Opsynvi (Macitentan and Tadalafil) for Pulmonary Hypertension

Overview
Opsynvi, approved by the U.S. Food and Drug Administration (FDA), is indicated for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO group 1) at WHO functional class 2 and 3. According to the prescribing information, it is available to females only through a restricted program and it should not be used by females who are pregnant, as it can cause harm to an unborn child. Opsynvi is also known by its drug names, macitentan and tadalafil.

Macitentan is an endothelin receptor antagonist (ERA), which works by blocking the effects of endothelin-1, a substance in the walls of blood vessels that causes them to narrow. Tadalafil is a phosphodiesterase-5 (PDE5) inhibitor, which helps relax muscles and blood vessels in the lungs to increase blood flow. Together, these actions help to reduce the pressure in the pulmonary arteries.

How do I take it?
Prescribing information states that Opsynvi should be taken orally once daily, with or without food. It is important to follow the prescribed dosage and regimen strictly as directed by your prescribing physician.

Side effects
Common side effects of Opsynvi include edema (fluid retention), anemia (low red blood cell count), and headache. These are typically manageable but should be regularly monitored by healthcare providers.

Rare but serious side effects may include hepatotoxicity (liver damage); hypotension (low blood pressure); a decrease in hemoglobin; worsening of pulmonary veno-occlusive disease; sudden loss of vision; sudden loss of hearing; significant fluid retention; decreased sperm count; and prolonged erection. 

For more information about this treatment, visit:

Label: Opsynvi — Macitentan and Tadalafil Tablet, Film Coated — DailyMed

Opsynvi — Drugs.com