Left Ventricular Dysfunction and Embryo-Fetal Toxicity

Left Ventricular Dysfunction

• MARGENZA may lead to reductions in left ventricular ejection fraction (LVEF). Evaluate cardiac function prior to and during treatment. Discontinue MARGENZA treatment for a confirmed clinically significant decrease in left ventricular function [see DOSAGE AND ADMINISTRATION (2.2), WARNINGS AND PRECAUTIONS (5.1), and ADVERSE REACTIONS (6.1)].

Embryo-Fetal Toxicity

• Exposure to MARGENZA during pregnancy can cause embryo-fetal harm. Advise patients of the risk and need for effective contraception [see WARNINGS AND PRECAUTIONS (5.2), USE IN SPECIFIC POPULATIONS (8.1, 8.3)].