SOMATULINE AUTOGEL

What it is

SOMATULINE AUTOGEL is lanreotide acetate supplied as a solution for injection in a pre-filled syringe, available in strengths of 60 mg, 90 mg and 120 mg. The formulation is a white to pale-yellow semi-solid designed for deep subcutaneous injection, with prolonged release of the peptide achieved by the physical nature of the supersaturated solution.

Approved indications

— Treatment of acromegaly when circulating levels of growth hormone and IGF-1 remain abnormal after surgery and/or radiotherapy or in patients who are dopamine agonist treatment refractory. — Treatment of symptoms of carcinoid syndrome associated with carcinoid (neuroendocrine) tumours. — Treatment of gastroenteropancreatic neuroendocrine tumours (GEP-NETs) in adult patients with unresectable locally advanced or metastatic disease.

Dosing overview

Dosage strength should be individualised according to response to treatment; dose may be increased if desired response is not obtained, or decreased if complete control is achieved. Patients well controlled on lanreotide can be treated with SOMATULINE AUTOGEL 120 mg every 42–56 days. Due to the wide therapeutic window of lanreotide, dose adjustment is not necessary in patients with renal or hepatic impairment.

Key safety warnings

Lanreotide inhibits secretion of insulin and glucagon, meaning patients may experience hypoglycaemia or hyperglycaemia; blood glucose levels should be monitored when treatment is initiated or dose altered, and treatment of diabetic patients should be adjusted accordingly. Lanreotide may reduce gall bladder motility and gall bladder echography is advised at the start of treatment and every six months thereafter; post-marketing reports describe gallstones resulting in complications including cholecystitis, cholangitis and pancreatitis requiring cholecystectomy. Lanreotide may decrease heart rate; in patients with underlying cardiac disorders, sinus bradycardia may occur and heart rate should be monitored, with care taken when initiating treatment in patients with bradycardia. Pancreatic exocrine insufficiency has been observed in some patients receiving lanreotide for GEP-NETs, with symptoms including steatorrhoea, loose stools, abdominal bloating and weight loss; screening and appropriate treatment should be considered in symptomatic patients.

Contraindications

SOMATULINE AUTOGEL should not be prescribed during lactation or in patients with hypersensitivity to the peptide, related peptides, or any excipients.

PBS listing

SOMATULINE AUTOGEL is listed on the PBS under Section 100 Highly Specialised Drugs Program (Community Access) for acromegaly and functional carcinoid tumour with Authority Required (Streamlined) restriction. The listing was extended in July 2018 to include treatment of non-functional gastroenteropancreatic neuroendocrine tumours in adult patients with unresectable locally advanced or metastatic disease.

Regulatory history

SOMATULINE AUTOGEL was first listed on the ARTG on 11 September 2003 in all three strengths (60 mg, 90 mg and 120 mg) under licence category RE. In November 2017, the PBAC recommended a change to extend the listing to Section 100 HSD Community Access with Streamlined Authority Required restriction for acromegaly and functional carcinoid tumour. In July 2018, the PBAC recommended a further change to extend the listing to include non-functional gastroenteropancreatic neuroendocrine tumours in adult patients with unresectable locally advanced or metastatic disease.