tment (including cyclophosphamide, methotrexate, and corticosteroids), patients receiving ENBREL® experienced more non-cutaneous solid malignancies than patients receiving placebo (see ADVERSE REACTIONS: Malignancies). The addition of ENBREL® to standard treatment was not associated with improved clinical outcomes when compared with standard therapy alone. The use of ENBREL® in patients with Wegener’s granulomatosis receiving immunosuppressive agents is not recommended. The use of ENBREL® in patients receiving concurrent cyclophosphamide therapy is not recommended.
Hepatitis B Virus Reactivation
Use of TNF blockers, including ENBREL®, has been associated with reactivation of hepatitis 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 medications that suppress the immune system, which may also contribute to HBV reactivation. Patients at risk for HBV infection should be eva luated for prior evidence of HBV infection before initiating TNF blocker therapy. Prescribers should exercise caution in prescribing TNF blockers for patients identified as carriers of HBV. Adequate data are not available on the safety or efficacy of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF blocker therapy to prevent HBV reactivation. Patients who are carriers of HBV and require treatment with ENBREL® should be closely monitored for clinical and laboratory signs of active HBV infection throughout therapy and for several months following termination of therapy. In patients who develop HBV reactivation, consideration should be given to stopping ENBREL® and initiating anti-viral therapy with appropriate supportive treatment. The safety of resuming ENBREL® therapy after HBV reactivation is controlled is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy in this situation.
Use in Patients with Moderate to Severe Alcoholic Hepatitis
In a study of 48 hospitalized patients treated with ENBREL® or placebo for moderate to severe alcoholic hepatitis, the mortality rate in patients treated with ENBREL® was similar to patients treated with placebo at one month but significantly higher after six months. Physicians should use caution when using ENBREL® in patients with moderate to severe alcoholic hepatitis.
PRECAUTIONS
General
Allergic reactions associated with administration of ENBREL® during clinical trials have been reported in < 2% of patients. If an anaphylactic reaction or other serious allergic reaction occurs, administration of ENBREL® should be discontinued immediately and appropriate therapy initiated.
Caution: The needle cap on the prefilled syringe and on the SureClick autoinjector contains dry natural rubber (a derivative of latex) which may cause allergic reactions in individuals sensitive to latex.
Information for patients
Patients or their caregivers should be provided the ENBREL® “Medication Guide” and provided an opportunity to read it and ask questions prior to initiation of therapy. The health care provider should ask the patient questions to determine any risk factors for treatment. Patients developing signs and symptoms of infection should see |
