SAFETY AND TOLERABILITY

Safety and Tolerability Profile of OPSYNVI®1,2

Results from the double-blind study

Adverse reactions occurring in 3% or more of patients treated with OPSYNVI®

OPSYNVI®
(n=107)
Macitentan
Monotherapy
(N=35)
Tadalafil
Monotherapy
(N=44)
Edema/fluid retention21%14%16%
Anemia19%3%2%
Headache18%17%14%
Abdominal pain7%3%14%
Hypotension7%0%0%
Myalgia6%0%5%
Nasopharyngitis6%3%0%
Nausea6%0%7%
Increased uterine bleeding5%0%0%
Back pain5%3%9%
Flushing4%6%0%
Vomiting4%0%5%
Palpitations4%3%5%
Pain in extremity3%0%7%
Epistaxis3%0%0%

Discontinuations due to adverse events among patients receiving OPSYNVI® was 8%, most frequently due to anemia and hemoglobin decreased (2% grouped) and peripheral edema and peripheral swelling (2% grouped).

No new safety or tolerability signals emerged versus macitentan and tadalafil as individual components.1,2

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References: 1. OPSYNVI® (macitentan/tadalafil) full Prescribing Information. Actelion Pharmaceuticals US, Inc. 2. Grünig E, Jansa P, Fan F, et al. Randomized trial of macitentan/tadalafil single-tablet combination therapy for pulmonary arterial hypertension. J Am Coll Cardiol. 2024;83(4):473-484.

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