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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THE CAMZYOS REMS PROGRAM

In some patients, CAMZYOS can cause the heart to become too relaxed, increasing the risk of heart failure. Because of this risk, CAMZYOS is only available through the CAMZYOS REMS program, which is required by the FDA to ensure the safe use of the medication.

Talk to your doctor about how to enroll in the CAMZYOS REMS program. Your doctor will give you information about the program when you enroll.

To enroll in the CAMZYOS REMS program and in order
to take (and continue taking) CAMZYOS, you will:

  • Review and discuss the REMS Patient Brochure with your doctor to understand the risks of CAMZYOS and the symptoms of heart failure, including when to seek medical attention
  • Tell your doctor about the prescription and over-the-counter medicines you take, including vitamins and herbal supplements and alert your doctor and pharmacist of any changes to your medications while on treatment. Do not stop or change the dose of a medicine or start a new medicine without telling your doctor
  • Get an echocardiogram to see if you are eligible for treatment with CAMZYOS
  • Complete the Patient Enrollment Form with your doctor
  • Get regular follow-up echocardiograms at the times
    recommended by your doctor while you are on CAMZYOS

In order to prescribe and dispense
CAMZYOS,
your doctor and pharmacy are required to:

  • Participate in the CAMZYOS REMS
    educational program
  • Be certified in the risks and requirements
    of using CAMZYOS

You will receive CAMZYOS through REMS-certified specialty pharmacies

  • Because of the special requirements of the CAMZYOS REMS program, CAMZYOS is only dispensed
    through REMS-certified
    specialty pharmacies and is not available through local retail pharmacies
  • Your doctor will give you information on how to get your CAMZYOS medication from a specialty pharmacy
  • A specialty pharmacy will send CAMZYOS directly to your home and will continue to call you to coordinate
    medication shipments and help with any medication issues that may arise

Have questions about the CAMZYOS REMS program?
To learn more, you can:

ADDITIONAL PRECAUTIONS

Your doctor needs to know the answers to these important questions before and during treatment with CAMZYOS:

Do you have other medical conditions? Are you pregnant or breastfeeding, or do you plan to become pregnant or breastfeed?

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 the Bristol Myers Squibb reporting line at 1-800-721-5072 or at 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 final 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

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.

Important to know

Before and during your treatment with CAMZYOS, tell your healthcare provider about all the medicines you are taking, plan to take, or plan to stop taking. Click here to learn more.

Tell your healthcare provider right away

if you experience new or worsening shortness of breath, chest pain, fatigue, swelling in your legs, a racing sensation of your heart (palpitations), or rapid weight gain.

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.

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