Pregnancy: An embryo-fetal perinatal developmental toxicity study has been performed in cynomolgus monkeys at dosages up to 100 mg/kg (373 times human AUC when given 40 mg SC) and has revealed no evidence of harm to the fetuses due to adalimumab.
Limited clinical data on pregnant women exposed to adalimumab are available. In a prospective cohort pregnancy exposure registry, 257 women with RA or CD treated with adalimumab at least during the first trimester and 120 women with RA or CD not treated with adalimumab were enrolled.
There were no significant differences in the overall rates for the primary endpoint of major birth defects (adjusted Odds Ratio 0.84, 95% Confidence Interval (CI) 0.34, 2.05) as well as the secondary endpoints which included minor birth defects, spontaneous abortion, preterm delivery, low birth weight, and serious or opportunistic infections. No stillbirths or malignancies were reported.
Although the registry has methodological limitations, including small sample size and non-randomized study design, the data show no increased risk of adverse pregnancy outcomes in women with RA or CD treated with adalimumab in comparison to women with RA or CD not treated with adalimumab. In addition, data from post-marketing surveillance does not establish the presence of a drug-associated risk. Even then, there are no adequate and well-controlled studies in pregnant women and therefore adalimumab should only be used during pregnancy if clearly needed.
Adalimumab may cross the placenta into the serum of infants born to women treated with adalimumab during pregnancy. Consequently, these infants may be at increased risk for infection. Administration of live vaccines to infants exposed to adalimumab in utero is not recommended for 5 months following the mother's last adalimumab injection during pregnancy.
Women of child-bearing potential should be advised not to get pregnant during adalimumab therapy.
Labor and Delivery: There are no known effects of adalimumab on labor or delivery.
Nursing Mothers: Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level. Given orally ingested immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability, systemic effects of adalimumab in a breast fed infant are unlikely. The developmental and health benefits of breastfeeding should be considered along with the mother's clinical need for adalimumab and any potential adverse effects on the breastfed child from adalimumab or from the underlying maternal condition.