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- Serious and sometimes fatal infections due to bacterial, mycobacterial, invasive fungal, viral, or other opportunistic pathogens have been reported in patients receiving XELJANZ. The risk of opportunistic infections is higher in Asian geographic regions (see section 4.8 of the XELJANZ Summary of Product Characteristics). Rheumatoid arthritis patients taking corticosteroids may be predisposed to infection.
- XELJANZ should not be initiated in patients with active infections, including localised infections. The risks and benefits of treatment should be considered prior to initiating XELJANZ in patients:
- with recurrent infections,
- with a history of a serious or an opportunistic infection,
- who have resided or travelled in areas of endemic mycoses,
- who have underlying conditions that may predispose them to infection,
- who are over 65 years of age.
- Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with XELJANZ. Treatment must be interrupted if a patient develops a serious infection, an opportunistic infection, or sepsis. A patient who develops a new infection during treatment with XELJANZ should undergo prompt and complete diagnostic testing appropriate for an immunocompromised patient, appropriate antimicrobial therapy should be initiated, and the patient should be closely monitored
- As there is a higher incidence of infections in the elderly and in the diabetic populations in general, caution should be used when treating the elderly and patients with diabetes. In patients over 65 years of age XELJANZ should only be considered if no suitable alternative treatment is available.
- Risk of infection may be higher with increasing degrees of lymphopenia and consideration should be given to lymphocyte counts when assessing individual patient risk of infection. Discontinuation and monitoring criteria for lymphopenia are discussed in section 4.2 of the XELJANZ Summary of Product Characteristics.
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