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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:

  1. Educating prescribers on the following:
    1. Serious risks of QT prolongation, Torsades de pointes, and sudden death associated with use of CAPRELSA.
    2. The need to monitor for QT prolongation and electrolyte abnormalities.
    3. Appropriate management of QT prolongation to minimize the occurrence of Torsades de pointes and sudden death associated with use of CAPRELSA.
  2. Informing patients on the following:
    1. 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).

View application holder(s) REMS Website See Disclaimer page regarding links to external sites

Health care providers who prescribe CAPRELSA must:

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Review the following: Prescriber Training Pamphlet or Prescriber Training Slide Deck.
  • Successfully complete the Prescriber Training Questions and submit it to the REMS.
  • Enroll by completing and submitting the Prescriber Enrollment Form to the REMS.
Before treatment initiation
  • Counsel the patient using the Patient Brochure.
At all times
  • Report QT prolongation, Torsades de pointes, and sudden death to the REMS.

Patients who are prescribed CAPRELSA:

Before treatment initiation
  • Receive counseling from the prescriber using the Patient Brochure.

Pharmacies that dispense CAPRELSA must:

To become certified to dispense
  • Designate an authorized representative to carry out the certification process and oversee implementation and compliance with the REMS on behalf of the pharmacy.
  • Have the authorized representative enroll by completing and submitting the Pharmacy Enrollment Form to the REMS.
  • Train all relevant staff involved in dispensing on the REMS program requirements.
  • Establish processes and procedures to verify the prescriber is certified.
Before dispensing
  • Verify that the prescriber is certified through the processes and procedures established as a requirement of the REMS.
At all times
  • Maintain records of prescriber certification each time the drug is dispensed.

Wholesalers-distributors that distribute CAPRELSA must:

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
At all times
  • Distribute CAPRELSA only to pharmacies certified in the CAPRELSA REMS Program.
  • Comply with audits carried out by the REMS Program to ensure that all processes and procedures are in place and are being followed.
Assessment Plan
This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
01/05/2024 Revised to add a Privacy Cookie Opt-out banner to the REMS website
04/13/2023 Modified to:

  1. Update the Patient brochure and REMS website with the new applicant address and logo.
  2. Update the REMS document format.
05/16/2017 Modified to:

  1. Remove the Medication Guide and the communication plan.
  2. Add the Caprelsa REMS Patient Brochure.
  3. Add changes to the REMS Document including updates to the goals and change in ownership.
  4. Include minor clarifying edits to the following REMS materials to accurately explain the enrollment process and prioritize the presentation of risk information: Caprelsa REMS Prescriber Training Slide Deck, Prescriber Training Pamphlet, Prescriber Training Questions, REMS website screen shots, and Pharmacy Enrollment Form.
11/27/2013 Modified to add information about the risk of upper respiratory tract infection to the Medication Guide.
06/22/2011 Modified to:

  1. Add the CAPRELSA (vandetanib) name to the Medication Guide and other REMS materials.
  2. Make editorial changes requested by FDA.
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.

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