ly, RENFLEXIS should not beadministered to patients with known hypersensitivity to inactive components of the productor to any murine proteins.
5 WARNINGS AND PRECAUTIONS
5.1 Serious Infections
Patients treated with infliximab products are at increased risk for developing seriousinfections involving various organ systems and sites that may lead to hospitalization or death.
Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, or parasiticorganisms including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis,cryptococcosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, salmonellosis andtuberculosis have been reported with TNF-blockers. Patients have frequently presented withdisseminated rather than localized disease.
Treatment with RENFLEXIS should not be initiated in patients with an active infection,including clinically important localized infections. Patients greater than 65 years of age,patients with co-morbid conditions and/or patients taking concomitant immunosuppressantssuch as corticosteroids or methotrexate may be at greater risk of infection.
The risks andbenefits of treatment should be considered prior to initiating therapy in patients:
with chronic or recurrent infection;
who have been exposed to tuberculosis;
with a history of an opportunistic infection;
who have resided or traveled in areas of endemic tuberculosis or endemicmycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; orwith underlying conditions that may predispose them to infection.
TuberculosisCases of reactivation of tuberculosis or new tuberculosis infections have been observed inpatients receiving infliximab products, including patients who have previously received treatment for latent or active tuberculosis. Cases of active tuberculosis have also occurred inpatients being treated with infliximab products during treatment for latent tuberculosis.
Patients should be eva luated for tuberculosis risk factors and tested for latent infection priorto initiating RENFLEXIS and periodically during therapy. Treatment of latent tuberculosisinfection prior to therapy with TNF blocking agents has been shown to reduce the risk oftuberculosis reactivation during therapy. Induration of 5 mm or greater with tuberculin skintesting should be considered a positive test result when assessing if treatment for latenttuberculosis is needed prior to initiating RENFLEXIS, even for patients previouslyvaccinated with Bacille Calmette-Guérin (BCG).
Anti-tuberculosis therapy should also be considered prior to initiation of RENFLEXIS inpatients with a past history of latent or active tuberculosis in whom an adequate course oftreatment cannot be confirmed, and for patients with a negative test for latent tuberculosis buthaving risk factors for tuberculosis infection. Consultation with a physician with expertise inthe treatment of tuberculosis is recommended to aid in the decision whether initiating antituberculosistherapy is appropriate for an individual patient.
Tuberculosis should be strongly considered in patients who develop a new infection duringRENFLEXIS treatment, especially in patients who have previously or recently traveled tocountries with a high preva lence of tuberculosis, or who have had close contact with a personwith active tuberculosis.
Monitoring
Patients should be closely monitored for the development of |
