MYTOLAC

What it is

Mytolac is lanreotide acetate supplied as a solution for injection in pre-filled syringes containing 60 mg, 90 mg or 120 mg of lanreotide. It is a white to pale-yellow semi-solid formulation designed for deep subcutaneous injection. Prolonged release of the peptide is achieved by the physical nature of the supersaturated solution.

Approved indications Mytolac is indicated for:

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

Dosing overview

For acromegaly, the recommended starting dose is 60 mg administered every 28 days in patients receiving a somatostatin analogue for the first time. Thereafter, dosage strength (60 mg, 90 mg or 120 mg) should be individualised according to the response to treatment. Patients well controlled on lanreotide can be treated with Mytolac 120 mg every 42–56 days. For symptoms of carcinoid syndrome, the recommended starting dose is 60 to 120 mg administered every 28 days, adjusted according to the degree of symptomatic relief obtained. For treatment of gastroenteropancreatic neuroendocrine tumours in adult patients with unresectable locally advanced or metastatic disease, the recommended dose is one injection of 120 mg administered every 28 days. Due to the wide therapeutic window of lanreotide, it is not necessary to adjust the dose in patients with renal or hepatic impairment.

Key safety warnings

Lanreotide inhibits secretion of insulin and glucagon, and patients treated with lanreotide may experience hypoglycaemia or hyperglycaemia. Blood glucose levels should be monitored when lanreotide treatment is initiated or when the dose is altered, and treatment of diabetic patients should be adjusted; in insulin-dependent patients, insulin requirements may be reduced. Lanreotide may reduce gall bladder motility, and post-marketing reports have documented gallstones resulting in complications including cholecystitis, cholangitis and pancreatitis requiring cholecystectomy. Gall bladder echography is advised at the start of treatment and every six months thereafter. Lanreotide may lead to a decrease in heart rate, and sinus bradycardia may occur in patients with pre-existing cardiac disorders, so heart rate should be monitored. Pancreatic exocrine insufficiency has been observed in some patients receiving lanreotide therapy for gastroenteropancreatic neuroendocrine tumours, with symptoms including steatorrhoea, loose stools, abdominal bloating and weight loss; screening and appropriate treatment according to clinical guidelines should be considered in symptomatic patients.

Contraindications

Mytolac should not be prescribed during lactation, nor in patients presenting with hypersensitivity to the peptide or related peptides or any of the excipients.

PBS listing

Mytolac 120 mg injection in single dose pre-filled syringe is listed on the PBS with 6 items under streamlined restriction at an ex-manufacturer price of A$1290.76. The 60 mg strength is listed with 3 items under streamlined restriction at A$849.73, and the 90 mg strength is listed with 3 items under streamlined restriction at A$1130.87.

Regulatory history

Mytolac was first registered on the ARTG on 10 August 2022, with all three strengths (60 mg, 90 mg and 120 mg) registered under licence category RE. In July 2018, the PBAC recommended the extension of listing to include treatment of non-functional GEP-NETS, determined to be sufficiently cost-effective. The PBAC recommended Mytolac for acromegaly, functional carcinoid tumour and non-functional GEP-NET in November 2022, with a further recommendation in July 2024 for the same indications.