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
Macitentanendothelin receptor antagonist
Tadalafilphosphodiesterase 5 (PDE5) inhibitor
Clinical data
Trade namesOpsynvi
License data
Pregnancy
category
  • Not recommended
Routes of
administration		By mouth
ATC code
Legal status
Legal status

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. Retrieved 25 March 2024.
  2. "Opsynvi- macitentan and tadalafil tablet, film coated". DailyMed. 22 March 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. Retrieved 25 March 2024.
  4. "Approval Letter: Opsynvi (macitentan and tadalafil)" (PDF). U.S. Food and Drug Administration.
  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. Retrieved 25 March 2024.
  • 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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