U.S. flag An official website of the United States government
  1. Home
  2. Drug Databases
  3. REMS

Approved Risk Evaluation and Mitigation Strategies (REMS)

Camzyos (mavacamten)
NDA #214998
REMS last update: 05/26/2022



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

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 |
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 (first dose)
  • 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
    | Patient Enrollment Form |
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 drugdrug 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 drugdrug 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.

Pharmacies that dispense CAMZYOS must:

To become certified to dispense
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
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 MyoKardia, Inc. or a third party acting on behalf of MyoKardia, Inc. 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 MyoKardia, Inc. or a third party acting on behalf of MyoKardia, Inc. 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 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_2022_05_26_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_2022_05_26_Education_Program_for_Healthcare_Providers_and_Pharmacies.pdf
Healthcare Provider Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Healthcare_Provider_Enrollment_Form.pdf
Healthcare Provider Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Healthcare_Provider_Knowledge_Assessment.pdf
Patient Brochure (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Patient_Brochure.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05-26_Patient_Enrollment_Form.pdf
Patient Status Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Patient_Status_Form.pdf
Pharmacy Authorized Representative Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Pharmacy_Authorized_Representative_Knowledge_Assessment.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_Pharmacy_Enrollment_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Full.pdf
REMS Program Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Program_Overview.pdf
REMS Website Screenshots (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Camzyos_2022_05_26_REMS_Website_Screenshots.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
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.

Back to Top