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Aflibercept ophthalmic Pregnancy and Breastfeeding Warnings

Aflibercept ophthalmic is also known as: Eylea

Medically reviewed on Aug 21, 2018

Aflibercept ophthalmic Pregnancy Warnings

Animal studies have revealed evidence of embryofetal toxicity at systemic exposures approximately 6 times higher than AUC values estimated to occur in humans at recommended clinical doses. Embryofetal effects included increased incidence of post implantation loss and fetal malformations, including anasarca, umbilical hernia, diaphragmatic hernia, gastroschisis, cleft palate, ectrodactyly, intestinal atresia, spina bifida, encephalomeningocele, heart and major vessel defects, and skeletal malformations. 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.

Benefit should outweigh risk

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

Risk Summary: Based on this drugs anti-VEGF mechanism of action, a risk to human embryofetal development cannot be ruled out; animal studies have shown adverse embryofetal effects and skeletal malformations.

Comments:
-Women of childbearing potential should be advised to use effective contraception prior to the initial dose, during treatment and for at least 3 months after the last injection.

See references

Aflibercept ophthalmic Breastfeeding Warnings

This drug is a large protein molecule which generally limits excretion into breast milk. Following a 2 mg intravitreal dose, Cmax is estimated to be more than 100-fold lower than the concentration required to half-maximally bind systemic vascular endothelial growth factor.

Not Recommended

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

Comments:
-There are no data on the effects of this drug on the breastfed infant or its effects on milk production.
-The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for this drug and any potential adverse effects to the breastfed infant from the drug or from the underlying maternal condition.

See references

References for pregnancy information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0
  3. "Product Information. Eylea (aflibercept ophthalmic)." Regeneron Pharmaceuticals Inc, Tarrytown, NY.

References for breastfeeding information

  1. United States National Library of Medicine "Toxnet. Toxicology Data Network. Available from: URL: http://toxnet.nlm.nih.gov/cgi-bin/sis/htmlgen?LACT." ([cited 2013 -]):
  2. "Product Information. Eylea (aflibercept ophthalmic)." Regeneron Pharmaceuticals Inc, Tarrytown, NY.
  3. Cerner Multum, Inc. "Australian Product Information." O 0
  4. Cerner Multum, Inc. "UK Summary of Product Characteristics." O 0

Further information

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

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