OPSUMIT® (macitentan) Patient Resources

The following resources are designed to help you as you start treatment with OPSUMIT®. You will also find common questions and answers about Janssen CarePath and OPSUMIT®.

Learn more about OPSUMIT®

More information is available at Opsumit.com.

Download the OPSUMIT® patient brochure to learn more about PAH and treatment with OPSUMIT®.


OPSUMIT® Prescribing Information
OPSUMIT® Medication Guide

Remember, your healthcare team should always be your first point of contact when you have questions about your health and your treatment.

Support from our PAH Companions

The Janssen CarePath PAH Companion* Program provides one-on-one educational support to help you start and stay on your prescribed Janssen medication and resources to help you partner with your healthcare team to better manage your pulmonary arterial hypertension (PAH).

Look to the PAH Companion Program for:

Tools to help you have more productive discussions with your healthcare team

Tips for engaging with your support network (friends, family, and peers)

Ongoing education on managing and living with PAH

Connection with a dedicated PAH Companion through email, phone, and/or text

As part of the program, PAH Companions are ready to answer your questions. Patients who have enrolled can talk to a PAH Companion by calling 866-300-1818, Monday-Friday, 8 AM to 9 PM ET.

*The PAH Companion Program is limited to education about your Janssen therapy, its administration, and/or PAH. It is intended to supplement your understanding of your therapy, and does not provide medical advice or replace a treatment plan from your doctor, nurse, or healthcare team.

Frequently Asked Questions (FAQs)

Janssen CarePath is a program that provides you with support and resources, including shipment verification, benefits verification, and coordination with your specialty pharmacy.

Janssen provides a wide range of support and resources through Janssen CarePath. If you choose to enroll, your Janssen CarePath Care Coordinator will call you to:

  • Help answer your questions about filling your prescription
  • Coordinate with your healthcare provider, insurance company, and specialty pharmacy to help find out if you have coverage for your medicine
  • Inform you of financial assistance programs based on your eligibility

The assistance of Janssen CarePath and our Care Coordinators is available at no cost to patients taking OPSUMIT®.

Enroll today. Call a Janssen CarePath Care Coordinator at 866-228-3546, Monday-Friday, 8 AM to 8 PM ET.

Multilingual phone support is available.

Your Janssen CarePath Care Coordinator may be able to help. Call 866-228-3546, Monday-Friday, 8 AM to 8 PM ET to speak with a Care Coordinator.

Multilingual phone support is available.

To learn about the basic steps of getting a Janssen medicine, download and review Steps to Getting Your Medicine.

A specialty pharmacy is a pharmacy that can ship certain medicines directly to your home. Janssen PAH medicines are available by mail from a specialty pharmacy.

Learn about Working With a Specialty Pharmacy.

When your prescription is submitted to a specialty pharmacy, you will receive a call to:

  • Coordinate with your healthcare provider and insurance company to find out if you have coverage for your medicine and explore financial assistance options
  • Arrange delivery of your medicine

Each month, you will get a call from your specialty pharmacy to:

  • Confirm your order
  • Arrange delivery of your medicine
  • Confirm any required testing

Once your medicine is shipped:

  • It will be delivered to your home, unless you have made other arrangements, such as your doctor's office
  • Someone will need to be at home to sign for the package. Your specialty pharmacy will confirm this when they call to arrange the delivery

Your insurance provider will need to gather information about your condition and your treatment before covering OPSUMIT®. Sometimes, all their questions are answered at the time of prescription, but they may also need more information from your healthcare team, including:

  • Diagnostic test results, such as the numbers from your right heart catheterization (RHC)
  • Additional test results, including acute vasoreactivity testing or 6-minute walk distance (6MWD)
  • Details on past treatments you and your healthcare team have tried
  • Information missing from your prescription forms

OPSUMIT® can cause serious birth defects if taken during pregnancy. If you are female, you must enroll in the OPSUMIT® Risk Evaluation and Mitigation Strategy (REMS) Program, which your healthcare team will enroll you in at the start of treatment.

The OPSUMIT® REMS Program requires that, if you are able to get pregnant, you use 2 acceptable forms of birth control during treatment with OPSUMIT® and for 1 month after stopping OPSUMIT®, because the medicine may still be in your body. It also includes a monthly pregnancy test.

