Inlyta

Control and monitor BP prior to and during therapy; permanently discontinue if Grade 4 hypertension or hypertensive crisis occurs. Risk of thromboembolic events; permanently discontinue based on severity of event. Untreated brain metastasis, recent active GI bleed: not recommended. Monitor for cardiac failure during therapy; manage accordingly based on event. GI perforation and fistula formation; monitor. Monitor thyroid, liver function (ALT, AST, bilirubin), and for proteinuria before starting therapy, then periodically. Monitor for hepatotoxicity more frequently in combination treatments. Withhold and reduce dose if moderate to severe proteinuria occurs. Risk of reversible posterior leukoencephalopathy syndrome; permanently discontinue if occurs. Impaired wound healing: withhold for ≥2 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. In combination with avelumab: monitor for major adverse cardiovascular events; permanently discontinue axitinib/avelumab for Grade 3–4 events. ESRD. Severe hepatic impairment: not studied. Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 week after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).