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 Actelion Pathways® 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

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 Nurse Counselors*

Patients who have enrolled with Actelion Pathways can speak with a Nurse Counselor* by calling
1-855-999-4724, Mon-Fri, 8 AM-8 PM ET. Nurse Counselors* are available to provide ongoing support and education to patients taking OPSUMIT.

*Nurse Counselors do not provide nursing services, treatment, or medical advice.

Frequently Asked Questions (FAQs)

The Actelion Pathways Patient Education Program provides education and support to help you partner with your healthcare team and better manage your condition. This program is part of the support that is offered to you when your healthcare team prescribes OPSUMIT and you are enrolled in the Actelion Pathways program.

Actelion Pathways is a program that provides you with support and services, including shipment verification, benefits verification, and coordination with your specialty pharmacy.

Actelion provides a wide range of support and services through Actelion Pathways. If you choose to enroll, your Actelion Pathways Case Manager 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 Actelion Pathways and Case Managers is available at no cost to patients taking OPSUMIT.

Enroll today. Call an Actelion Pathways Case Manager at 1-866-ACTELION (1-866-228-3546), Mon-Fri, 8 AM-8 PM ET.

Support in Spanish and other language services are available.

Your Actelion Pathways Case Manager may be able to help. Call 1-866-ACTELION (1-866-228-3546), Mon-Fri, 8 AM-8 PM ET to speak with a Case Manager.

Support in Spanish and other language services are available.

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

A specialty pharmacy is a pharmacy that can ship certain medicines directly to your home. Actelion 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 doctor 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, contact an Actelion Pathways Case Manager at 1-866-ACTELION (1-866-228-3546), Mon-Fri, 8 AM-8 PM ET.

All patients

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

OPSUMIT Voucher Program

Eligible patients age 18 or over may be able to obtain a 30-day supply of OPSUMIT at no charge by requesting it from the Actelion Pathways Case Manager during enrollment. This offer is only valid for the first 30-day supply of OPSUMIT.

Commercially insured

If you receive insurance through your employer or purchase it privately, you may be eligible for the following program:

Actelion Oral PAH Therapy Co-pay Program*

A savings program that lets eligible patients pay $5 per prescription fill per product. Contact an Actelion Pathways Case Manager for more information.

Government insured

If you receive your medication through Medicare or other government-funded plans, you may be eligible for the following:

Independent foundations

There may be support available from independent third-party patient support foundations. An Actelion Pathways Case Manager can provide general information about resources.

Uninsured or underinsured

If you are uninsured or you have insurance but are unable to afford the out-of-pocket costs, you may be eligible for the following programs:

Patient Assistance Program (PAP)

A yearly program that helps eligible patients receive medicine at no cost. Contact an Actelion Pathways Case Manager to learn more and to ensure the PAP program is the best option for you before applying.

Bridge Program (temporary patient assistance program)

Offers up to 60 days of drug at no cost to eligible patients waiting for a coverage determination.

*Applies to patients who have provided consent to services offered by Actelion Pathways. The Actelion Oral PAH Therapy Co-pay Program is only available for residents of the US and Puerto Rico who are 18 or older and have commercial health insurance with co-pay/co-insurance exceeding $5 per prescription fill per product. Patients ineligible for the Actelion Oral PAH Therapy Co-pay Program include those enrolled in Medicare, Medicaid, VA/DoD (Tricare), the Indian Health Service, or any other federal- or state-funded healthcare program, or where prohibited by law. The Actelion Oral PAH Therapy Co-pay Program is not prescription drug coverage or insurance. Actelion reserves the right to terminate or modify this program at any time or without notice. Other terms and conditions apply.

Find out more in Finding Support and Financial Assistance and by speaking with a Case Manager.

There are independent 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
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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 see full Prescribing Information and Medication Guide, including an Important Warning about Serious Birth Defects.

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 see full Prescribing Information and Medication Guide, including an Important Warning about Serious Birth Defects.


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.