ALOXI

What it is

ALOXI is a sterile, clear, colourless, non-pyrogenic, isotonic, buffered solution for intravenous administration containing palonosetron hydrochloride. Palonosetron hydrochloride is an antiemetic and antinauseant agent that is a selective serotonin subtype 3 (5-HT3) receptor antagonist with a strong binding affinity for this receptor. ALOXI is available in two strengths: 250 microgram per 5 mL vial and 75 microgram per 1.5 mL vial.

Approved indications —

Prevention of nausea and vomiting induced by cytotoxic chemotherapy — Prevention of postoperative nausea and vomiting (PONV) for up to 24 hours following surgery

Dosing overview

For CINV, ALOXI is to be infused intravenously over 30 seconds. For PONV, it is to be infused intravenously over 10 seconds. No dosage adjustment is recommended for geriatric patients or patients with impaired renal or hepatic function.

Key safety warnings

Hypersensitivity reactions may occur in patients who have exhibited hypersensitivity to other selective 5-HT3 receptor antagonists. There have been reports of serotonin syndrome with the use of 5-HT3 antagonists either alone or in combination with other serotonergic drugs including selective serotonin reuptake inhibitors (SSRI) and serotonin noradrenaline reuptake inhibitors (SNRIs). As palonosetron may increase large bowel transit time, patients with a history of constipation or signs of subacute intestinal obstruction should be monitored following administration. Caution should be exercised in the concomitant use of palonosetron with medicinal products that increase the QT interval or in patients who have or are likely to develop prolongation of the QT interval. Since palonosetron may induce dizziness, somnolence or fatigue, patients should be cautioned when driving or operating machines.

Contraindications

ALOXI is contraindicated in patients known to have hypersensitivity to the drug or any of its components.

Regulatory history

ALOXI 250 microgram per 5 mL solution for injection was first registered on the ARTG on 26 June 2006. The 75 microgram per 1.5 mL formulation was registered on 22 August 2017. In August 2013, the TGA approved a variation to the dosage for palonosetron hydrochloride to permit a multiple dosage regimen. This decision removed the previous single dose restriction for administration within a 7-day period, aligning the Australian Product Information with international labels.