Information for Female Patients

What is Opsumit (macitentan)?

Opsumit is a prescription medicine used to treat pulmonary arterial hypertension (PAH), which is high blood pressure in the arteries of your lungs.

Opsumit can improve your ability to exercise, improve some of your symptoms, and help slow down the progression of your disease. Opsumit can also lower your chance of being hospitalized for PAH.

It is not known if Opsumit is safe and effective in children.

What are the serious risks of Opsumit?

Opsumit can cause serious birth defects if taken during pregnancy. Women must not be pregnant when they start taking Opsumit or become pregnant while taking Opsumit.

What is the Opsumit REMS (Risk Evaluation and Mitigation Strategy) Program?

The Opsumit REMS Program is a program to tell patients and healthcare providers about the risk of serious birth defects when taking Opsumit. This program is required by the Food and Drug Administration (FDA). All females must enroll in the Opsumit REMS Program to receive Opsumit. REMS stands for Risk Evaluation and Mitigation Strategy.

If you are a female who can get pregnant, to receive Opsumit you must:

  • Talk to your healthcare provider about the risks and benefits of Opsumit
  • Read:
    1. The Opsumit Medication Guide  and
    2. The Opsumit REMS Guide for Females Who Can Get Pregnant
  • Have a pregnancy test before you start taking Opsumit
  • Have a pregnancy test before you receive your refill each month
  • Use reliable forms of birth control during Opsumit treatment and for one month after stopping treatment with Opsumit
  • Immediately notify your healthcare provider if you miss a menstrual period or suspect you are pregnant

Please see the resources below to learn more about taking Opsumit and the Opsumit REMS Program.

Opsumit REMS Guide for Females
Who Can Get Pregnant

Opsumit Medication Guide