hese reports have occurred in patients concomitantly receiving other medications that suppress theimmune system, which may also contribute to hepatitis B reactivation. Patients at risk for HBV infection should be eva luated for prior evidence of HBV infection before initiating TNF blocker therapy. Prescribers should exercisecaution in prescribing TNF blockers in patients previously infected with HBV. Adequate data are not available on thesafety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNFblockertherapy to prevent HBV reactivation. Patients previously infected with HBV and requiring treatment with
Eticovo should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy andfor several months following termination of therapy. In patients who develop HBV reactivation, consideration shouldbe given to stopping Eticovo and initiating anti-viral therapy with appropriate supportive treatment.
The safety ofresuming therapy with etanercept products after HBV reactivation is controlled is not known. Therefore, prescribersshould weigh the risks and benefits when considering resumption of therapy in this situation.
5.7 Allergic Reactions
Allergic reactions associated with administration of etanercept during clinical trials have been reported in < 2% ofpatients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of Eticovo should bediscontinued immediately and appropriate therapy initiated.
5.8 Immunizations
Live vaccines should not be given concurrently with Eticovo. It is recommended that pediatric patients, if possible, bebrought up-to-date with all immunizations in agreement with current immunization guidelines prior to initiatingEticovo therapy [see Drug Interactions (7.1) and Use in Specific Populations (8.4)].
5.9 Autoimmunity
Treatment with Eticovo may result in the formation of autoantibodies [see Adverse Reactions (6.1)] and, rarely (<0.1%), in the development of a lupus-like syndrome or autoimmune hepatitis [see Adverse Reactions (6.2)], whichmay resolve following withdrawal of Eticovo. If a patient develops symptoms and findings suggestive of a lupus-likesyndrome or autoimmune hepatitis following treatment with Eticovo, treatment should be discontinued and the patientshould be carefully eva luated.
5.10 Immunosuppression
TNF mediates inflammation and modulates cellular immune responses. TNF-blocking agents, including etanerceptproducts, affect host defenses against infections. The effect of TNF inhibition on the development and course ofmalignancies is not fully understood. In a study of 49 patients with RA treated with etanercept, there was no evidenceof depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration ofeffector cell populations [see Warnings and Precautions (5.1, 5.3) and Adverse Reactions (6.1)].
5.11 Use in Wegener’s Granulomatosis Patients
The use of Eticovo in patients with Wegener’s granulomatosis receiving immunosuppressive agents is notrecommended. In a study of patients with Wegener’s granulomatosis, the addition of etanercept to standard therapy(including cyclophosphamide) was associated with a higher incidence of non-cutaneous solid malignancies and wasnot associated with improved clinical outcomes when compared with standard th |
