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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No dose adjustment is required.

Enbrel 25 mg powder and solvent for solution for injection

No study has been performed in patients with psoriatic arthritis using the 50 mg once-weekly dosing regimen. Children ehbrel adolescents four to 17 years0.

With continued therapy, responses were maintained up to 48 weeks. Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept. Use of biologic agents such as etanercept in the treatment of rheumatic diseases has brought considerable benefits in terms of symptom control as well as in other patient-relevant outcomes. Of patients who fnbrel a clinical response at 90 days and entered part 2 of the study, some of the patients remaining on Enbrel continued to improve from month 3 through month 7, while those who received placebo did not improve.

Long-term studies enbrep assess the safety of the combination are ongoing.

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Adult patients with rheumatoid arthritis The efficacy of Enbrel was assessed in a randomised, double-blind, placebo-controlled study. Patients with RA may be more likely to get lymphoma. Wegener’s granulomatosis A placebo-controlled trial, in which 89 adult patients were treated s;c 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.

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All subdomains of the HAQ were improved in patients treated with Enbrel compared fnbrel controls at 3 and 6 months. Physicians should use caution when considering combination therapy with sulfasalazine.

There were 4 reports of macrophage activation syndrome in juvenile idiopathic arthritis clinical trials. Serious infections occurred in 6. Treatment of psoriatic arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. Analysis Statistical analysis was performed on the following quantitative stability-indicating parameters: The resources available will help you get started.

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Enbrel injection

In part 1, all patients received 0. Antibodies to etanercept have been detected in the sera of some dnbrel treated with etanercept. You are encouraged to report enbre, side effects of prescription drugs to the FDA.

In postmarketing reports, serious infections have been reported. Date of first authorisation: Non-interactions In clinical trials, no interactions have been observed when Enbrel was administered with glucocorticoids, salicylates except sulfasalazinenonsteroidal anti-inflammatory drugs NSAIDsanalgesics, or methotrexate.

Concurrent administration of Enbrel and anakinra has been associated with an increased risk of serious infections and neutropenia compared to Enbrel alone. Not all pack sizes may be marketed.

Hypersensitivity to the active substance or to any of the excipients listed in section 6. In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which Enbrel was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with Enbrel or sulfasalazine alone.

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Reports of various malignancies including breast and lung carcinoma and lymphoma have also been received in the postmarketing period see section 4.

Enbrel injection | News | Pharmaceutical Journal

The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated. Concurrent treatment with anakinra Concurrent administration of Enbrel and anakinra has been associated with an increased risk of serious infections and neutropenia compared to Enbrel alone.

The flow rate was 1. In the double-blind and open-label psoriatic arthritis trials, 1 patient reported a serious infection pneumonia. Patients should be evaluated for infections before, during, and after treatment with Enbrel, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours range 7 to hours. Mechanism of action Much of the joint pathology in rheumatoid arthritis and ankylosing spondylitis and skin pathology in plaque psoriasis is mediated by pro-inflammatory molecules that are linked in a network controlled by TNF.

Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of Enbrel compared to the adult rheumatoid enbrl patients. In a group of 7, patients treated with Enbrel in rheumatoid arthritis, psoriatic arthritis, ankylosing spondylitis and psoriasis clinical trials, 18 lymphomas were reported.

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