Hypersensitivity. Concomitant use w/ cyclosporine A. Baseline AST &/or ALT values >3 x ULN. Moderate to severe hepatic impairment (Child-Pugh class B or C). Women of childbearing potential not using effective contraception. Pregnancy.
Pulmonary veno-occlusive disease; PAH w/ concomitant left ventricular failure or associated w/ HIV infection; pulmonary HTN secondary to COPD. Monitor AST & ALT levels prior to & mthly thereafter. Check Hb conc prior to treatment, every mth for 1st 4 mth & quarterly thereafter. Avoid abrupt discontinuation. Not recommended w/ glibenclamide, fluconazole, rifampicin. Avoid co-administration of CYP3A4 & CYP2C9 inhibitors. May affect ability to drive or operate machinery. Avoid use in patients w/ moderate or severe hepatic impairment. Mild hepatic impairment. May affect male fertility. Women of childbearing potential should use effective contraception during & for 1 mth after last dose. Not to be used during pregnancy. Not recommended during lactation. Childn 12-18 yr. Elderly ≥65 yr.
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