Indications for OPSUMIT:

Treatment of pulmonary arterial hypertension (PAH) (WHO Group I) to delay disease progression. In clinical studies, treatment delayed disease progression (death, initiation of IV or SC prostanoids, or clinical worsening of PAH [decreased 6MWD, worsened PAH symptoms and need for additional PAH treatment]) and reduced hospitalization for PAH.

Adult Dose for OPSUMIT:

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

Children's Dose for OPSUMIT:

Not established.

Pharmacological Class:

Endothelin receptor antagonist.

Contraindications:

Pregnancy (Cat. X).

Warnings/Precautions:

In females of reproductive potential, exclude pregnancy prior to starting, monthly during, and for 1 month after treatment discontinuation; must use acceptable methods of contraception. Obtain liver function tests 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. 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.

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; decreased hemoglobin.

Note:

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

How Supplied:

Tabs—15, 30