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Enbrel - etanercept is used to treat the symptoms of rheumatoid arthritis, ankylosing spondylitis or psoriatic arthritis and to prevent joint damage caused by these conditions. Etanercept is also used to treat polyarticular juvenile idiopathic arthritis (JIA) in children who are at least 2 years old and plaque psoriasis in adults.
Important Enbrel safety information
Risk of serious infections: Patients treated with Enbrel are at increased risk for developing infections. Some of them are so serious that may lead to hospitalization or even death. Most patients that developed these infections were taking concomitant immunosuppressants (such as methotrexate or corticosteroids) or were predisposed to infection because of their underlying disease. Taking Enbrel should not be started in the presence of sepsis, active infections or allergy to Enbrel or its ingredients. If a patient develops a serious infection or sepsis, treatment with Enbrel should be discontinued.
Neurologic events: TNF inhibitors, including Enbrel, have been associated with rare cases of new onset or exacerbation of CNS demyelinating disorders. Some associated with permanent disability and some presenting with mental status changes. In association with Enbrel therapy multiple sclerosis, transverse myelitis, optic neuritis and cases of new onset or exacerbation of seizure disorders have been observed. Take extra caution when considering Enbrel for patients with these disorders.
Moderate to severe alcoholic hepatitis: Based on a study of patients treated for alcoholic hepatitis, physicians should use caution when using Enbrel in patients with moderate to severe alcoholic hepatitis.
Hematologic events: Rare cases of pancytopenia, including aplastic anemia (some fatal) have been reported. Extra caution must be taken in patients who have a previous history of significant hematologic abnormalities. Patients should seek immediate medical attention if they develop signs or symptoms of blood dyscrasias or infection. Considering of discontinuing Enbrel is important if significant hematologic abnormalities are confirmed.
Malignancies: In clinical trials of all TNF inhibitors, more cases of lymphoma were reported. The risk of lymphoma may be up to several-fold higher in rheumatoid arthritis and psoriasis patients. The role of TNF inhibitors in the development of malignancies is not known.
Hepatitis B reactivation: TNF inhibitors, including Enbrel, have been associated with reactivation of hepatitis B virus (HBV) in chronic carriers of this virus. The majority of these reports occurred in patients on concomitant immunosuppressive agents, which may also contribute to HBV reactivation. Doctors should take caution in prescribing TNF blockers for patients identified as carriers of HBV.
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