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.

Required Heart Function Testing Timeline

The Camzyos REMS program mandates specific echocardiogram testing schedules to monitor your heart's left ventricular ejection fraction (LVEF) and ensure the medication remains safe for continued use. Your healthcare provider will order an echo before starting treatment with Camzyos, and then additional testing as follows:

Initial Monitoring Phase:

• Week 4: First follow-up echocardiogram after starting treatment
• Week 8: Second assessment to evaluate heart function response
• Week 12: Third evaluation before transitioning to maintenance monitoring

Maintenance Phase Monitoring:

• Every 3-6 months: Ongoing echocardiograms as determined by your cardiologist
• Before dose increases: Additional testing required if your doctor considers increasing your Camzyos dose.

If new heart failure symptoms develop, an immediate echocardiogram is recommended.

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.

Specialty Pharmacy Distribution Requirements

Unlike most medications, Camzyos cannot be filled at your local retail pharmacy. The REMS program requires specialized distribution channels to ensure proper monitoring and safety protocols.

Specialty Pharmacy Network:

• Only REMS-certified specialty pharmacies can dispense Camzyos
• Your prescribing cardiologist will provide you with approved pharmacy options
• Most specialty pharmacies offer direct-to-home shipping services
• Coordination between your doctor, pharmacy, and insurance is handled by the specialty pharmacy team

What This Means for You:

• No walk-in pickup: You cannot pick up Camzyos at regular pharmacies like CVS, Walgreens, or grocery store pharmacies
• Advance planning: Allow extra time for prescription processing and shipping
• Direct communication: The specialty pharmacy will contact you directly about refills and delivery scheduling
• Insurance coordination: Specialty pharmacies work directly with insurance companies to manage prior authorizations and coverage

Prescription Process: How to Get Your Camzyos Prescription

• Your cardiologist sends your prescription to a certified specialty pharmacy
• The pharmacy verifies your REMS enrollment status
• Insurance coverage and prior authorization are processed
• Medication is shipped directly to your home address
• Follow-up calls ensure you understand dosing and monitoring requirements

Critical Drug Interactions and Contraindications

The REMS program requires comprehensive drug interaction screening because Camzyos can cause dangerous interactions with common medications.

Medications You Cannot Take with Camzyos

Strong CYP2C19 inhibitors and moderate to strong CYP2C19 inducers:

• Certain heartburn medications (omeprazole, esomeprazole)
• Some antifungal medications
• Specific psychiatric medications

Moderate to strong CYP3A4 inducers:

• Carbamazepine
• Phenytoin
• Efavirenz
• Modafinil
• St. John's wort

The medications listed above are a few examples, and other medications fall into these categories.

Why These Interactions Matter

When Camzyos is taken with these medications, your body cannot properly break down the drug or may break it down too quickly, leading to:

• Dangerously high Camzyos levels in your blood
• Increased risk of severe heart failure
• Potentially life-threatening complications

Before starting Camzyos, provide your doctor with a complete list of all medications, supplements, and over-the-counter drugs. Include herbal supplements, vitamins, and natural products. Mention all prescribers you see (primary care, specialists, dentists).

Your pharmacist will also screen for interactions before each refill, but maintaining an updated medication list is crucial for your safety.

References

1. Bristol-Myers Squibb Company. (n.d.). Scheduling echocardiograms. Camzyos. Retrieved July 23, 2025, from https://www.camzyos.com/taking-camzyos/scheduling-echocardiograms
2. camzyosrems.com. n.d. REMS. Accessed September 30, 2024 at https://www.camzyosrems.com/
3. Camzyos [package insert]. Updated April 2024. Myokardia, Inc. Accessed September 30, 2024 at https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=669c936b-3ee6-4e36-8a22-79dd11b1255b
4. U.S. Food and Drug Administration. May 2023. Risk Evaluation and Mitigation Strategies | REMS. Accessed September 30, 2024 at https://www.fda.gov/drugs/drug-safety-and-availability/risk-evaluation-and-mitigation-strategies-rems

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