Enbrel Use In Pregnancy & Lactation

The safe use of Enbrel during pregnancy has not been established. Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Enbrel therapy and for three weeks after discontinuation of therapy. An Enbrel pregnancy registry compared rates of major birth defects in live-born infants of mothers with rheumatic diseases or psoriasis exposed to Enbrel in the first trimester (n=319) versus those unexposed to Enbrel during pregnancy (n=144). The all-inclusive adjusted odds ratio for major birth defects was 2.77 (95% CI 1.04-7.35) and when chromosomal and known genetic disorders were removed was 2.49 (95% CI 0.92-6.68). The findings showed no increased rate of minor malformations, and no pattern of major or minor malformations. In addition, there was no increase in rates of intrauterine or postnatal growth deficits or delayed postnatal development. The use of Enbrel should be avoided during pregnancy. If Enbrel is used during pregnancy, or if the patient becomes pregnant while taking it, the woman should be advised of the possible risk to the fetus.
Preclinical data about peri- and post-natal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available. Developmental toxicity studies have been performed in rats and rabbits. The AUC-based systemic exposures of etanercept in rats and rabbits are 21- to 25-times higher than in humans at the usual human therapeutic dose of 50 mg weekly, and are approximately 10- to 13-times higher than in humans at the maximum recommended human dose of etanercept of 50 mg twice weekly (for psoriasis). No evidence of harm to the fetus in rats or rabbits or neonatal rats due to etanercept was observed. Animal reproduction studies are not always predictive of human response.
Enbrel crosses the placenta and has been detected in the serum of infants born to female patients treated with Enbrel during pregnancy. The clinical impact of this is unknown; however, infants may be at increased risk of infection. Administration of live vaccines to infants for 16 weeks after the mother's last dose of Enbrel is generally not recommended.
The safe use of Enbrel during lactation has not been established. Enbrel has been reported to be excreted in human milk following subcutaneous administration. In lactating rats, following subcutaneous administration etanercept was excreted in the milk and detected in the serum of the pups. Because immunoglobulins and many medicinal products can be excreted in human milk, a decision should be made whether to discontinue nursing or to discontinue Enbrel while nursing.