This drug crossed the placenta in animal studies but failed to reveal evidence of fetotoxicity or teratogenicity when administered throughout organogenesis and late gestation up to 150 mg/kg/week; however, it may compromise the immunity of the fetus and neonate. There are no controlled data in human pregnancy.

AU TGA pregnancy category C: Drugs which, owing to their pharmacological effects, have caused or may be suspected of causing, harmful effects on the human fetus or neonate without causing malformations. These effects may be reversible. Accompanying texts should be consulted for further details.

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 potential benefit justifies the potential risk to the fetus.

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

Risk Summary: Animal studies have revealed no evidence of adverse developmental effects were observed in infants born to pregnant monkeys after subcutaneous administration during organogenesis at doses up to 30 times the maximum recommended human dose (MRHD). Limited available human data with the use of this drug in pregnant women are insufficient to inform a drug associated risk of adverse developmental outcomes.

Comments:
-If this drug has been used during pregnancy, administration of live vaccines to newborns/infants for 16 weeks after the mother's last dose is not recommended.
-Women of childbearing potential should use an effective method of contraception during therapy and for at least 20 weeks after.

See references

Caution is recommended.

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

Comments:
-The effects in the nursing infant are unknown.
-Some experts advise that breastfeeding should be discontinued during therapy and for up to 20 weeks after.

No information is available on the clinical use of this drug during breastfeeding. Because it is a large protein molecule, the amount in milk is likely to be very low and absorption is unlikely because it is probably destroyed in the infant GI tract.

See references