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
- ANZEMET prolongs the QT interval in a dose dependent fashion and may cause Torsade de Pointes. Avoid ANZEMET in patients with congenital long QT syndrome, hypomagnesemia, hypokalemia, patients taking diuretics with potential for inducing electrolyte abnormalities or anti-arrhythmic drugs or drugs that lead to QT prolongation or cumulative high dose anthracycline therapy. Correct hypokalemia and hypomagnesemia before administering ANZEMET and monitor electrolytes after administration. Use ECG monitoring in patients with congestive heart failure, bradycardia, renal impairment and in elderly patients.
- ANZEMET has been shown to cause dose dependent prolongation of the PR and QRS interval and reports of second or third degree atrioventricular block, cardiac arrest and serious ventricular arrhythmias including fatalities in both adult and pediatric patients. ANZEMET should be used with caution and with ECG monitoring in patients with underlying structural heart disease and pre-existing conduction system abnormalities, elderly patients, patients with sick sinus syndrome, patients with atrial fibrillation with slow ventricular response, patients with myocardial ischemia or those receiving drugs known to prolong the PR and QRS interval. ANZEMET should be avoided in patients with, or at risk for, complete heart block, unless they have an implanted pacemaker.
- Serotonin syndrome has been reported with 5-HT3, receptor antagonists alone (with overdose) but particularly with concomitant use of serotonergic drugs. Serotonin syndrome can be life threatening. Symptoms associated with serotonin syndrome may include the following combination of signs and symptoms: mental status changes, autonomic instability, neuromuscular symptoms, and seizures, with or without gastrointestinal symptoms. Patients should be monitored for the emergence of serotonin syndrome, and if symptoms occur, discontinue ANZEMET and initiate supportive treatment. Patients should be informed of the increased risk of serotonin syndrome, especially if ANZEMET is used concomitantly with other serotonergic drugs such as medications to treat depression and migraines.
- The recommended adult dose of ANZEMET Tablets is 100 mg given within one hour before chemotherapy. In pediatric patients 2 to 16 years, the recommended dose is 1.8 mg/kg given within one hour before chemotherapy, up to a maximum dose of 100 mg. Doses should not be exceeded.
- Most common adverse reactions for ANZEMET: headache, fatigue, diarrhea, bradycardia, dizziness, pain, tachycardia, dyspepsia, and chills/shivering.
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.
- Caution should be exercised when ANZEMET is co-administered with drugs, including those used in chemotherapy, that prolong ECG intervals and/or cause hypokalemia or hypomagnesemia.
- Serotonin syndrome has been described following the concomitant use of 5-HT3 receptor antagonists and other serotonergic drugs, including SSRIs and SNRIs.
Use in Specific Populations
- ECG monitoring is recommended for elderly and renally impaired patients taking ANZEMET.
- ANZEMET should only be used during pregnancy if clearly needed.
- Caution should be exercised when ANZEMET Tablets are administered to a nursing woman.
- ANZEMET tablets are recommended for children old enough to swallow tablets. Safety and effectiveness in pediatric patients under 2 years of age have not been established