This drug should not be used during pregnancy unless the benefit outweighs the risk to the fetus.

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.
-Monoclonal antibodies are believed to cross the placental barrier and may suppress immune system of the fetus.

Comments:
-To minimize exposure, avoid use of this drug during pregnancy and for 30 days before planned pregnancy.
-Because of the increased movement of endogenous antibodies across the placental barrier during progression of pregnancy and owing to immunosuppressive effects of this drug, consider risks and benefits before administering live vaccines to infants exposed to this drug in utero.

-Subcutaneous administration of a surrogate anti-mouse CD3 antibody to pregnant mice during organogenesis through lactation showed reduction in the adaptive immune response of pups which was an anticipated effect due to its pharmacology.
-In an embryo fetal developmental toxicity study, a similar administration of this drug showed an increase in post-implantation loss and maternal toxicity at the highest dose level of 20 mg/kg.
-No maternal toxicity or increased incidence of post implantation loss was observed in a pre- and postnatal development toxicity study in pregnant mice at similar dose levels.
-There was presence of surrogate antibody in the mice offspring at a level less than 1.5% that of maternal serum at the high dose.
-There are no controlled data in human pregnancy.

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

A decision should be made to discontinue breastfeeding or discontinue the drug, taking into account the importance of the drug to the mother.

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

Comments:
-The effects in the nursing infant are unknown.
-Endogenous maternal IgG and monoclonal antibodies are known to be excreted in human milk.
-Considering the potential adverse effects to the breastfed child, lactating women may interrupt breastfeeding and pump and discard breast milk during the treatment and for 20 days after the administration to minimize drug exposure to a breastfed child.

See references