Aficamten

Aficamten is used in adults to treat a heart problem called obstructive hypertrophic cardiomyopathy (HCM). aficamten may improve people's symptoms and their ability to be active.

Aficamten is available only from a certified pharmacy under a special program. You must be registered in the program and understand the risks and benefits of this medicine.

Aficamten may also be used for purposes not listed in this medication guide.

Follow all directions on your prescription label and read all medication guides or instruction sheets. Your doctor may occasionally change your dose. Use the medicine exactly as directed.

Aficamten is usually taken once per day with or without food, at the same time each day. Follow your doctor's instructions.

Swallow the tablet whole and do not crush, chew, or break it.

Do not change your dose or stop taking this medicine without your doctor's advice.

You should get an echocardiogram before and during treatment with aficamten.

Your treatment may be changed or delayed based on the results or if you have certain side effects.

Store at room temperature away from moisture and heat.

Call your doctor at once if you have shortness of breath, chest pain, tiredness, swelling in your legs, rapid weight gain, or racing or pounding heartbeats.

Aficamten can cause heart failure. Your risk may be higher if you also use certain other medicines. Tell your doctor about all other medicines you use, including prescription and over-the-counter medicines, vitamins, and herbal products. Some drugs should not be used with aficamten.

Some drugs should not be used with aficamten. Your treatment plan may change if you also use rifampin.

Tell your doctor if you have or have ever had:

• an irregular heartbeat; or
• an infection.

It is not known if aficamten will harm an unborn baby. Tell your doctor if you are pregnant or become pregnant during treatment or within 3 weeks after your last dose.

If you are pregnant, you may be enrolled in a pregnancy safety study to track the effects of aficamten on the baby.

Ask a doctor if it is safe to breastfeed while using aficamten.

Get emergency medical help if you have signs of an allergic reaction: hives, difficult breathing, swelling of your face, lips, tongue, or throat.

Call your doctor at once or get emergency medical help if you have:

• new or worsening heart failure symptoms--shortness of breath, chest pain, tiredness, swelling in your legs, rapid weight gain, or racing or pounding heartbeats.

Common side effects of aficamten may include:

• high blood pressure.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Take the missed dose on the same day you remember it. Take your next dose at the regular time and stay on your once-daily schedule. Do not take two doses in one day.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Follow your doctor's instructions about any restrictions on food, beverages, or activity.

Sometimes it is not safe to use certain medicines at the same time. Some drugs can affect your blood levels of other drugs you use, which may increase side effects or make the medicines less effective.

Tell your doctor about all your other medicines, especially:

• fluconazole (if you used for more than 3 days);
• voriconazole; or
• fluvoxamine.

This list is not complete. Other drugs may affect aficamten, including prescription and over-the-counter medicines, vitamins, and herbal products. Not all possible drug interactions are listed here.