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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:
Monitor for detection of heart failure due to systolic dysfunction with periodic echocardiograms.
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.
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.
Pharmacies that dispense CAMZYOS must:
To become certified to
dispense
Designate an authorized representative to complete the certification
process and oversee implementation and compliance with the REMS on
behalf of the pharmacy.
Have the authorized representative enroll in the REMS on behalf of the
pharmacy by completing the Pharmacy Enrollment Form and submitting
it to the REMS.
| Pharmacy Enrollment Form |
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.
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).
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.
