CYRAMZA® (ramucirumab): Pregnancy and Lactation

Pregnancy Risk Summary

Based on its mechanism of action, ramucirumab can cause fetal harm when administered to a pregnant woman. There are no available data on ramucirumab use in pregnant women.¹ Animal models link

• angiogenesis

• VEGF, and

• VEGFR2

to critical aspects of

• female reproduction

• embryo-fetal development, and

• postnatal development.¹

No animal studies have been conducted to evaluate the effect of ramucirumab on reproduction and fetal development. Advise a pregnant woman of the potential risk to a fetus. In the U.S. general population the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2‑4% and 15‑20%, respectively.¹

Based on its mechanism of action, ramucirumab can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with ramucirumab and for 3 months after the last dose.¹

Lactation Risk Summary

There is no information on the

• presence of ramucirumab in human milk

• effects on the breastfed child, or

• on milk production.¹

Human IgG is present in human milk, but published data suggest that breast milk antibodies do not enter the neonatal and infant circulation in substantial amounts. Because of the potential risk for serious adverse reactions in breastfed children from ramucirumab, advise women not to breastfeed during treatment with ramucirumab and for 2 months after the last dose.¹

Enclosed Prescribing Information

CYRAMZA® (ramucirumab) injection, for intravenous use, Lilly

Reference

1. Cyramza [package insert]. Indianapolis, IN: Eli Lilly and Company; 2019.

Glossary

IgG = immunoglobulin G

VEGF = vascular endothelial growth factor

VEGFR-2 = vascular endothelial growth factor receptor 2