VOTRIENT Rx

Not indicated for use in combination with other cancer agents. Risk of severe and fatal hepatotoxicity (esp. ≥65yrs old). Monitor liver tests at baseline, and at Weeks 3, 5, 7, and 9, thereafter at Months 3 and 4, then periodically. Increase to weekly monitoring for those with elevated ALT until ALT returns to Grade 1 or baseline. Withhold therapy and resume at reduced dose with continued weekly monitoring for 8 weeks, or permanently discontinue with weekly monitoring until resolution based on severity of hepatotoxicity. Gilbert's syndrome (see full labeling). History of QT prolongation. Cardiac dysfunction risk (including previous anthracycline exposure): evaluate LVEF at baseline and periodically; monitor for CHF. Monitor ECG, electrolytes (eg, calcium, magnesium, potassium), thyroid function. Correct hypokalemia, hypomagnesemia, hypocalcemia prior to initiation and during treatment. Hemorrhagic events. Arterial thrombotic events. Monitor for VTE, PE, infection, proteinuria (reduce dose if 24-hour urine protein ≥3g), thrombotic microangiopathy, interstitial lung disease (ILD)/pneumonitis, GI perforation or fistula. Monitor BP and manage hypertension promptly. Closely monitor those at risk for tumor lysis syndrome (eg, rapidly growing tumors, a high tumor burden, renal dysfunction, dehydration). Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception and males (w. female partners; use condoms) during and for ≥2 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).

Not indicated for use in combination with other cancer agents. Risk of severe and fatal hepatotoxicity (esp. ≥65yrs old). Monitor liver tests at baseline, and at Weeks 3, 5, 7, and 9, thereafter at Months 3 and 4, then periodically. Increase to weekly monitoring for those with elevated ALT until ALT returns to Grade 1 or baseline. Withhold therapy and resume at reduced dose with continued weekly monitoring for 8 weeks, or permanently discontinue with weekly monitoring until resolution based on severity of hepatotoxicity. Gilbert's syndrome (see full labeling). History of QT prolongation. Cardiac dysfunction risk (including previous anthracycline exposure): evaluate LVEF at baseline and periodically; monitor for CHF. Monitor ECG, electrolytes (eg, calcium, magnesium, potassium), thyroid function. Correct hypokalemia, hypomagnesemia, hypocalcemia prior to initiation and during treatment. Hemorrhagic events. Arterial thrombotic events. Monitor for VTE, PE, infection, proteinuria (reduce dose if 24-hour urine protein ≥3g), thrombotic microangiopathy, interstitial lung disease (ILD)/pneumonitis, GI perforation or fistula. Monitor BP and manage hypertension promptly. Closely monitor those at risk for tumor lysis syndrome (eg, rapidly growing tumors, a high tumor burden, renal dysfunction, dehydration). Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Embryo-fetal toxicity. Advise females of reproductive potential to use effective contraception and males (w. female partners; use condoms) during and for ≥2 weeks after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 2 weeks after the last dose).