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This website is primarily intended for health care professionals in the European Union. OPSUMIT is approved by EMA and all materials on this web page reflect the approval status and label in Europe. If you are not from Europe please check with your local Actelion office to get information about OPSUMIT in your country.
Please see Important Safety Information for OPSUMIT.
OPSUMIT, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in adult patients of WHO Functional Class (FC) II to III. Efficacy has been shown in a PAH population including idiopathic and heritable PAH, PAH associated with connective tissue disorders, and PAH associated with corrected simple congenital heart disease.
Important Safety Information
OPSUMIT is to be taken orally at a dose of 10 mg once daily with or without food. The most commonly reported adverse drug reactions were nasopharyngitis, headache, and anemia. OPSUMIT should not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (>3x ULN). OPSUMIT is not recommended in patients with moderate hepatic impairment. OPSUMIT should not be initiated in patients with severe anemia. Elevations of liver aminotransferases or a decrease in hemoglobin concentration may occur while taking OPSUMIT; monitoring is recommended. If signs of pulmonary edema occur, the possibility of pulmonary veno-occlusive disease should be considered. OPSUMIT is contraindicated in patients with a known hypersensitivity to the active substance or to any of the excipients, women who are pregnant, breastfeeding, or of childbearing potential who are not using reliable contraception. OPSUMIT is not recommended in patients undergoing dialysis; caution is recommended in patients with severe renal impairment. Avoid using OPSUMIT with strong CYP3A4 inducers. Caution should be exercised when OPSUMIT is administered concomitantly with strong CYP3A4 inhibitors. The safety and efficacy of OPSUMIT in children have not yet been established. There is limited clinical experience in patients over the age of 75 years, therefore OPSUMIT should be used with caution in this population.