What is OPSUMIT®?
OPSUMIT® is a prescription medicine used to treat pulmonary arterial hypertension (PAH, WHO Group 1). PAH is high blood pressure in the arteries of your lungs. OPSUMIT® can:
The most important information about OPSUMIT®® (macitentan)
Do not take OPSUMIT® if you are pregnant or trying to get pregnant. OPSUMIT® can cause serious birth defects if taken while pregnant.
Women who are able to get pregnant must have negative pregnancy tests:
Benefits of OPSUMIT®
OPSUMIT® was studied in a large, long-term clinical trial of any endothelin receptor antagonist (ERA), which1-3:
- Compared 242 patients taking OPSUMIT® (macitentan) with 250 patients not taking it
- Included patients from 39 countries who were treated with OPSUMIT® for an average of 2 years
- Included a majority of patients who were already being treated with a specific therapy for PAH, either PDE-5 inhibitors (61%) and/or inhaled/oral prostanoids (6%)
OPSUMIT® helped patients walk farther2,3
Improvement was measured by the 6-minute walk distance (6MWD), a test that measures the distance you can walk in 6 minutes. It is one test that your doctor may perform to assess your condition.
OPSUMIT® improved patients' ability to do more physical activity2,4
More patients taking OPSUMIT® saw an improvement of at least one functional class. At Month 6 in the clinical trial, 22% of patients taking OPSUMIT® improved their functional class compared with 13% of patients not taking it.
Improved functional class can mean the ability to do more physical activity with:
Functional class is a common way for doctors to assess the seriousness of your PAH, which can help them with making treatment decisions. The higher the functional class, the more severe the disease. Improved functional class means you can do more physical activity with fewer limitations. It does not always mean symptom improvement. According to PAH experts, maintaining or improving functional class is often an important goal of PAH treatment. Talk to your doctor to discuss your own treatment goals.
OPSUMIT® reduced the risk of PAH progression2,3
Patients taking OPSUMIT® were 45% less likely to have their PAH progress than patients not taking it.*
*In the clinical trial, disease progression included the need for injectable PAH medication or other worsening of PAH (decreased 6MWD, PAH symptoms getting worse, and the need for new PAH treatment). Overall, 31.4% of patients who took OPSUMIT® and 46.4% of patients who did not take OPSUMIT® had their PAH progress. On average, patients took OPSUMIT® for 2 years.
OPSUMIT® lowered the chance of being hospitalized due to PAH2,3
In the clinical trial, 20.7% of patients who took OPSUMIT® and 33.6% of patients who did not take OPSUMIT® were hospitalized for PAH. On average, patients took OPSUMIT® for 2 years.
