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Women of childbearing potential: Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during etanercept therapy and for three weeks after discontinuation of therapy.
Pregnancy: Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept. A higher rate of major birth defects was observed in an observational study comparing pregnancies exposed to etanercept during the first trimester, with pregnancies not exposed to etanercept or other TNF-antagonists (adjusted odds ratio 2.4, 95% CI: 1.0-5.5). The types of major birth defects were consistent with those most commonly reported in the general population and no particular pattern of abnormalities was identified. No change in the rate of spontaneous abortion, stillbirth, or minor malformations was observed. Etanercept is not recommended during pregnancy.
Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with etanercept 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 etanercept is generally not recommended.
Breast-feeding: Etanercept 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 pups. Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue etanercept therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.
Fertility: Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available.
