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Eptinezumab Pregnancy and Breastfeeding Warnings

Medically reviewed by Drugs.com. Last updated on Mar 15, 2022.

Eptinezumab is also known as: Vyepti

Eptinezumab Pregnancy Warnings

Animal studies in pregnant rats and rabbits have shown no adverse effects on embryofetal development when this drug was dosed throughout the period of organogenesis at doses up to 25 times the maximum recommended human dose. Human IgG is known to cross the placental barrier; therefore, this drug may be transmitted from the mother to the developing fetus. There are no controlled data in human pregnancy.

AU TGA pregnancy category B1: Drugs which have been taken by only a limited number of pregnant women and women of childbearing age, without an increase in the frequency of malformation or other direct or indirect harmful effects on the human fetus having been observed. Studies in animals have not shown evidence of an increased occurrence of fetal damage.

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: Category B1
US FDA pregnancy category: Not assigned

Risk Summary: There are no data on developmental risk associated with use in pregnant women; animal studies have not shown developmental effects.

Comments:
-Published data have suggested that women with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy

See references

Eptinezumab Breastfeeding Warnings

Benefit should outweigh risk

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.

As this drug is a large protein, the amount, if excreted into breastmilk is likely to be very low and absorption unlikely because it would probably be destroyed in the infant's gastrointestinal tract.

See references

References for pregnancy information

  1. "Product Information. Vyepti (eptinezumab)." Lundbeck Inc, Deerfield, IL.
  2. Cerner Multum, Inc. "Australian Product Information." O 0

References for breastfeeding information

  1. Cerner Multum, Inc. "Australian Product Information." O 0
  2. 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 -]):
  3. "Product Information. Vyepti (eptinezumab)." Lundbeck Inc, Deerfield, IL.

Further information

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