Left Ventricular Dysfunction and Embryo-Fetal Toxicity

• Left Ventricular Dysfunction: PERJETA can cause subclinical and clinical cardiac failure manifesting as decreased LVEF and CHF. Evaluate cardiac function prior to and during treatment. Discontinue PERJETA treatment for a confirmed clinically significant decrease in left ventricular function [see Dosage and Administration (2.3), Warnings and Precautions (5.1) and Adverse Reactions (6.1)].

Embryo-Fetal Toxicity 

•  Exposure to Pertuzuamab can result in embryo-fetal death and birth defects. Studies in animals have resulted in oligohydramnios, delayed renal development, and death. Advise patients of these risks and the need for effective contraception.