Approved Risk Evaluation and Mitigation Strategies (REMS)
Caprelsa (vandetanib)
NDA #022405
REMS last update: 01/05/2024
What is the purpose of the REMS?
The goals of the CAPRELSA REMS Program are to mitigate the serious risks of QT prolongation, Torsades 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.
What do participants need to know?
Below is a general overview of the REMS for all REMS participants (e.g., patients, pharmacies, and healthcare providers). See the application holder(s) REMS Website or the approved REMS materials for more information.
What assessment is available to the REMS?
Assessment Plan |
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REMS assessment plan unavailable for posting at this time. |
What updates have been made to the REMS?
Date | Summary of change |
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01/05/2024 | Revised to add a Privacy Cookie Opt-out banner to the REMS website |
04/13/2023 | Modified to:
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05/16/2017 | Modified to:
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11/27/2013 | Modified to add information about the risk of upper respiratory tract infection to the Medication Guide. |
06/22/2011 | Modified to:
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04/06/2011 | Approval of the REMS. |
Disclaimer: This webpage provides general information about REMS programs to various REMS participants (e.g., patients, pharmacies, and healthcare providers). The summary information provided herein is not comprehensive and may not include all of the information relevant to REMS participants. This webpage does not constitute a replacement, modification, or revision of the approved REMS document, including any appended REMS materials. Refer to the approved REMS document for complete information on the REMS requirements for each approved application.