cartridge is listed with three items, authority required restriction, and ex-manufacturer price of A$469.08.

Regulatory history

Omnitrope 5 mg/1.5 mL injection cartridge was first listed on the ARTG on 11 October 2004. The 10 mg/1.5 mL strength was registered on 29 September 2010. The 15 mg/1.5 mL strength was registered on 16 December 2013. Pre-assembled cartridge holder variants for the 5 mg and 10 mg strengths were registered on 28 October 2014.