Enbrel Use In Pregnancy & Lactation

Use in pregnancy: The safe use of etanercept during pregnancy has not been established. Use etanercept during pregnancy only if clearly needed.
Developmental toxicity studies have been performed in rats and rabbits at doses resulting in AUC-based systemic exposure levels of etanercept that were at least 21- to 25-fold higher than in humans at the recommended therapeutic dose of 50 mg weekly, and are approximately 10- to 13-fold higher than in humans at the maximum recommended human dose of 50 mg twice weekly (for psoriasis) have revealed no evidence of harm to the fetus or neonatal rat due to etanercept. Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available.
Use in lactation: The safe use of etanercept during lactation has not been established.
It is not known whether etanercept is excreted in human milk. 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.