Macitentan/tadalafil

Macitentan/tadalafil, sold under the brand name Opsynvi, is a fixed dose combination medication used for the treatment of pulmonary arterial hypertension.^[2] It contains macitentan, an endothelin receptor antagonist (ERA); and tadalafil, a phosphodiesterase 5 (PDE5) inhibitor.^[2]

Macitentan/tadalafil

Combination of
Macitentan	endothelin receptor antagonist
Tadalafil	phosphodiesterase 5 (PDE5) inhibitor
Clinical data
Trade names	Opsynvi
License data	US DailyMed: Macitentan and tadalafil
Pregnancy category	Not recommended
Routes of administration	By mouth
ATC code	C02KX54 (WHO)
Legal status
Legal status	CA: ℞-only^[1] US: ℞-only^[2]

Macitentan/tadalafil was approved for medical use in Canada in October 2021,^[3] and in the United States in March 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.^[2]

Adverse effects

Macitentan/tadalafil may cause harm to the fetus.^[2]

References

1. "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. from the original on 25 March 2024. Retrieved 25 March 2024.
2. "Opsynvi- macitentan and tadalafil tablet, film coated". DailyMed. 22 March 2024. from the original on 2 April 2024. Retrieved 2 April 2024.
3. "Opsynvi (macitentan and tadalafil) Becomes the First and Only Health Canada-Approved Once Daily Fixed Dose Combination Treatment for Patients with Pulmonary Arterial Hypertension (PAH)". Johnson & Johnson (Press release). 15 October 2021. from the original on 25 March 2024. Retrieved 25 March 2024.
4. "Approval Letter: Opsynvi (macitentan and tadalafil)" (PDF). U.S. Food and Drug Administration. (PDF) from the original on 25 March 2024. Retrieved 25 March 2024.
5. "U.S. FDA Approves Opsynvi (macitentan and tadalafil) as the First and Only Once-Daily Single-Tablet Combination Therapy for Patients with Pulmonary Arterial Hypertension (PAH)". Johnson & Johnson (Press release). 22 March 2024. from the original on 25 March 2024. Retrieved 25 March 2024.

External links

• Clinical trial number NCT03904693 for "Clinical Study to Compare the Efficacy and Safety of Macitentan and Tadalafil Monotherapies With the Corresponding Fixed-dose Combination Therapy in Subjects With Pulmonary Arterial Hypertension (PAH) (A DUE)" at ClinicalTrials.gov