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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.
Counsel the patient using the Patient Brochure.
| 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.
| 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.
| Pharmacy Enrollment Form |
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.
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. For a specific Medication Guide of a product in the Caprelsa REMS, see the DailyMed link(s).
REMS assessment plan unavailable for posting at this time.
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:
Update the Patient brochure and REMS website with the new applicant address and logo.
Update the REMS document format.
05/16/2017
Modified to:
Remove the Medication Guide and the communication plan.
Add the Caprelsa REMS Patient Brochure.
Add changes to the REMS Document including updates to the goals and change in ownership.
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:
Add the CAPRELSA (vandetanib) name to the Medication Guide and other REMS materials.
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.
