Erelzi Disease Interactions

Etanercept, has been associated with reactivation of hepatitis B, in some cases fatal, in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-blocking agents. Therefore, screening for viral hepatitis should be performed in accordance with published guidelines before starting therapy with etanercept. Monitor patients at risk or with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation. Prescribers should exercise caution in prescribing TNF blockers in patients previously infected with HBV Monitor patients with evidence of current or prior HBV infection for clinical and laboratory signs of hepatitis or HBV reactivation during and for several months following etanercept therapy. In patients who develop HBV reactivation, consideration should be given to stopping etanercept and initiating anti-viral therapy with appropriate supportive treatment. The safety of resuming etanercept therapy after HBV reactivation is controlled is not known. Therefore, prescribers should weigh the risks and benefits when considering resumption of therapy.

Etanercept is contraindicated in patients with sepsis and it should be discontinued if a patient develops a serious infection or sepsis. Etanercept therapy should not be initiated in patients with an active infection, including clinically important localized infections. Patients should be closely monitored for the development of signs and symptoms of infection during and after treatment with etanercept. A patient who develops a new infection during treatment with etanercept should be closely monitored, undergo a prompt and complete diagnostic workup appropriate for an immunocompromised patient, and appropriate antimicrobial therapy should be initiated.

Etanercept has been associated with the reactivation of tuberculosis and new tuberculosis infections have been observed during the course of treatment, including patients who have previously received treatment for latent or active tuberculosis. Tuberculosis has developed in patients who tested negative for latent tuberculosis prior to initiation of therapy. Patients should be evaluated for tuberculosis risk factors and tested for latent infection prior to initiating etanercept and periodically during therapy. Anti-tuberculosis therapy should also be considered prior to initiation of etanercept 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. Tuberculosis should be strongly considered in patients who develop a new infection during etanercept 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.

A study in patients with moderate to severe alcoholic hepatitis treated with etanercept or placebo, showed that the mortality rate in patients in both groups was similar at 1 month but significantly higher after 6 months on the etanercept group. Caution should be exercised when using etanercept in patients with moderate to severe alcoholic hepatitis.

Etanercept, has been associated with worsening of congestive heart failure (CHF), with and without identifiable precipitating factors. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known preexisting cardiovascular disease. Care should be exercised when prescribing etanercept to patients at risk cardiovascular disease or with heart failure.

Rare events of pancytopenia including very rare events of aplastic anemia, some with a fatal outcome, have been reported in patients treated with etanercept. Discontinuation of etanercept therapy should be considered in patients with confirmed significant hematologic abnormalities. Caution should be exercised in patients being treated with etanercept who have a previous history of significant hematologic abnormalities. 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, pallor) while on therapy with etanercept.

There have been reports of hypoglycemia following initiation of etanercept therapy in patients receiving medication for diabetes, necessitating a reduction in anti-diabetic medication in some of these patients. Care should be taken when prescribing this agent to diabetic patients.

Etanercept has been associated with rare 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. There have been postmarketing reports of transverse myelitis, optic neuritis, multiple sclerosis, Guillain-Barré syndromes, other peripheral demyelinating neuropathies, and new onset or exacerbation of seizure disorders with etanercept therapy. Care should exercise when considering the use of etanercept in patients with preexisting or recent-onset central or peripheral nervous system demyelinating disorders.

The manufacturer of etanercept recommends that patients with a significant exposure to varicella virus should temporarily discontinue therapy and be considered for prophylactic treatment with varicella zoster immune globulin.

The use of etanercept in patients with Wegener's granulomatosis receiving immunosuppressive agents is not recommended. In a study, the addition of etanercept to standard therapy, including cyclophosphamide, to patients with Wegener's granulomatosis was associated with a higher incidence of non-cutaneous solid malignancies and was not associated with improved clinical outcomes when compared with standard therapy alone. Therefore, prescribers should weigh the risks and benefits when considering therapy in this situation.