Cyramza® (ramucirumab): Pregnancy and Lactation

Pregnancy Risk Summary

No animal studies have been specifically conducted to evaluate the effect of ramucirumab on female reproduction and fetal development, and there are no studies in pregnant women¹

Based on ramucirumab’s mechanism of action, it is likely that ramucirumab will inhibit angiogenesis and may potentially result in adverse effects during pregnancy and postnatal development.¹

Avoid the use of ramucirumab in pregnant women, and only use if the potential benefit to the mother justifies the potential risk to the fetus. Counsel women of childbearing potential or women who become pregnant during treatment of the potential risks of ramucirumab to the fetus and for maintaining pregnancy.¹

Based on the half-life of ramucirumab, advise females of reproductive potential to avoid getting pregnant while receiving ramucirumab and for at least 3 months after the last dose of ramucirumab.¹

Animal Data

Animal models link

• angiogenesis

• VEGF, and

• VEGFR-2

to critical aspects of

• female reproduction

• embryofetal development, and

• postnatal development.²

Lactation Risk Summary

No studies have been conducted to assess ramucirumab’s impact on

• milk production

• its presence in breast milk, or

• its effects on the breast-fed child.¹

It is not known whether ramucirumab is secreted in human milk. Human immunoglobulin G is excreted in human milk and due to potential risks to the nursing infant, it is recommended to discontinue nursing or discontinue ramucirumab.¹

References

1. Cyramza [summary of product characteristics]. Eli Lilly Nederland B.V., The Netherlands.

2. Data on file, Eli Lilly and Company and/or one of its subsidiaries.

Glossary

VEGF = vascular endothelial growth factor

VEGFR-2 = vascular endothelial growth factor receptor 2