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Approved Risk Evaluation and Mitigation Strategies (REMS)

Camzyos (mavacamten)
NDA #214998
REMS last update: 12/19/2023



What is the purpose of the REMS?

The goal of the Camzyos Risk Evaluation and Mitigation Strategy (REMS) Program is to mitigate the risk of heart failure due to systolic dysfunction.

Objectives:

  1. Monitor for detection of heart failure due to systolic dysfunction with periodic echocardiograms.
  2. Screen for drug interactions prior to each dispense.

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

Pharmacies that dispense CAMZYOS must:

To become certified to dispense
Before dispensing, (first dose only) within 90 calendar days of submission of the Patient Enrollment Form
  • For patients who delay treatment initiation: Assess the patient’s treatment start date. Document and submit the patient’s new start date using the REMS website.
Before dispensing
  • Counsel the patient on drug-drug interactions.
  • Assess the patient’s prescription and nonprescription medications and supplements for drug-drug interactions. Document and submit to the REMS using the Drug Interaction and Counseling Checklist for Pharmacies.
    | Drug Interaction and Counseling Checklist for Pharmacies |
  • Document the prescribed dose.
  • Obtain authorization to dispense each prescription by contacting the REMS to verify that the prescriber is certified, the patient is enrolled, the healthcare provider has authorized the patient to receive the drug, the patient is counseled, and the pharmacy identified and resolved any drug-drug interactions.
  • Provide the patient with the Patient Brochure.
    | Patient Brochure |
  • Dispense no more than a 35-day supply of CAMZYOS.
To maintain certification to dispense
  • Have the new authorized representative enroll in the REMS by successfully completing the Pharmacy Authorized Representative Knowledge Assessment and completing the Pharmacy Enrollment Form if the authorized representative changes.
    | Pharmacy Authorized Representative Knowledge Assessment |
At all times
  • Report adverse events of heart failure due to systolic dysfunction to Bristol Myers Squibb.
  • Do not distribute, transfer, loan, or sell CAMZYOS, except to a certified pharmacy.
  • Maintain records of dispensing information.
  • Maintain records of completion of the REMS training by relevant staff.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Comply with audits conducted by Bristol-Myers Squibb Company or a third party acting on behalf of Bristol-Myers Squibb Company to ensure that all processes and procedures are in place and are being followed.

Wholesalers-distributors that distribute CAMZYOS must:

To be able to distribute
  • Establish processes and procedures to ensure that the drug is distributed only to certified pharmacies.
  • Train all relevant staff involved in distributing CAMZYOS on the REMS requirements.
At all times
  • Distribute only to certified pharmacies.
  • Maintain records of drug distribution for all CAMZYOS shipments.
  • Comply with audits conducted by Bristol-Myers Squibb Company or a third party acting on behalf of Bristol-Myers Squibb Company to ensure that all processes and procedures are in place and are being followed.

Healthcare providers who prescribe CAMZYOS must:

To become certified to prescribe
Before treatment initiation (first dose)
  • Counsel the patient using the Patient Brochure on the risk of heart failure due to systolic dysfunction.
    | Patient Brochure |
  • Counsel the patient using the Patient Brochure on the risk of drug-drug interactions with CYP2C19 and CYP3A4 inhibitors and inducers and the need to inform healthcare providers of all the prescription and nonprescription medications they take.
    | Patient Brochure |
  • Provide the patient with the Patient Brochure.
    | Patient Brochure |
  • Assess the patient’s cardiovascular status and the appropriateness of initiating treatment by obtaining an echocardiogram. Document and submit confirmation of an echocardiogram and authorization for treatment to the REMS using the Patient Enrollment Form.
    | Patient Enrollment Form |
  • Assess the patient’s prescription and nonprescription medications and supplements for drug-drug interactions. Document and submit to the REMS using the Patient Enrollment Form.
    | Patient Enrollment Form |
  • Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS.
    | Patient Enrollment Form |
Before treatment initiation (first dose), within 90 calendar days of submission of the Patient Entrollment Form
  • For patients who delay treatment initiation: Assess the patient's treatment start date. Document and submit the patient's new start date using the REMS website.
During treatment: 4, 8, and 12 weeks after treatment initiation and every 12 weeks thereafter unless dose change, initiating a weak CYP2C19 inhibitor, or initiating a moderate CYP3A4 inhibitor
  • Counsel the patient on the risks of heart failure due to systolic dysfunction and drug-drug interactions with CYP2C19 and CYP3A4 inhibitors and inducers, and the related safe-use requirements using the Patient Brochure.
    | Patient Brochure |
  • Assess the patient’s cardiovascular status and the appropriateness of continuing treatment by echocardiogram. Document and submit confirmation of an echocardiogram and authorization for treatment to the REMS using the Patient Status Form.
    | Patient Status Form |
  • Assess the patient’s prescription and nonprescription medications and supplements for drug-drug interactions. Document and submit authorization for continuing treatment to the REMS using the Patient Status Form.
    | Patient Status Form |
During treatment: 4 and 12 weeks after any dose change, initiating a weak CYP2C19 inhibitor, or initiating a moderate CYP3A4 inhibitor, and every 12 weeks thereafter
  • Counsel the patient on the risks of heart failure due to systolic dysfunction and drug-drug interactions with CYP2C19 and CYP3A4 inhibitors and inducers, and the related safe-use requirements using the Patient Brochure.
    | Patient Brochure |
  • Assess the patient’s cardiovascular status and the appropriateness of continuing treatment by echocardiogram. Document and submit confirmation of an echocardiogram and authorization for continuing treatment to the REMS using the Patient Status Form.
    | Patient Status Form |
  • Assess the patient’s prescription and nonprescription medications and supplements for drug-drug interactions. Document and submit authorization for continuing treatment to the REMS using the Patient Status Form.
    | Patient Status Form |
At all times
  • Report adverse events of heart failure due to systolic dysfunction to Bristol Myers Squibb.

