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

This drug activates T-cells, causing cytokine release and immune activation, which may compromise pregnancy maintenance. This drug may cause B-cell lymphocytopenia in infants exposed to it in-utero.

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.

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.

Comments:
-Verify pregnancy status in females of childbearing potential prior to starting treatment with this drug.
-Based on its mechanism of action, this drug may cause fetal harm when administered to a pregnant woman.
-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.
-Inform women of the potential risk to the fetus.
-Adequate methods of contraception should be encouraged during treatment with this drug and for 3 months after the last dose.

See references

Breastfeeding is not recommended during use of this drug and for 3 months after the last dose.

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

Comments:
-Human immunoglobulin (IgG) is known to be secreted into human milk.
-This drug has the potential to cause B-cell depletion in exposed infants.
-The effects on the nursing infants or on milk production are unknown.

See references