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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Alcoholic hepatitis In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with Enbrel or placebo for moderate to severe alcoholic hepatitis, Enbrel was not efficacious, and the mortality rate in patients treated with Enbrel was significantly higher after 6 dpc.

Enbrel treatment resulted in enbrl in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years.

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You will be re-directed back to this page where you will have the ability to comment. If re-treatment with Enbrel is indicated, the same guidance on treatment duration should be followed.

The types of infections reported were generally mild and similar to those usually seen in children. After a single subcutaneous dose of 25 mg Enbrel, the average maximum serum concentration observed in healthy volunteers was 1. Assays The stability assays used to assess the key attributes of purity, quality, potency, and safety are summarized in Table 1.

Preclinical data about peri- and postnatal enbrrl of etanercept and of effects of etanercept on fertility and general reproductive performance are not available. Worsening of symptoms of dermatomyositis. The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement.

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Enbrel injection

The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma. A higher rate of major birth defects was observed in an observational study comparing pregnancies exposed to etanercept during the first trimester, with pregnancies not exposed to etanercept or other TNF-antagonists adjusted odds ratio 2. Safety and efficacy of etanercept in children with the JIA categories extended oligoarthritis, enthesitis-related arthritis and psoriasis arthritis.

Establishing the stability of etanercept DP at an alternative storage condition of ambient temperature would offer improved flexibility for patients. In clinical studies conducted for more than 2 years with ankylosing spondylitis patients, 6 malignancies were reported in Enbrel-treated patients. Residual analysis was used to check the validity of the linear models.

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Each patient is responsible for costs above these amounts. In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received Enbrel were observed compared with younger patients.

Haematologic reactions Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with Enbrel.

Explore a condition below. Allergic reactions have included angioedema and urticaria; serious reactions have occurred.

Etanercept may also modulate biologic responses controlled by additional downstream molecules e. Juvenile chronic arthritis patients should, if possible, be brought up to date with all immunisations prior to initiating therapy.

Mean serum concentration profiles at steady state in treated RA patients were C max of 2. A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. After the week double-blind treatment period, all patients received Enbrel 0.

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Etanercept (Enbrel®) alternative storage at ambient temperature

Please see Prescribing Information and Medication Guide. Clear or almost clear defined as 0 or 1 on a 0 to 5 scale. These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of enbrl.

This information is intended only for U. Find out more here. Long-term studies to assess the safety of the combination are ongoing. Graumann K, Premstaller A.

Among patients receiving Enbrel, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always occurred by 3 months.

Paediatric patients with plaque psoriasis Patients with paediatric plaque psoriasis aged 4 to 17 years were administered 0. The 10 mg Enbrel dose had consistently less effect on structural damage than the 25 mg dose.

There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with Enbrel from post-marketing sources, including a very small number of cases indicating a positive rechallenge see section 4. ENBREL is indicated for reducing signs and symptoms of moderately to severely active polyarticular juvenile idiopathic arthritis JIA in children ages 2 years and older.

ACR 20 and 50 responses were higher in patients treated with Enbrel at 3 and 6 months than in patients treated with placebo ACR Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept.

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