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Return to previous pageSAFETY 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 retention | 21% | 14% | 16% |
| Anemia | 19% | 3% | 2% |
| Headache | 18% | 17% | 14% |
| Abdominal pain | 7% | 3% | 14% |
| Hypotension | 7% | 0% | 0% |
| Myalgia | 6% | 0% | 5% |
| Nasopharyngitis | 6% | 3% | 0% |
| Nausea | 6% | 0% | 7% |
| Increased uterine bleeding | 5% | 0% | 0% |
| Back pain | 5% | 3% | 9% |
| Flushing | 4% | 6% | 0% |
| Vomiting | 4% | 0% | 5% |
| Palpitations | 4% | 3% | 5% |
| Pain in extremity | 3% | 0% | 7% |
| Epistaxis | 3% | 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.
