Patients

A Risk Evaluation and Mitigation Strategy (REMS) is a drug safety program that the US Food and Drug Administration (FDA) can require for certain medicines to ensure they are used safely. Drug companies and healthcare providers must take extra steps to make sure the benefits of using the drug are greater than the risks. The FDA must approve these steps as part of the REMS.

In some patients, CAMZYOSTM can cause heart failure due to systolic dysfunction, when the heart is unable to pump enough blood to the body. CAMZYOS has a REMS because of the risk of heart failure due to systolic dysfunction.

The risk of heart failure due to systolic dysfunction can increase for people who are taking certain medicines or supplements with CAMZYOS. These medicines can affect the amount of CAMZYOS in their blood. As part of the REMS, your healthcare provider will discuss these interactions with CAMZYOS, including examples of which over-the-counter medicines and supplements to avoid.

Tell your healthcare provider about all the medicines you take, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements, even if you don’t take them every day. Do not start taking a new medicine, stop taking existing medicines, or change the dose of any of your medicines without talking to your healthcare provider. CAMZYOS and other medicines may affect each other, causing side effects.

To enroll in the CAMZYOS REMS and receive CAMZYOS, you must:

Before taking CAMZYOS:

1.

Receive and review the Patient Brochure. Your doctor will provide you with a copy of the brochure.

2.

Discuss with your healthcare provider whether treatment with CAMZYOS is right for you. You should discuss the:

  • Risk of heart failure due to systolic dysfunction, when your heart is unable to pump enough blood to the body
  • Symptoms of heart failure, including shortness of breath, chest pain, fatigue, a racing sensation in your heart (palpitations), swelling in your legs, and rapid weight gain
  • Need to report new or worsening symptoms of heart failure to your healthcare provider or to seek other medical attention
  • Risks of CAMZYOS interacting with other medicines, including over-the-counter medicines and supplements
  • Need to get regular echocardiograms (an echocardiogram is a test that uses sound waves to create pictures of your heart)
3.

Get an echocardiogram to see if you are eligible for treatment with CAMZYOS.

4.

Complete the Patient Enrollment Form with your healthcare provider.

While taking CAMZYOS:

5.

Get echocardiograms as directed below. Echocardiograms will be done:

Before
treatment
starts

At 4 weeks
after treatment
is started

At 8 weeks
after treatment
is started

At 12 weeks
after treatment
is started

Every 12 weeks
thereafter

Echocardiograms may also be needed:

  • 4 weeks after a change in the dose of CAMZYOS
  • After a break in treatment (as directed by your healthcare provider)
  • 4 weeks and 12 weeks after starting certain medicines that are known to affect CAMZYOS

Your healthcare provider will let you know if these echocardiograms are required.

6.

During treatment, discuss with your healthcare provider:

  • The risk of heart failure due to systolic dysfunction
  • The symptoms of heart failure
  • The need to report new or worsening symptoms of heart failure to your healthcare provider or to seek other medical attention
  • Any changes to the medicines you take in addition to CAMZYOS, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements
  • The need to get regular echocardiograms
7.

Discuss with your pharmacist the risks of CAMZYOS interacting with other medicines, including over-the-counter medicines and supplements.

At all times:

8.

Report new or worsening symptoms of heart failure to your healthcare provider or seek other medical attention.

9.

Let all your healthcare providers and pharmacists know that you are taking CAMZYOS and all other products you are taking, including prescription medicines and over-the-counter medicines, vitamins, and herbal supplements.

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