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What is ®?

® is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1). PAH is high blood pressure in the arteries of your lungs. ® can:

The most important information about ® (macitentan)

Do not take ® if you are pregnant or trying to get pregnant. ® can cause serious birth defects if taken while pregnant.

Women who are able to get pregnant must have negative pregnancy tests:

Getting Started on OPSUMIT®

When you’re prescribed OPSUMIT® (macitentan), it’s important to understand the possible risks and benefits of this pulmonary arterial hypertension (PAH) treatment. The steps below explain your role and how you can get off to a good start.

When you are prescribed OPSUMIT®:

  • You and your doctor will review important information, including the OPSUMIT® Medication Guide, and complete the OPSUMIT® Prescription Statement of Medical Necessity (PSMN) form. You should also ask questions about OPSUMIT® at this time
  • If you are a woman, you must enroll in the OPSUMIT® Risk Evaluation and Mitigation Strategy (REMS) Program, due to the risk of serious birth defects. You must agree to all instructions in the program
  • If you are a woman who can get pregnant, you must also:
    • Review the OPSUMIT® REMS Guide for Female Patients
    • Have a negative pregnancy test before starting OPSUMIT®, each month while taking OPSUMIT®, and for 1 month after you stop taking OPSUMIT®
    • Use acceptable forms of birth control when taking OPSUMIT® and for 1 month after stopping OPSUMIT®. Acceptable birth control options are included in the OPSUMIT® Medication Guide. Your doctor will help you choose the types of birth control that are right for you

Have questions about getting started on OPSUMIT® or paying for OPSUMIT®?

Please call 866-228-3546. For questions about OPSUMIT® medication, contact your doctor.



Support for patients and their caregivers

Once you and your healthcare provider have decided that OPSUMIT® is right for you, Janssen CarePath will help you find the resources you may need to get started and stay on track. We will give you information on your insurance coverage, potential out-of-pocket costs, and treatment support, and identify options that may help make your treatment more affordable.

Visit JanssenCarePath.com/OPSUMIT

OPSUMIT® is not available at your local retail pharmacy and is only available through a specialty pharmacy, which will send your medicine to your home. When OPSUMIT® arrives at your home, take OPSUMIT® as prescribed by your doctor.

  • Each month, your specialty pharmacy will call you to review your current medicines, discuss the OPSUMIT® Medication Guide, and reorder OPSUMIT®
    • OPSUMIT® can be shipped in as little as 24 hours once your enrollment is confirmed with a Janssen CarePath Coordinator and a specialty pharmacist
  • If you are a woman who is able to get pregnant:
    • You need to use 2 acceptable forms of birth control and take pregnancy tests as recommended by your doctor. Do not get pregnant. Tell your doctor right away if you have unprotected sex, think that your birth control has failed, miss a menstrual period, or think you are pregnant
    • Be ready to talk about your monthly pregnancy test results with your specialty pharmacy
    • The refill may not be done on time if you have not had your pregnancy test

The specialty pharmacy may not ship your medicine if they don’t speak with you first. Be sure to answer when they call and call them back if they leave a message.

Need Help?

Call a Janssen CarePath Care Coordinator at 866-228-3546, Monday-Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support is available.

See More

What is OPSUMIT®?

OPSUMIT® is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1). PAH is high blood pressure in the arteries of your lungs. OPSUMIT® can:

  • Improve your ability to exercise as measured by the 6-minute walk distance (6MWD). In a clinical study of mainly WHO FC II-III patients, those taking OPSUMIT® walked, on average, 22 meters farther at Month 6 than patients not taking it

The most important information about OPSUMIT® (macitentan)

Do not take OPSUMIT® if you are pregnant or trying to get pregnant. OPSUMIT® can cause serious birth defects if taken while pregnant.

Women who are able to get pregnant must have negative pregnancy tests:

  • Before starting OPSUMIT®
  • Each month while taking OPSUMIT®
  • For 1 month after stopping OPSUMIT®