OPSYNVI Film-coated tablet Ref.[109722] Active ingredients: Macitentan Macitentan and Tadalafil Tadalafil

2.1 Recommended Dosage

OPSYNVI is taken orally once daily with or without food. Swallow the tablets whole, with water. Do not cut, crush, or chew tablets. If the 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. Tell the patient not to take two doses at the same time if a dose has been missed.

For patients who are treatment-naïve to any PAH specific therapy or transitioning from ERA monotherapy

The recommended starting dose of OPSYNVI is one 10 mg/20 mg tablet taken orally once daily with or without food for one week. If tolerated, up titrate OPSYNVI to one 10 mg/40 mg tablet taken orally once daily with or without food as the maintenance dose.

For patients transitioning from PDE5 inhibitor monotherapy or PDE5 inhibitor and ERA therapy in combination

The recommended dose of OPSYNVI is one 10 mg/40 mg tablet taken orally once daily.

2.2 Pregnancy Testing in Females of Reproductive Potential

Obtain a pregnancy test in females of reproductive potential prior to OPSYNVI treatment, monthly during treatment and one month after stopping OPSYNVI. Initiate treatment with OPSYNVI in females of reproductive potential only after a negative pregnancy test [see Contraindications (4.1), Warnings and Precautions (5.1), and Use in Specific Populations (8.3)].

In the event of an overdose, standard supportive measures should be taken, as required. Dialysis is unlikely to be effective because macitentan is highly protein-bound.

Macitentan

Macitentan has been administered as a single dose of up to and including 600 mg to healthy subjects (60 times the approved dosage). Adverse reactions of headache, nausea and vomiting were observed.

Tadalafil

Single doses of tadalafil up to 500 mg have been given to healthy male subjects, and multiple daily doses up to 100 mg have been given to male patients with erectile dysfunction. Adverse reactions were similar to those seen at lower doses. Doses greater than 40 mg have not been studied in patients with PAH. Hemodialysis contributes negligibly to tadalafil elimination.

Store at 20ºC to 25ºC (68ºF to 77ºF); excursions are permitted between 15°C and 30°C (59°F and 86°F) [see USP Controlled Room Temperature]. Store and dispense in the original package to protect from moisture. Do not discard the desiccant.