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Cyramza Summary of Product Characteristics (SmPC)
Based on its mechanism of action, ramucirumab may cause foetal harm. It is recommended to avoid pregnancy and discontinue nursing while taking ramucirumab.
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
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.
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