KYTRIL

What it is

KYTRIL is a concentrated solution for injection containing granisetron hydrochloride, available in two strengths: 1 mg/mL and 3 mg/3 mL. It is a sterile, clear, colourless solution, practically free of visible particles. KYTRIL is a potent antiemetic and highly selective antagonist of 5-hydroxytryptamine (5-HT₃) receptors.

Approved indications

— Prevention and treatment of nausea and vomiting induced by cytotoxic chemotherapy in adults. — Prevention of nausea and vomiting induced by radiotherapy in adults. — Prevention of nausea and vomiting induced by cytotoxic chemotherapy in paediatric patients.

Dosing overview

For prevention of chemotherapy-induced nausea and vomiting in adults, a single dose of 3 mg of KYTRIL should be administered as an intravenous infusion, diluted in 20–50 mL infusion fluid and administered over 5 minutes prior to the start of chemotherapy. For treatment of established nausea and vomiting in adults, a single dose of 1 mg should be administered as a 5-minute infusion, with further treatment doses administered if required at least 10 minutes apart. The maximum dose is 9 mg per 24 hours. In paediatric patients, the recommended intravenous dose is 20–40 μg/kg body weight (up to 3 mg), administered as an intravenous infusion, diluted in 10–30 mL infusion fluid and administered over 5 minutes, no more than 30 minutes before the start of chemotherapy. For prevention of radiotherapy-induced nausea and vomiting in adults, a single dose of 3 mg should be administered as an intravenous infusion, diluted in 20–50 mL infusion fluid and administered over 5 minutes prior to the start of radiotherapy. No dosage adjustment is required for the elderly, renally impaired or hepatically impaired patients.

Key safety warnings

KYTRIL may reduce lower bowel motility, and patients with signs of sub-acute intestinal obstruction should be monitored following administration. ECG modifications including QT prolongation have been reported with granisetron, though the changes were minor and generally not of clinical significance with no evidence of proarrhythmia. However, in patients with pre-existing arrhythmias or cardiac conduction disorders, this might lead to clinical consequences. Caution should be exercised in patients with cardiac co-morbidities, on cardio-toxic chemotherapy and/or with concomitant electrolyte abnormalities. Cases of serotonin syndrome (including altered mental status, autonomic dysfunction and neuromuscular abnormalities) have been reported following concomitant use of granisetron and other serotonergic medicines. If concomitant treatment with granisetron and other serotonergic medicines is clinically warranted, appropriate observation of the patient is advised.

Contraindications

KYTRIL is contraindicated in patients hypersensitive to granisetron or any of the excipients.

PBS listing

The KYTRIL tablet 2 mg formulation is listed on the PBS with a streamlined restriction at an ex-manufacturer price of A$8.29.

Regulatory history

KYTRIL was first approved on 5 April 2013. The KYTRIL 3 mg/3 mL injection was first listed on the ARTG on 2 December 2003, and the 1 mg/1 mL injection was first listed on 9 February 2005.