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Serious infections: Patients treated with Etarfion are at increased risk for developing serious infections involving various organ systems and sites that may lead to hospitalization or death.
Opportunistic infections due to bacterial, mycobacterial, invasive fungal, viral, parasitic, or other opportunistic pathogens, including aspergillosis, blastomycosis, candidiasis, coccidioidomycosis, histoplasmosis, legionellosis, listeriosis, pneumocystosis, and tuberculosis have been reported with TNF-blockers. Patients have frequently presented with disseminated rather than localized disease.
Treatment with Etarfion 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 immunosuppressants (such as corticosteroids or Methotrexate), may be at greater risk of infection. The risks and benefits of treatment should be considered prior to initiating therapy in patients: Who have chronic or recurrent infection; Who have been exposed to tuberculosis; With a history of opportunistic infection; Who have resided or travelled in areas of endemic tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis; or with underlying conditions that may predispose them to infection such as advanced or poorly controlled diabetes.
Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with Etarfion. Etarfion should be discontinued if a patient develops a serious infection or sepsis. A patient who develops a new infection during treatment with Etarfion should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.
Tuberculosis: Cases of reactivation of tuberculosis or new tuberculosis infections have been observed in patients receiving Etanercept, including patients who have previously received treatment for latent or active tuberculosis.
Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating Etarfion and periodically during therapy. Tests for latent tuberculosis infection may be falsely negative while on therapy with Etarfion.
Treatment of latent tuberculosis infection prior to therapy with TNF-blocking agents has been shown to reduce the risk of tuberculosis reactivation during therapy. In duration of 5 mm or greater with tuberculin skin testing should be considered a positive test result when assessing if treatment for latent tuberculosis is needed prior to initiating Etarfion, even for patients previously vaccinated with Bacille Calmette-Guerin (BCG).
Anti-tuberculosis therapy should also be considered prior to initiation of Etarfion in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed, and for patients with a negative test for latent tuberculosis but having risk factors for tuberculosis infection. Consultation with a physician with expertise in the treatment of tuberculosis is recommended to aid in the decision whether initiating anti-tuberculosis therapy is appropriate for an individual patient.
Tuberculosis should be strongly considered in patients who develop a new infection during Etarfion treatment, especially in patients who have previously or recently traveled to countries with a high prevalence of tuberculosis, or who have had close contact with a person with active tuberculosis.
Invasive fungal infections: Cases of serious and sometimes fatal fungal infections, including histoplasmosis, have been reported with TNF blockers, including Etarfion. For patients who reside or travel in regions where mycoses are endemic, invasive fungal infection should be suspected if they develop a serious systemic illness.
Appropriate empiric anti-fungal therapy should be considered while a diagnostic workup is being performed.
Antigen and antibody testing for histoplasmosis may be negative in some patients with active infection.
When feasible, the decision to administer empiric anti-fungal therapy in these patients should be made in consultation with a physician with expertise in the diagnosis and treatment of invasive fungal infections and should take into account both the risk for severe fungal infection and the risks of anti-fungal therapy.
Neurologic events: Treatment with TNF-blocking agents, including Etarfion, has been associated with rare (<0.1%) cases of new onset or exacerbation of central nervous system demyelinating disorders, some presenting with mental status changes and some associated with permanent disability, and with peripheral nervous system demyelinating disorders. Prescribers should exercise caution in considering the use of Etarfion in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.
Malignancies: Lymphomas: In the controlled portions of clinical trials of TNF-blocking agents, more cases of lymphoma have been observed among patients receiving a TNF blocker compared to control patients.
Leukemia: Cases of acute and chronic leukemia have been reported in association with postmarketing TNF-blocker use in rheumatoid arthritis patients. Even in the absence of TNF-blocker therapy, patients with rheumatoid arthritis may be at higher risk (approximately 2-fold) than the general population for the development of leukemia.
Melanoma and non-melanoma skin cancer (NMSC): Melanoma and non-melanoma skin cancer have been reported in patients treated with TNF antagonists including Etanercept.
Other malignancies: For malignancies other than lymphoma and non-melanoma skin cancer, there was no difference in exposure-adjusted rates between Etanercept and control arms in the controlled portions of clinical studies for all indications.
Patients with heart failure: Physicians should exercise caution when using Etarfion in patients who also have heart failure, and monitor patients carefully.
Hematologic events: All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias or infection (eg, persistent fever, bruising, bleeding, or pallor) while on Etarfion. Discontinuation of Etarfion therapy should be considered in patients with confirmed significant hematologic abnormalities.
Hepatitis B Virus (HBV) reactivation: In some instances, hepatitis B 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 hepatitis B reactivation. Patients at risk for HBV infection should be evaluated for prior evidence of HBV infection before initiating TNF-blocker therapy. Physicians should exercise caution in prescribing TNF blockers in patients previously infected with 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 previously infected with HBV and require treatment with Etarfion 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 Etarfion and initiating anti-viral therapy with appropriate supportive treatment. The safety of resuming Etarfion therapy after HBV reactivation is controlled is not known. Therefore, physicians should weigh the risks and benefits when considering resumption of therapy in this situation.
Allergic Reactions: If an anaphylactic reaction or other serious allergic reaction occurs, administration of Etarfion should be discontinued immediately and appropriate therapy initiated.
Immunizations: Live vaccines should not be given concurrently with Etarfion.
Autoimmunity: If a patient develops symptoms and findings suggestive of a lupus-like syndrome or autoimmune hepatitis following treatment with Etarfion, treatment should be discontinued and the patient should be carefully evaluated.
Immunosuppression: TNF mediates inflammation and modulates cellular immune responses. TNF-blocking agents including Etarfion affect host defenses against infections. The effect of TNF inhibition on the development and course of malignancies is not fully understood.
Use with Anakinra or Abatacept: Use of Etarfion with Anakinra or Abatacept is not recommended.
Use in patients with moderate or severe alcoholic hepatitis: Physicians should use caution when using Etarfion in patients with moderate to severe alcoholic hepatitis.
