Tuberculosis: As cases of tuberculosis have been reported in patients treated with Benepali, your doctor will check for signs and symptoms of tuberculosis before starting Benepali. To help you remember, it may be helpful to write in a diary which day(s) of the week Benepali should beused. A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients. In a polyarticular-course juvenile idiopathic arthritis trial with etanercept, 69 patients (aged 4 to 17 years) were administered 0.4 mg etanercept/kg twice weekly for three months. These included abscess (at various sites), bacteraemia, bronchitis, bursitis, cellulitis, cholecystitis, diarrhoea, diverticulitis, endocarditis (suspected), gastroenteritis, hepatitis B, herpes zoster, leg ulcer, mouth infection, osteomyelitis, otitis, peritonitis, pneumonia, pyelonephritis, sepsis, septic arthritis, sinusitis, skin infection, skin ulcer, urinary tract infection, vasculitis, and wound infection. Responses were similar in patients who were or were not receiving concomitant therapies at baseline. In a fourth study, the safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly vs. 25 mg etanercept administered twice weekly were evaluated in a double-blind, placebo-controlled study of 356 patients with active ankylosing spondylitis. Hi HevJ, I would have the dental treatment and then just see how you feel after that theres only you knows your body and how your feeling the only thing i can add is the fact that the benapali works similar to MTX and can take up to 12 weeks to start working so time for your teeth to heal in the meantime, Good luck Reply (0) Report It is not intended to provide practical advice on how to use Benepali. Mean (SE) annualized change from baseline in total sharp score. 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 those commonly seen in outpatient paediatric populations. Your doctor will determine if Benepali is an appropriate treatment. Serious and fatal infections have been reported during use of etanercept; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi. Rare (may affect up to 1in 1,000people), Serious allergic reactions (including severe localised swelling of the skin and wheezing); lymphoma (a type of blood cancer); leukaemia (cancer affecting the blood and bone marrow); melanoma (a type of skin cancer); combined low platelet, red, and white blood cell count; nervous system disorders (with severe muscle weakness and signs and symptoms similar to those of multiple sclerosis or inflammation of the nerves of the eyes or spinal cord); tuberculosis; new onset congestive heart failure; seizures; lupus or lupus-like syndrome. Benepali treatment should be started and supervised by a specialist doctor who has experience in the diagnosis and treatment of the diseases that Benepali is used to treat. Components. Do not try to give yourself the injection unless your doctor or nurse has shown you how to give the injection. If you have psoriasis, do not inject into any raised, thick, red, or scaly skin patches, or lesions. Additionally, there have been rare reports of peripheral demyelinating polyneuropathies (including Guillain-Barr syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy). TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body's defenses against infection and cancer. ), appendicitis, gastroenteritis, depression/personality disorder, cutaneous ulcer, oesophagitis/gastritis, group A streptococcal septic shock, type I diabetes mellitus, and soft tissue and post-operative wound infection. Women using Benepali should not breast-feed, since Benepali passes into human breastmilk. Do not use the pre-filled syringe if the needle cover is missing or not securely attached. The usual recommended dose is 50 mg once a week. Paediatric patients with juvenile idiopathic arthritis. . Patients in the etanercept in combination with methotrexate therapy group had significantly higher ACR 20, ACR 50, ACR 70 responses and improvement for DAS and HAQ scores at both 24 and 52 weeks than patients in either of the single therapy groups (results shown in table below). Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. Her weight was far below the 62.5 klg , by the way . Attention! I have had root fillings in the past and have to say theyve never been an issue. Alternatively, 50mg may be given twice a week for up to 12weeks, followed by 25mg twice a week or 50mg once aweek. In addition, one study found more birth defects when the mother had received etanercept in pregnancy, compared with mothers who had not received etanercept or other similar medicines (TNF-antagonists), but there was no particular kind of birth defect reported. 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. The observed rates and incidences in these clinical trials were similar to those expected for the population studied. The half-life is long, approximately 70 hours. Etanercept 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months. Treatment with Benepali may result in the formation of autoimmune antibodies. Reintroduction of treatment with etanercept after discontinuation of up to 24 months resulted in the same magnitudes of responses as patients who received etanercept without interruption of therapy based on results of open-label studies. 