Approved Risk Evaluation and Mitigation Strategies (REMS)

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Caprelsa (vandetanib)
NDA #022405
REMS last update: 05/16/2017

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

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 Training Slide Deck.
  • Successfully complete the Prescriber Training Questions and submit it to the REMS Program.
  • Enroll in the REMS by completing the Prescriber Enrollment Form and submitting it to the REMS Program.
Before treatment initiation
  • Counsel the patient or caregiver using the Patient Brochure.

Patients who are prescribed Caprelsa

Before the first prescription
  • Receive counseling from the prescriber using the Patient Brochure.

Pharmacies that dispense Caprelsa must

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

Wholesalers 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
  • Comply with audits carried out by the REMS Program 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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