| 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
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
- ^ "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
- 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
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This page was last edited on 30 April 2024, at 04:35