Enhertu

Not substitutable for or with trastuzumab or ado-trastuzumab emtansine. Monitor for new or worsening respiratory symptoms; permanently discontinue if symptomatic (grade ≥2) interstitial lung disease (ILD)/pneumonitis develops. Monitor CBCs prior to initiation and each dose, then as clinically indicated; interrupt or reduce dose based on severity of neutropenia. Risk of left ventricular dysfunction. Assess LVEF prior to initiation and at regular intervals during treatment as clinically indicated; permanently discontinue if LVEF <40% or absolute decrease from baseline >20% is confirmed. Permanently discontinue in patients with symptomatic CHF or if severe infusion reactions occur. History of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment: not studied. Moderate renal (CrCl ≥30–<60mL/min) or moderate hepatic (total bilirubin >1.5–3×ULN and any AST) impairment: monitor closely. Severe renal (CrCL <30mL/min) or severe hepatic (total bilirubin >3×ULN and any AST) impairment: dosage has not been established. Embryo-fetal toxicity (oligohydramnios, others). Advise to use effective contraception during and for ≥7 months (females) or ≥4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 months after the last dose).

Not substitutable for or with trastuzumab or ado-trastuzumab emtansine. Monitor for new or worsening respiratory symptoms; permanently discontinue if symptomatic (grade ≥2) interstitial lung disease (ILD)/pneumonitis develops. Monitor CBCs prior to initiation and each dose, then as clinically indicated; interrupt or reduce dose based on severity of neutropenia. Risk of left ventricular dysfunction. Assess LVEF prior to initiation and at regular intervals during treatment as clinically indicated; permanently discontinue if LVEF <40% or absolute decrease from baseline >20% is confirmed. Permanently discontinue in patients with symptomatic CHF or if severe infusion reactions occur. History of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment: not studied. Moderate renal (CrCl ≥30–<60mL/min) or moderate hepatic (total bilirubin >1.5–3×ULN and any AST) impairment: monitor closely. Severe renal (CrCL <30mL/min) or severe hepatic (total bilirubin >3×ULN and any AST) impairment: dosage has not been established. Embryo-fetal toxicity (oligohydramnios, others). Advise to use effective contraception during and for ≥7 months (females) or ≥4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 months after the last dose).

Not substitutable for or with trastuzumab or ado-trastuzumab emtansine. Monitor for new or worsening respiratory symptoms; permanently discontinue if symptomatic (grade ≥2) interstitial lung disease (ILD)/pneumonitis develops. Monitor CBCs prior to initiation and each dose, then as clinically indicated; interrupt or reduce dose based on severity of neutropenia. Risk of left ventricular dysfunction. Assess LVEF prior to initiation and at regular intervals during treatment as clinically indicated; permanently discontinue if LVEF <40% or absolute decrease from baseline >20% is confirmed. Permanently discontinue in patients with symptomatic CHF or if severe infusion reactions occur. History of clinically significant cardiac disease or LVEF <50% prior to initiation of treatment: not studied. Moderate renal (CrCl ≥30–<60mL/min) or moderate hepatic (total bilirubin >1.5–3×ULN and any AST) impairment: monitor closely. Severe renal (CrCL <30mL/min) or severe hepatic (total bilirubin >3×ULN and any AST) impairment: dosage has not been established. Embryo-fetal toxicity (oligohydramnios, others). Advise to use effective contraception during and for ≥7 months (females) or ≥4 months (males w. female partners) after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers: not recommended (during and for 7 months after the last dose).