Source: European Medicines Agency (EU) Revision Year: 2020 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.
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 (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.
No dose adjustment is required in patients over the age of 65 years (see section 5.2). There is limited clinical experience in patients over the age of 75 years. Therefore, Opsumit should be used with caution in this population (see section 4.4).
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).
The safety and efficacy of macitentan in children and adolescents below 18 years have not yet been established. No data are available.
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.
Macitentan has been administered as a single dose of up to 600 mg to healthy 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.
Shelf life: 5 years.
Do not store above 30°C.
White, opaque PVC/PE/PVdC/Aluminium blisters in cartons containing 15 or 30 film-coated tablets.
White high-density polyethylene (HDPE) bottles with child-resistant closure and a silica gel desiccant. Cartons containing 1 bottle of 30 film-coated tablets.
Not all pack sizes may be marketed.
No special requirements.
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