FOTIVDA Rx

Withhold, reduce dose or discontinue therapy based on severity and type of adverse reaction; see full labeling. SBP >150mmHg or DBP >100mmHg: not studied. Control BP prior to initiation. Monitor BP after 2 weeks and at least monthly thereafter. Symptomatic cardiac failure, arterial thrombotic event, myocardial infarction, unstable angina, or significant bleeding within the preceding 6 months prior to Fotivda initiation: not studied. Monitor periodically for symptoms of cardiac failure. Monitor closely in patients who are risk for, or who have a history of cardiac ischemia, thromboembolic events, hemorrhagic events. Monitor proteinuria and thyroid function prior to initiation, then periodically during therapy. Impaired wound healing: withhold for ≥24 days prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Discontinue if reversible posterior leukoencephalopathy syndrome (RPLS) occurs. ESRD. Moderate hepatic impairment: see Adult dose. Severe hepatic impairment (total bilirubin >3–10×ULN with any AST). Embryo-fetal toxicity. Advise females of reproductive potential and males (w. female partners) to use effective contraception during and for 1 month after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 1 month after the last dose).