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: This drug likely causes fetal B-cell depletion based on animal studies and the its mechanism of action. Monoclonal antibodies are transferred across the placenta. In animal reproduction studies, weekly IV administration from day 20 of pregnancy until parturition (which includes the period of organogenesis) at doses with exposures up to 2.4 times the maximum recommended human dose (MRHD), produced opportunistic infections and immune complex mediated hypersensitivity reactions. No embryotoxic or teratogenic effects were observed in animals.

Comments:
-Women of childbearing potential should use effective contraception during therapy and for 18 months after the last dose.
-Infants born to mothers who have been exposed to this drug during pregnancy should not receive live vaccines until their B-cell levels are within normal ranges.

Animal studies failed to reveal evidence of teratogenicity at exposures that were 2.4 times the recommended human exposure; however, B cells were completely depleted in offspring at day 28 postpartum. B-cell counts and immunologic function returned to normal within 6 months after birth. 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 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.

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No information is available on the 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. The manufacturer recommends that breastfeeding be discontinued during therapy.

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: Unknown
Excreted into animal milk: Yes

Comments:
-The effects in the nursing infant are unknown.
-Human IgG is excreted in human milk and this drug is a monoclonal antibody of the IgG1 subclass.
-Women should be advised to discontinue breastfeeding during therapy and for 18 months after the last dose.

See references