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Welcome to the CAPRELSA REMS Program

CAPRELSA® (vandetanib) Tablets, a kinase inhibitor, is approved by the Food and Drug Administration (FDA) for the treatment of symptomatic or progressive medullary thyroid cancer in patients with unresectable locally advanced or metastatic disease. Use CAPRELSA in patients with indolent, asymptomatic or slowly progressing disease only after careful consideration of the treatment related risks of CAPRELSA.

CAPRELSA can prolong the QT interval and cases of Torsades de pointes and sudden death have occurred in patients receiving CAPRELSA. Because of this risk, CAPRELSA is only available through the CAPRELSA Risk Evaluation and Mitigation Strategy (REMS) Program. Read more.

The goals of the CAPRELSA REMS Program are to mitigate the serious risks of QT prolongation, Torsdes de pointes, and sudden death associated with use of CAPRELSA by:

  • Educating prescribers on the following:
    • Serious risks of QT prolongation,Torsades de pointes, and sudden death associated with use of CAPRELSA
    • The need to monitor for QT prolongation and electrolyte abnormalities
    • Appropriate management of QT prolongation to minimize the occurrence of Torsades de pointes and sudden death associated with use of CAPRELSA
  • Informing patients on the following:
    • Serious risks of QT prolongation, Torsades de pointes, and sudden death associated with use of CAPRELSA

Under the CAPRELSA REMS Program, only certified prescribers can prescribe CAPRELSA.

 

Please see the Prescribing Information for CAPRELSA, including boxed WARNING. pdf

 

Only certified prescribers can prescribe CAPRELSA.

Enroll in the CAPRELSA REMS Program to become certified to prescribe.


You are encouraged to report negative side effects of prescription drugs to the FDA.
Visit www.FDA.gov/medwatch or call 1-800-FDA-1088.


CAPRELSA is a registered trademark of Genzyme Corporation.