Animal studies have revealed no evidence of embryotoxicity or teratogenicity. There are no controlled data in human pregnancy. It is not known whether this drug can cause fetal harm or adversely affect reproductive capacity in humans.

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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

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

Risk Summary: Limited available data with use in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes. Human IgG is known to cross the placental barrier; therefore, this drug may be transferred from the mother to the fetus.

Comments:
-Adequate methods of contraception should be encouraged.

See references

Benefit should outweigh risk.

Excreted into human milk: Data not available
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Human IgG is known to be present in human milk.

No information is available on the use of this drug during breastfeeding. Because it is a large protein molecule absorption by the infant is unlikely after the first few weeks postpartum, and it will probably be destroyed in the infant GI tract.

See references