Pregnancy: Limited clinical data is available on exposed pregnancies for Adalimumab.
Preclinical studies conducted in monkeys revealed no indication of maternal toxicity, embryotoxicity or teratogenicity; postnatal toxicity and fertility effects of Adalimumab are unavailable.
Adalimumab can affect normal immune responses of the newborn if administered during pregnancy due to its inhibition of TNF and hence it is not recommended in pregnancy. Women should use adequate contraception during Adalimumab treatment and for a further five months after the last dose to prevent pregnancy as it bears the potential to cross the placenta into the serum of infants. This could lead to increased risk of infection to the infant. Live vaccinations to infants exposed to Adalimumab in utero is not recommended for at least 5 months after the mother's last injection.
Lactation: It is not recommended for women to breast-feed for at least five months after the last Adalimumab injection as human immunoglobulins are excreted in milk and there is no data suggesting whether Adalimumab is excreted in human milk or absorbed systemically after ingestion.