control patients. Of these, the mostcommon malignancies were breast, colorectal, and melanoma. The rate of malignanciesamong infliximab-treated patients was similar to that expected in the general population
whereas the rate in control patients was lower than expected.
In a clinical trial exploring the use of infliximab in patients with moderate to severe chronicobstructive pulmonary disease (COPD), more malignancies, the majority of lung or head andneck origin, were reported in infliximab-treated patients compared with control patients. Allpatients had a history of heavy smoking [see Adverse Reactions (6.1)].
Prescribers shouldexercise caution when considering the use of RENFLEXIS in patients with moderate tosevere COPD.
Psoriasis patients should be monitored for nonmelanoma skin cancers (NMSCs), particularlythose patients who have had prior prolonged phototherapy treatment. In the maintenanceportion of clinical trials for infliximab, NMSCs were more common in patients with previousphototherapy [see Adverse Reactions (6.1)].
The potential role of TNF-blocking therapy in the development of malignancies is not known[see Adverse Reactions (6.1)].
Rates in clinical trials for infliximab cannot be compared torates in clinical trials of other TNF-blockers and may not predict rates observed in a broaderpatient population.
Caution should be exercised in considering RENFLEXIS treatment inpatients with a history of malignancy or in continuing treatment in patients who develop
malignancy while receiving RENFLEXIS.
5.3 Hepatitis B Virus Reactivation
Use of TNF blockers, including infliximab products, has been associated with reactivation ofhepatitis B virus (HBV) in patients who are chronic carriers of this virus. In some instances,HBV reactivation occurring in conjunction with TNF blocker therapy has been fatal.
The majority of these reports have occurred in patients concomitantly receiving other medicationsthat suppress the immune system, which may also contribute to HBV reactivation. Patientsshould be tested for HBV infection before initiating TNF blocker therapy, includingRENFLEXIS. For patients who test positive for hepatitis B surface antigen, consultation witha physician with expertise in the treatment of hepatitis B is recommended. Adequate data arenot available on the safety or efficacy of treating patients who are carriers of HBV with antiviraltherapy in conjunction with TNF blocker therapy to prevent HBV reactivation.
Patientswho are carriers of HBV and require treatment with TNF blockers should be closelymonitored for clinical and laboratory signs of active HBV infection throughout therapy andfor several months following termination of therapy. In patients who develop HBVreactivation, TNF blockers should be stopped and antiviral therapy with appropriatesupportive treatment should be initiated. The safety of resuming TNF blocker therapy afterHBV reactivation is controlled is not known. Therefore, prescribers should exercise cautionwhen considering resumption of TNF blocker therapy in this situation and monitor patientsclosely.
5.4 Hepatotoxicity
Severe hepatic reactions, including acute liver failure, jaundice, hepatitis and cholestasis,have been reported in postmarketing data in patients receiving infliximab products.
Autoimmune hepatitis has been diagnosed in some of these cases. Severe hepatic reactionsoccurred between 2 weeks to more than 1 year after initiation of inflixim |
