Lenvima

Control BP prior to treatment; monitor after 1 week, every 2 weeks for the first 2 months, and then at least monthly thereafter during therapy. Permanently discontinue if Grade 4 hypertension or cardiac dysfunction, arterial thrombotic event, hepatic failure, nephrotic syndrome, GI perforation, Grade 3 or 4 fistula, severe and persistent neurologic symptoms, or other Grade 4 reactions (eg, diarrhea, hemorrhage, hypocalcemia) occur. Withhold if Grade 3 hypertension persists despite therapy, Grade 3 cardiac dysfunction, Grade 3 or 4 liver/renal impairment, ≥2g of proteinuria/24hrs, QT prolongation >500ms, reversible posterior leukoencephalopathy syndrome (RPLS), other persistent/intolerable Grade 2 or 3 reactions, or Grade 4 lab abnormality occurs. Monitor for signs/symptoms of cardiac dysfunction. Monitor liver function prior to treatment, every 2 weeks for the first 2 months, then at least monthly during treatment. Monitor for proteinuria prior to, and periodically during treatment. Monitor for dehydration and treat if diarrhea develops. Hypovolemia. Congenital long QT syndrome, CHF, bradyarrhythmias, or those taking Class Ia or III antiarrhythmic drugs; monitor ECGs. Monitor and correct electrolyte abnormalities. Monitor blood calcium levels at least monthly; replace as needed during treatment. Monitor thyroid function prior to initiation and at least monthly thereafter; treat hypothyroidism as needed. Concomitant exposure to other risk factors (eg, bisphosphonates, denosumab, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Lenvima for ≥1 week prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. ESRD. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥30 days after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).

Control BP prior to treatment; monitor after 1 week, every 2 weeks for the first 2 months, and then at least monthly thereafter during therapy. Permanently discontinue if Grade 4 hypertension or cardiac dysfunction, arterial thrombotic event, hepatic failure, nephrotic syndrome, GI perforation, Grade 3 or 4 fistula, severe and persistent neurologic symptoms, or other Grade 4 reactions (eg, diarrhea, hemorrhage, hypocalcemia) occur. Withhold if Grade 3 hypertension persists despite therapy, Grade 3 cardiac dysfunction, Grade 3 or 4 liver/renal impairment, ≥2g of proteinuria/24hrs, QT prolongation >500ms, reversible posterior leukoencephalopathy syndrome (RPLS), other persistent/intolerable Grade 2 or 3 reactions, or Grade 4 lab abnormality occurs. Monitor for signs/symptoms of cardiac dysfunction. Monitor liver function prior to treatment, every 2 weeks for the first 2 months, then at least monthly during treatment. Monitor for proteinuria prior to, and periodically during treatment. Monitor for dehydration and treat if diarrhea develops. Hypovolemia. Congenital long QT syndrome, CHF, bradyarrhythmias, or those taking Class Ia or III antiarrhythmic drugs; monitor ECGs. Monitor and correct electrolyte abnormalities. Monitor blood calcium levels at least monthly; replace as needed during treatment. Monitor thyroid function prior to initiation and at least monthly thereafter; treat hypothyroidism as needed. Concomitant exposure to other risk factors (eg, bisphosphonates, denosumab, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Lenvima for ≥1 week prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. ESRD. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥30 days after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).

Control BP prior to treatment; monitor after 1 week, every 2 weeks for the first 2 months, and then at least monthly thereafter during therapy. Permanently discontinue if Grade 4 hypertension or cardiac dysfunction, arterial thrombotic event, hepatic failure, nephrotic syndrome, GI perforation, Grade 3 or 4 fistula, severe and persistent neurologic symptoms, or other Grade 4 reactions (eg, diarrhea, hemorrhage, hypocalcemia) occur. Withhold if Grade 3 hypertension persists despite therapy, Grade 3 cardiac dysfunction, Grade 3 or 4 liver/renal impairment, ≥2g of proteinuria/24hrs, QT prolongation >500ms, reversible posterior leukoencephalopathy syndrome (RPLS), other persistent/intolerable Grade 2 or 3 reactions, or Grade 4 lab abnormality occurs. Monitor for signs/symptoms of cardiac dysfunction. Monitor liver function prior to treatment, every 2 weeks for the first 2 months, then at least monthly during treatment. Monitor for proteinuria prior to, and periodically during treatment. Monitor for dehydration and treat if diarrhea develops. Hypovolemia. Congenital long QT syndrome, CHF, bradyarrhythmias, or those taking Class Ia or III antiarrhythmic drugs; monitor ECGs. Monitor and correct electrolyte abnormalities. Monitor blood calcium levels at least monthly; replace as needed during treatment. Monitor thyroid function prior to initiation and at least monthly thereafter; treat hypothyroidism as needed. Concomitant exposure to other risk factors (eg, bisphosphonates, denosumab, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Lenvima for ≥1 week prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. ESRD. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥30 days after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).

Control BP prior to treatment; monitor after 1 week, every 2 weeks for the first 2 months, and then at least monthly thereafter during therapy. Permanently discontinue if Grade 4 hypertension or cardiac dysfunction, arterial thrombotic event, hepatic failure, nephrotic syndrome, GI perforation, Grade 3 or 4 fistula, severe and persistent neurologic symptoms, or other Grade 4 reactions (eg, diarrhea, hemorrhage, hypocalcemia) occur. Withhold if Grade 3 hypertension persists despite therapy, Grade 3 cardiac dysfunction, Grade 3 or 4 liver/renal impairment, ≥2g of proteinuria/24hrs, QT prolongation >500ms, reversible posterior leukoencephalopathy syndrome (RPLS), other persistent/intolerable Grade 2 or 3 reactions, or Grade 4 lab abnormality occurs. Monitor for signs/symptoms of cardiac dysfunction. Monitor liver function prior to treatment, every 2 weeks for the first 2 months, then at least monthly during treatment. Monitor for proteinuria prior to, and periodically during treatment. Monitor for dehydration and treat if diarrhea develops. Hypovolemia. Congenital long QT syndrome, CHF, bradyarrhythmias, or those taking Class Ia or III antiarrhythmic drugs; monitor ECGs. Monitor and correct electrolyte abnormalities. Monitor blood calcium levels at least monthly; replace as needed during treatment. Monitor thyroid function prior to initiation and at least monthly thereafter; treat hypothyroidism as needed. Concomitant exposure to other risk factors (eg, bisphosphonates, denosumab, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Lenvima for ≥1 week prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥1 week prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. ESRD. Embryo-fetal toxicity. Pregnancy: exclude status prior to initiation. Advise females of reproductive potential to use effective contraception during and for ≥30 days after the last dose. Nursing mothers: not recommended (during and for ≥1 week after the last dose).