OPSUMIT® (macitentan): The ONLY once-daily, oral ERA with no titration required^1,2*

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)	Significantly reduce macitentan exposure Concomitant use of OPSUMIT® with strong CYP3A4 inducers should be avoided
Strong inhibitors of CYP3A4 (eg, ketoconazole)	Approximately double macitentan exposure Concomitant use of OPSUMIT® with strong CYP3A4 inhibitors should be avoided Use other PAH treatment options when strong CYP3A4 inhibitors are needed as part of HIV treatment (eg, ritonavir)
Moderate dual inhibitors of CYP3A4 and CYP2C9 (eg, fluconazole and amiodarone)	Predicted to increase macitentan exposure Concomitant use of OPSUMIT® with moderate dual inhibitors of CYP3A4 and CYP2C9 should be avoided
Combined moderate CYP3A4 inhibitor and moderate CYP2C9 inhibitor	Concomitant use of OPSUMIT® with both a moderate CYP3A4 inhibitor and moderate CYP2C9 inhibitor should be avoided

*OPSUMIT® is approved in combination with PDE-5is or inhaled prostanoids, but not oral prostanoids.

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.

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OPSUMIT® (macitentan): The ONLY once-daily, oral ERA with no titration required1,2*

Drug-drug interactions1

SERAPHIN PAH-related hospitalization results

View SERAPHIN PAH-CTD subgroup data

Review theREPAIR study

OPSUMIT® (macitentan): The ONLY once-daily, oral ERA with no titration required^1,2*

Drug-drug interactions¹

Review the
REPAIR study