infants born to women exposed to etanercept during pregnancy. Erelzi should only be used during pregnancy if clearly needed. 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 Erelzi is generally not recommended. Breast-feeding In lactating rats following subcutaneous administration, etanercept was excreted in the milk and detected in the serum of pups.
Limited information from the published literature indicates etanercept has been detected at low levels in human milk. Etanercept could be considered for use during breast-feeding taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman. While systemic exposure in a breastfed infant is expected to be low because etanercept is largely degraded in the gastrointestinal tract, limited data regarding systemic exposure in the breastfed infant are available.
Therefore, the administration of live vaccines (e.g., BCG) to a breastfed infant when the mother is receiving etanercept could be considered 16 weeks after stopping breast-feeding (or at an earlier timepoint if the infant etanercept serum levels are undetectable). Fertility Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available. 4.7 Effects on ability to drive and use machines Erelzi has no or negligible influence on the ability to drive and use machines.
4.8 Undesirable effects Summary of the safety profile The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), headache, allergic reactions, development of autoantibodies, itching, and fever. Serious adverse reactions have also been reported for etanercept. TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body’s defences against infection and cancer. Serious infections affect fewer than 1 in 100 patients treated with etanercept.
Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with use of etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma). Serious haematological, neurological and autoimmune reactions have also been reported. These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use. There have been rare reports of lupus, lupus-related conditions, and vasculitis.
Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials in adults and on post-marketing experience. 11