Label Changes for:
Anzemet (dolasetron mesylate) tablets and Anzemet (dolasetron mesylate) injection
September 2011
Changes have been made to the WARNINGS sections of the safety label.
Detailed View: Safety Labeling Changes Approved By FDA Center for Drug Evaluation and Research (CDER)
September 2011
WARNINGS
QT Interval Prolongation
- Anzemet prolongs the QT interval in a dose dependent fashion. Torsade de Pointes has been reported during post-marketing experience. Avoid Anzemet in patients with congenital long
QT syndrome, hypomagnesemia, or hypokalemia. Hypokalemia and hypomagnesemia must be
corrected prior to Anzemet administration. Monitor these electrolytes after administration as
clinically indicated. Use ECG monitoring in patients with congestive heart failure, bradycardia,
renal impairment, and elderly patients.
PR and QRS Interval Prolongation
- 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. At particular risk are
patients with underlying structural heart disease and preexisting conduction system
abnormalities, elderly, patients with sick sinus syndrome, patients with atrial fibrillation with
slow ventricular response, patients with myocardial ischemia or patients receiving drugs known
to prolong the PR interval (such as verapamil) and QRS interval (e.g., flecainide or quinidine).
Anzemet should be used with caution and with ECG monitoring in these patients.
Anzemet should be avoided in patients with complete heart block or at risk for complete heart
block, unless they have an implanted pacemaker.
October 2009
PRECAUTIONS
Anzemet (dolasetron mesylate) injection
- When intravenous dolastron (200 mg once daily) was coadministered with cimetidine (300mg four times daily) for 7 days, the systemic exposure (i.e., AUC) of hydrodolasetron increased by 24% and the maximum plasma concentration of hydrodolasetron increased by 15%. When intravenous dolastron (200 mg once daily) was coadministered with rifamprin (600mg once daily) for 7 days, the systemic exposure of hydrodolasetron decreased by 28% and the maximum plasma concentration of hydrodolasetron decreased by 17%.
Anzemet (dolasetron mesylate) tablets
- When oral dolastron (200 mg once daily) was coadministered with cimetidine (300mg four times daily) for 7 days, the systemic exposure (i.e., AUC) of hydrodolasetron increased by 24% and the maximum plasma concentration of hydrodolasetron increased by 15%. When oral dolastron (200 mg once daily) was coadministered with rifamprin (600mg once daily) for 7 days, the systemic exposure of hydrodolasetron decreased by 28% and the maximum plasma concentration of hydrodolasetron decreased by 17%.
