Remicade

[Infliximab]

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RISK OF INFECTIONS

TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT CLINICAL PRESENTATION),INVASIVE FUNGAL INFECTIONS, AND OTHER OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED INPATIENTS RECEIVING REMICADE. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE WARNINGS).PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION WITH A TUBERCULIN SKINTEST.1 TREATMENT OF LATENT TUBERCULOSIS INFECTION SHOULD BE INITIATED PRIOR TO THERAPYWITH REMICADE.

WARNINGS

RISK OF INFECTIONS

(See boxed WARNING)

SERIOUS INFECTIONS, INCLUDING SEPSIS, HAVE BEEN REPORTED IN PATIENTS RECEIVING TNF-BLOCKING AGENTS. SOME OF THESE INFECTIONS HAVE BEEN FATAL. MANY OF THE SERIOUS INFECTIONS IN PATIENT STREATED WITH REMICADE HAVE OCCURRED IN PATIENTS ON CONCOMITANT IMMUNOSUPPRESSIVE THERAPY THAT, IN ADDITION TO THEIR CROHN’S DISEASE OR RHEUMATOID ARTHRITIS, COULD PREDISPOSE THEM TO INFECTIONS.

REMICADE SHOULD NOT BE GIVEN TO PATIENTS WITH A CLINICALLY IMPORTANT, ACTIVE INFECTION. CAUTION SHOULD BE EXERCISED WHEN CONSIDERING THE USE OF REMICADE IN PATIENTS WITH A CHRONIC INFECTION OR A HISTORY OF RECURRENT INFECTION. PATIENTS SHOULD BE MONITORED FOR SIGNS AND SYMPTOMS OFINFECTION WHILE ON OR AFTER TREATMENT WITH REMICADE. NEW INFECTIONS SHOULD BE CLOSELY MONITORED.

IF A PATIENT DEVELOPS A SERIOUS INFECTION, REMICADE THERAPY SHOULD BE DISCONTINUED(see ADVERSE REACTIONS, Infections). CASES OF HISTOPLASMOSIS, COCCIDIOIDOMYCOSIS, LISTERIOSIS, PNEUMOCYSTOSIS, TUBERCULOSIS, OTHERBACTERIAL, MYCOBACTERIAL, AND FUNGAL INFECTIONS HAVE BEEN OBSERVED IN PATIENTS RECEIVING REMICADE. FOR PATIENTS WHO HAVE RESIDED IN REGIONS WHERE HISTOPLASMOSIS OR COCCIDIOIDOMYCOSIS IS ENDEMIC, THE BENEFITS AND RISKS OF REMICADE TREATMENT SHOULD BECAREFULLY CONSIDERED BEFORE INITIATION OF REMICADE THERAPY.SERIOUS INFECTIONS WERE SEEN IN CLINICAL STUDIES WITH CONCURRENT USE OF ANAKINRA AND ANOTHER TNF_-BLOCKING AGENT, ETANERCEPT, WITH NO ADDED CLINICAL BENEFIT COMPARED TO ETANERCEPT ALONE.

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