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)?
The Opsumit REMS 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 to receive Opsumit. REMS stands for Risk Evaluation and Mitigation Strategy.
Females who cannot get pregnant
You are considered a female who is not able to get pregnant if you:
- Have not yet entered puberty, or
- Do not have a uterus, or
- Have gone through menopause. (Menopause means that you have not had a menstrual period for at least 12 months for natural reasons, or that you have had your ovaries removed.), or
- Are infertile for other medical reasons and this infertility is permanent and cannot be reversed.
To receive Opsumit, you must:
- Enroll in the Opsumit REMS by completing the Patient Enrollment and Consent Form
- Your prescriber will help you complete this form
- You must understand your requirements in the Opsumit REMS and provide your signature:
- electronically (if enrolling online), or
- on the form itself (if enrolling by paper), or
- by calling Opsumit REMS to provide your verbal consent (if enrolling by phone)
- Tell your prescriber if you become pregnant or your ability to become pregnant changes
- Receive counseling from your prescriber on the risk of serious birth defects (only if you are premenopausal)
- Be monitored every year to see if your ability to become pregnant changes and tell your prescriber if your ability to become pregnant changes (only if you are over the age of 8)
- Note: If you are a parent or caregiver of a female child who started taking Opsumit before reaching puberty, you should check your child regularly to see if she is developing signs of puberty. Tell your doctor right away if you notice that she is developing breast buds or pubic hair. Your doctor should decide if your child has reached puberty. Your child may reach puberty before having her first menstrual period
Females who can get pregnant
You are considered a female who can get pregnant if you:
- Have entered puberty, even if you have not started your period, and
- Have a uterus, and
- Have not gone through menopause (have not had a period for at least 12 months for natural reasons, or have had your ovaries removed)
To receive Opsumit, you must:
- Enroll in the Opsumit REMS by completing the Patient Enrollment and Consent Form
- Your prescriber will help you complete this form
- You must understand your requirements in the Opsumit REMS and provide your signature:
- electronically (if enrolling online), or
- on the form itself (if enrolling by paper), or
- by calling Opsumit REMS to provide your verbal consent (if enrolling by phone)
- Talk to your healthcare provider about the risks and benefits of Opsumit
- Read the Guide for Female Patients
- Have a negative pregnancy test:
- before you start taking Opsumit
- each month before you receive your refill
- for one month after you stop taking Opsumit
- Your healthcare provider will order the pregnancy tests for you. You may not receive your Opsumit refill on time if you do not confirm with the pharmacy that you have had your monthly pregnancy test
- Use reliable forms of birth control at all times during Opsumit treatment and for one month after stopping treatment with Opsumit
- Do not have unprotected sex
- 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.