To learn more about the OPSUMIT® REMS Program, visit OpsumitREMS.com.

There are several programs to help support you as an OPSUMIT® patient. For information on these programs, call a Janssen CarePath Care Coordinator at 866-228-3546, Monday-Friday, 8 AM to 8 PM ET.

All patients

The following program is open to all patients, regardless of their coverage:

OPSUMIT® Voucher Program

A free 30-day trial offer is available for eligible patients to help you become familiar with OPSUMIT®.

At the conclusion of the program, you and your healthcare provider decide if it is appropriate to continue treatment. Subject to 1 (one) use per lifetime for the first 30-day supply of OPSUMIT®. Terms expire at the end of each calendar year and may change. This Voucher Program is open to patients who have commercial insurance, government coverage, or no insurance coverage; however, there is no guarantee of continuous accessibility after the program ends. Ask your doctor about the OPSUMIT® Voucher Program.
See full program requirements.

Commercially insured

Janssen CarePath Oral PAH Savings Program for OPSUMIT®

Eligible patients using commercial or private insurance can save on out-of-pocket medication costs for OPSUMIT®. Depending on the health insurance plan, savings may apply toward co-pay, coinsurance or deductible. Eligible patients pay $5 per prescription fill with a $20,000 maximum program benefit per calendar year across all oral PAH therapies in the program. Not valid for patients using Medicare, Medicaid, or other government-funded programs to pay for their medications. Terms expire at the end of each calendar year and may change. There is no income requirement.
See full eligibility requirements.

Government insured or no insurance

If you use a government-funded healthcare program to pay for OPSUMIT® or have no insurance coverage and need help paying for your medication:

Janssen CarePath can provide information about other resources that may be able to help with your out-of-pocket medication costs for OPSUMIT®.

Call a Janssen CarePath Care Coordinator at 866-228-3546 for more information about affordability programs and independent foundations that may have funding available.

Independent co-pay assistance foundations have their own rules for eligibility. We cannot guarantee a foundation will help you. We only can refer you to a foundation that supports your disease state. This information is provided as a resource for you. We do not endorse any particular foundation.

Commercially insured

Janssen PAH Link for OPSUMIT®

The Janssen PAH Link program enables eligible commercially insured patients to receive OPSUMIT® (macitentan) at no cost until you receive coverage or through the rest of the calendar year if an approval decision has not been made in 90 days.
See full program requirements
This program is not available to individuals who use any state or federal government-funded healthcare program to cover a portion of medication costs, such as Medicare, Medicaid, TRICARE, Department of Defense, or Veterans Administration. Program is for medication only. Terms expire at the end of each program year and may change.

There are independent patient advocacy organizations that can provide you with additional support and information:

The Pulmonary Hypertension Association is dedicated to increasing awareness and advocacy by providing information about PAH to both physicians and patients.

The Scleroderma Foundation offers a site for scleroderma patients, caregivers, and family members—dedicated to support, education, and research.

see more

What is OPSUMIT® (macitentan)?

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

IMPORTANT SAFETY INFORMATION

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®
back to top

IMPORTANT SAFETY INFORMATION

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®

Your doctor will decide when you should take pregnancy tests.

You are medically able to get pregnant if you are a woman who fits all of the following guidelines:

  • has started puberty, even if you have not had a menstrual period yet
  • has a uterus
  • has not gone through menopause (menopause means you have not had a menstrual period for at least 12 months for natural reasons, or have had your ovaries removed)

You are not medically able to get pregnant if you are a woman who fits at least 1 of the following guidelines:

  • has not started puberty
  • does not have a uterus
  • has gone through menopause (you have not had a menstrual period for at least 12 months for natural reasons, or have had your ovaries removed)
  • is infertile for other medical reasons and this infertility is permanent and cannot be reversed

While taking OPSUMIT®, and for 1 month after stopping OPSUMIT®, women who are able to get pregnant must use 2 acceptable forms of birth control. Women who have had a tubal sterilization, a progesterone implant, or have an IUD (intrauterine device) do not need a second form of birth control. Talk to your doctor or gynecologist about which birth control to use while on OPSUMIT®. If you decide to change your form of birth control, talk with your doctor or gynecologist. This way you can be sure to choose another acceptable form of birth control. Also review the Medication Guide for acceptable birth control options.

