Myqorzo

Myqorzo (aficamten) is a prescription medicine used to treat symptomatic obstructive hypertrophic cardiomyopathy (oHCM) in adults. Obstructive hypertrophic cardiomyopathy is a condition in which the heart muscle becomes abnormally thick, making it harder for blood to flow out of the heart and around the body.

Myqorzo helps improve heart function and symptoms such as shortness of breath, chest pain, dizziness, and exercise intolerance by reducing excessive heart muscle contraction.

Myqorzo tablets are taken once daily, starting at 5 mg and gradually increased to an individualized maintenance dose or a maximum of 20 mg once daily.

• Take Myqorzo once daily at about the same time each day, with or without food. Swallow the tablet whole.
• Take this medicine exactly as your healthcare provider tells you to take it.
• Do not change your dose of Myqorzo without talking to your healthcare provider first.

WARNING: RISK OF HEART FAILURE

Myqorzo has a boxed warning for the risk of heart failure. A boxed warning is the strongest warning the FDA has about a significant, serious, or even life-threatening side effect.

Myqorzo can cause serious side effects, including heart failure, a condition where the heart cannot pump with enough force. Heart failure is a serious condition that can lead to death. You must have echocardiograms before and during treatment with Myqorzo and monitor for signs and symptoms of heart failure.

People who develop a serious illness, such as a serious infection, or who develop a new or worsening irregular heartbeat, have a greater risk of heart failure during treatment with Myqorzo.

Tell your healthcare provider or get medical help right away if you develop new or worsening:

• shortness of breath
• fatigue
• swelling in your legs
• chest pain
• a racing sensation in your heart (palpitations)
• rapid weight gain

Drug interactions can lead to an increased risk of heart failure or loss of effectiveness. Tell your healthcare provider about both prescribed and obtained over-the-counter medicines you take, start taking or stop taking due to the potential for drug interactions.

Because of the risk of heart failure, Myqorzo is only available through a restricted distribution program called

To reduce the risk of heart failure, your healthcare provider must be enrolled in the Myqorzo REMS Program for you to be prescribed Myqorzo.

• Before you start treatment with this medicine, you must enroll in the REMS Program. Talk to your healthcare provider about how to enroll in the program. You will be given information about the program when you enroll.
• Before you take this medicine, your healthcare provider and pharmacist will make sure you understand how to take it safely, which will include returning for echocardiograms when advised by your healthcare provider.
• Myqorzo can only be dispensed by a certified pharmacy that participates in the Myqorzo REMS Program.
• Your healthcare provider can give you information on how to find a certified pharmacy.
• If you have any questions about the Myqorzo REMS Program, ask your healthcare provider, go to www.MYQORZOREMS.com, or call 1-844-285-7367.

Do not take Myqorzo if you take a medicine called rifampin.

Before taking Myqorzo, tell your healthcare provider about all of your medical conditions, including if you have or have ever had:

• an irregular heartbeat; or
• an infection.

Tell your healthcare provider if you are pregnant or plan to become pregnant, as it is not known if these tablets can cause harm to your unborn baby. Tell your healthcare provider if you become pregnant during treatment or within 3 weeks after the last dose of Myqorzo. There is a pregnancy safety study for Myqorzo. Your healthcare provider should report your pregnancy exposure to Cytokinetics, Inc

Tell your healthcare providers if you are breastfeeding or plan to breastfeed, as it is not known if Myqorzo passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with this medicine.

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 Myqorzo side effects may include high blood pressure (hypertension), which may affect 8% of patients.

Also, see the Warnings Section.

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.

Myqorzo works by blocking cardiac myosin, the protein responsible for heart muscle contraction. It binds to β-cardiac myosin, reducing excessive actin–myosin cross-bridge formation and limiting abnormally strong and prolonged contraction. By reducing overactive contraction, Myqorzo lowers blockage in the left ventricle, allowing the heart to pump blood more effectively. This leads to improved symptoms and increased exercise capacity in people with oHCM.

Myqorzo is an allosteric and reversible cardiac myosin inhibitor.

Myqorzo FDA approval was granted on December 19, 2025, for the treatment of symptomatic obstructive hypertrophic cardiomyopathy (oHCM) to improve functional capacity and symptoms, in adults. FDA approval was based on positive results from the Phase 3 clinical trial SEQUOIA-HCM (NCT05186818).

Myqorzo patients had a significant improvement in exercise capacity compared to placebo, in the SEQUOIA-HCM clinical trial, at Week 24:

• pVO₂ increased by 1.7 mL/min/kg with Myqorzo versus 0.0 with placebo (LS mean difference 1.7, 95% CI 1.0–2.4; p < 0.0001).

An increase in pVO₂ means patients can tolerate more physical activity and often feel less breathless and more functional.

Recommended Myqorzo: starting dose is 5 mg orally once daily.

Dose titration: Increase the dose every 2 to 8 weeks by 5 mg until a maintenance dose or the maximum recommended dose of 20 mg once daily is achieved.

Maintenance dose of Myqorzo is individualized based on the patient’s echocardiographic assessments and clinical status. Refer to Full Prescribing Information for instructions on dosage modification.

Note: Your healthcare provider may change your dose or temporarily stop your treatment with MYQORZO if you have certain side effects.

Myqorzo tablets: 5 mg, 10 mg, 15 mg, 20 mg

If you miss a dose of this medicine, take it as soon as possible and take your next dose at your regularly scheduled time the next day. Do not take 2 doses on the same day to make up for a missed dose.

If you take too much Myqorzo, call your healthcare provider or Poison Control Help Line at 1-800-222-1222 or go to the nearest hospital emergency room right away.

Before and during treatment with Myqorzo, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Myqorzo with certain medicines may lead to increased levels of Myqorzo in your blood and increase your risk of heart failure.

Do not stop or change the dose of a medicine or start a new medicine without telling your healthcare provider.

Especially tell your healthcare provider if you take the medicines:

• fluconazole (if used for more than 3 days)
• voriconazole
• Fluvoxamine

Not all possible drug interactions are listed here.

Store at room temperature between 68°F to 77°F (20°C to 25°C).

Active ingredients: aficamten

Inactive ingredients: croscarmellose sodium, hydroxypropyl cellulose, magnesium stearate (non-bovine), mannitol, microcrystalline cellulose, and sodium lauryl sulfate.

The tablet coating contains: carmine, FD&C Blue No. 2, glyceryl mono and dicaprylate, polyvinyl alcohol, polyvinyl alcohol graft polyethylene copolymer, talc and titanium dioxide.

Cytokinetics, Incorporated, South San Francisco, CA 94080