INFLECTRA (infliximab for Injection) Serious Warnings And Precautions Box

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Serious Warnings and Precautions

RISK OF INFECTIONS

Tuberculosis (frequently disseminated or extrapulmonary at clinical presentation), invasive fungal infections, and other opportunistic infections, have been observed in patients receiving infliximab for injection. Some of these infections have been fatal.

Patients must be evaluated for the risk of tuberculosis, including latent tuberculosis, prior to initiation of INFLECTRA®. This evaluation should include a detailed medical history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. Appropriate screening tests, i.e. tuberculin skin test and chest x-ray (if indicated), should be performed in all patients. Prescribers are reminded of the risk of false negative tuberculin skin test results especially in patients who are severely ill or immunocompromised. Treatment of latent tuberculosis infection should be initiated prior to therapy with INFLECTRA® (see WARNINGS AND PRECAUTIONS, Risk of Infections).

Hepatosplenic T-cell Lymphoma
Post-marketing cases of hepatosplenic T-cell lymphoma have been reported in patients treated with TNF-blockers including infliximab for injection. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Almost all patients had received treatment with azathioprine or 6-mercaptopurine concomitantly with or immediately prior to a TNF-blocker. The vast majority of infliximab for injection cases have occurred in patients with Crohn’s disease or ulcerative colitis and most were reported in adolescent or young adult males. (see WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis).

Pediatric Malignancy
Lymphoma and other malignancies, some fatal, have been reported in children and adolescent patients treated with TNF-blockers, including infliximab for injection (see WARNINGS AND PRECAUTIONS, Carcinogenesis and Mutagenesis).