In animal studies at doses equivalent to or greater human doses, increased perinatal mortality, depletion of B-cell populations, renal, bone marrow, and testicular toxicity were observed in the offspring. 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.

This drug should be used during pregnancy only if the benefit outweighs the risk.

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

Risk Summary: There are no adequate data on the developmental risk associated with this drug in pregnant women. There are no data on B-cell levels in human neonates following maternal exposure; however, transient peripheral B-cell depletion and lymphocytopenia have been reported in infants born to mothers exposed to other anti-CD20 antibodies during pregnancy. This drug is a humanized monoclonal antibody of an immunoglobulin G1 subtype and immunoglobulins do cross the placental barrier.

Comments:
-Women of childbearing potential should use adequate contraception while receiving this drug and for 6 months after the last dose.

See references

Safety has not been established.

Excreted into human milk: Unknown
Excreted into animal milk: Yes

Comments:
-Human IgG is excreted in human milk and the potential for absorption of this drug leading to B-cell depletion in the infant is unknown.

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. Until more data become available, this drug should be used with caution during breastfeeding, especially while nursing a newborn or preterm infant.

See references