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Galcanezumab Pregnancy and Breastfeeding Warnings

Galcanezumab is also known as: Emgality

Medically reviewed by Drugs.com. Last updated on Jun 13, 2019.

Galcanezumab Pregnancy Warnings

Benefit should outweigh risk

US FDA pregnancy category: Not assigned

Risk Summary: There are no data on the developmental risks associated with this drug in human pregnancy; animal data have not shown adverse effects on embryofetal development.

Comments: Published data suggest that women with migraine may be at increased risk of preeclampsia during pregnancy.

No adverse effects on development have been observed in rats and rabbits receiving this drug during organogenesis or rats receiving this drug throughout pregnancy and lactation. Tested doses were up to 38 times (rats) and 64 times (rabbits) the plasma exposure expected at recommended human dose. 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.

See references

Galcanezumab 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. Emgality (galcanezumab)." Lilly, Eli and Company, Indianapolis, IN.

References for breastfeeding information

  1. "Product Information. Emgality (galcanezumab)." Lilly, Eli and Company, Indianapolis, IN.

Further information

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

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