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FDA approved Ondansetron Injection, USP (ondansetron hydrochloride) for prevention of nausea and vomiting associated with emetogenic cancer chemotherapy and postoperative nausea/vomitingFDA approved a new injection to help prevent nausea and vomiting from cancer treatment and surgery

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Key Takeaway
Consider ondansetron injection for antiemetic prophylaxis in chemotherapy and postoperative settings per age-specific indications.

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)
Mechanism of Action

Ondansetron is a 5-HT3 receptor antagonist.

Indication & Patient Population

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.

Dosing & Administration

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.

Key Clinical Trial Data

Trial data not available in label.

Warnings & Contraindications

Not reported in label.

Place in Therapy

Not reported in label.

The U.S. Food and Drug Administration has approved a new medication called Ondansetron Injection. This drug helps prevent nausea and vomiting that can happen during cancer chemotherapy treatments, including strong chemotherapy drugs like cisplatin. It also helps prevent nausea and vomiting after surgery. These symptoms can be very difficult for patients and can affect their recovery and quality of life.

This approval means the injection can now be used for children as young as 6 months old for chemotherapy-related nausea and vomiting, and for children as young as 1 month old for nausea after surgery. For adults, it's also approved for both uses. Having this option available gives healthcare providers another tool to help patients who experience these challenging symptoms during cancer treatment or after operations.

It's important to understand that while this approval provides another treatment choice, the FDA specifically notes that this medication shouldn't be used routinely for all patients after surgery. For people at low risk of nausea after surgery, the benefits might not outweigh the potential risks. The approval simply means this medication has been found to be safe and effective for specific uses when prescribed appropriately.

If you or someone you care about experiences nausea and vomiting during cancer treatment or after surgery, the most important step is to talk with your healthcare provider. They can help determine if this medication or other options might be appropriate based on individual circumstances, age, and specific medical needs.

What this means for you:
Talk to your doctor if you experience nausea from cancer treatment or surgery to see if this new option might help.

Study Details

Study typeFda approval
PublishedDec 2006
View Original Abstract ↓
1 INDICATIONS AND USAGE Ondansetron Injection, USP is a 5-HT 3 receptor antagonist indicated for the prevention of: • nausea and vomiting associated with initial and repeat courses of emetogenic cancer chemotherapy. ( 1.1 ) • postoperative nausea and/or vomiting. ( 1.2 ) 1.1 Prevention of Nausea and Vomiting Associated with Initial and Repeat Courses of Emetogenic Cancer Chemotherapy 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. Ondansetron is approved for patients aged 6 months and older. 1.2 Prevention of Postoperative Nausea and/or Vomiting Ondansetron Injection, USP is indicated for the prevention of postoperative nausea and/or vomiting. As with other antiemetics, routine prophylaxis is not recommended for patients in whom there is little expectation that nausea and/‌or vomiting will occur postoperatively. In patients in whom nausea and/or vomiting must be avoided postoperatively, Ondansetron Injection, USP is recommended even when the incidence of postoperative nausea and/or vomiting is low. For patients who do not receive prophylactic Ondansetron Injection, USP and experience nausea and/or vomiting postoperatively, Ondansetron Injection, USP may be given to prevent further episodes. Ondansetron Injection, USP is approved for patients aged 1 month and older.
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