FDA Approves Ondansetron Injection, USP (ondansetron hydrochloride) for prevention of nausea and vomiting associated with emetogenic cancer chemotherapy and postoperative nausea/vomiting
The FDA has approved Ondansetron Injection, USP (ondansetron hydrochloride) for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin, and for the prevention of postoperative nausea and/or vomiting. This approval provides a treatment option for these conditions in pediatric and adult patients, with specific age indications and dosing guidelines.
For chemotherapy-induced nausea and vomiting, the injection is indicated for patients aged 6 months and older, while for postoperative use, it is approved for those aged 1 month and older. The approval underscores the need for effective antiemetic management in clinical settings where these symptoms can impact patient outcomes and quality of care, with recommendations against routine prophylaxis in low-risk postoperative cases.
＋ Clinical Details (Mechanism · Dosing · Trial Data · Warnings)
Ondansetron is a 5-HT3 receptor antagonist.
Ondansetron Injection, USP is indicated for the prevention of nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy, including high-dose cisplatin, for patients aged 6 months and older. It is also indicated for the prevention of postoperative nausea and/or vomiting for patients aged 1 month and older. Routine prophylaxis is not recommended for patients with little expectation of postoperative nausea/vomiting, but it is recommended when avoidance is necessary, even with low incidence.
For prevention of nausea and vomiting associated with emetogenic cancer chemotherapy in adults and pediatric patients 6 months and older: dilute in 50 mL of 5% Dextrose Injection or 0.9% Sodium Chloride Injection (for pediatric patients 6 months to 1 year and/or ≤10 kg, may dilute in 10 to 50 mL), administer 0.15 mg/kg per dose for 3 doses (max 16 mg per dose) IV over 15 minutes, with first dose 30 minutes before chemotherapy and subsequent doses 4 and 8 hours after first dose. For prevention of postoperative nausea/vomiting in adults and pediatric patients 1 month and older: dilution not required; for adults and pediatric patients >12 years, single dose of 4 mg IV over at least 30 seconds (preferably 2-5 minutes) or IM, administered immediately before anesthesia induction or postoperatively. Do not exceed total daily dose of 8 mg in patients with severe hepatic impairment.
Trial data not available in label.
Not reported in label.
Not reported in label.
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