ENBREL SPC PDF

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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The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma. There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy.

ENBREL is indicated for reducing signs and symptoms, keeping joint damage from getting worse, and improving physical function in patients with moderately to severely active rheumatoid arthritis. Patient-reported outcomes in a randomized trial comparing four different treatment strategies in recent-onset rheumatoid arthritis.

Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. In general, side effects in children were similar in frequency and type as those seen in adult patients. Work disability rates in RA. No studies on the effects on the ability to drive and use machines have been performed.

J Manag Care Pharm. In patients who develop HBV infection, Enbrel should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.

The proportion of patients treated with Enbrel who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients. Establishing the stability of etanercept DP at an alternative storage condition of ambient temperature would offer enbeel flexibility for patients.

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. The long-term safety and effectiveness of Enbrel 0. 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.

Reports have included fatal and life-threatening infections and sepsis.

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Etanercept (Enbrel®) alternative storage at ambient temperature

This article has been cited by other articles in PMC. Among patients with ankylosing spondylitis who received Enbrel, the clinical responses were apparent at the time of the first visit 2 weeks and were maintained through 6 months of therapy. Acknowledgments The study was funded by Pfizer.

These mean concentrations in patients with paediatric plaque psoriasis were similar to the concentrations observed in patients with juvenile idiopathic arthritis treated with 0. Enbrel has been shown to improve physical function in patients with psoriatic arthritis, and to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease.

No dose-limiting toxicities observed in trials. Vaccinations Live vaccines should not be given concurrently with Enbrel. In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency incidence proportion of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0. For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment.

This is not health insurance. Curr Med Res Opin. Enbrel 25mg is reconstituted with 1ml water for injections. TNF-antagonists, such as Enbrel, affect the immune system and their use may affect the body’s defenses against infection and cancer.

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Perspective article Review article Research article. The possibility exists for TNF-antagonists, including Enbrel, to enberl host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses. Latest views Mark Lyonette: 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.

CNS demyelinating events suggestive of multiple sclerosis or localised demyelinating conditions, such as optic neuritis and transverse myelitis see section 4.

Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive ‘latent’ tuberculosis. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised. 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.

Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose.

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Enbrel is available in strengths of 10, 25 and 50 mg. Elderly The impact envrel advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations. Author information Copyright and License information Disclaimer. In the toxicological studies with Enbrel, no dose-limiting or target organ toxicity was xpc. 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® (etanercept)

Test methods assessing key attributes of purity, quality, potency, and safety were performed over time, following storage of etanercept DP presentations under a range of conditions. Am J Health Syst Pharm. In each of the JIA subtypes, slc majority of patients met ACR Pedi 30 criteria and demonstrated clinical improvement in secondary endpoints such as number of tender joints and physician global assessment. Serious infections occurred in 6.

National Center for Biotechnology InformationU. Key results of studies 2, 3 and 4 are shown below. Etanercept 50 mg PFP DP The etanercept 50 mg PFP DP presentation is a spring-powered injection eenbrel consisting of two subassemblies, front and rear, enclosing a single etanercept 50 mg solution for injection in PFS, the contents of which are delivered to the patient subcutaneously. Clinical efficacy and safety This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study soc adults with ankylosing spondylitis, one study in adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with enbrell psoriasis.

Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with Enbrel during pregnancy.

The stability assays used to assess the key attributes of purity, quality, potency, and safety are summarized in Table 1. Long-term studies to assess the safety of the combination are ongoing. The types of infections seen in clinical trials in juvenile idiopathic arthritis patients aged 2 to 18 years were generally mild to moderate and consistent with enbrrel commonly seen in outpatient paediatric populations.

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