Source: European Medicines Agency (EU) Revision Year: 2025 Publisher: Janssen-Cilag International NV, Turnhoutseweg 30, B 2340 Beerse, Belgium
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 (see section 5.1).
Opsumit, as monotherapy or in combination, is indicated for the long-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged less than 18 years and bodyweight ≥40 kg with WHO Functional Class (FC) II to III (see section 5.1).
Treatment should only be initiated and monitored by a physician experienced in the treatment of PAH.
The recommended dose is 10 mg once daily. 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.
The 10 mg film-coated tablets are only recommended in paediatric patients weighing at least 40 kg. For paediatric patients weighing less than 40 kg, a lower strength of dispersible tablets of 2.5 mg is available. Please refer to the Opsumit dispersible tablets Summary of Product Characteristics.
No dose adjustment is required in patients over the age of 65 years (see section 5.2).
Based on pharmacokinetic (PK) data, no dose adjustment is required in patients with mild, moderate or severe hepatic impairment (see sections 4.4 and 5.2). 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 sections 4.3 and 4.4).
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 sections 4.4 and 5.2).
Dosing and efficacy of macitentan in children below 2 years of age have not been established. Currently available data are described in sections 4.8, 5.1 and 5.2 but no recommendation on a posology can be made.
The film-coated tablets are not breakable and are to be swallowed whole, with water. They may be taken with or without food.
Macitentan has been administered as a single dose of up to 600 mg to healthy adult subjects. Adverse reactions of headache, nausea, and vomiting were observed. In the event of an overdose, standard supportive measures must be taken, as required. Due to the high degree of protein binding of macitentan, dialysis is unlikely to be effective.
5 years.
Do not store above 30°C.
White, opaque PVC/PE/PVdC/Aluminium blisters in cartons containing 15 or 30 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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