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Hypersensitivity REMICADE has been associated with hypersensitivity reactions that vary in their time of onset and required hospitalization in some cases. Most hypersensitivity reactions, which include urticaria, dyspnea, and/or hypotension, have occurred during or within 2 hours of REMICADE infusion. However, in some cases, serum sickness-like reactions have been observed in Crohn’s disease patients 3 to 12 days after REMICADE therapy was reinstituted following an extended period without REMICADE treatment. Symptoms associated with these reactions include fever, rash, headache, sore throat, myalgias, polyarthralgias, hand and facial edema, and/or dysphagia. These reactions were associated with marked increase in antibodies to infliximab, loss of detectable serum concentrations of infliximab, and possible loss of drug efficacy. REMICADE should be discontinued for severe reactions. Medications for the treatment of hypersensitivity reactions (e.g., acetaminophen, antihistamines, corticosteroids, and/or epinephrine) should be available for immediate use in the event of a reaction (see ADVERSE REACTIONS, Infusion-related Reactions). Text Continues Below
Neurologic Events Infliximab and other agents that inhibit TNF have been associated in rare cases with optic neuritis, seizure, and new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system (CNS) demyelinating disorders, including multiple sclerosis, and CNS manifestation of systemic vasculitis. Prescribers should exercise caution in considering the use of REMICADE in patients with pre-existing or recent onset of CNS demyelinating or seizure disorders. Discontinuation of REMICADE should be considered in patients who develop significant CNS adverse reactions. Malignancies In the controlled portions of clinical trials of all the TNFa-blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker compared with control patients. During the controlled portions of REMICADE trials in patients with moderately to severely active rheumatoid arthritis and Crohn's disease, 1 patient developed lymphoma among 1389 REMICADE-treated patients versus 0 among 483 control patients (median duration of follow-up 1.1 years). In the controlled and open-label portions of these clinical trials of REMICADE, 3 patients developed lymphomas (1 patient with rheumatoid arthritis and 2 patients with Crohn’s disease) among 2410 patients (median duration of follow-up 1.1 years). Page: << Prev | 1 | 2 | 3 | 4 | Next >>
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