• Indications: PAH (WHO Group I) to reduce disease progression and hospitalization.

• Dosage: 10 mg once daily orally. Higher doses not studied or recommended.

• Administration: With or without food. Do not split, crush, or chew tablets.

• Contraindications: Pregnancy. Females of reproductive potential must use reliable contraception during treatment and for 1 month after discontinuation.

• Warnings/Precautions:

• Embryo-fetal toxicity: Contraindicated in pregnant females. Requires monthly pregnancy testing and enrollment in a restricted program (REMS).

• Hepatotoxicity: Monitor liver enzymes. Discontinue if significant elevations occur.

• Fluid retention: May require intervention, especially in patients with left ventricular dysfunction.

• Hemoglobin decrease: Monitor hemoglobin levels.

• Pulmonary edema with PVOD: Discontinue if confirmed.

• Decreased sperm counts: Counsel male patients about potential fertility effects.

Adverse Reactions

Common adverse reactions (>3% vs. placebo) include anemia, nasopharyngitis/pharyngitis, bronchitis, headache, influenza, and urinary tract infection.

Storage

Store at 20°C–25°C (68°F–77°F); excursions permitted between 15°C and 30°C (59°F and 86°F).