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: Fenrirn Gardalkis
Country: Gambia
Language: English (Spanish)
Genre: Life
Published (Last): 14 November 2005
Pages: 245
PDF File Size: 18.49 Mb
ePub File Size: 20.46 Mb
ISBN: 926-9-85278-784-5
Downloads: 16694
Price: Free* [*Free Regsitration Required]
Uploader: Mazushicage

Enbrel injection

These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Caution should be exercised when considering TNF-antagonist therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy. The mean serum steady-state trough concentrations ranged from 1. However, the occurrence was rare, epc the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.

Etanercept (Enbrel®) alternative storage at ambient temperature

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. New onset cardiac failure congestive see section 4.

Adults, injection site reactions, upper respiratory tract infections. Size exclusion high-performance liquid chromatography SE-HPLC is performed to assess the purity of etanercept by separation of the high-molecular-weight component Zpc from homogenous dimeric etanercept and low-molecular-weight component LMWC; clipped species based on molecular size, and resolves etanercept into two principal peaks: This site uses cookies.

Women of child-bearing potential should be advised not to get pregnant during use. Tuberculosis Cases of active tuberculosis, including sspc tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with Enbrel.

  ALAN KOLATA PDF

Enbrel can be given as monotherapy in case of soc to methotrexate or when continued treatment with methotrexate is inappropriate. A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving Enbrel-treated psoriatic arthritis patients. Manufacturing of recombinant therapeutic proteins in microbial systems.

Search for a Medicine

Double-Blind Clinical Responses at Week Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once weekly.

Instructions for use and handling Enbrel is reconstituted with 1 ml water for injections before use, and administered by subcutaneous injection.

Societal cost of rheumatoid arthritis patients in the US. Clearance and volume estimates in patients aged 65 to 87 years were similar enbrrel estimates in patients less than 65 years of age.

Among patients with plaque psoriasis who received Enbrel, significant responses relative to placebo were apparent at the time of the first visit 2 weeks and were maintained through 24 weeks of therapy.

In a double-blind, placebo-controlled, randomised clinical study in adult patients with psoriatic arthritis, patients also received a multivalent pneumococcal polysaccharide vaccine at week 4. Storage conditions The storage conditions at which stability tests were performed on the various etanercept DP presentations are summarized in Table 2.

Several adverse events sp reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of Enbrel compared to the adult rheumatoid arthritis patients. Work disability rates in RA. The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with Enbrel spcc in the control group.

  FRANKA SOLIDA III MANUAL PDF

Autoantibody formation Treatment with Enbrel may result in the formation of autoimmune antibodies see section 4. Posology and administration are the same as for adults years of age. This alternative storage condition represents further innovation in the etanercept product lifecycle, providing greater flexibility and enhanced overall convenience for patients.

Published online Jul Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin. Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein.

Enbrel is not recommended during pregnancy. Company contact details Pfizer Limited.

Clinical Efficacy Results at 12 Months: Advances and Applications are provided here courtesy of Dove Press. In this study, most psoriatic arthritis patients receiving Enbrel were able to mount effective B-cell immune response to pneumococcal polysaccharide vaccine, but titres in aggregate were moderately lower, and few patients had enbdel rises in titres compared to patients not receiving Enbrel.

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.