Cyramza 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.
Comments:
-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
Cyramza Breastfeeding Warnings
No information is available on the clinical use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.
Use is not recommended.
Excreted into human milk: Unknown
Excreted into animal milk: Data not available
Comments:
-The effects in the nursing infant are unknown.
-Human IgG is present in human milk.
-Breastfeeding should be delayed for at least 3 months after the last dose of this drug.
See references
