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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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 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.

Learn How to Take CAMZYOS