Efficacy
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).
Study 1:
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.
Study 2:
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
Indications
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.
Contraindications
ANZEMET Tablets are contraindicated in patients known to have hypersensitivity to the drug.
Warnings and Precautions
Adverse Reactions
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.