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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Etanercept is a human tumour necrosis factor receptor p75 Fc fusion protein produced by recombinant DNA technology in a Chinese hamster ovary CHO mammalian expression system. Etanercept contains amino acids and has an apparent molecular weight of approximately kilodaltons.

The specific activity of etanercept is 1. Enbrel in combination with methotrexate is indicated for the treatment of moderate to severe active rheumatoid arthritis in adults when the response to disease-modifying antirheumatic drugs, including methotrexate unless contraindicatedhas been inadequate. Enbrel can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Enbrel is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.

Enbrel, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Treatment of polyarthritis rheumatoid factor positive or negative and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. 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.

Treatment of enthesitis-related arthritis in adolescents from the age of 12 years who have had an inadequate response to, or who have proved intolerant of, conventional therapy. Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. 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.

Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. Treatment of adults with moderate to severe plaque psoriasis who failed to respond to, or who have a contraindication to, or are intolerant to other systemic therapy, including ciclosporin, methotrexate or psoralen and ultraviolet-A light PUVA see section 5.

Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. Enbrel treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, non-radiographic axial spondyloarthritis, plaque psoriasis or paediatric plaque psoriasis.

Patients treated with Enbrel should be given the Patient Alert Card. Alternatively, 50 mg administered once weekly has been shown to be safe and effective see section 5. Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis.

The recommended dose is 25 mg Enbrel administered twice weekly, or 50 mg administered once weekly. For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment.

Continued therapy should be carefully reconsidered in a patient not responding within this time period. The recommended dose of Enbrel is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or 50 mg once weekly.

Enbrel injection | News | Pharmaceutical Journal

Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks. Continuous therapy beyond 24 weeks may be appropriate for some adult patients see section 5. Treatment should be discontinued in patients who show no response after 12 weeks.

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If re-treatment with Enbrel is indicated, the same guidance on treatment duration should be followed. The dose should be 25 mg twice weekly or 50 mg scp weekly. No dose adjustment is required. Posology and administration are the same as for adults years of age. The recommended dose is 0.

Discontinuation of treatment should be considered in patients who show no response after 4 months. The 10 mg vial strength may be more appropriate for administration to children with Wpc below the weight of 25 kg. No formal clinical trials have been conducted in children aged 2 to 3 years.

Enbrel 25 mg powder and solvent for solution for injection

However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0. There is generally no applicable use of Enbrel in children aged below 2 years in the indication juvenile idiopathic arthritis.

If re-treatment with Enbrle is indicated, the above guidance on treatment duration should be followed. The dose should be 0.

There is generally no applicable use of Enbrel in children aged below 6 years in the indication plaque psoriasis. Enbrel is administered by subcutaneous injection. Enbrel powder for solution must be reconstituted in 1 ml of solvent before use see section 6. Comprehensive instructions for nebrel preparation and administration of the reconstituted Enbrel vial are given in the package leaflet, section 7, “Instructions for preparation and giving an injection of Enbrel.

Treatment with Enbrel should not be initiated in patients with active infections, including chronic or localised infections. In order to improve the traceability of biological medicinal eenbrel, the trademark and the batch number of the administered product should be clearly recorded or stated in the patient file.

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.

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Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of Enbrel see section 4.

These infections were due to bacteria, mycobacteria, fungi, viruses and parasites including protozoa. In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death. In evaluating patients for infections, the patient’s risk for relevant opportunistic infections e.

Patients who develop a new infection while undergoing treatment with Enbrel should be monitored closely. Administration of Enbrel should be discontinued if a patient develops a serious infection. The safety and efficacy of Enbrel in patients with chronic infections have not been evaluated. Physicians should exercise caution when considering the use of Enbrel in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes.

Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with Enbrel. Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive ‘latent’ tuberculosis. Appropriate screening tests, i. It is recommended that the conduct of these tests should be recorded in the patient’s alert card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.

If active tuberculosis is diagnosed, Enbrel therapy must not be initiated. If inactive ‘latent’ tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Enbrel, and in accordance with local recommendations. 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.

Patients should be tested for HBV infection before initiating treatment with Enbrel. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Caution should be exercised when administering Enbrel in patients previously infected with HBV. These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy.

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Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF-antagonist therapy are not available. In patients who develop HBV infection, Enbrel should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. There have been reports of worsening of hepatitis C in patients receiving Enbrel.

Enbrel should be used with caution in patients with a history of hepatitis C. Concurrent administration of Enbrel and anakinra has been associated with an increased risk of serious infections and neutropenia compared to Enbrel alone.

This combination has not demonstrated increased clinical benefit. Thus, the combined use of Enbrel and anakinra is not recommended see sections 4. In clinical studies, concurrent administration of abatacept and Enbrel resulted spx increased incidences of serious adverse events. Enbrrl combination has enbre, demonstrated increased clinical benefit; such use is not recommended see section 4. Allergic reactions associated with Enbrel administration have been reported commonly.

Allergic reactions have included angioedema and urticaria; serious reactions have occurred. If any serious allergic or anaphylactic reaction occurs, Enbrel therapy should be discontinued immediately and appropriate therapy initiated.

The possibility exists for TNF-antagonists, including Enbrel, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.

In a study of 49 adult patients with rheumatoid arthritis treated with Enbrel, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations. Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae.

Patients with a significant exposure to varicella virus should temporarily discontinue Enbrel therapy and be considered for prophylactic treatment with Varicella Zoster Immune Globulin. Reports of various malignancies including breast and lung carcinoma and lymphoma have been received in the postmarketing period see section 4.

In the controlled portions of clinical trials of TNF-antagonists, more cases of lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients.

However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy.

In the postmarketing setting, cases of leukaemia have been reported in patients treated with TNF-antagonists. There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation.

Based on current knowledge, a possible risk for the development of lymphomas, leukaemia or other haematopoietic or solid malignancies in patients treated with a TNF-antagonist cannot be excluded.

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.

Approximately half the cases were lymphomas. The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression.

A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with Enbrel.

Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer. Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving Enbrel compared with control patients, particularly in patients with psoriasis. Live vaccines should not be given concurrently with Enbrel.

No data are available on the secondary transmission of infection by live vaccines in patients receiving Enbrel. 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.

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 two-fold rises in titres compared to patients not receiving Enbrel.