How to use Opsynvi (Macitentan and Tadalafil)

Opsynvi (Macitentan and Tadalafil) is available as film-coated tablets in two dosage strengths, macitentan 10mg/Tadalafil 20mg and macitentan 10mg/Tadalafil 40mg. After development and marketing, it is used for the chronic treatment of adults with pulmonary arterial hypertension (PAH, WHO group I and WHO functional class [FC] II-III). On an individual basis, Macitentan reduced the risk of clinical worsening events and hospitalization, and Tadalafil improved exercise capacity.

A pregnancy test is performed on females of reproductive potential before treatment with Opsynvi, monthly during treatment, and one month after stopping treatment. Opsynvi treatment should be started in women of reproductive potential only after a negative pregnancy test.

For patients not receiving any specific treatment for pulmonary arterial hypertension (PAH) or transitioning from endothelin receptor antagonist (ERA) monotherapy, the recommended starting dose of Opsynvi is one 10 mg/20 mg tablet taken orally once daily for one week; if tolerated, increase to one 10 mg/40 mg tablet taken orally once daily as a maintenance dose. For patients transitioning from phosphodiesterase5 (PDE5) inhibitor monotherapy or combination therapy with a PDE5 inhibitor and ERA, the recommended dose of Opsynvi is one 10 mg/40 mg tablet taken orally once daily.

Opsynvi is taken by mouth once daily, with or without food. Swallow the tablets whole with water. Do not cut, crush, or chew tablets. If a patient misses a dose of Opsynvi, tell the patient to take it as soon as possible and then take the next dose at the regularly scheduled time. If a dose is missed, tell the patient not to take both doses at the same time.