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® Enrollment and Prescription Form. You should also ask questions about OPSUMIT® at this time
- If you are a woman, OPSUMIT® is available only through a restricted program called the Macitentan-Containing Products REMS, because of 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 Macitentan-Containing Products 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
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.
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 Care 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 866-228-3546866-228-3546, Monday-Friday, 8:00 AM to 8:00 PM ET. Multilingual phone support is available.