Macitentan/tadalafil

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

Combination of
Macitentan	Endothelin receptor antagonist
Tadalafil	Phosphodiesterase 5 (PDE5) inhibitor
Clinical data
Trade names	Opsynvi
AHFS/Drugs.com	Monograph
MedlinePlus	a624029
License data	US DailyMed: Macitentan and tadalafil
Pregnancy category	Not recommended
Routes of administration	By mouth
ATC code	C02KX54 (WHO)
Legal status
Legal status	AU: S4 (Prescription only)[1] CA: ℞-only[2] US: ℞-only[3] EU: Rx-only[4][5]
Identifiers
KEGG	D12963

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]

Medical uses

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]

Adverse effects

Macitentan/tadalafil may cause harm to the fetus.^[3]

Society and culture

Legal status

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]