Macitentan/tadalafil
Appearance
Combination of | |
---|---|
Macitentan | endothelin receptor antagonist |
Tadalafil | phosphodiesterase 5 (PDE5) inhibitor |
Clinical data | |
Trade names | Opsynvi |
License data | |
Pregnancy category |
|
Routes of administration | By mouth |
ATC code | |
Legal status | |
Legal status |
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 was approved for medical use in Canada in October 2021,[3] and in the United States in March 2024.[4][5]
Medical uses[edit]
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[edit]
Macitentan/tadalafil may cause harm to the fetus.[2]
References[edit]
- ^ "Health product highlights 2021: Annexes of products approved in 2021". Health Canada. 3 August 2022. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
- ^ a b c d e "Opsynvi- macitentan and tadalafil tablet, film coated". DailyMed. 22 March 2024. Archived from the original on 2 April 2024. Retrieved 2 April 2024.
- ^ "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. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
- ^ "Approval Letter: Opsynvi (macitentan and tadalafil)" (PDF). U.S. Food and Drug Administration. Archived (PDF) from the original on 25 March 2024. Retrieved 25 March 2024.
- ^ "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. Archived from the original on 25 March 2024. Retrieved 25 March 2024.
External links[edit]
- 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