Do not take 2 doses at the same time to make up for a missed dose. See "The most important information about OPSUMIT" Some medicines that are like OPSUMIT can cause liver problems. Call your doctor for medical advice about side effects. This medication may be taken with food or on an empty stomach. Females of reproductive potential must comply with the pregnancy testing and contraception requirements [see. Advise patients that they should contact their doctor if they have unexplained Counsel men about potential effects on fertility [see Use In Specific Populations and Nonclinical Toxicology ]. We comply with the HONcode standard for trustworthy health information -. Advise patients that they should contact their doctor Subscribe to Drugs.com newsletters for the latest medication news, alerts, new drug approvals and more. groups. No overall differences in safety or effectiveness were observed between these subjects and younger subjects. General disorders and administration site conditions: edema/fluid retention. Our Opsumit (macitentan) Side Effects Drug Center provides a comprehensive view of available drug information on the potential side effects when taking this medication. The European Commission granted a marketing authorisation valid throughout the European Union for Opsumit on 20 December 2013. If clinically significant fluid retention develops, evaluate the patient to determine the cause, such as OPSUMIT or underlying heart failure, and the possible need to discontinue OPSUMIT. Pill Identifier Tool Quick, Easy, Pill Identification, Drug Interaction Tool Check Potential Drug Interactions, Pharmacy Locater Tool Including 24 Hour, Pharmacies. if they have unusual weight increase or swelling of the ankles or legs. Your healthcare provider may also need to do these tests during treatment with OPSUMIT. Kidney function: Kidney disease or reduced kidney function may cause this medication to build up in the body, causing side effects. If experienced, these tend to have a Severe expression. Adverse reactions of headache, nausea and vomiting were observed. Opsumit side effects (in more detail) If OVERDOSE is suspected: If you think there has been an overdose, call your poison control center or get medical care right away. If you become pregnant while taking this medication, contact your doctor immediately. It must also not be used in patients with severe reduction in liver function or high levels of liver enzymes in the blood. Nose or throat irritation. OPSUMIT can cause serious birth defects (see the Medication Guide section above called "What is the most important information I should know about OPSUMIT?"). See additional information. Side effects requiring immediate medical attention. Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure. OPSUMIT was consistently shown to have teratogenic effects when administered to animals. If you take too much OPSUMIT, call your healthcare provider or go to the nearest hospital emergency room right away. At plasma levels obtained with dosing at 10 mg once daily, macitentan has no relevant inhibitory or inducing effects on CYP enzymes. Warfarin: Macitentan once daily dosing did not alter the exposure to R-and S-warfarin or their effect on international normalized ratio (INR). The Agency’s Committee for Medicinal Products for Human Use (CHMP) concluded that Opsumit’s benefits are greater than its risks and recommended that it be approved for use in the EU. The pharmacokinetics of macitentan and its active metabolite have been studied primarily in healthy subjects. Side effects can be mild or severe, temporary or permanent. Advise patients to report symptoms suggesting hepatic injury (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching). See additional information. If you miss a dose of OPSUMIT, take it as soon as you remember that day. People with severely reduced liver function should not use this medication. Children: The safety and effectiveness of using this medication have not been established for children less than 18 years of age. The active substance in Opsumit, macitentan, works by blocking ‘endothelin receptors’. hepatotoxicity. It is used for the long-term treatment of pulmonary arterial hypertension (PAH), a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue. If you are a female who can get pregnant, you must talk to your healthcare provider, understand the benefits and risks of OPSUMIT, and agree to all of the instructions in the OPSUMIT REMS Program. It may harm a fetus. methods of contraception while taking OPSUMIT and for one month after discontinuing OPSUMIT [see Use In Specific Populations]. OPSUMIT may cause fetal harm when administered during pregnancy and is contraindicated for use in females who are pregnant. WebMD does not provide medical advice, diagnosis or treatment. Do not split, crush, or chew OPSUMIT tablets. COPD Foods to Boost Your Health - COPD Diet Tips. A critical secondary endpoint was time to PAH death or PAH hospitalization. OPSUMIT and other medicines may affect each other causing side effects. The ‘class’ reflects the seriousness of the disease: patients with class II PAH have slight limitation of physical activity and those with class III disease have marked limitation of physical activity. Opsumit must therefore not be used in pregnant or breastfeeding women or in women who could become pregnant and who are not using reliable contraception. There may be new information. This Medication Guide has been approved by the U.S. Food and Drug Administration. Immune system disorders: hypersensitivity reactions (angioedema, pruritus and rash), Respiratory, thoracic and mediastinal disorders: nasal congestion, Gastrointestinal disorders: Elevations of liver aminotransferases (ALT, AST) and liver injury have been reported with OPSUMIT use; in most cases alternative causes could be identified (heart failure, hepatic congestion, autoimmune hepatitis). This is not a complete list of side effects and others may occur. Many of these side effects can be managed, and some may go away on their own over time. In PAH there is severe narrowing of the arteries of the lungs. The blood alter the exposure to R-and S-warfarin or their effect on international ratio... 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