Opsumit Dosage/Direction for Use

Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Posology: The recommended dose is 10 mg once daily.
Special populations: Elderly: No dose adjustment is required in patients over the age of 65 years (see Pharmacology: Pharmacokinetics under Actions).
Hepatic impairment: Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see Precautions and Pharmacology: Pharmacokinetics under Actions). However, there is no clinical experience with the use of macitentan in PAH patients with moderate or severe hepatic impairment. Opsumit must not be initiated in patients with severe hepatic impairment, or clinically significant elevated hepatic aminotransferases (greater than 3 times the Upper Limit of Normal (> 3 × ULN); see Contraindications and Precautions.
Renal impairment: Based on PK data, no dose adjustment is required in patients with renal impairment. There is no clinical experience with the use of macitentan in PAH patients with severe renal impairment. The use of Opsumit is not recommended in patients undergoing dialysis (see Precautions and Pharmacology: Pharmacokinetics under Actions).
Paediatric population: The safety and efficacy of macitentan in children and adolescents below 18 years have not yet been established. No data are available.
Method of administration: The film-coated tablets are not breakable and are to be swallowed whole, with water. They may be taken with or without food.
Opsumit should be taken every day at about the same time. If the patient misses a dose of Opsumit, the patient should be told to take it as soon as possible and then take the next dose at the regularly scheduled time. The patient should be told not to take two doses at the same time if a dose has been missed.