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Eptinezumab Pregnancy and Breastfeeding Warnings

Eptinezumab is also known as: Vyepti

Medically reviewed by Drugs.com. Last updated on March 25, 2020.

Eptinezumab Pregnancy Warnings

IV administration weekly to pregnant rats and rabbits have shown no adverse effects on embryofetal development. Study doses included a high dose estimated to be 30 times the maximum recommended human dose. Administration to female rats showed no adverse effects on pre and postnatal development. There are no controlled data in human pregnancy.

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

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.

See references

References for pregnancy information

  1. "Product Information. Vyepti (eptinezumab)." Lundbeck Inc, Deerfield, IL.

References for breastfeeding information

  1. "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.