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Author: Admin | 2025-04-28
This information is intended for US healthcare professionals to access current scientific information about J&J Innovative Medicine products. It is prepared by Medical Information and is not intended for promotional purposes, nor to provide medical advice.OPSYNVI® (macitentan and tadalafil)Medical InformationOPSYNVI® (macitentan and tadalafil)-->OPSYNVI - Dosage and Administration-->SUMMARYFor patients who are treatment-naïve to any pulmonary arterial hypertension (PAH)-specific therapy or transitioning from endothelin receptor antagonist (ERA) monotherapy: the recommended starting dose of OPSYNVI is one macitentan 10 mg/tadalafil 20 mg tablet taken orally once daily with or without food for 1 week. If tolerated, uptitrate OPSYNVI to one macitentan 10 mg/tadalafil 40 mg tablet taken orally once daily with or without food as the maintenance dose.1For patients transitioning from phosphodiesterase type-5 inhibitor (PDE5i) monotherapy or PDE5i and ERA therapy in combination: the recommended dose of OPSYNVI is one 10 mg/40 mg tablet taken orally once daily.1The dosages recommended in section 2 of the OPSYNVI prescribing information are based on dosages administered in the phase 3 A DUE study2,3 and further supported by phase 1 bioequivalence studies.4,5PRESCRIBING INFORMATIONOPSYNVI is taken orally once daily with or without food. Swallow the tablets whole, with water.1For patients who are treatment-naïve to any PAH-specific therapy or transitioning from ERA monotherapyThe recommended starting dose of OPSYNVI is one 10 mg/20 mg tablet taken orally once daily for 1 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 PDE5i monotherapy or PDE5i and ERA therapy in combinationThe recommended dose of OPSYNVI is one 10 mg/40 mg tablet taken orally once daily.CLINICAL DATAThe A DUE StudyA DUE was a prospective, multicenter, double-blind, randomized, active-controlled, triple-dummy, parallel group, group-sequential, adaptive phase 3 study (NCT03904693) that evaluated the efficacy and safety of OPSYNVI as a single tablet combination therapy (STCT) vs macitentan 10 mg and tadalafil 40 mg monotherapies in patients with PAH, including treatment-naïve patients and patients on prior ERA or PDE5i monotherapy at baseline.2Study Design/MethodsThe double-blind treatment had 2 phases: a 2-week tadalafil titration phase followed by a maintenance phase. In week 1 of the titration phase, patients were given macitentan 10 mg, tadalafil 20 mg, or both once daily (as separate tablets), along with relevant placebos (to maintain blinding). In week 2, tadalafil was uptitrated to 40 mg once daily; patients on baseline PDE5i therapy (tadalafil 40 mg, sildenafil 60-120 mg, or vardenafil 10 mg daily) were administered tadalafil 40 mg once daily from day 1. The maintenance phase spanned from day 15 to the end of week 16, when patients received macitentan 10 mg, tadalafil 40 mg, or OPSYNVI once daily, along with the relevant placebos. Downtitration of tadalafil to 20 mg was permitted for tolerability issues, while downtitration of macitentan was not.2,3 During the titration phase, if a participant could not tolerate tadalafil 40 mg daily (or placebo), the dose was to be decreased back to 20 mg daily. Within the first 2-3 weeks after decreasing the dose
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