Animal studies revealed no fetal harm or malformations with IV administration of this drug during organogenesis and later in gestation, at doses that produced exposures up to approximately 373 times the maximum recommended human dose (MRHD). There are no controlled data in human pregnancy.

To monitor the outcomes of pregnant women exposed to this drug, a pregnancy registry has been established. Physicians are encouraged to register patients and pregnant women are encouraged to register themselves by calling 1-877-311-8972 or http://mothertobaby.org/pregnancy-studies/.

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.

Use is not recommended.

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

Risk Summary: Studies report a rate of 5.6% for major birth defects with first trimester use of this drug in pregnant women with rheumatoid arthritis (RA), and a rate of 7.8% and 5.5% for major birth defects in the disease-matched and non-diseased comparison groups. This drug is actively transferred across the placenta during the third trimester and may affect immune response in the in-utero exposed infant.

Comments: Women of childbearing potential should use effective contraception during therapy and for at least 5 months following the last dose.

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: Yes

Comments: Human immunoglobulins are excreted in breast milk; therefore, the manufacturer recommends a woman receiving this drug not breastfeed during therapy for at least 5 months after the last dose.

Because this drug is a large protein molecule absorption is unlikely because it is probably destroyed in the infant GI tract. Some experts say this drug is probably safe during nursing if used cautiously.

See references