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.

Author: Nigar JoJogore
Country: Turkmenistan
Language: English (Spanish)
Genre: Literature
Published (Last): 4 March 2013
Pages: 473
PDF File Size: 11.24 Mb
ePub File Size: 20.30 Mb
ISBN: 972-3-49993-612-5
Downloads: 2189
Price: Free* [*Free Regsitration Required]
Uploader: Nesida

Worsening of symptoms of dermatomyositis. A placebo-controlled trial, in which 89 adult patients were treated with Enbrel in addition to standard therapy including cyclophosphamide or methotrexate, and glucocorticoids for a median duration of 25 months, has not shown Enbrel to be an effective treatment for Wegener’s granulomatosis.

enbdel Elderly The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations. Stevens-Johnson syndrome, cutaneous vasculitis including hypersensitivity vasculitiserythema multiforme. Serious infections experienced by Enbrel-treated patients included cellulitis, gastroenteritis, pneumonia, cholecystitis, osteomyelitis, gastritis, appendicitis, Streptococcal fasciitis, myositis, septic shock, diverticulitis and abscess.

In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with Enbrel alone 25 mg twice weeklymethotrexate alone 7. This site uses cookies small files stored on your computer to simplify and improve your experience of this website.

A total of patients were enrolled, from which were treated with Enbrel. However, caution should be exercised when treating the elderly and spx attention paid with respect to occurrence of infections.

The etanercept 50 mg PFP DP presentation is a spring-powered injection system 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. Methods Stability studies were conducted on multiple batches manufactured at three commercial manufacturing sites.

Breast-feeding Etanercept has been reported to be excreted in human milk following subcutaneous administration. Rates of serious adverse events and serious infections did not increase with long-term exposure.

Search for a Medicine

The syringes are type I glass. Enbrfl are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised. Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection, along with the simultaneous appearance of injection site reactions at previous injection sites.

  COLDNESS AND CRUELTY DELEUZE PDF

Manufacturing of recombinant therapeutic proteins in microbial systems. Enrollment in the program is for 12 months.

Enbrel 25 mg powder and solvent for solution for injection

There was no significant degradation observed, reflecting a satisfactory stability profile, and all data remained within specification for 4 weeks Figure 2. Plaque psoriasis The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once enberl.

The efficacy of Enbrel in patients with non-radiographic axial spondyloarthritis nr-AxSpa was assessed in a randomised, week double-blind, placebo-controlled study. These reactions were generally transient and did not recur with treatment. Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with Enbrel due to the development of neutralising antibodies in rodents.

An analysis of clinical enrel data did not reveal any baseline disease characteristics that would assist clinicians in selecting the most appropriate dosing option intermittent or continuous. Treatment of active polyarticular-course juvenile chronic arthritis in children aged four to 17 years who have had an inadequate response to, or who have proved intolerant of, methotrexate.

Find a Medicine Results

Enter email address Submit. In the double-blind periods of controlled clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency incidence proportion of adverse events of elevated liver enzymes was 4.

This procedure was used to separate proteins based primarily on their molecular weights MWs. Company contact details Pfizer Limited. It is recommended that the conduct of these tests should be recorded in the patient’s alert card. Patients with significant exposure to varicella virus should temporarily discontinue etanercept and be considered for prophylactic treatment with varicella zoster immune globulin.

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. The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 i. Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive ‘latent’ tuberculosis.

  COURTING SUSANNAH LINDA LAEL MILLER PDF

In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients. Paediatric Plaque Psoriasis Outcomes at 12 Weeks. If curvature was observed in the residuals plotted against the predicted values, then nonlinear models were sought.

The central volume of distribution of etanercept is 7. Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with Enbrel.

Open to patients who have an ENBREL prescription and who have commercial or private insurance, including plans available through state and federal healthcare exchanges.

No change in the rate of spontaneous abortion, stillbirth, or minor malformations was observed. The safety profile was consistent with that observed in other Spcc studies. In this study, 53 patients received placebo, patients received 50 mg Enbrel once weekly ebbrel patients received 25 mg Enbrel twice weekly. Such patients should be investigated urgently, including full blood count; if blood dyscrasias are confirmed, Enbrel should be discontinued. Etanercept is cleared slowly from the body.

The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with Enbrel than in the control group.

Some white foam may remain in the vial — this is normal. Injection site reactions usually occurred in the first month. For patients who received 25 mg twice weekly throughout the study, the PASI 75 response continued to improve between weeks 12 and Powder and solvent for solution for injection powder for injection.

See SPC for details of other undesirable effects. Click here to view.

SPC; [Accessed November 22, ].