Healthcare Providers

Counseling before treatment:

Counsel the patient, using the Patient Brochure, on the:

• Risk of heart failure due to systolic dysfunction, including how to recognize and respond to the symptoms of heart failure due to systolic dysfunction
• 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

Provide the patient with the Patient Brochure.

Assessments before treatment:

Assess the patient’s cardiovascular status and the appropriateness of initiating treatment by obtaining an echocardiogram. Additionally, assess the patient’s prescription and nonprescription medications and supplements for drug-drug interactions. Document confirmation of an echocardiogram, assessment of drug-drug interactions, and authorization for treatment using the Patient Enrollment Form. Enroll the patient by completing and submitting the Patient Enrollment Form to the REMS. Retain a copy for the patient’s medical record.

• For patients who delay treatment initiation up to 90 days from Patient Enrollment Form submission: Assess the patient’s treatment start date. Document and submit the new start date using the REMS website.

During treatment:

• Assess the patient’s cardiovascular status, and the appropriateness of continuing treatment by obtaining echocardiograms at the frequency described in the Prescribing Information
• Counsel the patient as described above
• Assess the patient’s prescription and nonprescription medications and supplements for drug-drug interactions

Document and submit that the patient has been counseled, the echocardiogram has been performed, the patient’s medications have been assessed for drug-drug interactions, and it is appropriate to continue treatment using the Patient Status Form.

At all times:

Report any adverse events of heart failure due to systolic dysfunction, including full details of the patient’s medical status and dose of CAMZYOS at the time of the event, to Bristol Myers Squibb