SANDOSTATIN

What it is

Sandostatin contains octreotide, a synthetic octapeptide analogue of naturally occurring somatostatin. It is presented as a solution for injection. Sandostatin is available in three immediate-release strengths (50 micrograms, 100 micrograms, and 500 micrograms per 1 mL) and three modified-release strengths (10 mg, 20 mg, and 30 mg).

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. — Symptomatic control in acromegalic 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

Dosing varies by indication. For acromegaly, the initial dose is 0.05–0.1 mg by subcutaneous injection every 8 or 12 hours, with dosage adjustment based on monthly assessment of GH and IGF-1 levels and clinical symptoms. In most patients the optimal daily dose is 0.2 to 0.3 mg, with a maximum dose of 1.5 mg per day. For gastro-entero-pancreatic endocrine tumours, the initial dose is 0.05 mg once or twice daily by subcutaneous injection, with dosage gradually increased to 0.2 mg three times daily depending on clinical response. For reduction of complications following pancreatic surgery, the dose is 0.1 mg three times daily by subcutaneous injection for seven consecutive days, starting on the day of operation.

Key safety warnings

Pancreatic exocrine insufficiency has been observed in some patients receiving octreotide therapy for gastroenteropancreatic neuroendocrine tumours. Symptoms can include steatorrhoea, loose stools, abdominal bloating, and weight loss. Screening and appropriate treatment for pancreatic exocrine insufficiency according to clinical guidelines should be considered in symptomatic patients. Cases of bradycardia have been reported frequently. 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 Sandostatin treatment and may be associated with cholecystitis and biliary duct dilatation. Additionally, cases of cholangitis have been reported as a complication of cholelithiasis. Ultrasonic examination of the gallbladder before and at 6 to 12 monthly intervals during Sandostatin therapy is therefore recommended. As GH secreting pituitary tumours may sometimes expand, thereby causing serious complications such as visual field defects, it is essential that all patients be carefully monitored. If evidence of tumour expansion appears, alternative procedures may be advisable. In patients with concomitant hypersecretion of insulin, Sandostatin may increase the depth of, and prolong the duration of hypoglycaemia. Such patients should be closely observed on introduction of Sandostatin therapy and at each change of dosage.

Contraindications

Hypersensitivity to octreotide or to any component of the formulation.

PBS listing

Sandostatin is listed on the PBS in immediate-release formulations at 50 micrograms, 100 micrograms, and 500 micrograms per 1 mL, with ex-manufacturer prices of A$14.00, A$28.00, and A$103.91 respectively. The modified-release formulations are listed at 10 mg (A$394.58), 20 mg (A$525.31), and 30 mg (A$603.66). All strengths have streamlined restriction status.

Regulatory history

Sandostatin was first approved on 5 January 1993. The three immediate-release formulations (50 micrograms, 100 micrograms, and 500 micrograms per 1 mL) were first listed on the ARTG on 1 January 1993, whilst the three modified-release formulations (10 mg, 20 mg, and 30 mg) were first listed on 3 March 2015. In July 2018, the PBAC recommended an extension of current listings to include Section 100 (Highly Specialised Drugs Program – Community Access) streamlined authority required listings for functional carcinoid tumours, acromegaly, and vasoactive intestinal peptide secreting tumours. In July 2019, the PBAC recommended a new Section 100 Highly Specialised Drugs Program streamlined authority required listing for unresectable locally advanced or metastatic, non-functional neuroendocrine tumours of midgut or suspected midgut origin on a cost minimisation basis with lanreotide.