Remicade - Warnings & Precautions

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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).

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).

In rheumatoid arthritis patients, this is approximately 3-fold higher than expected in the general population. In the combined clinical trial population for rheumatoid arthritis and Crohn’s disease, this is approximately 6-fold higher than expected in the general population. Rates in clinical trials for REMICADE cannot be compared to rates of clinical trials of other TNF blockers and may not predict rates observed in a broader patient population. Patients with Crohn's disease or rheumatoid arthritis, particularly patients with highly active disease and/or chronic exposure to immunosuppressant therapies, may be at a higher risk (up to several fold) than the general population for the development of lymphoma. The potential role of TNFa-blocking therapy in the development of malignancies is not known (see ADVERSE REACTIONS, Malignancies). No studies have been conducted that include patients with a history of malignancy or that continue treatment in patients who develop malignancy while receiving REMICADE; thus additional caution should be exercised in considering REMICADE treatment of these patients.