PAH is high blood pressure in the arteries of your lungs. Decreases in hemoglobin seldom require transfusion. Galiè N, Humbert M, Vachiery JL, et al. 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. References: 1. This information and assistance are made available as a convenience to patients, and there is no requirement that patients or HCPs use any Actelion product in exchange for this information or assistance. Actelion has not reviewed and does not endorse any information presented on the third-party website. Eur Respir Rev. 4. 3. Pulmonary Hypertension: A Patientâs Survival Guide. 5th ed. Macitentan and morbidity and mortality in pulmonary arterial hypertension.
Postmarketing cases of edema and fluid retention occurring within weeks of starting OPSUMIT, some requiring intervention with a diuretic or hospitalization for decompensated heart failure, have been reported. Iglarz M, Binkert C, Morrison K, et al. Please see the Terms and Conditions for more information. To contact the Actelion Medical Information Department, or to report suspected adverse reactions, If clinically relevant aminotransferase elevations occur, or if elevations are accompanied by an increase in bilirubin >2 x ULN, or by clinical symptoms of hepatotoxicity, discontinue OPSUMIT. Your message has been sent. 3. He or she may recommend using a form of emergency birth control. South San Francisco, CA: Actelion Pharmaceuticals US, Inc. References: 1. Use other PAH treatment options when strong CYP3A4 inhibitors are needed as part of HIV treatment. Concomitant use of OPSUMIT with strong CYP3A4 inducers should be avoided. Eur Respir Rev. 5. THIS SITE IS INTENDED FOR U.S. Men who are prescribed OPSUMIT do not need to enroll in this program. 2012;21(126):321-327. If you decide to change your form of birth control, talk with your doctor or gynecologist. Definitions and diagnosis of pulmonary hypertension. 2013;369(9):809-818. The incidence of elevated aminotransferases in the SERAPHIN study >3 x ULN was 3.4% for OPSUMIT vs 4.5% for placebo, and >8 x ULN was 2.1% vs 0.4%, respectively. Females of reproductive potential must comply with the pregnancy testing and contraception requirements. Most common adverse reactions (more frequent than placebo by â¥3%) were anemia (13% vs 3%), nasopharyngitis/pharyngitis (20% vs 13%), bronchitis (12% vs 6%), headache (14% vs 9%), influenza (6% vs 2%), and urinary tract infection (9% vs 6%). 7. Eur Respir J. You must also agree to all of the instructions in the program.
The availability of information and assistance may vary based on the Actelion medication, geography and other program differences. The third-party service providers, not Actelion, are responsible for the information and assistance provided under this program. South San Francisco, CA: Actelion Pharmaceuticals US, Inc. 2. Please see the Terms and Conditions for more information. Talk to your doctor if you have a side effect that bothers you or does not go away. 2015;46(4):903-975.
Ryan JJ, Archer SL. © 2020 Actelion Pharmaceuticals US, Inc. All rights reserved. 2. Discontinuations for hepatic adverse events were 3.3% for OPSUMIT vs 1.6% for placebo. Your child may reach puberty before having her first menstrual period. Reference: 1. Chest. Do not start any new medicine until you check with your doctor. Eur Respir J. Hoeper MM, Bogaard HJ, Condliffe R, et al. Actelion assumes no responsibility for and does not guarantee the quality, scope, or availability of the information and assistance provided. Adverse EventsâTo report suspected adverse reactions, contact Actelion at 1â866âACTELION (1-866-228-3546) or Food and Drug Administration (FDA) at 1-800-FDA-1088 or www.fda.gov/medwatch.
Information on OPSUMIT certified pharmacies or wholesale distributors is available through Actelion Pathways at 1-866-228-3546. In a small study of pulmonary hypertension due to left ventricular dysfunction, more patients in the OPSUMIT group developed significant fluid retention and had more hospitalizations due to worsening heart failure compared to placebo. For more information, ask your doctor or pharmacist. All claims and other submissions to payers should be in compliance with all applicable requirements. Actelion Pathways assists healthcare providers (HCPs) in the determination of whether treatment could be covered by the applicable third-party payer based on coverage guidelines provided by the payer, and patient information provided by the HCP under appropriate authorization following the providerâs exclusive determination of medical necessity. 2014;130(24):2189-2208. OPSUMIT is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1). © 2020 Actelion Pharmaceuticals US, Inc. All rights reserved.
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