Patients who are prescribed CAMZYOS:

Before treatment initiation
  • Receive counseling from the healthcare provider on the risk of heart failure due to systolic dysfunction (when the heart is unable to pump enough blood to the body) using the Patient Brochure.
    | Patient Brochure |
  • Receive counseling from the healthcare provider on the risk of drugdrug interactions and the need to inform healthcare providers of all prescription and over-the-counter medicines and supplements they take, using the Patient Brochure.
    | Patient Brochure |
  • Get an echocardiogram to check their heart.
  • Enroll in the REMS by completing the Patient Enrollment Form with the healthcare provider. Enrollment information will be provided to the REMS.
    | Patient Enrollment Form |
  • For patients who delay treatment initiation 7 or more days from the date CAMZYOS was received: Notify the healthcare provider with the new date the patient will start treatment.
During treatment: 4, 8, and 12 weeks after treatment initiation and every 12 weeks thereafter unless dose change or starting certain new medicines
  • Receive counseling from the healthcare provider on the risk of heart failure due to systolic dysfunction (when the heart is unable to pump enough blood to the body).
  • Receive counseling from the healthcare provider on the risk of drug-drug interactions and the need to inform healthcare providers of all the prescription and over-the-counter medicines and supplements they take, using the Patient Brochure.
    | Patient Brochure |
  • Get an echocardiogram to check their heart.
During treatment: 4 and 12 weeks after dose changes and starting certain new medicines and every 12 weeks thereafter
  • Receive counseling from the healthcare provider on the risk of heart failure due to systolic dysfunction.
  • Receive counseling from the healthcare provider on the risk of drug-drug interactions and the need to inform healthcare providers of all the prescription and over-the-counter medicines and supplements they take, using the Patient Brochure.
    | Patient Brochure |
  • Get an echocardiogram to check their heart.
Before each prescription dispense
  • Review all prescriptions and over-the-counter medicines and supplements with the pharmacist.
  • Receive counseling from the pharmacist on drug-drug interactions.
At all times
  • Inform the healthcare provider or seek other medical attention if there are new or worsening symptoms of heart failure.
  • Inform other healthcare providers about treatment with CAMZYOS.
  • Inform healthcare providers of all medicines and any changes, including over-the-counter medicines and supplements.

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 Camzyos REMS, see the DailyMed link(s).
Material Name Material Name Link
Drug Interaction and Counseling Checklist for Pharmacies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Drug_Interaction_and_Counseling_Checklist_for_Pharmacies.pdf
Education Program for Healthcare Providers and Pharmacies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Education_Program_for_Healthcare_Providers_and_Pharmacies.pdf
Healthcare Provider Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Healthcare_Provider_Enrollment_Form.pdf
Healthcare Provider Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Healthcare_Provider_Knowledge_Assessment.pdf
Patient Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Patient_Brochure.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Patient_Enrollment_Form.pdf
Patient Status Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Patient_Status_Form.pdf
Pharmacy Authorized Representative Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Pharmacy_Authorized_Representative_Knowledge_Assessment.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Pharmacy_Enrollment_Form.pdf
Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_Program_Overview.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_REMS_Full.pdf
REMS Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2023_12_19_REMS_Website.pdf

What assessment is available to the REMS?

Assessment Plan
REMS assessment plan unavailable for posting at this time.

What updates have been made to the REMS?

Date Summary of change
12/19/2023 Modified to:
  1. Allow early dispenses for patients who are going on extended travel and for humanitarian reasons
  2. Create a “Support Staff” role for non-licensed medical professionals to assist HCP offices with administrative REMS activities
  3. Update the REMS Document to conform with January 2023 version of “Format and Content of a REMS Document Guidance for Industry”
  4. Update examples of medications that are contraindicated and interact with Camzyos
  5. Adding a link to a Frequently Asked Questions resource on the REMS Website
06/15/2023 Editorial updates to the Education Program for Healthcare Providers and Pharmacies Slides
01/13/2023 Modified to allow:
  1. Healthcare providers and pharmacists at certified pharmacies to manually adjust the treatment start date up to 90 days from Patient Enrollment Form submission to allow for providers and patients to schedule echocardiograms, manage prior authorizations, and potential delays due to patient travel or illness. This ensures the Patient Status Form submission schedule is correct for each patient.
  2. Patients who are transitioning from clinical trials and are on a stable dose of CAMZYOS to bypass the early frequent visits (eg, Week 4 and 8) of the Initiation Phase and continue treatment under the Maintenance Phase schedule (PSF submission every 12 weeks).
11/22/2022
  1. reflect updates to include the registered trademark
  2. update a change in NDA holder
  3. provide edits to the Camzyos REMS webpages and Drug Interaction and Counseling Checklist for clarity and to improve ease of use
05/26/2022 Editorial change.
04/28/2022 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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