Benefit should outweigh risk

AU TGA pregnancy category: B1
US FDA pregnancy category: Not assigned

Risk Summary: There are no data on the developmental risk associated with use of this drug in human pregnancy; in monkeys, adverse effects were not observed in offspring at doses approximately 20 times the human dose of 140 mg per month.

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

In monkeys administered this drug subcutaneously from gestation day 20 to 22 through birth, no adverse effects on offspring were observed. The dose administered (50 mg/kg twice a week) provided serum exposures expected to be 20 times that in humans at a dose of 140 mg per month. Published data have suggested that pregnant women who experience migraines may be at increased risk of preeclampsia during pregnancy. The estimated rate of major birth defects among women with migraine are similar to rates reported in women without migraine. 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.

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Human IgGs are known to be excreted in breast milk during the first few days after birth and decreasing to low concentrations soon after. Theoretically, a risk during this period cannot be ruled out. As this drug is a large protein molecule, the amount in milk is likely to be low and absorption is unlikely because it will probably be destroyed in the infant's gastrointestinal tract.

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.

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