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.

Step 1:

Your doctor prescribes OPSUMIT ®

When you are prescribed OPSUMIT ® :

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

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

• 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, you must enroll in the Macitentan 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 Macitentan 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 866-228-3546 . For questions about OPSUMIT ® medication, contact your doctor.

  Step 2:

  Your Janssen CarePath Care Coordinator contacts 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.

  Step 3:

  Your specialty pharmacy calls you before OPSUMIT ® ships

  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.

  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.

  • 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
    • 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?

    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.

    About OPSUMIT ®

    • How OPSUMIT ® Can Help
    • Benefits of OPSUMIT ®
    • Important Safety Information