What is the Camzyos REMS program and why must you enroll?

The Camzyos REMS program is a drug safety program required by the U.S. FDA. The program is designed to manage serious side effects that are possible to occur from taking Camzyos (mavacamten). It requires prescribers, patients, and pharmacies to enroll in the program and comply with ongoing requirements. Additionally, wholesalers and distributors can only distribute Camzyos to pharmacies that are certified through the REMS program.

Why is Camzyos restricted?

Camzyos is restricted for use under the Camzyos Risk Evaluation and Mitigation Strategy (REMS) program because it has the potential to cause heart failure. This is because the medication reduces systolic contraction (when the heart muscle squeezes blood into blood vessels). The risk of this side effect is higher in people who are ill or have a history of heart problems, like arrhythmia. If you become ill, tell your prescriber because they might need to adjust your dose of Camzyos.

Signs and symptoms of heart failure include:

• Chest pain
• Shortness of breath
• Fatigue
• Racing heart or abnormal heart rhythm
• Swelling the the legs

If you notice any of the symptoms above, contact your healthcare provider right away.

What are the objectives of the Camzyos REMS?

The purpose of the Camzyos REMS program is to ensure the medication is being used safely. The program has two main objectives:

1. Monitor for heart failure
2. Screen for drug interactions

During treatment, your healthcare provider will check your heart with echocardiograms. This is a non-invasive test that uses sound waves to show your healthcare provider images of your heart. They will also ask about medications you take each time you have Camzyos dispensed.

What are the requirements of the Camzyos REMS?

Prescribers, patients, and pharmacies are all required to enroll in the Camzyos REMS. The requirements are different for each.

Prescribers: In order to prescribe Camzyos, prescribers must complete the Camzyos REMS training program. This includes reviewing the prescribing information and other training materials. They also must complete and submit the Healthcare Provider Knowledge Assessment. Lastly, prescribers must enroll using the enrollment form online or by printing and faxing it to 1-833-299-9539.

Patients: To take Camzyos, patients must review a brochure, get an echocardiogram, and complete the patient enrollement form. Your prescriber will discuss with you the risk of heart failure and symptoms to watch out for. Your pharmacist will ask you about your current medications to check for interactions.

Pharmacies: To dispense Camzyos, pharmacies must complete a training program that includes reviewing educational materials. They must complete and submit a knowledge assessment and enroll in the program using a pharmacy enrollment form. Patients should be counseled on interactions and their medications should be reviewed every time Camzyos is dispensed.

For more information about the Camzyos REMS program, visit www.CAMZYOSREMS.com or call 1-833-628-7367.