Fremanezumab Pregnancy and Breastfeeding Warnings

Brand names: Ajovy

Medically reviewed by Drugs.com. Last updated on Feb 21, 2024.

Fremanezumab Pregnancy Warnings

Benefit should outweigh risk

AU TGA pregnancy category: B1
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.
-Some authorities advise this drug be avoided during pregnancy as a precautionary measure.
-There is a pregnancy exposure registry that monitors pregnancy outcomes in women exposed to this drug during pregnancy; healthcare providers are encouraged to register pregnancy patients or pregnant women may enroll themselves (phone: 1-833-927-2605 or www.tevamigrainepregnancyregistry.com)

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. Monoclonal antibodies, such as this drug, are transported across the placenta in a linear fashion as pregnancy progresses. Therefore, exposure of the fetus is likely to be greater during the second and third trimester of pregnancy. 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.

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

Further information

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