Macitentan/tadalafil explained

Type:combo
Component1:Macitentan
Class1:Endothelin receptor antagonist
Component2:Tadalafil
Class2:Phosphodiesterase 5 (PDE5) inhibitor
Tradename:Opsynvi
Dailymedid:Macitentan and tadalafil
Pregnancy Category:Not recommended
Routes Of Administration:By mouth
Atc Prefix:C02
Atc Suffix:KX54
Legal Ca:Rx-only
Legal Ca Comment:[1]
Legal Us:Rx-only
Legal Us Comment:[2]

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

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.

Adverse effects

Macitentan/tadalafil may cause harm to the fetus.

Society and culture

Legal status

In July 2024, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency adopted a positive opinion, recommending the granting of a marketing authorization for the medicinal product Yuvanci, intended for the treatment of pulmonary arterial hypertension (PAH). The applicant for this medicinal product is Janssen-Cilag International NV.[6]

Notes and References

  1. Web site: Health product highlights 2021: Annexes of products approved in 2021 . . 3 August 2022 . 25 March 2024 . 25 March 2024 . https://web.archive.org/web/20240325234307/https://www.canada.ca/en/health-canada/services/publications/drugs-health-products/health-product-highlights-2021/appendices.html . live .
  2. Web site: Opsynvi- macitentan and tadalafil tablet, film coated . DailyMed . 22 March 2024 . 2 April 2024 . 2 April 2024 . https://web.archive.org/web/20240402062050/https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=6945b183-18d3-40de-afd1-c88e33cc1a63 . live .
  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) . . 15 October 2021 . 25 March 2024 . 25 March 2024 . https://web.archive.org/web/20240325234015/https://www.jnj.com/media-center/press-releases/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 . live .
  4. Web site: Approval Letter: Opsynvi (macitentan and tadalafil) . U.S. Food and Drug Administration . 25 March 2024 . 25 March 2024 . https://web.archive.org/web/20240325234308/https://www.accessdata.fda.gov/drugsatfda_docs/appletter/2024/218490Orig1s000ltr.pdf . live .
  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) . . 22 March 2024 . 25 March 2024 . 25 March 2024 . https://web.archive.org/web/20240325233727/https://www.jnj.com/media-center/press-releases/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 . live .
  6. Web site: Yuvanci EPAR . European Medicines Agency . 25 July 2024 . 27 July 2024. Text was copied from this source which is copyright European Medicines Agency. Reproduction is authorized provided the source is acknowledged.

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