Approved Risk Evaluation and Mitigation Strategies (REMS)

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Caprelsa (vandetanib)
NDA #022405
REMS last update: 11/27/2013

View the Caprelsa Prescribing Information and Medication Guide at DailyMed.
View Caprelsa's Regulatory Information at Drugs@FDA

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.

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

Healthcare Providers who prescribe Caprelsa

To be able to prescribe Caprelsa
  • Review the prescribing information for Caprelsa.
  • Review the educational materials for prescribers, including: HCP Education Pamphlet or Slide set.
  • Complete the Prescriber Training Program Questions and submit to the sponsor.
  • Enroll in the REMS by completing and submitting the Prescriber Enrollment Form.
Before writing the first prescription for a patient
  • Counsel the patient on risks and benefits of Caprelsa using the Medication Guide.

Patients who receive Caprelsa

Before receiving the initial Caprelsa prescription
  • Receive counseling from the prescriber on risks and benefits of Caprelsa using the Medication Guide.

Pharmacies that dispense Caprelsa

To be able to dispense Caprelsa
  • Designate an authorized representative to carry out the certification process on behalf of the pharmacy.
  • Train all relevant staff involved in the dispensing of Caprelsa on the risks and requirements of the REMS program.
  • Establish processes and procedures to verify prescriber enrollment.
  • Enroll in the REMS by completing and submitting the Pharmacy Enrollment Form.
Before dispensing Caprelsa
  • Verify that the prescriber is enrolled.
  • Provide the patient with a copy of the Medication Guide.
  • Maintain a system that documents compliance with the program requirements, including verifying prescriber enrollment.
  • Cooperate with audits carried out by the sponsor to ensure that all processes and procedures are in place and are being followed.

What materials are included in the REMS?

The REMS includes a REMS Document. In addition, the REMS includes the following materials intended for patients and healthcare providers:

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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