It’s important not to have unprotected sex while taking OPSUMIT®. Tell your doctor right away if you have unprotected sex, think your birth control has failed, miss a menstrual period, or think you may be pregnant. He or she may recommend using a form of emergency birth control.

If you are the parent or caregiver of a female child who started taking OPSUMIT® before reaching puberty, check with your child regularly for any signs of puberty. Your child may reach puberty before having her first menstrual period. Talk to your doctor if you think your child is showing signs of puberty or if you have any questions about the signs of puberty.

Before starting OPSUMIT®, women must enroll in a program called the OPSUMIT® Risk Evaluation and Mitigation Strategy (REMS). If you are a woman who is able to get pregnant, you must talk to your doctor to learn the benefits and risks of OPSUMIT®. You must also agree to all of the instructions in the program. Men who are prescribed OPSUMIT do not need to enroll in this program.

Who should not take OPSUMIT®?

Do not take OPSUMIT® if you are pregnant, plan to become pregnant, or become pregnant during treatment with OPSUMIT®. OPSUMIT® can cause serious birth defects. See “The most important information about OPSUMIT®.”

Talk to your doctor about all your medical conditions, as well as all the medicines, vitamins, and supplements you take. OPSUMIT® and other medicines may affect each other causing side effects. Tell your doctor right away if you take an HIV medicine. Do not start any new medicine until you check with your doctor.

What should I avoid while taking OPSUMIT®?

  • Do not get pregnant. OPSUMIT® can cause serious birth defects. See “The most important information about OPSUMIT®.” If you miss a menstrual period or think you may be pregnant, call your doctor right away
  • You should not breastfeed if you take OPSUMIT®. It is not known if OPSUMIT® passes into your breast milk. Talk to your doctor about the best way to feed your baby

What are the possible side effects of OPSUMIT®?

OPSUMIT® can cause serious side effects, including:

  • Serious birth defects. See “The most important information about OPSUMIT®
  • Some medicines that are like OPSUMIT® can cause liver problems. Your doctor should do blood tests to check your liver before you start OPSUMIT®. Tell your doctor if you have any of these symptoms, which could be a sign of liver problems while on OPSUMIT®:
    • Nausea or vomiting
    • Pain in the upper right stomach
    • Feeling tired
    • Loss of appetite
    • Your skin or the whites of your eyes turn yellow
    • Dark urine
    • Fever
    • Itching
  • Fluid retention could happen during the first weeks after starting OPSUMIT®. Tell your doctor right away if you notice unusual weight gain or swelling in your ankles or legs. Your doctor will look for the cause
  • Low red blood cell levels (anemia) can happen while taking OPSUMIT®, usually during the first weeks after starting OPSUMIT®. In some cases a blood transfusion may be needed, but this is not common. Your doctor will do blood tests to check for anemia before you start OPSUMIT®. You may also need to do these blood tests while taking OPSUMIT®
  • Decreased sperm counts. OPSUMIT®, and other medicines like OPSUMIT®, may cause decreased sperm counts in men who take these medicines. If fathering a child is important to you, tell your doctor

The most common side effects are:

  • Stuffy nose or sore throat
  • Irritation of the airways (bronchitis)
  • Headache
  • Flu
  • Urinary tract infection

Talk to your doctor if you have a side effect that bothers you or does not go away. These are not all the possible side effects of OPSUMIT®. For more information, ask your doctor or pharmacist.

You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.


Please read the full Prescribing Information and Medication Guide for OPSUMIT®, including an Important Warning about Serious Birth Defects.

cp-113980

IMPORTANT SAFETY INFORMATION

+

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®

Your doctor will decide when you should take pregnancy tests.

You are medically able to get pregnant if you are a woman who fits all of the following guidelines:

  • has started puberty, even if you have not had a menstrual period yet
  • has a uterus
  • has not gone through menopause (menopause means you have not had a menstrual period for at least 12 months for natural reasons, or have had your ovaries removed)

You are not medically able to get pregnant if you are a woman who fits at least 1 of the following guidelines:

  • has not started puberty
  • does not have a uterus
  • has gone through menopause (you have not had a menstrual period for at least 12 months for natural reasons, or have had your ovaries removed)
  • is infertile for other medical reasons and this infertility is permanent and cannot be reversed

While taking OPSUMIT®, and for 1 month after stopping OPSUMIT®, women who are able to get pregnant must use 2 acceptable forms of birth control. Women who have had a tubal sterilization, a progesterone implant, or have an IUD (intrauterine device) do not need a second form of birth control. Talk to your doctor or gynecologist about which birth control to use while on OPSUMIT®. If you decide to change your form of birth control, talk with your doctor or gynecologist. This way you can be sure to choose another acceptable form of birth control. Also review the Medication Guide for acceptable birth control options.

