Perform test for latent TB if positive, start treatment for TB prior to starting infliximab-abda. Discontinue infliximab-abda if a patient develops a serious infection. Increased risk of serious infections leading to hospitalization or death, including TB, bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens. The majority of reported cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were in adolescent and young adult males. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with a TNF blocker at or prior to diagnosis. These cases have had a very aggressive disease course and have been fatal. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with infliximab-dyyb, including the possible development of tuberculosis in patients who tested negative for latent tuberculosis infection prior to initiating therapy.MalignancyLymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF blockers, including infliximab products.Postmarketing cases of hepatosplenic T-cell lymphoma (HSTCL), a rare type of T-cell lymphoma, have been reported in patients treated with TNF blockers including infliximab products. 3) Bacterial, viral and other infections due to opportunistic pathogens, including Legionella and Listeria.The risks and benefits of treatment with infliximab-dyyb should be carefully considered prior to initiating therapy in patients with chronic or recurrent infection. Empiric anti-fungal therapy should be considered in patients at risk for invasive fungal infections who develop severe systemic illness. Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection. Patients with histoplasmosis or other invasive fungal infections may present with disseminated, rather than localized, disease. 2) Invasive fungal infections, including histoplasmosis, coccidioidomycosis, candidiasis, aspergillosis, blastomycosis, and pneumocystosis. Treatment for latent infection should be initiated prior to Infliximab-dyyb use. Patients should be tested for latent tuberculosis before infliximab-dyyb use and during therapy. Patients with tuberculosis have frequently presented with disseminated or extrapulmonary disease. Active tuberculosis, including reactivation of latent tuberculosis. Infliximab-dyyb should be discontinued if a patient develops a serious infection or sepsis.Reported infections include: 1) Active tuberculosis, including reactivation of latent tuberculosis. Most patients who developed these infections were taking concomitant immunosuppressants such as methotrexate or corticosteroids. Warning: Serious Infections and MalignancySerious InfectionsPatients treated with infliximab products are at increased risk for developing serious infections that may lead to hospitalization or death. The majority of infliximab cases were reported in patients with Crohn’s disease or ulcerative colitis, most of whom were adolescent or young adult males. Almost all had received azathioprine or 6-mercaptopurine concomitantly with a TNF-blocker at or prior to diagnosis. Postmarketing cases of fatal hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with TNF blockers including infliximab. Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with tumor necrosis factor (TNF) blockers, including infliximab. Monitor all patients for active TB during treatment, even if initial latent TB test is negative. Perform test for latent TB if positive, start treatment for TB prior to starting infliximab. Discontinue infliximab if a patient develops a serious infection. Increased risk of serious infections leading to hospitalization or death, including tuberculosis (TB), bacterial sepsis, invasive fungal infections (such as histoplasmosis) and infections due to other opportunistic pathogens.
0 Comments
Leave a Reply. |
AuthorWrite something about yourself. No need to be fancy, just an overview. ArchivesCategories |