OCTREOTIDE GH

What it is

Octreotide GH is a solution for injection containing octreotide as acetate. Each 1 mL ampoule contains 0.05 mg, 0.1 mg or 0.5 mg octreotide (present as acetate). Octreotide is a synthetic octapeptide analogue of naturally occurring somatostatin with similar pharmacological effects, but with a considerably prolonged duration of action. It inhibits the secretion of serotonin and the gastro-entero-pancreatic peptides: gastrin, vasoactive intestinal peptide, insulin, glucagon, secretin, motilin, and pancreatic polypeptide, and of growth hormone (GH).

Approved indications

— Symptomatic control and reduction of growth hormone and IGF-1 plasma levels in patients with acromegaly, including those who are inadequately controlled by surgery, radiotherapy, or dopamine agonist treatment. — Acromegaly in patients unfit or unwilling to undergo surgery, or in the interim period until radiotherapy becomes fully effective. — Relief of symptoms associated with carcinoid tumours with features of the carcinoid syndrome. — Relief of symptoms associated with vasoactive intestinal peptide secreting tumours (VIPomas). — Reduction of the incidence of complications following pancreatic surgery.

Dosing overview

Key safety warnings

Cases of bradycardia have been reported. Medical review including dose adjustment of this agent and dose adjustments of drugs such as beta-blockers, calcium channel blockers, or agents to control fluid and electrolyte balance, may be necessary. Cholelithiasis is a very common event during octreotide treatment and may be associated with cholecystitis and biliary duct dilatation. Cases of cholangitis have been reported as a complication of cholelithiasis in patients taking octreotide in the post-marketing setting. Ultrasonic examination of the gallbladder before and at 6 to 12 monthly intervals during octreotide therapy is therefore recommended. Pancreatic exocrine insufficiency (PEI) has been observed in some patients receiving octreotide therapy for gastroenteropancreatic neuroendocrine tumours. Symptoms of PEI can include steatorrhoea, loose stools, abdominal bloating, and weight loss. Screening and appropriate treatment for PEI according to clinical guidelines should be considered in symptomatic patients. In patients with concomitant hypersecretion of insulin, octreotide, because of its greater relative potency in inhibiting secretion of growth hormone and glucagon than of insulin, and its shorter duration of action on inhibition of the latter, may increase the depth of, and prolong the duration of hypoglycaemia. Such patients should be closely observed on introduction of octreotide therapy and at each change of dosage.

Contraindications

Hypersensitivity to octreotide or to any component of the formulation.

PBS listing

Octreotide GH 50 micrograms, 100 micrograms, and 500 micrograms injection are listed on the PBS as streamlined items with ex-manufacturer prices of A$36.45, A$36.77, and A$103.91 respectively.

Regulatory history

Octreotide GH was first approved on 20 August 2009. All three strengths (50 micrograms, 100 micrograms, and 500 micrograms per 1 mL injection ampoule) were first listed on the ARTG on 28 October 2009.