Cardiomyopathy, Embryo-Fetal Toxicity and Pulmonary Toxicity

Cardiomyopathy

• Cardiomyopathy: HERCEPTIN HYLECTA can result in subclinical and clinical cardiac failure manifesting as CHF, and decreased LVEF, with greatest risk when administered concurrently with anthracyclines. Evaluate cardiac function prior to and during treatment. Discontinue HERCEPTIN HYLECTA for cardiomyopathy.

Embryo-Fetal Toxicity

• Embryo-Fetal Toxicity: Exposure to HERCEPTIN HYLECTA during pregnancy can result in oligohydramnios, in some cases complicated by pulmonary hypoplasia and neonatal death. Advise patients of these risks and the need for effective contraception.

Pulmonary Toxicity

• Pulmonary Toxicity: Discontinue HERCEPTIN HYLECTA for anaphylaxis, angioedema, interstitial pneumonitis or acute respiratory distress syndrome.