Safety has not been established during pregnancy. The manufacturer makes no recommendation regarding use during pregnancy.

US FDA pregnancy category: Not assigned.

Risk summary:
-No data available on use of this drug in pregnant women to inform a drug-related risk.
-This drug has the potential to harm a developing fetus when administered to a pregnant woman.
-Human immunoglobulin G (IgG) is known to cross the placental barrier; therefore, this drug is likely to be transferred from the mother to the developing fetus.

Comments:
-Females of reproductive potential should be advised to use effective contraception during therapy and for 5 months after the last dose.
-Negative pregnancy status should be verified in females of childbearing potential prior to initiating therapy.
-Females of childbearing potential should be apprised of the potential of this drug to cause fetal harm if used during pregnancy.

Animal studies have not been reported. There are no controlled data in human pregnancy.

-This drug causes T-cell activation and cytokine release, which may compromise pregnancy maintenance.
-This drug is a humanized immunoglobulin G4-proline, alanine, and alanine (IgG4-PAA) antibody. Human immunoglobulin G (IgG) is known to cross the placenta; therefore, this drug has the potential to be transmitted from the mother to the developing fetus.
-Assess immunoglobulin levels in newborns of mothers treated with this drug, as this drug is associated with hypogammaglobulinemia.

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

Breastfeeding is not recommended during use of this drug.

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

Comments:
-A risk to the newborn/infant cannot be excluded.
-Maternal immunoglobulin is known to be secreted into human milk.
-The effects of local gastrointestinal exposure and limited systemic exposure in the breastfed child are unknown.
-Because of the potential for serious adverse reactions in a breastfed child, breastfeeding is not recommended during treatment with this drug and for 5 months after the last dose.

See references