BOXED WARNING
RISK OF INFECTIONS
TUBERCULOSIS (FREQUENTLY DISSEMINATED OR EXTRAPULMONARY AT CLINICAL PRESENTATION), INVASIVE FUNGAL INFECTIONS, AND OTHER OPPORTUNISTIC INFECTIONS, HAVE BEEN OBSERVED IN PATIENTS RECEIVING HUMIRA. SOME OF THESE INFECTIONS HAVE BEEN FATAL (SEE WARNINGS). ANTI-TUBERCULOSIS TREATMENT OF PATIENTS WITH LATENT TUBERCULOSIS INFECTION REDUCES THE RISK OF REACTIVATION IN PATIENTS RECEIVING TREATMENT WITH HUMIRA. HOWEVER, ACTIVE TUBERCULOSIS HAS DEVELOPED IN PATIENTS RECEIVING HUMIRA WHOSE SCREENING FOR LATENT TUBERCULOSIS INFECTION WAS NEGATIVE.
PATIENTS SHOULD BE EVALUATED FOR LATENT TUBERCULOSIS INFECTION WITH A TUBERCULIN SKIN TEST. TREATMENT OF LATENT TUBERCULOSIS INFECTION SHOULD BE INITIATED PRIOR TO THERAPY WITH HUMIRA. PHYSICIANS SHOULD MONITOR PATIENTS RECEIVING HUMIRA FOR SIGNS AND SYMPTOMS OF ACTIVE TUBERCULOSIS, INCLUDING PATIENTS WHO ARE TUBERCULIN SKIN TEST NEGATIVE
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