For U.S. Healthcare Professionals
OPSUMIT® (macitentan): The ONLY once-daily, oral ERA with no titration required1,2*
- The recommended dosage of OPSUMIT® is 10 mg once daily for oral administration1
- No titration is necessary1
- Tablets can be administered with or without food1
- Doses higher than 10 mg once daily have not been studied in patients with PAH and are not recommended1
Liver enzyme tests and hemoglobin should be measured prior to initiation of OPSUMIT® and should be repeated during treatment as clinically indicated.1
Advise patients to report symptoms suggesting hepatic injury (nausea, vomiting, right upper quadrant pain, fatigue, anorexia, jaundice, dark urine, fever, or itching).1
Obtain a pregnancy test in females of reproductive potential prior to OPSUMIT® treatment, monthly during treatment and 1 month after stopping OPSUMIT®. Initiate treatment with OPSUMIT® in females of productive potential only after a negative pregnancy test.1
Drug-drug interactions1
MEDICATION | EFFECT |
---|---|
Strong inducers of CYP3A4 (eg, rifampin) |
|
Strong inhibitors of CYP3A4 (eg, ketoconazole) |
|
Moderate dual inhibitors of CYP3A4 and CYP2C9 (eg, fluconazole and amiodarone) |
|
Combined moderate CYP3A4 inhibitor and moderate CYP2C9 inhibitor |
|
*OPSUMIT® is approved in combination with PDE-5is or inhaled prostanoids, but not oral prostanoids.
SERAPHIN PAH-related hospitalization results
View the DataView SERAPHIN PAH-CTD subgroup data
See the DataReview the
REPAIR study
DISCOVER THE DATA
CYP=cytochrome P450;
ERA=endothelin receptor antagonist;
HIV=human immunodeficiency virus;
PAH=pulmonary arterial hypertension;
PDE-5i=phosphodiesterase type 5 inhibitor.
References:
1. OPSUMIT® [prescribing information]. Actelion Pharmaceuticals US, Inc.
2. Data on file. Actelion Pharmaceuticals US, Inc.