Treatment with TNF-blocking agents, including ENBREL, has been associated with rare (<0.1%) cases of new onset orĮxacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and someĪssociated with permanent disability, and with peripheral nervous system demyelinating disorders. Were receiving concomitant immunosuppressants.
Immunosuppression and malignancies that are not usually observed in children and adolescents. Other cases included rare malignancies usually associated with
Lymphomas (Hodgkin's and non-Hodgkin's lymphoma). In patients who initiated therapy at ≤18 years of age, approximately half of the reported malignancies were
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Periodic skin examinations should be considered for all patients at increased risk for skin cancer. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF blockers, includingĮNBREL. The risk of leukemia may be higher in patients with RA (approximately 2-fold) than the general The role of TNF blocker therapy in the development ofĬases of acute and chronic leukemia have been reported in association with postmarketing TNF blocker use in RA and Of lymphoma may be up to several-fold higher in RA patients. In adult clinical trials of all TNF blockers, more cases of lymphoma were seen compared to control patients. Lymphoma and other malignancies, some fatal, have been reported in children andĪdolescent patients treated with tumor necrosis factor (TNF) blockers, including ENBREL. With ENBREL, including the possible development of TB in patients who tested negative for latent TB prior to Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment The risks and benefits of treatment with ENBREL should be carefully considered priorġ) with chronic or recurrent infection, 2) who have been exposed to TB, 3) who have resided or traveled in areas ofĤ) with underlying conditions that may predispose them to infections such as advanced or poorly controlled diabetes. EmpiricĪntifungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemicģ) Bacterial, viral, and other infections due to opportunistic pathogens, including Legionella and Listeria. Patients with histoplasmosis or other invasive fungal infections may present withĭisseminated, rather than localized, disease.Īntigen and antibody testing for histoplasmosis may be negative in some patients with active infection.
Treatment for latent infection should be initiated prior to ENBREL use,Ģ) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis,īlastomycosis, and pneumocystosis. Patients should be tested for latent TB beforeĮNBREL use and periodically during therapy. Patients with TB haveįrequently presented with disseminated or extrapulmonary disease. Reported infections include: 1) Active tuberculosis (TB), including reactivation of latent TB. Immunosuppressants such as methotrexate or corticosteroids or were predisposed to infection because of theirĮNBREL should not be initiated in the presence of sepsis, active infections, or allergy to ENBREL or its components.ĮNBREL should be discontinued if a patient develops a serious infection or sepsis. Most patients who developed these infections were taking concomitant That may lead to hospitalization or death. Patients treated with ENBREL are at increased risk for developing serious infections IMPORTANT SAFETY INFORMATION AND INDICATIONS Prescription Enbrel ® (etanercept) is administered by injection.
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