U.S. Full Prescribing Information, including Boxed WARNING Medication Guide
U.S. Healthcare Professionals Indication

Indication

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.

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Finding Hope,
Making a Change

“

Since taking CAMZYOS, my symptoms have been improving and things have changed for the better.

—Dani

Dani, a Rx CAMZYOS® (mavacamten) patient

Dani, a patient living with symptomatic obstructive HCM, and her daughter Kassidy were compensated for their time.

Individual results may vary.

“

Since taking CAMZYOS, my symptoms have been improving and things have changed for the better.

—Dani

Dani was diagnosed with obstructive HCM in her 50s. It started with symptoms like shortness of breath, or fatigue while doing simple things like shopping or walking. When she was diagnosed, Dani tried an oral medication, but her obstruction didn’t improve and she eventually needed a myectomy, a type of open heart surgery. Despite this, and having tried a few other treatment options, her symptoms did not improve. Then, her doctor prescribed CAMZYOS.

See other stories >

Individual results may vary.

Clinical Study Results

In a clinical study, CAMZYOS improved symptoms* and the ability to be active.†

A 30-week clinical study of 251 people compared two groups of adults with symptomatic obstructive HCM. One group (123 people) took CAMZYOS and the other group (128 people) took a placebo. All participants who enrolled in the study were symptomatic (73% had NYHA Class II symptoms and 27% had Class III symptoms*). Though it wasn’t a requirement of the study, most of the participants (231) remained on their previous medication, a beta blocker or calcium channel blocker.

WHAT THE STUDY
RESULTS SHOWED‡

The study first looked at how many people experienced either:

Some improvement‡ in their ability to be active and an improvement in their symptoms

OR

More improvement‡ in their ability to be active and no worsening of their symptoms

Results showed that more people taking CAMZYOS achieved this outcome (37%, 45/123)
compared with those taking placebo (17%, 22/128).

*Symptoms were measured using the New York Heart Association (NYHA) classification.

†The ability to be active was determined by measuring peak oxygen consumption or pVO2, which is the maximum amount of oxygen the body uses during exercise. This was measured during exercise testing on a bicycle or treadmill.

‡Some improvement=improved pVO2, by at least 1.5 mL/kg/min. More improvement=improved pVO2 by at least 3.0 mL/kg/min.

The study then looked at other data and measurements referred to as secondary endpoints.

Compared to people taking placebo, people taking CAMZYOS were assessed in the following areas: change in symptoms, obstruction, and patient-reported outcomes.

~2 out of 3 people taking CAMZYOS
had their symptoms improve

What the data showed: Of those taking CAMZYOS, 65% (80/123) improved by one or more NYHA class compared with 31% (40/128) of those taking a placebo.

How was this measured? Symptom improvement was defined as a lower NYHA class at the end of the study.

Obstruction to blood flow within the heart decreased 4x more with CAMZYOS when compared with placebo

What the data showed: People who took CAMZYOS had an average decrease in their LVOT gradient of 47 mmHg (started at 86 mmHg and went down to 38 mmHg), and people who took a placebo had an average decrease of 10 mmHg (started at 84 mmHg and went down to 73 mmHg).

How was this measured? At the beginning and end of the study, the obstruction in people’s hearts was measured with an echocardiogram after they exercised. This was done to find out how much blood was able to pump out of the heart in millimeters of mercury, or mmHg. Doctors call this measurement the left ventricular outflow tract, or LVOT, gradient. A lower LVOT gradient means there is less obstruction in the heart.

Why is this
important?
3x greater improvement
in symptom burden and
physical limitations

What the data showed: From when they started the study to when it ended, people taking CAMZYOS reported an average change in score of +14, and those who took placebo reported an average change in score of +4. The average baseline score was 71 for patients starting the trial.

How was this measured? How much people were bothered by their symptoms and experienced physical limitations was assessed using the Kansas City Cardiomyopathy Questionnaire (23-item version)–Clinical Summary Score (KCCQ-CSS). Higher scores represent better health status.

3x greater improvement
in shortness of breath

What the data showed: From when they started the study to when it ended, people taking CAMZYOS reported an average change in score of -3 and those who took placebo reported an average change in score of -1. The average baseline score was 5 for patients starting the trial.

How was this measured? The frequency and severity of people’s shortness of breath was assessed using the Hypertrophic Cardiomyopathy Symptom Questionnaire–Shortness-of-Breath subscore (HCMSQ-SoB). Lower scores represent less shortness of breath.

CAMZYOS will not work for everyone.
Individual results may vary.

Side Effects

If you and your doctor are considering CAMZYOS, it’s important to know the answers to these questions:

What are the serious side effects of CAMZYOS?

A serious side effect is a side effect that can sometimes be life-threatening and 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 the FDA at 1-800-FDA-1088. You may also report side effects to Bristol Myers Squibb at 1-800-721-5072

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.

Get Tips for Talking
with Your Doctor

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.

  • Look out for the following icons as you read:

  • Talk to your healthcare provider

  • Call a healthcare provider right away

  • Helpful information to remember

What is CAMZYOS?

CAMZYOS is a prescription medicine used to treat:

adults with symptomatic obstructive hypertrophic cardiomyopathy (obstructive HCM). CAMZYOS may improve your symptoms and your ability to be active.

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 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 serious 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 only get CAMZYOS 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 www.bms.com.

      If you are a female and able to become pregnant, your healthcare provider will do a pregnancy test before you start receiving 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 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
      • 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
      • 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 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 (non-bovine), mannitol, and silicon dioxide.

Capsule: contains black iron oxide, gelatin, red iron oxide, titanium dioxide, and yellow iron oxide.

Take CAMZYOS exactly as your healthcare provider tells you.

  • Once 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 two 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.

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