Macitentan/tadalafil

Last updated

Macitentan/tadalafil
Combination of
Macitentan endothelin receptor antagonist
Tadalafil phosphodiesterase 5 (PDE5) inhibitor
Clinical data
Trade names Opsynvi
License data
Pregnancy
category
  • Not recommended
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]

Contents

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]

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References

  1. "Health product highlights 2021: Annexes of products approved in 2021". Health Canada . 3 August 2022. Retrieved 25 March 2024.
  2. 1 2 3 4 5 "Highlight of Prescribing Information: OPSYNVI (macitentan and tadalafil) tablets, for oral use" (PDF). Actelion Pharmaceuticals US, Inc. U.S. Food and Drug Administration. 2004.
  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.