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Ramucirumab Pregnancy and Breastfeeding Warnings

Ramucirumab is also known as: Cyramza

Medically reviewed by Last updated on Nov 7, 2018.

Ramucirumab Pregnancy Warnings

Use is not recommended.

AU TGA pregnancy category: D
US FDA pregnancy category: Not assigned.

Risk Summary: Based on its mechanism of action this drug can cause fetal harm. Animal models link angiogenesis, VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development.

-Based on its mechanism of action, this drug may cause fetal harm.
-If a patient becomes pregnant while taking this drug, she should be apprised of the potential hazard to a fetus.
-Female patients should be advised to avoid getting pregnant while receiving this drug and for at least 3 months after the last dose.
-Females of reproductive potential should be advised that this drug may impair fertility.

No animal studies have been conducted to evaluate the effect of the drug on reproduction and fetal development. There are no controlled data in human pregnancy.

AU TGA pregnancy category D: Drugs which have caused, are suspected to have caused or may be expected to cause, an increased incidence of human fetal malformations or irreversible damage. These drugs may also have adverse pharmacological effects. Accompanying texts should be consulted for further details.

US FDA pregnancy category Not Assigned: The US FDA has amended the pregnancy labeling rule for prescription drug products to require labeling that includes a summary of risk, a discussion of the data supporting that summary, and relevant information to help health care providers make prescribing decisions and counsel women about the use of drugs during pregnancy. Pregnancy categories A, B, C, D and X are being phased out.

See references

Ramucirumab Breastfeeding Warnings

A decision should be made whether to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

Excreted into human milk: Unknown
Excreted into animal milk: Data not available

-The effects in the nursing infant are unknown.
-Breastfeeding should be delayed for at least 3 months after the last dose of this drug.

See references

References for pregnancy information

  1. "Product Information. Cyramza (ramucirumab)." Eli Lilly and Company, Indianapolis, IN.

References for breastfeeding information

  1. "Product Information. Cyramza (ramucirumab)." Eli Lilly and Company, Indianapolis, IN.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.