A Proven Brand with Established Efficacy
Oral Anzemet® (dolasetron mesylate, USP) Tablets at a dose of 100 mg prevents nausea and vomiting associated with moderately emetogenic cancer therapy as shown by 24-hour efficacy data from 2 double-blind clinical studies.
Efficacy was based on complete response (defined as no vomiting and no use of rescue medication).
The first randomized, double-blind trial compared single oral Anzemet Tablets doses of 25, 50, 100, and 200 mg in 60 male and 259 female cancer patients receiving cyclophosphamide and/or doxorubicin.
Results demonstrated the 100 mg Anzemet Tablets dose produced a 61% complete response rate. There was no statistically significant difference in complete response between the 100 mg and 200 mg doses.
Another double-blind trial compared single oral Anzemet Tablets doses of 25, 50, 100, and 200 mg in 307 patients receiving moderately emetogenic chemotherapy. In this study, there was a 73% response rate with ANZEMET 100 mg.
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Important Safety Information
ANZEMET® (dolasetron mesylate, USP) Tablets are indicated for the prevention of nausea and vomiting associated with moderately emetogenic cancer chemotherapy, including initial and repeat courses in adults and children 2 years and older.
ANZEMET Tablets are contraindicated in patients known to have hypersensitivity to the drug.
Warnings and Precautions
To report SUSPECTED ADVERSE REACTIONS, contact Validus Pharmaceuticals LLC at 1-866-982-5438 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.