Camzyos

Approved Uses

Camzyos is specifically indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM). This is a condition where the heart muscle becomes abnormally thick, which can block or reduce the flow of blood from the heart to the rest of the body.

Treatment Goals

The medication is prescribed to help improve heart function and physical capabilities in patients with oHCM. The primary goals of treatment include:

• Improving functional capacity: Helping patients perform daily physical activities and exercise more easily.
• Reducing symptoms: Addressing common issues associated with the condition, such as shortness of breath and fatigue during exertion.
• Improving clinical status: Helping to improve the patient's New York Heart Association (NYHA) functional class, which is a standard measure of heart failure severity.

Healthcare providers use Camzyos to target the underlying cause of the obstruction in the heart, aiming to improve the overall quality of life for those living with this chronic condition.

Targeting Heart Muscle Proteins

Camzyos belongs to a class of medications called cardiac myosin inhibitors. It is specifically designed to treat obstructive hypertrophic cardiomyopathy (oHCM), a condition where the heart muscle becomes thickened and overactive.

In a healthy heart, proteins called myosin and actin work together to make the heart muscle contract. In people with oHCM, these proteins create too many connections, known as cross-bridges. This causes the heart to contract with too much force and prevents it from relaxing properly between beats.

Improving Heart Function

Camzyos works by binding to the myosin proteins to reduce the number of active cross-bridges. This process leads to several key changes in how the heart functions:

• Reduced Contraction Force: By limiting the number of connections between muscle proteins, the medication prevents the heart from squeezing too hard.
• Better Relaxation: The heart muscle can relax more easily, which allows the heart chambers to fill with more blood.
• Decreased Obstruction: Reducing the force of contraction helps clear the path for blood to flow out of the heart and into the rest of the body.

By addressing the underlying cause of the overactive heart muscle, Camzyos helps improve the heart's efficiency and reduces symptoms associated with the condition.

Common Side Effects

The most common side effects reported by people taking Camzyos include:

• Dizziness
• Fainting (syncope)

Serious Side Effects

Camzyos can cause serious side effects, most notably heart failure due to systolic dysfunction. This happens when the heart muscle does not contract strongly enough to pump enough blood to the rest of the body. Contact your doctor immediately if you experience symptoms of heart failure, such as:

• New or worsening shortness of breath
• Chest pain
• Fatigue or weakness
• Swelling in the legs, ankles, or feet
• Rapid weight gain
• A racing or pounding heartbeat (palpitations)

Because of these risks, healthcare providers use heart ultrasounds (echocardiograms) to monitor heart function before and during treatment. Taking certain other medications or supplements while using Camzyos can also increase the risk of heart failure.

Heart Failure Risk

Camzyos can reduce the left ventricular ejection fraction (LVEF), which is the measurement of how much blood the heart pumps out with each contraction. When this measurement becomes too low, it can lead to heart failure. Because of this risk, the medication includes a boxed warning, the most serious warning required by the FDA.

REMS Program

Due to the risk of heart failure, Camzyos is available only through a restricted program called the Camzyos Risk Evaluation and Mitigation Strategy (REMS). Healthcare providers, pharmacies, and patients must all be enrolled in this program to ensure the medication is used safely and that heart function is monitored appropriately.

Drug Interactions

Many other medications can interact with Camzyos, affecting how the body processes it. Certain drugs can increase the levels of Camzyos in the blood, which significantly raises the risk of heart failure. Other medications may decrease its effectiveness. It is essential for healthcare providers to review all prescription drugs, over-the-counter medicines, and herbal supplements before and during treatment.

Required Monitoring

Regular heart monitoring is a requirement for anyone taking Camzyos. This involves periodic echocardiograms (ultrasounds of the heart) to check the LVEF. If heart function drops below a specific level, the medication may need to be paused or the dose adjusted.

Pregnancy and Fetal Risk

Based on animal studies, Camzyos may cause fetal harm when administered to a pregnant person. Females of reproductive potential are typically advised to use effective contraception during treatment and for four months after the final dose. A pregnancy test is usually required before starting the medication.

Pregnancy

Based on animal studies, Camzyos may cause fetal harm and birth defects when used during pregnancy. There is limited data on its effects in humans, so it is generally avoided unless the potential benefit justifies the risk to the fetus.

Individuals who can become pregnant should confirm they are not pregnant before starting this medication. Effective contraception is required during treatment and for 4 months after the last dose. Because Camzyos can interact with and reduce the effectiveness of some hormonal contraceptives, healthcare providers may recommend using non-hormonal birth control or specific combinations of methods.

Breastfeeding

It is not known if Camzyos passes into breast milk or if it could harm a nursing infant. Because of the potential for serious adverse reactions, breastfeeding is usually not recommended during treatment. Patients should discuss infant feeding options with their healthcare provider to determine the safest course of action.

Dosage Forms

Camzyos is supplied in the following form:

• Oral Capsule: This medication is taken by mouth, typically once per day.

The medication is available in several different strengths. A healthcare provider will determine the appropriate strength for each patient and may adjust it over time based on the results of heart function monitoring.

FDA Approval and Indication

The U.S. Food and Drug Administration (FDA) approved Camzyos in April 2022. It is indicated for the treatment of adults with symptomatic obstructive hypertrophic cardiomyopathy (oHCM) who have New York Heart Association (NYHA) class II-III symptoms. The medication is designed to improve physical capacity and reduce the severity of symptoms in these patients.

Boxed Warning

Camzyos carries a Boxed Warning regarding the risk of heart failure. The drug reduces the left ventricular ejection fraction (LVEF), which is a measurement of how much blood the heart pumps out with each contraction. If LVEF becomes too low, it can lead to heart failure due to systolic dysfunction. Because of this risk, patients must have their LVEF measured by echocardiogram before starting the medication and at regular intervals during treatment.

REMS Program

Due to the risk of heart failure, Camzyos is only available through a restricted distribution program called the CAMZYOS Risk Evaluation and Mitigation Strategy (REMS). The requirements of this program include:

• Prescribers must be certified by enrolling in the REMS program.
• Pharmacies must be certified and only dispense the medication to authorized patients.
• Patients must be enrolled in the program and comply with the required heart monitoring (echocardiograms).

Drug Interactions

The FDA warns that Camzyos can interact with many other medications, including certain over-the-counter drugs and herbal supplements. These interactions can increase the concentration of Camzyos in the body, raising the risk of heart failure, or decrease its concentration, making it less effective. It is contraindicated for use with certain strong cytochrome P450 inhibitors or inducers.

The price of Camzyos can vary based on several factors, including your insurance plan's formulary and the specialty pharmacy used to fill the prescription. Because Camzyos is a brand-name medication and there is currently no generic version available, the cost may be higher than other heart medications.

Insurance Coverage

Many insurance plans, including private insurance and Medicare, may cover Camzyos, but the out-of-pocket costs like copays or coinsurance will depend on your specific plan. Because this drug is only available through a restricted program called the Camzyos REMS, it must be dispensed by a certified specialty pharmacy rather than a standard retail pharmacy.

Financial Assistance

The manufacturer of Camzyos may offer financial support programs to help reduce the cost for eligible patients. These programs often include copay cards for individuals with commercial insurance or patient assistance programs for those who are uninsured or underinsured. Patients are encouraged to discuss these options with their healthcare provider or the specialty pharmacy handling their prescription.

Generic Availability

There is currently no generic version of mavacamten (the active ingredient in Camzyos). Brand-name drugs typically have higher costs because they are protected by patents that prevent other companies from making generic versions for a set period of time.