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Important Facts About CAMZYOS® (mavacamten)

This is a summary of important information that you need to know about CAMZYOS. Your healthcare provider can work with you to help answer any questions you may have about this medication. Keep this information in a safe place so you can refer to it before and during your treatment.

 

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What is CAMZYOS?

CAMZYOS is a prescription medicine used to treat:

adults and children weighing 66 pounds (30 kg) or more with symptomatic obstructive hypertrophic cardiomyopathy (HCM). CAMZYOS may improve your symptoms and your ability to be active. It is not known if CAMZYOS is safe and effective in children weighing less than 66 pounds (30 kg).

WARNING: RISK OF HEART FAILURE

 

CAMZYOS may cause serious side effects, including heart failure.

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 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.  Echocardiograms (echos) are imaging tests, a type of ultrasound study, which take pictures of your heart and show how well your heart is working.

People who develop a serious infection or an irregular heartbeat have a greater risk of heart failure during treatment with CAMZYOS.

Get medical help right away if you experience new or worsening symptoms, including:

  • shortness of breath
  • chest pain
  • fatigue
  • racing heart (palpitations)
  • leg swelling
  • rapid weight gain

The risk of heart failure is also increased when CAMZYOS is taken with certain other medications. 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 risk of heart failure, CAMZYOS is only available through a restricted program called the CAMZYOS Risk Evaluation and Mitigation Strategy (REMS) Program. This means:

You and your healthcare provider must both be enrolled in the CAMZYOS REMS program in order to have it prescribed. Talk to your healthcare provider about how to enroll and for more information about the program.

Your healthcare provider and pharmacist will make sure you understand how to take CAMZYOS safely, which includes returning for echos when advised by your healthcare provider.

You can get CAMZYOS only from a certified pharmacy that is part of the CAMZYOS REMS program. Talk to your healthcare provider about finding a certified pharmacy. You will not be able to get CAMZYOS from a local pharmacy.

If you have questions about the CAMZYOS REMS Program, ask your healthcare provider, visit www.CAMZYOSREMS.com or call 1‑833‑628‑7367.

What should I discuss with my healthcare provider before starting CAMZYOS?

Talk to 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 are pregnant during treatment with CAMZYOS. You may also report your pregnancy by calling Bristol Myers Squibb at 1-800-721-5072 or by visiting www.bms.com.

If you are a female and able to become pregnant, your healthcare provider will do a pregnancy test before you start taking CAMZYOS. You should use an effective method of birth control (contraception) during treatment and for at least 4 months after your last dose of CAMZYOS.

CAMZYOS may reduce how well some hormonal birth control works. Talk to your healthcare provider about the use of effective forms of birth control during treatment with CAMZYOS.

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.

What medicines should I discuss with my healthcare provider?

Tell your healthcare provider about  all of the medicines you take before and during treatment with CAMZYOS, including:

 
  • prescription medicines
  • over-the-counter medicines
 
  • vitamins
  • herbal supplements
Taking CAMZYOS with certain medicines or grapefruit juice may cause heart failure.

Especially tell your healthcare provider if you:

 
  • take over-the-counter medicines, including medications like 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

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

What are the serious side effects of CAMZYOS?

A  serious side effect  is a side effect that can sometimes become life-threatening and can lead to death.

CAMZYOS may cause serious side effects, including heart failure (a condition where the heart cannot pump with enough force).

Get medical help right away if you experience new or worsening symptoms, including:

 
  • shortness of breath
  • chest pain
 
  • fatigue
  • racing heart (palpitations)
 
  • leg swelling
  • rapid weight gain

What are the most common side effects?

The most common side effects of CAMZYOS include dizziness and fainting (syncope).

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

These are not all of the possible side effects of CAMZYOS.

Talk to your healthcare provider for more information about side effects. You may report side effects to FDA at 1-800-FDA-1088. You may also report side effects to Bristol Myers Squibb at 1-800-721-5072.

How should I take CAMZYOS?

Before starting treatment with CAMZYOS, your healthcare provider will do an echocardiogram (echo) to assess your obstructive HCM. Your heart must be regularly monitored with echos while on treatment to help your healthcare provider understand how your heart is responding to CAMZYOS.

Talk to your healthcare provider for more information about echos and your echo schedule.

CAMZYOS comes in immediate release capsules, containing 1, 2.5, 5, 10, or 15 mg of mavacamten. Each capsule is marked with the word MAVA and the number of milligrams (mg) it contains.

Inactive ingredients: croscarmellose sodium, hypromellose, magnesium stearate, mannitol, and silicon dioxide.
Capsule:  contains ferric oxide red, ferric oxide yellow, ferrosoferric oxide, gelatin and titanium dioxide.

Take CAMZYOS exactly as your healthcare provider tells you.

1 time a day, by mouth

Swallow the capsule whole

Do not  break, open, bite, or chew the capsule

Do not change your dose of CAMZYOS without talking to your healthcare provider first

Talk to your healthcare provider about the right dose for you.

What if I miss a dose?

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.

What if I take too much CAMZYOS?

Call your healthcare provider or go to the nearest hospital emergency room right away.

How should I store CAMZYOS?

Store CAMZYOS capsules between 68°F-77°F (20°C-25°C). Keep CAMZYOS and all medicines out of the reach of children.

For more information, please see the U.S. Full Prescribing Information, including Boxed WARNING, and Medication Guide for CAMZYOS. Talk to your healthcare provider for more information about this medication.

3500-US-2600470 09/26

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