Prescribing InformationMedication GuideU.S. Healthcare ProfessionalsREMS Program

Taking MYQORZO™

MYQORZO REMS Program

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MYQORZO Risk Evaluation and Mitigation Strategy (REMS)

To help protect the health of people taking medicines that have certain serious risks, the U.S. Food and Drug Administration (FDA) sometimes requires a REMS program. In some people, MYQORZO can increase the risk of heart failure. The MYQORZO REMS program is designed to help reinforce safe use by providing special instructions, monitoring, and provider and patient education.

In order for you to start and continue taking MYQORZO, your healthcare provider will:

1.

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Have you get echocardiograms to make sure you are able to take MYQORZO

It is important that you complete your echocardiograms at the times recommended by your doctor

2.

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Help you complete the Patient Enrollment Form (required for you to start taking MYQORZO)

Your provider will also discuss the risks and benefits of MYQORZO treatment

To learn more about REMS:Visit MYQORZOREMS.com or call 844-285-7367

Helpful information about getting your medicine

MYQORZO is only available through REMS-certified specialty pharmacies. This means that your doctor will send in your prescription to the pharmacy, and the pharmacy will arrange getting the medication to you each month.

When taking MYQORZO, it is important to know:

People who develop a serious infection or a new or worsening heart rhythm problem may have a greater risk of heart failure during treatment with MYQORZO.

Tell your healthcare provider or get medical help right away if you develop ANY of these:

  • New or worsening shortness of breath, chest pain, fatigue, leg swelling, a racing sensation in your heart (palpitations), or rapid weight gain as these may be signs of heart failure
  • A serious illness such as a serious infection
  • New or worsening irregular heartbeat

There are known drug interactions that may increase or decrease the amount of MYQORZO in your body, which could increase your risk of heart failure. As a result, it is important to inform your healthcare provider of all prescription and over-the-counter medications and supplements that you take prior to and during MYQORZO treatment.

IMPORTANT SAFETY INFORMATION

What is the most important information I should know about MYQORZO?

MYQORZO can cause serious side effects, including:

  • Heart failure, a condition where the heart cannot pump with enough force, is a serious condition that can lead to death. You must have echocardiograms (echos) 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, chest pain, fatigue, leg swelling, a racing sensation in your heart (palpitations), or rapid weight gain.

  • The risk of heart failure is also increased when MYQORZO is taken with certain other medicines. Tell your healthcare provider about any prescribed and over-the-counter medicines you take, before and during your treatment with MYQORZO

  • Because of the risk of heart failure, MYQORZO is only available through a restricted distribution program called the MYQORZO Risk Evaluation and Mitigation Strategy (REMS) Program

    • Your healthcare provider must be enrolled in the MYQORZO REMS Program for you to be prescribed MYQORZO
    • Before you start treatment with MYQORZO, you must enroll in the MYQORZO 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 MYQORZO, your healthcare provider and pharmacist will make sure you understand how to take MYQORZO safely, which will include returning for echos when advised by your healthcare provider. MYQORZO can only be dispensed by a certified pharmacy that participates in the MYQORZO REMS Program
    • 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

Who should not take MYQORZO?

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

What are the possible side effects of MYQORZO?

MYQORZO can cause serious side effects, including heart failure.

What should I tell my healthcare provider before taking MYQORZO?

Before taking MYQORZO, tell your healthcare provider about all of your medical conditions, including if you:

  • Are pregnant or plan to become pregnant. It is not known if MYQORZO 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 study for MYQORZO. Your healthcare provider should report your pregnancy exposure to Cytokinetics, Inc
  • Are breastfeeding or plan to breastfeed. 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 MYQORZO

Before and during MYQORZO treatment, tell your healthcare provider about all the prescription and over-the-counter medicines, vitamins, and herbal supplements you take. Taking MYQORZO with certain medicines may lead to increased levels of MYQORZO in your blood and increase the 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 fluconazole (if used for more than 3 days), voriconazole, or fluvoxamine.

What are the most common side effects of MYQORZO?

The most common side effect of MYQORZO is high blood pressure (hypertension).

These are not all the possible side effects of MYQORZO. Talk to your healthcare provider for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Cytokinetics at 1-833-633-2986.

INDICATION AND USAGE

MYQORZO is a prescription medicine used to treat adults with symptomatic obstructive cardiomyopathy (oHCM) to improve functional capacity and symptoms.

It is not known if MYQORZO is safe and effective in children.

Please see full Prescribing Information, including Boxed WARNING, and Medication Guide.