Animal studies have failed to reveal evidence of fetal harm. There are no controlled data in human pregnancy. The use of TNF-alpha inhibitors, including this drug, may affect normal immune response in the newborn. A pediatrician should be consulted regarding the risks and benefits of administering live vaccines in the exposed newborn during the first 12 weeks of life.

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.

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 to the fetus.

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

See references

Use is generally considered acceptable; benefit to mother should outweigh risk to the infant.

Excreted into human milk: Yes

Comment: The absolute bioavailability is expected to be very low in a breastfed infant as this drug is degraded in the gastrointestinal tract after oral administration.

See references