RESEARCH TRIANGLE PARK, NC--Zofran Tablets (ondansetron), from Cerenex Pharmaceuticals, Division of Glaxo Inc., has received FDA approval for a new indication--the prevention of radiation-induced nausea and vomiting. The oral agent, a 5-HT3 antagonist, is currently marketed for prevention of emesis in cancer patients receiving moderately emetogenic chemotherapy.
The specific recommendation is for patients receiving either total body irradiation, single high-dose fraction, or daily fractions to the abdomen. The recommended oral dosage for the new indication is one 8 mg Zofran Tablet given three times a day. In radiotherapy trials, the most commonly reported side effects of Zofran Tablets were constipation (6%), headache (5%), and diarrhea (2%).