QT Prolongation, Torsades De Pointes, and Sudden Death

QT Prolongation

• 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

• Only prescribers and pharmacies certified with the restricted distribution program are able to prescribe and dispense CAPRELSA [see Warnings and Precautions (5.1, 5.15)].