Wirkstoffe & Arzneimittelsicherheit

Nebenwirkungen · Enbrel

Enbrel 25 mg solution for injection in dose-dispenser cartridge Enbrel 50 mg solution for injection in dose-dispenser cartridge · Abschnitt 4.8 · PDF-Seite 159

HOS-090519 · Präparat HOS-084041

Serious infections In placebo-controlled trials, no increase in the incidence of serious infections (fatal, life threatening, or requiring hospitalisation or intravenous antibiotics) was observed. Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with Enbrel for up to 48 months. These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection. In the 2-year active-controlled study where patients were treated with either Enbrel alone, methotrexate alone or Enbrel in combination with methotrexate, the rates of serious infections were similar among the treatment groups. However, it cannot be excluded that the combination of Enbrel with methotrexate could be associated with an increase in the rate of infections.

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