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Bevacizumab Pregnancy and Breastfeeding Warnings

Bevacizumab is also known as: Avastin, Mvasi

Medically reviewed on Jun 14, 2018

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.

Most experts consider use of this drug in pregnancy to be 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:
-Women of childbearing potential should be encouraged to use adequate methods of contraception during and for at least 6 months after therapy.
-Advise pregnant women of the potential risk to a fetus.
-This drug could impair female fertility. Fertility preservation methods should be discussed with women of child bearing potential before initiation of treatment.

See references

Bevacizumab Breastfeeding Warnings

Use is not recommended.

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

Comments:
-Women should discontinue breastfeeding during and for at least 6 months after therapy.
-Human IgG1 is secreted into human milk. The potential for absorption and harm to the infant is unknown.

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

References for pregnancy information

  1. "Product Information. Avastin (bevacizumab)." Genentech, South San Francisco, CA.
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):

References for breastfeeding information

  1. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  2. Pharmaceutical Society of Australia "APPGuide online. Australian prescription products guide online. Available from: URL: http://www.appco.com.au/appguide/default.asp." ([2006]):
  3. "Product Information. Avastin (bevacizumab)." Genentech, South San Francisco, CA.

Further information

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

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