Animal studies have shown no adverse effects on embryofetal or postnatal development when this drug was dosed throughout the period of organogenesis through lactation at doses up to 30 times the maximum recommended human dose. Animal studies showed no impact on female and male fertility. 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.

Safety has not been established during pregnancy; the benefit should outweigh the risk.

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

Risk summary: There is limited data available on the use of this drug in pregnant patients to inform a drug-associated risk.

Comments:
-Human IgG is known to cross the placental barrier; therefore, this drug may be transmitted from the pregnant patient to the developing fetus.
-Published data have suggested that patients with migraine may be at increased risk of preeclampsia and gestational hypertension during pregnancy.

See references

The 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 as well as the mother's clinical need for this drug.
-Human IgG is known to be excreted in breast milk and may be transmitted through lactation to the nursing infant.
-The quantity of this drug in breast milk or absorbed by the breastfed child is expected to be low due to the large molecular weight of this drug and its probable destruction within the infant gastrointestinal tract.
-According to some authorities, waiting at least 2 weeks postpartum to resume treatment with this drug may minimize transfer to the nursing infant.

See references