Enbrel® (etanercept) is a prescription medicine used to treat five chronic diseases, including moderate to severe rheumatoid arthritis. These highlights do not include all the information needed to use Enbrel safely and effectively. See full prescribing information for Enbrel. Enbrel® (etanercept). What is Enbrel (etanercept) and what is it used for? of Product Characteristics ( SPC) for Enbrel these can be found at the electronic Medicines Compendium.

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Healthcare professionals are asked to report any suspected adverse reactions via the Yellow Card Scheme at www. Neoplasms benign, malignant and unspecified including cysts and polyps.

The clinical significance of this interaction is unknown. Since the first clinical trials of etanercept inover 4.

Enbrel® (etanercept)

Disclosure All the authors are full-time employees of Pfizer and hold stock or stock options. TNF and lymphotoxin are pro-inflammatory cytokines that bind to two distinct cell surface receptors: Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel. These reactions were generally transient and did not recur with treatment. There have been rare reports of lupus, lupus-related conditions, and vasculitis. The types of major birth defects were consistent with those most commonly reported in the general population and no particular pattern of abnormalities was identified.

If any serious allergic or anaphylactic reaction occurs, Enbrel therapy should be discontinued immediately and appropriate therapy initiated. Enter email address Submit. DSGA bclear or almost clear. Open to patients who have an ENBREL prescription and who have commercial or private insurance, including plans available through state and federal healthcare exchanges. Headache, nausea, abdominal pain and vomiting were reported more commonly in juvenile chronic arthritis patients than in adults in trials.

Reports of various malignancies including breast and lung carcinoma and lymphoma have also been received in the postmarketing period see section 4. Studies have not been done in patients with juvenile idiopathic arthritis to assess the effects of continued Enbrel therapy in patients who do not respond within 3 months of initiating Enbrel therapy.


Clearance is approximately 0. Additionally, the pharmacokinetics of Enbrel in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar.

Paediatric population Juvenile idiopathic arthritis The recommended dose is 0. Allergic reactions Allergic reactions associated with Enbrel administration have been reported commonly. Paediatric population Vaccinations It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating Enbrel therapy see Vaccinations, above.

The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally enbel to moderate and consistent with those commonly seen in outpatient paediatric populations.

Show table of contents Hide table of contents 1. Marketing authorisation holder 8. There is evidence to suggest that initiation of treatments early in the disease course not only offers substantial improvements in functional ability and quality of life, 15 but also brings significant benefits in terms of productivity, due to reduced sick leave and lost employment, 16 and a decline in work disability.

Non-interactions In clinical trials, no interactions have been observed when Enbrel was administered with glucocorticoids, salicylates except sulfasalazinenonsteroidal anti-inflammatory drugs NSAIDsanalgesics, or methotrexate.

Instead, the safety and efficacy of Enbrel were assessed in four randomised, double-blind, placebo-controlled studies. In a study of 49 adult patients with rheumatoid arthritis treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations. With continued therapy, responses were maintained up to 48 weeks.

Adults, injection site reactions, upper respiratory tract infections. The biochemical and physical structures of recombinant protein biologics are dictated by their primary amino acid sequence and, where present, by posttranslational modifications such as glycosylation. Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus HBV and had received concomitant TNF-antagonists, including Enbrel, has been reported.


For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and Patients with complete ankylosis of the spine were not included in the study.

Reporting suspected adverse reactions after authorisation of the medicinal product is important. Immunosuppression The possibility exists for TNF-antagonists, including Enbrel, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune dnbrel. Lactation, excretion in human milk unknown see SPC.

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In a week study in children aged 4 to nebrel years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis. Adult patients with rheumatoid arthritis The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study.

Perspective article Review article Research article.

Patients with significant exposure to varicella virus should temporarily discontinue etanercept and be enbeel for prophylactic treatment with varicella zoster immune globulin. Travel in patients receiving TNF-alpha inhibitors. Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to Enbrel treatment. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with Enbrel. At week 12, more patients randomised to Enbrel had positive efficacy responses e.