Approved Risk Evaluation and Mitigation Strategies (REMS)

Camzyos (mavacamten)

NDA #214998

REMS last update: 12/19/2023

• View Camzyos's Regulatory Information at Drugs@FDA

• Goals
• Summary
• REMS Materials
• Assessment Plan
• Update history

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

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: Allow early dispenses for patients who are going on extended travel and for humanitarian reasons Create a “Support Staff” role for non-licensed medical professionals to assist HCP offices with administrative REMS activities Update the REMS Document to conform with January 2023 version of “Format and Content of a REMS Document Guidance for Industry” Update examples of medications that are contraindicated and interact with Camzyos 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: 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. 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	reflect updates to include the registered trademark update a change in NDA holder 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.