TROPISETRON-AFT

What it is

Tropisetron-AFT is a solution for injection or infusion presented as a clear colourless to faintly yellow-brown aqueous solution containing 1 mg/mL tropisetron in ampoules of either 2 mL or 5 mL. Each ampoule contains tropisetron hydrochloride equivalent to either 2 mg or 5 mg tropisetron per ampoule. Tropisetron is a highly potent and selective competitive antagonist of the 5-HT3 receptor, a subclass of serotonin receptors located on peripheral neurons and within the central nervous system.

Approved indications

— Prevention of nausea and vomiting induced by cytotoxic therapy (5 mg/5 mL ampoule only). — Treatment and prevention of post-operative nausea and vomiting in adults (2 mg/2 mL ampoule only).

Dosing overview

For the prevention of post-operative nausea and vomiting, tropisetron should be administered shortly before the induction of anaesthesia.

Key safety warnings

Caution should be taken in patients with cardiac rhythm or conduction disturbances, or patients treated with anti-arrhythmic or beta-adrenergic blocking agents, as limited experience is available with concurrent use of tropisetron and anaesthetics. Prolongations of the QTc interval which are not clinically significant have been observed after high intravenous doses of tropisetron, and it cannot be excluded that lower doses have also contributed to QTc interval prolongation seen occasionally in patients undergoing general anaesthesia. In patients with uncontrolled hypertension, daily doses of tropisetron above 10 mg should be avoided as they may cause a further increase in blood pressure. Hypersensitivity reactions (type 1 reactions) with one or more of the following symptoms have been observed: flushing and/or generalised urticaria, chest discomfort, dyspnoea, acute bronchospasm, hypotension.

Contraindications

Tropisetron-AFT is contraindicated in patients with hypersensitivity to tropisetron, other 5-HT3 receptor antagonists, or any other components of the formulation, and in pregnancy and lactation.

Regulatory history

Tropisetron-AFT was first listed on the Australian Register of Therapeutic Goods on 16 November 2012, with both the 2 mg/2 mL and 5 mg/5 mL formulations registered on the same date. The product information was last revised on 23 August 2019.