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CAPRELSA - Genzyme Corporation

Manufacturer
Genzyme Corporation
Effective date
2023-04-13
Label type
Risk Evaluation & Mitigation Strategies
Version
3
Source
full-release
Hydrated at
2026-06-04 22:50:36

Label at a glance#

ProductCAPRELSA
Label structure6 sections

Label contents#

Full prescribing information#

I. Administrative Information

REMS ADMINISTRATIVE INFORMATION

Risk: QT prolongation, Torsades de pointes, and Sudden Death

Application Number: NDA 022405

Application Holder: Genzyme Corporation

Initial REMS Approval: 04/2011

Most Recent REMS Update: 04/2023

II. REMS Goals

REMS Goals

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.

III. REMS Requirements

REMS REQUIREMENTS

REMS PARTICIPANT REQUIREMENTS

Genzyme Corporation must ensure that healthcare providers, patients, pharmacies, and wholesaler-distributors comply with the following requirements:

  • 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.

REMS PARTICIPANT REQUIREMENTS

  • Patients who are prescribed CAPRELSA:
Before treatment initiation
  • Receive counseling from the prescriber using the Patient Brochure.

REMS PARTICIPANT REQUIREMENTS

  • 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.

REMS PARTICIPANT REQUIREMENTS

  • 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.

REMS APPLICANT REQUIREMENTS

Genzyme Corporation must provide training to healthcare providers who prescribe CAPRELSA.

The training includes the following educational materials: Prescriber Training Pamphlet, Prescriber Training Slide Deck, and Prescriber Training Questions. The training must be available to healthcare providers and is accessible online and by calling the REMS Call Center.

To support REMS operations, Genzyme Corporation must:

  1. Establish and maintain a REMS website, www.CAPRELSAREMS.com. The REMS website must include the capability to complete prescriber certification and enrollment online, the capability to verify prescriber certification status, and the option to print the Prescribing Information and REMS materials. The REMS website must not link back to the promotional product website(s).
  2. Make the REMS Program website fully operational and all REMS materials available through the website or call center within 30 calendar days of REMS modification approval (04/25/2023).
  3. Establish and maintain a REMS Call Center for REMS participants at 1-800-817-2722.
  4. Establish and maintain a validated, secure database of all REMS participants who are enrolled and/or certified in the CAPRELSA REMS.
  5. Ensure prescribers are able to enroll in the REMS online and by phone.
  6. Ensure pharmacies are able to enroll in the REMS by contacting the REMS Call Center to request the Pharmacy Enrollment Form and submit the completed form by email.
  7. Ensure pharmacies are able to access and review the database of certified prescribers to obtain certification status via the REMS website and the REMS Call Center.
  8. Notify prescribers within one day after they become certified in the REMS Program
  9. Provide certified pharmacies access to the database of certified prescribers.

To ensure REMS participants' compliance with the REMS, Genzyme Corporation must:

  1. Maintain adequate records to demonstrate that REMS requirements have been met, including, but not limited to records of: CAPRELSA distribution and dispensing; certification of prescribers, and pharmacies. These records must be readily available for FDA inspections.
  2. Establish and maintain a plan for addressing noncompliance with REMS requirements.
  3. Monitor prescribers, and pharmacies on an ongoing basis to ensure the requirements of the REMS are being met. Take corrective action if non-compliance is identified, including decertification.
  4. Audit wholesaler-distributors no later than within 180 calendar days after they become authorized to distribute CAPRELSA to ensure that all REMS processes and procedures are in place, functioning, and support the REMS requirements.
  5. Take reasonable steps to improve operations of and compliance with the requirements in the CAPRELSA REMS based on monitoring and evaluation of the CAPRELSA REMS.

IV. REMS Assessment Timetable

REMS TIMETABLE FOR SUBMISSION ASSESSMENTS

Genzyme Corporation must submit REMS Assessments annually from the date of the initial approval of the REMS (04/06/2011). To facilitate inclusion of as much information as possible while allowing reasonable time to prepare the submission, the reporting interval covered by each assessment should conclude no earlier than 60 calendar days before the submission date of the assessment. Genzyme must submit each assessment so that it will be received by the FDA on or before the due date.

V. REMS Materials

REMS Material

The following materials are part of the CAPRELSA REMS:

Enrollment Forms

  • Healthcare Providers:
    • Prescriber Enrollment Form Screenshots
  • Pharmacy:
    • Pharmacy Enrollment Form

Training and Educational Materials

  • Healthcare Providers:
    • Prescriber Training Pamphlet
    • Prescriber Training Questions
    • Prescriber Training Slide Deck
  • Patients:
    • Patient Brochure

Other Materials

VI. Statutory Elements

SPL UNCLASSIFIED SECTION

This REMS is approved under section 505-1 of the Federal Food, Drug, and Cosmetic Act (FD&C Act) (21 U.S.C. 355-1) and consists of the following elements:

  1. Elements to Assure Safe Use (ETASU):
    • Health care providers who prescribe CAPRELSA are specially certified under 505-1(f)(3)(A)
    • Pharmacies and health care settings that dispense CAPRELSA are specially certified under 505-1(f)(3)(B)
  2. Implementation System
  3. Timetable for Submission of Assessments

DailyMed Product Concepts#

Product concept, Relation, Version table
Product conceptRelationVersionEffective
fb646bf8-68ce-77ab-41a2-74f40b7c9dbcProduct name120140508

DailyMed REMS / Drug Safety Documents#

Labels related to this REMS document

DailyMed label, Relation, Version table
DailyMed labelRelationVersionEffectiveManufacturerSource
These highlights do not include all the information needed to use CAPRELSA safely and effectively. See full prescribing information for CAPRELSA. CAPRELSA ® (vandetanib) tablets, for oral use Initial U.S. Approval: 2011SPL related document2026-04-23Genzyme Corporation | Lonza AG | Penn Pharmaceutical Services Limited | AstraZeneca Pharmaceuticals LP | HVL Pharma UK Limited20230913_a9bdff33-335f-4cca-8daf-8c172130b0fe.zip!8fe347f6-e382-4b54-8525-a2dad1d3de09.xml

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Brand, Generic, Manufacturer table
BrandGenericManufacturerSPL set IDEffective dateAvailable safety fieldsJoin
CAPRELSAVANDETANIBGenzyme Corporatione5721cb8-4185-47b9-bbb3-1c587e558a032026-04-23Boxed warning, Warnings, Adverse reactionsName fallback
brand name: CAPRELSA

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