FDA Approves Ondansetron Injection, USP (ondansetron hydrochloride) for Prevention of Chemotherapy-Induced and Postoperative Nausea/Vomiting

Ondansetron is a 5-HT3 receptor antagonist.

Ondansetron Injection, USP is indicated for the prevention of: 1) nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin. This is approved for patients aged 6 months and older. 2) postoperative nausea and/or vomiting. This is approved for patients aged 1 month and older. For postoperative use, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea/vomiting will occur. It is recommended when nausea/vomiting must be avoided postoperatively, even if the incidence is low. It may also be given to prevent further episodes in patients who did not receive prophylaxis and experience postoperative nausea/vomiting.

For prevention of chemotherapy-induced nausea/vomiting in adults and pediatric patients ≥6 months: The recommended dosage is 0.15 mg/kg per dose for 3 doses (max 16 mg/dose), infused IV over 15 minutes. The first dose is given 30 minutes before chemotherapy, with subsequent doses 4 and 8 hours after the first. Dilution in 50 mL of 5% Dextrose or 0.9% Sodium Chloride is required before administration. For pediatric patients 6 months to 1 year and/or ≤10 kg, dilution may be in 10-50 mL based on fluid needs.

For prevention of postoperative nausea/vomiting: A single dose is recommended. For adults and pediatric patients >12 years: 4 mg. It may be administered IV (infuse undiluted over at least 30 seconds, preferably 2-5 minutes) or IM (inject undiluted). It should be administered immediately before induction of anesthesia or postoperatively. Dilution is not required before administration for this indication. See full prescribing information for dosing in patients 1 month to 12 years.

General administration notes: Do not mix with alkaline solutions. Inspect for particulate matter and discoloration before use; discard if present. After dilution for chemotherapy, do not use beyond 24 hours. For patients with severe hepatic impairment: Do not exceed a total daily dose of 8 mg.

Trial data not available in label.

Not reported in label.

Ondansetron Injection, USP is indicated for antiemetic prophylaxis in two specific settings: emetogenic cancer chemotherapy and postoperative recovery. The label guidance advises against routine postoperative prophylaxis in low-risk patients but supports its use when avoiding nausea/vomiting is clinically important. It also provides an option for rescue treatment in postoperative patients who did not receive prophylaxis.