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Fremanezumab Pregnancy and Breastfeeding Warnings

Fremanezumab is also known as: Ajovy

Medically reviewed by Drugs.com. Last updated on Oct 3, 2018.

Fremanezumab 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.

Comments: This drug has a long half-life (31 days); this should be taken into consideration for women who are pregnant or plan to become pregnant.

Administration to rats and rabbits during organogenesis did not produce developmental adverse effects in doses greater than those expected clinically. Published data suggest that women with migraine headaches may be at an increased risk of preeclampsia during pregnancy. The estimated rate of major birth defects and miscarriage in women with migraine are similar to rates reported in women without migraine. 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

Fremanezumab 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.

This drug is a large protein molecule and therefore the amount in milk, if excreted, is likely to be very low and absorption is unlikely because it is probably destroyed in the infant's gastrointestinal tract. Human IgG is known to be excreted in breast milk during the first few days after birth. Therefore, consider holding this drug for the first few days after birth, and then, may consider use if clinically needed.

See references

References for pregnancy information

  1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  2. "Product Information. Ajovy (fremanezumab)." Nephroceuticals, Miamisburg, OH.

References for breastfeeding information

  1. EMEA. European Medicines Agency "EPARs. European Union Public Assessment Reports. Available from: URL: http://www.ema.europa.eu/ema/index.jsp?curl=pages/includes/medicines/medicines_landingpage.jsp&mid."
  2. "Product Information. Ajovy (fremanezumab)." Nephroceuticals, Miamisburg, OH.

Further information

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

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