Camzyos is a prescription medication used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM).

Camzyos belongs to a group of drugs called cardiac myosin inhibitors. With HCM, the heart muscle contracts too much. Camzyos works by binding to a heart protein called myosin to allow the heart muscle to relax more.

This medication comes in capsule form. It is taken once daily. Swallow Camzyos capsules whole. Do not crush, chew or open the capsules.

Common side effects include dizziness and fainting. Do not operate heavy machinery until you know how this medication affects you.

Camzyos is a prescription medicine used to treat adults with symptomatic obstructive hypertrophic cardiomyopathy (HCM). Camzyos may improve your symptoms and your ability to be active.

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

Serious side effects have been reported. See "Camzyos Precautions".

Common side effects include:

• dizziness
• fainting

This is not a complete list of Camzyos side effects. Ask your doctor or pharmacist for more information.

Tell your doctor if you have any side effect that bothers you or that does not go away.

Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088.

Before and during Camzyos treatment, tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Taking Camzyos with certain medicines or grapefruit juice may cause 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 over-the-counter medicines such as omeprazole (for example, Prilosec), esomeprazole (for example, Nexium), or cimetidine (for example, Tagamet).
• Take other medicines to treat your obstructive HCM disease.
• Develop an infection

Camzyos may 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 you take your first dose and during your treatment with Camzyos to help your healthcare provider understand how your heart is responding to Camzyos. People who develop a serious infection or irregular heartbeat have a greater risk of heart failure during treatment with Camzyos.

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

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

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

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

  • Your healthcare provider must be enrolled in the Camzyos REMS Program in order for you to be prescribed Camzyos.

  • Before you take Camzyos, you must enroll in the Camzyos REMS Program. Talk to your healthcare provider about how to enroll in the Camzyos REMS Program. You will be given information about the program when you enroll.

  • Before you take Camzyos, your healthcare provider and pharmacist will make sure you understand how to take Camzyos safely, which will include returning for echocardiograms when advised by your healthcare provider. Camzyos can only be dispensed by a certified pharmacy that participates in the Camzyos REMS Program. Your healthcare provider can give you information on how to find a certified pharmacy. You will not be able to get Camzyos at a local pharmacy.

Grapefruit and grapefruit juice may interact with this medication and can lead to potentially dangerous effects including heart failure. Discuss the use of grapefruit products with your healthcare provider.

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

• are pregnant or plan to become pregnant. Camzyos may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Camzyos. You may also report your pregnancy by calling Bristol-Myers Squibb at 1-800-721-5072 or www.bms.com. If you are a female and able to become pregnant:
  • Your healthcare provider will do a pregnancy test before you start treatment with Camzyos.
  • You should use effective birth control (contraception) during treatment with Camzyos and for 4 months after your last dose of Camzyos.
  • Camzyos may reduce how well hormonal birth control works. Talk to your healthcare provider about the use of effective forms of birth control during treatment with Camzyos.
• are breastfeeding or plan to breastfeed. It is not known if Camzyos passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Camzyos.

Tell your healthcare provider if you are pregnant or plan to become pregnant. Camzyos may harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with Camzyos. You may also report your pregnancy by calling Bristol-Myers Squibb at 1-800-721-5072.

Tell your healthcare provider if you are breastfeeding or plan to breastfeed. It is not known if Camzyos passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with Camzyos.

• Take Camzyos exactly as your healthcare provider tells you to take it.
• Do not change your dose of Camzyos without talking to your healthcare provider first.
• Take Camzyos once a day.
• Swallow the capsule whole. Do not break, open, or chew the capsule.
• If you miss a dose of Camzyos, 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.
• Your healthcare provider may change your dose, temporarily stop, or permanently stop your treatment with Camzyos if you have certain side effects.
• If you take too much Camzyos, call your healthcare provider or go to the nearest hospital emergency room right away.

If you take too much Camzyos, call your healthcare provider or go to the nearest hospital emergency room right away.

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

Keep Camzyos and all medicines out of the reach of children.

WARNING: RISK OF HEART FAILURE

Camzyos reduces left ventricular ejection fraction (LVEF) and can cause heart failure due to systolic dysfunction.

Echocardiogram assessments of LVEF are required prior to and during treatment with Camzyos. Initiation of Camzyos in patients with LVEF <55% is not recommended. Interrupt Camzyos if LVEF is <50% at any visit or if the patient experiences heart failure symptoms or worsening clinical status.

Concomitant use of Camzyos with certain cytochrome P450 inhibitors or discontinuation of certain cytochrome P450 inducers may increase the risk of heart failure due to systolic dysfunction; therefore, the use of Camzyos is contraindicated with the following:

•Moderate to strong CYP2C19 inhibitors or strong CYP3A4 inhibitors

•Moderate to strong CYP2C19 inducers or moderate to strong CYP3A4 inducers

Because of the risk of heart failure due to systolic dysfunction, Camzyos is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called Camzyos REMS PROGRAM.