Embryo-Fetal Toxicity

Based on its mechanism of action, zenocutuzumab can cause fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1)]. There are no available data on the use of zenocutuzumab in pregnant women to inform a drug-associated risk.

Animal studies have demonstrated that HER2 and/or HER3 deficiency results in embryo-fetal malformation, including effects on cardiac, vascular and neuronal development, and embryo-lethality (see Data).

Human IgG1 is known to cross the placenta; therefore, zenocutuzumab has the potential to be transmitted from the mother to the developing fetus. Advise patients of the potential risk to a fetus.

There are clinical considerations if zenocutuzumab is used in pregnant women, or if a patient becomes pregnant within 2 months after the last dose of zenocutuzumab (see Clinical Considerations).

In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2% to 4% and 15% to 20%, respectively.

Clinical Considerations

Fetal/Neonatal Adverse Reactions

Monitor women who received zenocutuzumab during pregnancy or within 2 months prior to conception for oligohydramnios. If oligohydramnios occurs, perform fetal testing that is appropriate for gestational age and consistent with community standards of care.