KADCYLA Rx

Do not substitute for or with trastuzumab. Hepatotoxicity; monitor serum transaminases and bilirubin prior to starting and to each dose; reduce dose or discontinue if occurs. Permanently discontinue if serum transaminases >3×ULN and with total bilirubin >2×ULN, or if nodular regenerative hyperplasia develops. Risk of left ventricular dysfunction. Assess LVEF prior to initiation and every 3 months during treatment; interrupt and discontinue as appropriate. Permanently discontinue if interstitial lung disease or pneumonitis occurs. Adjuvant therapy: permanently discontinue if Grade ≥3 or unresponsive Grade 2 radiation pneumonitis occurs. Monitor for extravasation, infusion-related or hypersensitivity reactions; if significant, slow or interrupt infusion; discontinue if life-threatening. Patients who permanently discontinued trastuzumab due to infusion-related reactions and/or hypersensitivity: not recommended. Monitor platelets at baseline and prior to each dose; if platelets <50,000/mm³, delay dose until recovery to ≥75,000/mm³; if platelets <25,000/mm³, delay until recovery to ≥75,000/mm³ and reduce dose. If thrombocytopenia occurs <100,000/mm³ and concomitant anticoagulants, monitor closely. Monitor for neurotoxicity; withhold temporarily if Grade 3 or 4 peripheral neuropathy occurs. Test for HER2 protein overexpression or gene amplification using FDA-approved tests by labs with demonstrated proficiency. Hepatic impairment: monitor closely. Embryo-fetal toxicity. Advise to use effective contraception during therapy and for 7 months (females) or 4 months (males w. female partners) after last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 months after last dose).