Aficamten

Aficamten may cause heart failure. Tell your doctor if you have an infection or if you have or have ever had heart arrhythmias or other heart problems. If you experience any of the following symptoms, call your doctor immediately: shortness of breath, swelling in your legs, fast or irregular heartbeat, fatigue, chest pain, or sudden weight gain.

Keep all appointments with your doctor and the laboratory. Your doctor will order an echocardiogram before and during your treatment with aficamten. Your doctor may also order certain tests to check your body's response to aficamten.

Aficamten is available only through a special restricted distribution program. A MYQORZO REMS program (Risk Evaluation and Mitigation Strategies) has been set up because of the risk of heart failure. You will only be able to receive aficamten if you, your doctor, and your pharmacy are enrolled in this program.

You will be given the Medication Guide. Read the information carefully and ask your doctor or pharmacist if you have any questions.

Talk to your doctor about the risks of taking aficamten.

Aficamten is used to treat obstructive hypertrophic cardiomyopathy (oHCM; a condition that causes heart muscle to work too hard and get thick and stiff). Aficamten is in a class of medications called cardiac myosin inhibitors. It works by blocking myosin (a protein in the heart), which helps the heart to contract and relax more normally.

Aficamten comes as a tablet to take by mouth. Take once a day. Take aficamten at around the same time every day.

Take aficamten exactly as directed. Do not take more or less of it or take it more often than prescribed by your doctor.

Swallow the tablets whole; do not split, chew, or crush them.

Your doctor will probably start you on a low dose of aficamten and gradually increase your dose, not more than once every 2 weeks.

Aficamten controls obstructive hypertrophic cardiomyopathy but does not cure it. Continue to take aficamten even if you feel well. Do not stop taking aficamten without talking to your doctor.

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

Before taking aficamten,

• tell your doctor or pharmacist if you are allergic to this medication, any part of this medication, or any other medications, foods or substances. Tell your doctor or pharmacist about the allergy and what symptoms you had.
• some medications should not be taken with aficamten. Other medications may cause dosing changes or extra monitoring when taken with aficamten. Make sure you have discussed any medications you are currently taking or plan to take before starting aficamten with your doctor and pharmacist. Before starting, stopping, or changing any medications while taking aficamten, please get the advice of your doctor or pharmacist.
• the following herbal products may interact with aficamten: St. John's Wort. Be sure to let your doctor and pharmacist know that you are taking these medications before you start taking aficamten. Do not start any of these medications while taking aficamten without discussing with your healthcare provider.
• tell your doctor if you have or have ever had high blood pressure.
• tell your doctor if you are pregnant, plan to become pregnant, or are breast-feeding. If you become pregnant while taking aficamten or within 3 weeks after your final dose, call your doctor.

Unless your doctor tells you otherwise, continue your normal diet.

Take the missed dose as soon as you remember it. However, if it is almost time for the next dose, skip the missed dose and continue your regular dosing schedule. Do not take a double dose to make up for a missed one.

Aficamten may cause side effects. If you experience any of the symptoms in the IMPORTANT WARNING section, call your doctor immediately.

Aficamten may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (https://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

Keep this medication in the container it came in, tightly closed, and out of reach of children. Store it at room temperature and away from excess heat and moisture (not in the bathroom).

Keep all medication out of sight and reach of children as many containers are not child-resistant. Always lock safety caps. Place the medication in a safe location – one that is up and away and out of their sight and reach. https://www.upandaway.org

Dispose of unneeded medications in a way so that pets, children, and other people cannot take them. Do not flush this medication down the toilet. Use a medicine take-back program. Talk to your pharmacist about take-back programs in your community. Visit the FDA's Safe Disposal of Medicines website https://goo.gl/c4Rm4p for more information.

In case of overdose, call the poison control helpline at 1-800-222-1222. Information is also available online at https://www.poisonhelp.org/help. If the victim has collapsed, had a seizure, has trouble breathing, or can't be awakened, immediately call emergency services at 911.

Symptoms of overdose may include:

• shortness of breath
• swelling in your legs
• fast or irregular heartbeat
• fatigue
• chest pain
• sudden weight gain

Do not let anyone else take your medication. Ask your pharmacist any questions you have about refilling your prescription.

Keep a written list of all of the prescription and nonprescription (over-the-counter) medicines, vitamins, minerals, and dietary supplements you are taking. Bring this list with you each time you visit a doctor or if you are admitted to the hospital. You should carry the list with you in case of emergencies.

• Myqorzo ^®