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WARNING

QT PROLONGATION, TORSADES DE POINTES, AND SUDDEN DEATH

CAPRELSA can prolong the QT interval. Torsades de pointes and sudden death have been reported in patients receiving CAPRELSA. CAPRELSA should not be used in patients with hypocalcemia, hypokalemia, hypomagnesemia, or long QT syndrome. Hypocalcemia, hypokalemia and/or hypomagnesemia must be corrected prior to CAPRELSA 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 interval at baseline, at 2-4 weeks and 8-12 weeks after starting treatment with CAPRELSA 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. Only prescribers and pharmacies certified with the restricted distribution program are able to prescribe and dispense CAPRELSA [see WARNINGS AND PRECAUTIONS].