Phesgo

Increased risk of cardiomyopathy. Conduct cardiac assessment (eg, history, physical exam, LVEF) prior to initiation. Assess LVEF at regular intervals during treatment (eg, every 12wks for MBC or EBC [once for neoadjuvant therapy]); permanently discontinue if LVEF has not improved, declined further, and/or symptomatic after repeat assessment within 3wks. Monitor and assess LVEF every 6 months for ≥2yrs after therapy (if adjuvant). Pretreatment LVEF value of <55% (EBC) or <50% (MBC), history of CHF, uncontrolled hypertension, recent MI, serious cardiac arrhythmia requiring treatment or a cumulative prior anthracycline exposure to >360mg/m² of doxorubicin or its equivalent: not studied. Symptomatic intrinsic lung disease. Extensive tumor involvement of the lungs. Discontinue if anaphylaxis, angioedema, interstitial pneumonitis, or acute respiratory distress syndrome occurs. Monitor for hypersensitivity and injection-related reactions during and for 30mins after initial dose, and for 15mins after subsequent doses; slow or interrupt the injection and treat if occurs; permanently discontinue if anaphylaxis or severe reactions occur. Test for HER2 protein overexpression and HER2 gene amplification using FDA-approved tests specific for breast cancer. Elderly. Embryo-fetal toxicity (eg, oligohydramnios); monitor during pregnancy or within 7 months prior to conception. Advise females of reproductive potential to use effective contraception during and for 7 months after the last dose. Pregnancy: exclude status prior to initiation. Nursing mothers.