Opsumit is a medicine used for the long\-term treatment of pulmonary arterial hypertension (PAH), a condition in which there is abnormally high blood pressure in the arteries of the lungs, causing symptoms such as breathlessness and fatigue. Opsumit is used for adults, adolescents and children aged 2 years and older in whom PAH comes with moderate or marked limitations in physical activity (corresponding to WHO functional class II or III, respectively). Opsumit can be used alone or in combination with other PAH medicines. Opsumit contains the active substance macitentan.
Therapeutic Indication
Adults 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. Paediatric population 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. Opsumit, as monotherapy or in combination, is indicated for the long\-term treatment of pulmonary arterial hypertension (PAH) in paediatric patients aged 2 years to less than 18 years with WHO Functional Class (FC) II to III.
Therapeutic Area (MeSH)
ATC Code
C02KX04
ATC Item
N/A
Pharmacotherapeutic Group
Antihypertensives
Active Substance (Summary)
INN / Common Names
| Substance | CAS | Monograph |
|---|---|---|
| macitentan | N/A | macitentan |
EMA Name
Opsumit
Medicine Name
Opsumit
Aliases
N/ANo risk management plan link.
