WARNINGS

RISK OF INFECTIONS

Patients treated with REMICADE are at increased risk for infections, including progression to serious infections leading to hospitalization or death (see WARNINGS and ADVERSE REACTIONS). These infections have included bacterial sepsis, tuberculosis, invasive fungal and other opportunistic infections. Patients should be educated about the symptoms of infection, closely monitored for signs and symptoms of infection during and after treatment with REMICADE, and should have access to appropriate medical care. Patients who develop an infection should be evaluated for appropriate antimicrobial therapy and for serious infections REMICADE should be discontinued.

Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation) has been observed in patients receiving REMICADE. Patients should be evaluated for tuberculosis risk factors and be tested for latent tuberculosis infection^{1, 2} prior to initiating REMICADE and during therapy. Treatment of latent tuberculosis infection should be initiated prior to therapy with REMICADE. Treatment of latent tuberculosis in patients with a reactive tuberculin test reduces the risk of tuberculosis reactivation in patients receiving REMICADE. Some patients who tested negative for latent tuberculosis prior to receiving REMICADE have developed active tuberculosis. Physicians should monitor patients receiving REMICADE for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis infection.

HEPATOSPLENIC T-CELL LYMPHOMAS

Rare postmarketing cases of hepatosplenic T-cell lymphoma have been reported in adolescent and young adult patients with Crohn's disease treated with REMICADE. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. All of these hepatosplenic T-cell lymphomas with REMICADE have occurred in patients on concomitant treatment with azathioprine or 6-mercaptopurine.