Bevacizumab Pregnancy and Breastfeeding Warnings

Brand names: Alymsys, Avastin, Avzivi, Mvasi, Vegzelma, Zirabev

Medically reviewed by Drugs.com. Last updated on Jun 30, 2023.

Bevacizumab Pregnancy Warnings

Animal studies revealed evidence of fetotoxicity and teratogenicity. Teratogenic effects included reduced or irregular ossification in the skull, jaw, spine, ribs, tibia, and bones of the paws, fontanel, rib and hindlimb deformities, corneal opacity, and absent hindlimb phalanges. 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.

Use should be avoided.
-According to some authorities: Use is contraindicated.

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

Risk Summary: This drug can cause fetal harm based on animal studies and its mechanism of action. Fetal malformations have been reported; however, these reports are insufficient to determine drug associated risks. In animal reproduction studies, IV administration to pregnant animals every 3 days during organogenesis at doses approximately 1 to 10 times the clinical dose of 10 mg/kg produced fetal resorptions, decreased maternal and fetal weight gain, and multiple congenital malformations including corneal opacities and abnormal ossification of the skull and skeleton including limb and phalangeal defects. Also, animal models link angiogenesis and VEGF and VEGF Receptor 2 (VEGFR2) to critical aspects of female reproduction, embryofetal development, and postnatal development.

Comments:
-This drug increases the risk of ovarian failure and may impair fertility; long-term effects on fertility are not known.
-Women of childbearing potential should be encouraged to use adequate methods of contraception during therapy and for at least 6 months after.

See references

Bevacizumab Breastfeeding Warnings

Use is not recommended.

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

Comments:
-Human IgG is excreted in human milk, but data suggest that breast
milk antibodies do not enter the neonatal and infant circulation in substantial amounts.
-Because of the potential for serious adverse reactions in breastfed infants, breastfeeding should be discontinued during therapy and for at least 6 months after.

No information is available on the IV 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. The manufacturer recommends that breastfeeding be discontinued during therapy.

See references

Further information

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