Sutent

Risk of hepatotoxicity (may be severe). Monitor LFTs at baseline, during each cycle of treatment and as clinically needed; interrupt if Grade 3 or 4 hepatotoxicity occurs and discontinue if no resolution, severe changes in LFTs, or other signs/symptoms of failure. Cardiovascular events: monitor for CHF, LVEF at baseline and periodically; interrupt and/or reduce dose if LVEF >20% but <50% below baseline; discontinue if CHF occurs. History of QT prolongation or pre-existing cardiac disease, bradycardia, electrolyte disturbances; perform periodic ECG, monitor electrolytes. Monitor BP at baseline and as indicated; withhold if hypertension develops until controlled. Not for use in lung cancer patients. Perform serial CBCs and physical exams to assess for hemorrhagic events. Risk of tumor lysis syndrome: monitor closely in RCC and GIST patients with high tumor burden. Permanently discontinue if severe cutaneous reactions (eg, erythema multiforme, SJS, TEN) develop. Monitor for proteinuria; perform baseline and periodic urinalyses; interrupt and reduce dose if 24-hr urine protein ≥3g; discontinue if nephrotic syndrome or repeat urine protein ≥3g persists. Monitor thyroid function at baseline, during treatment, and as indicated. Monitor blood glucose levels at baseline, during and after treatment discontinuation; adjust antidiabetic therapies as needed. Concomitant exposure to other risk factors (eg, bisphosphonates therapy, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Sutent therapy for ≥3 weeks prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥3 weeks prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Severe hepatic impairment. Embryo-fetal toxicity. Advise use of effective contraception during and for ≥4 weeks (females) or 7 weeks (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥4 weeks after the last dose).

Risk of hepatotoxicity (may be severe). Monitor LFTs at baseline, during each cycle of treatment and as clinically needed; interrupt if Grade 3 or 4 hepatotoxicity occurs and discontinue if no resolution, severe changes in LFTs, or other signs/symptoms of failure. Cardiovascular events: monitor for CHF, LVEF at baseline and periodically; interrupt and/or reduce dose if LVEF >20% but <50% below baseline; discontinue if CHF occurs. History of QT prolongation or pre-existing cardiac disease, bradycardia, electrolyte disturbances; perform periodic ECG, monitor electrolytes. Monitor BP at baseline and as indicated; withhold if hypertension develops until controlled. Not for use in lung cancer patients. Perform serial CBCs and physical exams to assess for hemorrhagic events. Risk of tumor lysis syndrome: monitor closely in RCC and GIST patients with high tumor burden. Permanently discontinue if severe cutaneous reactions (eg, erythema multiforme, SJS, TEN) develop. Monitor for proteinuria; perform baseline and periodic urinalyses; interrupt and reduce dose if 24-hr urine protein ≥3g; discontinue if nephrotic syndrome or repeat urine protein ≥3g persists. Monitor thyroid function at baseline, during treatment, and as indicated. Monitor blood glucose levels at baseline, during and after treatment discontinuation; adjust antidiabetic therapies as needed. Concomitant exposure to other risk factors (eg, bisphosphonates therapy, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Sutent therapy for ≥3 weeks prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥3 weeks prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Severe hepatic impairment. Embryo-fetal toxicity. Advise use of effective contraception during and for ≥4 weeks (females) or 7 weeks (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥4 weeks after the last dose).

Risk of hepatotoxicity (may be severe). Monitor LFTs at baseline, during each cycle of treatment and as clinically needed; interrupt if Grade 3 or 4 hepatotoxicity occurs and discontinue if no resolution, severe changes in LFTs, or other signs/symptoms of failure. Cardiovascular events: monitor for CHF, LVEF at baseline and periodically; interrupt and/or reduce dose if LVEF >20% but <50% below baseline; discontinue if CHF occurs. History of QT prolongation or pre-existing cardiac disease, bradycardia, electrolyte disturbances; perform periodic ECG, monitor electrolytes. Monitor BP at baseline and as indicated; withhold if hypertension develops until controlled. Not for use in lung cancer patients. Perform serial CBCs and physical exams to assess for hemorrhagic events. Risk of tumor lysis syndrome: monitor closely in RCC and GIST patients with high tumor burden. Permanently discontinue if severe cutaneous reactions (eg, erythema multiforme, SJS, TEN) develop. Monitor for proteinuria; perform baseline and periodic urinalyses; interrupt and reduce dose if 24-hr urine protein ≥3g; discontinue if nephrotic syndrome or repeat urine protein ≥3g persists. Monitor thyroid function at baseline, during treatment, and as indicated. Monitor blood glucose levels at baseline, during and after treatment discontinuation; adjust antidiabetic therapies as needed. Concomitant exposure to other risk factors (eg, bisphosphonates therapy, dental disease/invasive procedures) may increase the risk of osteonecrosis of the jaw (ONJ); withhold Sutent therapy for ≥3 weeks prior to scheduled dental surgery/invasive procedures or for development of ONJ until resolution. Impaired wound healing: withhold for ≥3 weeks prior to elective surgery; do not give for ≥2 weeks after major surgery and until adequate healing. Severe hepatic impairment. Embryo-fetal toxicity. Advise use of effective contraception during and for ≥4 weeks (females) or 7 weeks (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for ≥4 weeks after the last dose).