ENBREL SPC PDF

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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Juvenile idiopathic arthritis Treatment of polyarthritis rheumatoid factor positive or negative and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Assays The stability assays used to assess the key attributes of purity, quality, potency, and safety are summarized in Table 1. However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.

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.

Posology Rheumatoid arthritis 25 mg Enbrel administered twice weekly is the recommended dose. Specific guidance is provided on the stability testing of biologic products, 11 particularly since these are sensitive to environmental factors such as temperature, oxidation, light, ionic content, or shear, and stringent conditions for storage are usually required.

This article has been cited by other articles in PMC.

The International Conference on Harmonization Q5C provides enbrfl to applicants regarding the type of stability studies to be provided in support of marketing authorization applications and amendments for biologic medicinal products. Enbrel should not be used if all the powder in the vial is not dissolved within 10 minutes.

Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra alone historical data. Plaque psoriasis The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once weekly. To email a medicine you must sign up envrel log in. Women of child-bearing potential should be advised not to get pregnant during use. In part 1, all patients received 0. The use of Enbrel in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied.

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Vasculitis including anti-neutrophilic cytoplasmic antibody positive vasculitis. Renal and hepatic impairment, no dose adjustment required.

Incorporating the treat-to-target concept in rheumatoid arthritis. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.

It is not valid for cash paying patients or where prohibited by law. Some have occurred within sp few weeks after initiating treatment with Enbrel in patients who have underlying conditions e. Enbrel is reconstituted with 1 ml water for injections before use, and administered by subcutaneous injection. Sign Up Log In Cancel. Paediatric patients with plaque psoriasis Patients with paediatric plaque psoriasis aged 4 to 17 years were administered 0.

Enbrel 25 mg powder and solvent for solution for injection

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.

Fertility Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available. Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients. There is no apparent pharmacokinetic difference between males and females. Enbrel was significantly better than placebo in all components of the ACR criteria, as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness.

Enbrel treatment may increase mortality in patients with established sepsis. After a single subcutaneous dose of 25 mg Enbrel, the average maximum serum concentration observed in healthy volunteers was 1.

Children under four years, etanercept has not been studied.

Enbrel® (etanercept)

Patients may continue in the program after that by renewing enrollment every 12 months. In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events.

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Various malignancies have also been reported with use of Enbrel, including cancers of the breast, lung, skin and lymph glands lymphoma. This work is published and licensed by Dove Medical Press Limited. There is generally no applicable use of Enbrel in children aged below 2 years in the indication juvenile idiopathic arthritis. For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and Clear or almost clear defined as 0 or 1 on a 0 to 5 scale.

The U cells were incubated at Enter email address Submit. Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. Open in a separate window. In controlled trials in patients with plaque psoriasis, approximately The proteins were separated by electrophoresis and the gel was stained with 0.

Summary of the safety profile The most commonly reported adverse reactions are injection site reactions such as pain, swelling, itching, reddening and bleeding at the puncture siteinfections such as upper respiratory infections, bronchitis, bladder infections and skin infectionsallergic reactions, development of autoantibodies, itching, and fever.

Hypersensitivity to active substance or excipients; sepsis or risk of sepsis. Method of administration Enbrel is administered by subcutaneous injection. Based on the supportive stability results for the etanercept 25 and 50 mg PFS DP, studies were initiated to support long-term storage at refrigerated temperatures that included ambient storage at the end of shelf life for up to 4 weeks out wpc the refrigerator.

Comprehensive instructions for the preparation and administration of the reconstituted Enbrel vial are given enbrdl the package leaflet, section 7, “Instructions for preparation and giving an injection of Enbrel.

Adults, recommended dose is 25mg etanercept administered twice weekly as a subcutaneous injection.