safety
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%) |
Pain | 0 | 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
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.