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

Tablet not shown at actual size.

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 approximately 4-fold 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

^*Patients were treated with OPSUMIT® monotherapy or in combination with phosphodiesterase type 5 inhibitors or inhaled prostanoids.¹

Prescribing OPSUMIT®

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SERAPHIN pivotal trial

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CYP=cytochrome P450; ERA=endothelin receptor antagonist; HIV=human immunodeficiency virus; PAH=pulmonary arterial hypertension; PDE5i=phosphodiesterase type 5 inhibitor.

References: 1. OPSUMIT® (macitentan) full 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

Prescribing OPSUMIT®

SERAPHIN pivotal trial

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

Drug-drug interactions¹