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Approved Risk Evaluation and Mitigation Strategies (REMS)

Myqorzo (aficamten)
NDA #219083
REMS last update: 03/26/2026



What is the purpose of the REMS?

The goal of the MYQORZO REMS is to mitigate the risk of heart failure due to systolic dysfunction.

Objective 1: Healthcare providers monitor left ventricular ejection fraction (LVEF) by echocardiogram during treatment according to the frequency described in the Prescribing Information to detect heart failure due to systolic dysfunction.

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 MYQORZO must:

To become certified to prescribe
  • Review the drug’s Prescribing Information.
  • Review the REMS Overview and Education Program for Healthcare Providers and Pharmacies.
  • Successfully complete the Healthcare Provider Knowledge Assessment and submit it to the REMS.
  • Enroll by completing and submitting the Healthcare Provider Enrollment Form to the REMS.
Before treatment initiation (first dose)
  • Counsel the patient on the risk of heart failure due to systolic dysfunction using the Patient Guide. Provide a copy of the material to the patient.
  • Assess the patient’s cardiovascular status and the appropriateness of initiating treatment by obtaining an echocardiogram. Document and submit confirmation of review of the patient’s echocardiogram results and authorization for treatment to the REMS using the Patient Enrollment Form.
  • Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS.
During treatment, between 2 to 8 weeks after treatment initiation and each dose adjustment, then every 3 or 6 months thereafter (depending on echocardiogram results)
  • Counsel the patient on the risk of heart failure due to systolic dysfunction using the Patient Guide.
  • Assess the patient’s cardiovascular status and the appropriateness of continuing treatment by obtaining an echocardiogram.
  • Document and submit confirmation of review of the patient’s echocardiogram results and authorization for treatment to the REMS using the Patient Monitoring Form.
At all times
  • Report adverse events of heart failure due to systolic dysfunction to Cytokinetics, Inc.

Patients who are prescribed MYQORZO must:

Before treatment initiation (first dose)
  • Receive counseling from the healthcare provider on the risk of heart failure due to systolic dysfunction (where the heart cannot pump with enough force) using the Patient Guide.
  • 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.
During treatment, between 2 to 8 weeks after treatment initiation and each dose adjustment, then every 3 or 6 months thereafter (depending on echocardiogram results)
  • Receive counseling from the healthcare provider on the risk of heart failure due to systolic dysfunction (where the heart cannot pump with enough force) using the Patient Guide.
  • Get an echocardiogram to check their heart.
At all times
  • Inform the healthcare provider or seek other medical attention if there are new or worsening symptoms of heart failure.

Pharmacies that dispense MYQORZO 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 review the Prescribing Information, REMS Overview, and Education Program for Healthcare Providers and Pharmacies.
  • Have the Authorized Representative enroll by completing and submitting the Pharmacy Enrollment Form to the REMS.
  • Train all relevant staff involved in dispensing MYQORZO using the REMS Overview and Education Program for Healthcare Providers and Pharmacies.
Before dispensing
  • Obtain authorization to dispense each prescription from the MYQORZO REMS to verify that the healthcare provider is certified, the patient is enrolled, the healthcare provider has authorized the patient to receive MYQORZO, and the requested dose is an allowable dose.
  • For patients initiating treatment, undergoing a dose adjustment, or re-initiating dose titration: Dispense no more than a 30 days’ supply.
  • For patients on a maintenance dose: Dispense no more than a 90 days’ supply.
At all times
  • Report adverse events of heart failure due to systolic dysfunction to Cytokinetics, Inc.
  • Not distribute, transfer, loan, or sell MYQORZO, except to a certified pharmacy.
  • Maintain records of dispensing information and provide such data during audits conducted by Cytokinetics, Inc. or a third party acting on behalf of Cytokinetics, Inc.
  • 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 Cytokinetics, Inc. or a third party acting on behalf of Cytokinetics, Inc. to ensure that all processes and procedures are in place and are being followed.
To maintain certification to dispense
  • Any new Authorized Representative must enroll by completing and submitting the Pharmacy Enrollment Form to the REMS.

Wholesalers-distributors that distribute MYQORZO 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 MYQORZO on the REMS requirements.
At all times
  • Distribute only to certified pharmacies.
  • Maintain records of drug distribution for all MYQORZO shipments.
  • Maintain records that all processes and procedures are in place and are being followed.
  • Comply with audits conducted by Cytokinetics, Inc. or a third party acting on behalf of Cytokinetics, 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 Myqorzo REMS, see the DailyMed link(s).
Material Name Material Name Link
Education Program for Healthcare Providers amd Pharmacies (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_Education_Program_for_Healthcare_Providers_and_Pharmacies.pdf
Healthcare Provider Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_Healthcare_Provider_Enrollment_Form.pdf
Healthcare Provider Knowledge Assessment (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_Healthcare_Provider_Knowledge_Assessment.pdf
Patient Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_Patient_Enrollment_Form.pdf
Patient Guide (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_Patient_Guide.pdf
Patient Monitoring Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_Patient_Monitoring_Form.pdf
Pharmacy Enrollment Form (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_Pharmacy_Enrollment_Form.pdf
REMS Document (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_REMS_Document.pdf
REMS Full (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_REMS_Full.pdf
REMS Overview (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_REMS_Overview.pdf
REMS Website (PDF) https://www.accessdata.fda.gov/drugsatfda_docs/rems/Myqorzo_2026_03_26_REMS_Website.pdf
Assessment Plan
Myqorzo REMS Assessment Plan

This webpage provides REMS assessment plan measures, metrics, and indicators for drug and biological products with a REMS. The REMS assessment plan measures, metrics, and indicators are part of the overall REMS assessment plan used by FDA to evaluate the performance of a REMS and are included in FDA approval letters. The current REMS assessment plan measures, metrics, and indicators are extracted from regulatory letters that contain REMS information, including FDA approval letters, and posted here as they become available.

What updates have been made to the REMS?

Date Summary of change
03/26/2026 Revised to update URL in the REMS Overview to correct a typographical error
02/05/2026 Modification to the REMS consists of:
  1. Modifying the language in REMS materials regarding treatment interruptions for left ventricular ejection fraction (LVEF) 40% to <50% to align with the approved label.
  2. Modifying the indication statement in REMS materials to align with the indication in the approved label.
  3. Editorial revisions to the REMS Document and other REMS materials. Modification to the REMS consists of:
    1. Modifying the language in REMS materials regarding treatment interruptions for left ventricular ejection fraction (LVEF) 40% to <50% to align with the approved label.
    2. Modifying the indication statement in REMS materials to align with the indication in the approved label.
    3. Editorial revisions to the REMS Document and other REMS materials.
12/19/2025 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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