Combination of | |
---|---|
Macitentan | Endothelin receptor antagonist |
Tadalafil | Phosphodiesterase 5 (PDE5) inhibitor |
Clinical data | |
Trade names | Opsynvi |
AHFS/Drugs.com | Monograph |
MedlinePlus | a624029 |
License data | |
Pregnancy category |
|
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status | |
Identifiers | |
KEGG |
Macitentan/tadalafil, sold under the brand name Opsynvi, is a fixed dose combination medication used for the treatment of pulmonary arterial hypertension. [3] [6] It contains macitentan, an endothelin receptor antagonist (ERA); and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor. [3]
Macitentan/tadalafil was approved for medical use in Canada in October 2021, [7] in the United States in March 2024, [8] [9] and in the European Union in September 2024. [4] [5]
Macitentan/tadalafil is indicated for the chronic treatment of pulmonary arterial hypertension (PAH, WHO Group I) in adults of WHO functional class (FC) II-III. [3]
Macitentan/tadalafil may cause harm to the fetus. [3]
In July 2024, the Committee for Medicinal Products for Human Use of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yuvanci, intended for the treatment of pulmonary arterial hypertension (PAH). [4] The applicant for this medicinal product is Janssen-Cilag International NV. [4] The combination was authorized for medical use in the European Union in September 2024. [4] [5]