Zofran Approved for Prevention of RT Emesis
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.
RESEARCH TRIANGLE PARK, NC--Zofran Tablets (ondansetron), fromCerenex Pharmaceuticals, Division of Glaxo Inc., has receivedFDA approval for a new indication--the prevention of radiation-inducednausea and vomiting. The oral agent, a 5-HT3 antagonist, is currentlymarketed for prevention of emesis in cancer patients receivingmoderately emetogenic chemotherapy.
The specific recommendation is for patients receiving either totalbody irradiation, single high-dose fraction, or daily fractionsto the abdomen. The recommended oral dosage for the new indicationis one 8 mg Zofran Tablet given three times a day. In radiotherapytrials, the most commonly reported side effects of Zofran Tabletswere constipation (6%), headache (5%), and diarrhea (2%).
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