A Proven Brand with an Established Safety Profile
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. In controlled clinical trials, 943 adult cancer patients received Anzemet Tablets. These patients were receiving concurrent chemotherapy, predominantly cyclophosphamide and doxorubicin regimens.
Adverse Events ≥2% from Chemotherapy-Induced Nausea and Vomiting Studies
The following adverse events were reported in ≥2% of patients receiving 25 mg or 100 mg doses of Anzemet Tablets for prevention of cancer chemotherapy induced nausea and vomiting in controlled clinical trials.
|Event||ANZEMET 25 mg (N=235)||ANZEMET 100 mg (N=227)|
|Headache||42 (17.9%)||52 (22.9%)|
|Fatigue||6 (2.6%)||13 (5.7%)|
|Diarrhea||5 (2.1%)||12 (5.3%)|
|Bradycardia||12 (5.1%)||9 (4.0%)|
|Dizziness||3 (1.3%)||7 (3.1%)|
|Tachycardia||7 (3.0%)||6 (2.6%)|
|Dyspepsia||7 (3.0%)||5 (2.2%)|
|Chills/Shivering||3 (1.3%)||5 (2.2%)|
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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.