Opsumit Dosage/Direction for Use

Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
Posology: Opsumit is to be taken orally at a dose of 10 mg once daily, with or without food. The film-coated tablets are not breakable and are to be swallowed whole, with water.
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.
Elderly patients: No dose adjustment is required in patients over the age of 65 years (see Pharmacology: Pharmacokinetics under Actions). There is limited clinical experience in patients over the age of 75 years. Therefore Opsumit should be used with caution in this population (see Precautions).
Patients with hepatic impairment: Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see Pharmacology: Pharmacokinetics under Actions and Precautions). 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 x ULN); see Contraindications and Precautions).
Patients with 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 Pharmacology: Pharmacokinetics under Actions and Precautions).
Paediatric population: The safety and efficacy of macitentan in children have not yet been established.