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OPSUMIT
Pulmonary hypertension
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Drug Name:

OPSUMIT Rx

Generic Name and Formulations:
Macitentan 10mg; tabs.

Company:
Actelion Pharmaceuticals

Therapeutic Use:

Indications for OPSUMIT:

Treatment of pulmonary arterial hypertension (PAH, WHO Group I) to delay disease progression and to reduce hospitalization for PAH.

Adult:

10mg once daily. Doses >10mg once daily: not recommended.

Children:

Not established.

Contraindications:

Pregnancy (Cat.X).

Boxed Warning:

Embryo-fetal toxicity.

Warnings/Precautions:

Embryo-fetal toxicity: in females of reproductive potential, exclude pregnancy prior to initiation, monthly during, and for 1 month after treatment discontinuation; must use acceptable methods of contraception. Obtain LFTs prior to initiation and repeat during treatment as clinically indicated. Discontinue if clinically relevant ALT/AST elevations or if elevations accompanied by bilirubin >2xULN, or by symptoms of hepatotoxicity occur. Underlying left ventricular dysfunction: monitor for fluid retention; evaluate if develops. Severe anemia: not recommended. Measure Hgb prior to initiation and repeat during treatment as clinically indicated. Consider pulmonary veno-occlusive disease if signs of pulmonary edema occur; discontinue if confirmed. Potential decrease in sperm count; counsel men on fertility effects. Nursing mothers: not recommended.

Pharmacological Class:

Endothelin receptor antagonist.

Interactions:

Potentiated by strong CYP3A4 inhibitors (eg, ketoconazole, ritonavir); avoid concomitant use. Antagonized by strong CYP3A4 inducers (eg, rifampin); avoid concomitant use.

Adverse Reactions:

Anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, urinary tract infection; hepatotoxicity, decreased hemoglobin.

Note:

For all female patients: available only through the Opsumit REMS program. To enroll call (866) 228-3546 or www.OpsumitREMS.com.

REMS:

YES

Generic Availability:

NO

How Supplied:

Tabs—15, 30


Data provided by MPR.

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