Product Dossier
Granisetron-AFT
Product Dossier for Granisetron-AFT (granisetron, AFT Pharmaceuticals). ARTG record, PBS listing, PBAC outcomes — compiled by arcimedes.
- Sponsor: AFT Pharmaceuticals
- Active ingredient: granisetron
- Therapeutic area: Oncology
- Related brand: KYTRIL
- Same area: TALZENNA
- Same area: ZARZIO
What it is
Granisetron-AFT contains granisetron hydrochloride and is available as injections containing 1 mg or 3 mg of granisetron, and as tablets containing 2 mg of granisetron. Granisetron-AFT is a potent antiemetic and highly selective antagonist of 5-hydroxytryptamine (5-HT)3 receptors.
Approved indications
In adults, Granisetron-AFT (tablets and injection) is indicated for the prevention of nausea and vomiting induced by cytotoxic chemotherapy and the prevention of nausea and vomiting induced by radiotherapy. — Prevention of nausea and vomiting induced by cytotoxic chemotherapy in adults — Prevention of nausea and vomiting induced by radiotherapy in adults — Treatment of nausea and vomiting induced by cytotoxic chemotherapy in adults (injection only) — Prevention and treatment of post-operative nausea and vomiting in adults (injection only) — Prevention of nausea and vomiting induced by cytotoxic chemotherapy in paediatric patients (injection only)
Dosing overview
Key safety warnings
Granisetron-AFT may reduce lower bowel motility, and patients with signs of sub-acute intestinal obstruction should be monitored following administration. Cases of ECG modifications including QT prolongation have been reported with Granisetron-AFT. The ECG changes were minor and generally not of clinical significance with no evidence of proarrhythmia. However, caution should be exercised in patients with cardiac comorbidities, those on cardiotoxic chemotherapy and those 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-AFT and other serotonergic drugs. If concomitant treatment is clinically warranted, appropriate observation of the patient is advised.
Contraindications
Granisetron-AFT is contraindicated in patients with known hypersensitivity to granisetron or to any of its excipients.
Regulatory history
Granisetron-AFT received initial approval on 5 August 1997. Two variants are registered on the ARTG: Granisetron-AFT 1 mg/1 mL concentrated injection and Granisetron-AFT 3 mg/3 mL concentrated injection, both first listed on 31 May 2018.