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.
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. 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.
- 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-10881-800-FDA-1088 or .
Please see full Prescribing Information and Medication Guide, including an Important Warning about Serious Birth Defects.
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.