It’s important not to have unprotected sex while taking OPSUMIT®. Tell your doctor right away if you have unprotected sex, think your birth control has failed, miss a menstrual period, or think you may be pregnant. He or she may recommend using a form of emergency birth control.

If you are the parent or caregiver of a female child who started taking OPSUMIT® before reaching puberty, check with your child regularly for any signs of puberty. Your child may reach puberty before having her first menstrual period. Talk to your doctor if you think your child is showing signs of puberty or if you have any questions about the signs of puberty.

Before starting OPSUMIT®, women must enroll in a program called the OPSUMIT® Risk Evaluation and Mitigation Strategy (REMS). If you are a woman who is able to get pregnant, you must talk to your doctor to learn the benefits and risks of OPSUMIT®. You must also agree to all of the instructions in the program. Men who are prescribed OPSUMIT® do not need to enroll in this program.

Who should not take OPSUMIT®?

Do not take OPSUMIT® if you are pregnant, plan to become pregnant, or become pregnant during treatment with OPSUMIT®. OPSUMIT® can cause serious birth defects. See “The most important information about OPSUMIT®.”

Talk to your doctor about all your medical conditions, as well as all the medicines, vitamins, and supplements you take. OPSUMIT® and other medicines may affect each other causing side effects. Tell your doctor right away if you take an HIV medicine. Do not start any new medicine until you check with your doctor.

What should I avoid while taking OPSUMIT®?

  • Do not get pregnant. OPSUMIT® can cause serious birth defects. See “The most important information about OPSUMIT®.” If you miss a menstrual period or think you may be pregnant, call your doctor right away
  • You should not breastfeed if you take OPSUMIT®. It is not known if OPSUMIT® passes into your breast milk. Talk to your doctor about the best way to feed your baby

What are the possible side effects of OPSUMIT®?

OPSUMIT® can cause serious side effects, including:

  • Serious birth defects. See “The most important information about OPSUMIT®
  • Some medicines that are like OPSUMIT® can cause liver problems. Your doctor should do blood tests to check your liver before you start OPSUMIT®. Tell your doctor if you have any of these symptoms, which could be a sign of liver problems while on OPSUMIT®:
    • Nausea or vomiting
    • Pain in the upper right stomach
    • Feeling tired
    • Loss of appetite
    • Your skin or the whites of your eyes turn yellow
    • Dark urine
    • Fever
    • Itching
  • Fluid retention could happen during the first weeks after starting OPSUMIT®. Tell your doctor right away if you notice unusual weight gain or swelling in your ankles or legs. Your doctor will look for the cause
  • Low red blood cell levels (anemia) can happen while taking OPSUMIT®, usually during the first weeks after starting OPSUMIT®. In some cases a blood transfusion may be needed, but this is not common. Your doctor will do blood tests to check for anemia before you start OPSUMIT®. You may also need to do these blood tests while taking OPSUMIT®
  • Decreased sperm counts. OPSUMIT®, and other medicines like OPSUMIT®, may cause decreased sperm counts in men who take these medicines. If fathering a child is important to you, tell your doctor

The most common side effects are:

  • Stuffy nose or sore throat
  • Irritation of the airways (bronchitis)
  • Headache
  • Flu
  • Urinary tract infection

Talk to your doctor if you have a side effect that bothers you or does not go away. These are not all the possible side effects of OPSUMIT®. For more information, ask your doctor or pharmacist.

You may report side effects to FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

Please read the full Prescribing Information and Medication Guide for OPSUMIT®, including an Important Warning about Serious Birth Defects.

cp-113980


What is OPSUMIT® (macitentan)?

+

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
  • Improve some of your symptoms
  • Help slow down the progression of your disease
  • Lower your chance of being hospitalized for PAH

It is not known if OPSUMIT® is safe and effective in children.