Not to be used in patients w/ soya hypersensitivity. Liver function, discontinue use if unexplained clinically relevant aminotransferase elevations occur, or if elevations are accompanied by increased bilirubin >2 x ULN or by clinical symptoms of liver injury (eg, jaundice), obtain liver enzyme tests prior to initiation of treatment; not to be initiated in patients w/ elevated aminotransferases (>3 x ULN). Hb conc, not recommended in patients w/ severe anemia, measure Hb conc prior to initiation & tests repeated during treatment as clinically indicated. Pulmonary veno-occlusive disease, monitor for signs of pulmonary oedema. Not to be taken by patients w/ galactose intolerance, total lactase deficiency or glucose-galactose malabsorption. Avoid combination w/ strong CYP3A4 inducers. Concomitant use w/ strong CYP3A4 inhibitors, moderate dual inhibitors of CYP3A4 & CYP2C9, moderate CYP3A4 & CYP2C9 inhibitors. May affect ability to drive & use machines. Renal impairment, consider monitoring of BP & Hb; not recommended in severe renal impairment. Women of childbearing potential should use effective contraception. Spermatogenesis in men. Not to be used during pregnancy & lactation. Childn & adolescents <18 yr.
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