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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:

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:

Janssen CarePath will help you find the resources you may need to get started and stay on track.


Get Support for OPSUMIT®

Once you and your healthcare provider have decided OPSUMIT® is right for you, Janssen CarePath will help you find the resources you may need to get started and stay on track, including:

Paying for OPSUMIT®

Janssen CarePath can explain your potential out-of-pocket costs and identify cost support options that may help with managing your out-of-pocket costs—whether you have commercial or private health insurance, government-funded healthcare coverage such as Medicare or Medicaid, or have no insurance coverage:

  • Janssen CarePath Oral PAH Savings Program for eligible patients with commercial or private health insurance
  • If you need additional financial support, we can provide you with information about independent foundations that may be able to help

If you use commercial or private health insurance to pay for your medication:
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, co-insurance or deductible. Eligible patients pay $5 per prescription fill for OPSUMIT® 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 at OPSUMIT.JanssenCarePathSavings.com.

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 or visit JanssenCarePath.com for more information about affordability programs and independent foundations that may have funding available.

Getting Started

A personally assigned Janssen CarePath Care Coordinator will work closely with you and your doctor to help you get started by:

  • Reviewing your health plan benefits to help answer questions you may have about insurance coverage
  • Identifying and coordinating with a specialty pharmacy to arrange shipment of your Janssen medication

OPSUMIT® (macitentan) 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.

Staying on Track

We understand how important it is for you to take the OPSUMIT® your healthcare provider prescribed. That’s why we’ve created some tools to help you stay on your treatment:

  • Patient education and tools, including internet resources

Visit JanssenCarePath.com/Opsumit
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.

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.

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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

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
  • 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.

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.

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References: 1. Iglarz M, Binkert C, Morrison K, et al. Pharmacology of macitentan, an orally active tissue-targeting dual endothelin receptor antagonist. J Pharmacol Exp Ther. 2008;327(3):736-745. 2. Humbert M, Lau EM, Montani D, Jaïs X, Sitbon O, Simonneau G. Advances in therapeutic interventions for patients with pulmonary arterial hypertension. Circulation. 2014;130(24):2189-2208. 3. OPSUMIT [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.

References: 1. Sitbon O, Morrell N. Pathways in pulmonary arterial hypertension: the future is here. Eur Respir Rev. 2012;21(126):321-327. 2. OPSUMIT [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc. 3. Pulido T, Adzerikho I, Channick RN, et al; SERAPHIN Investigators. Macitentan and morbidity and mortality in pulmonary arterial hypertension. N Engl J Med. 2013;369(9):809-818. 4. McLaughlin VV, Gaine SP, Howard LS, et al. Treatment goals of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25)(suppl):D73-D81.

References: 1. OPSUMIT [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc. 2. Sitbon O, Morrell N. Pathways in pulmonary arterial hypertension: the future is here. Eur Respir Rev. 2012;21(126):321-327. 3. Humbert M, Lau EM, Montani D, Jaïs X, Sitbon O, Simonneau G. Advances in therapeutic interventions for patients with pulmonary arterial hypertension. Circulation. 2014;130(24):2189-2208. 4. Galiè N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2015;46(4):903-975. 5. Hayes GB. Pulmonary Hypertension: A Patient’s Survival Guide. 5th ed. Silver Spring, MD: Pulmonary Hypertension Association; 2012. 6. Ryan JJ, Archer SL. The right ventricle in pulmonary arterial hypertension: disorders of metabolism, angiogenesis and adrenergic signaling in right ventricular failure. Circ Res. 2014;115(1):176-188. 7. Frost AE, Badesch DB, Barst RJ, et al. The changing picture of patients with pulmonary arterial hypertension in the United States: how REVEAL differs from historic and non-US Contemporary Registries. Chest. 2011;139(1):128-137. 8. Simonneau G, Gatzoulis MA, Adatia I, et al. Updated clinical classification of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25)(suppl):D34-D41.

References: 1. Galiè N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2015;46(4):903-975. 2. Hoeper MM, Bogaard HJ, Condliffe R, et al. Definitions and diagnosis of pulmonary hypertension. J Am Coll Cardiol. 2013;62(25)(suppl):D42-D50. 3. Connolly HM, Oh JK. Echocardiography. In: Bonow RO, Mann DL, Zipes DP, Libby P, eds. Braunwald's Heart Disease: A Textbook of Cardiovascular Medicine. 9th ed. Philadelphia, PA: Elsevier Saunders; 2012:200-276. 4. Pagana KD, Pagana TJ. Mosby's Diagnostic and Laboratory Test Reference. 6th ed. St. Louis, MO: Mosby, An Affiliate of Elsevier Science; 2003.

Reference: 1. OPSUMIT [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc.

References: 1. Galiè N, Humbert M, Vachiery JL, et al. 2015 ESC/ERS Guidelines for the diagnosis and treatment of pulmonary hypertension. Eur Respir J. 2015;46(4):903-975. 2. OPSUMIT [package insert]. South San Francisco, CA: Actelion Pharmaceuticals US, Inc. 3. Humbert M, Lau EM, Montani D, Jaïs X, Sitbon O, Simonneau G. Advances in therapeutic interventions for patients with pulmonary arterial hypertension. Circulation. 2014;130(24):2189-2208.