QT Prolongation, Torsades De Pointes, and Sudden Death
- Vandetanib can prolong the QT interval. Torsades de pointes and sudden death have been reported in patients receiving vandetanib.
- Vandetanib should not be used in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Hypocalcemia, hypokalemia and/or hypomagnesemia must be corrected prior to vandetanib administration and should be periodically monitored.
- Drugs known to prolong the QT interval should be avoided. If a drug known to prolong the QT interval must be administered, more frequent ECG monitoring is recommended.
- Given the half-life of 19 days, ECGs should be obtained to monitor the QT at baseline, at 2-4 weeks and 8-12 weeks after starting treatment with vandetanib and every 3 months thereafter. Following any dose reduction for QT prolongation, or any dose interruptions greater than 2 weeks, QT assessment should be conducted as described above.
- Because of the 19-day half-life, adverse reactions including a prolonged QT interval may not resolve quickly. Monitor appropriately.
Restricted Distribution Program
Approved Risk Evaluation and Mitigation Strategies (REMS)
Patient Counseling Information
Updated January 2018