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. Good luck. Tell your doctor if you or the child develop any change in the appearance of the skin or growths on theskin. Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or powder for solution for injection presentations (see below for dosing for specific indications). Adult patients had serum samples tested for autoantibodies at multiple timepoints. Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. 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 4.18% (frequency common). 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). Your symptoms may return upon discontinuation. Based on pharmacokinetic data , no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited. Adult patients with ankylosing spondylitis. Benepali is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. A single 50 mg/ml injection of etanercept was found to be bioequivalent to two simultaneous injections of 25 mg/ml. Do not inject into areas that are red, hard, bruised, or tender. The efficacy of etanercept was compared to methotrexate in a randomised, active-controlled study with blinded radiographic evaluations as a primary endpoint in 632 adult patients with active rheumatoid arthritis (< 3 years duration) who had never received treatment with 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. The solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein. There is generally no applicable use of etanercept in children aged below 6 years in the indication plaque psoriasis. Some vaccines, such as oral polio vaccine, should not be given while using Benepali. This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the reference medicine. if you or the child you are caring for, are allergic to etanercept or any of the other ingredients of this medicine (listed in, if you or the child have, or are at risk of developing a serious blood infection called sepsis. Rheumatoid arthritis, psoriatic arthritis, and axial spondyloarthritis including ankylosing spondylitis The usual dose is 25mg given twice a week or 50mg once a week as an injection under the skin. The presence of renal impairment should not require a change in dosage. 50 mg solution for injection in pre-filled syringe. 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. Do not inject into areas that are red, hard, bruised, or tender. The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement. If active tuberculosis is diagnosed, Benepali therapy must not be initiated. In controlled trials in patients with plaque psoriasis, approximately 13.6% of patients treated with etanercept developed injection site reactions compared with 3.4% of placebo-treated patients during the first 12 weeks of treatment. Mean serum concentration profiles at steady state in treated RA patients were Cmax of 2.4 mg/l vs. 2.6 mg/l, Cmin of 1.2 mg/l vs. 1.4 mg/l, and partial AUC of 297 mg hr/l vs. 316 mg hr/l for 50 mg etanercept once weekly (n = 21) vs. 25 mg etanercept twice weekly (n = 16), respectively. Pre-filled pen containing a pre-filled syringe of Benepali. Among patients receiving etanercept, the clinical responses generally appeared within 1 to 2 weeks after initiation of therapy and nearly always occurred by 3 months. No differences for the occurrence of inefficacy or adverse effects were found between treatment groups. Pairwise comparison p-values: = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept. Failure of the bone marrow to produce crucial blood cells; toxic epidermal necrolysis (a lifethreatening skin condition). The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression. *see Description of selected adverse reactions, below. Today I have started on Benepali. With a quick, dart-like motion, insert the needle fully into the skin. Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). No dose adjustment is required. The results are shown in the figure below. These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice-weekly. The Committee recommended that Benepali be given marketing authorisation. 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. These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Radiographic progression: Comparison of etanercept vs. methotrexate in patients with RA of < 3 years duration. This medicines product information is available in all official EU languages.Select available languages to access the language you need. In this study, 53 patients received placebo, 214 patients received 50 mg etanercept once weekly and 153 patients received 25 mg etanercept twice weekly. Congestive heart failure (Cardiac failure congestive). All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, and paleness) whilst on Benepali, they should seek immediate medical advice. Etanercept treatment resulted in improvement in physical function during the double-blind period, and this benefit was maintained during the longer-term exposure of up to 2 years. Pillintrip.com does not provide medical or pharmacological advice, diagnosis or treatment. The highest dose level evaluated has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous doses of 16 mg/m2 administered twice weekly. The European Commission granted a marketing authorisation valid throughout the European Union for Benepali on 14 January 2016. The most common side effects with Benepali are injection-site reactions (including bleeding, redness, itching, pain and swelling) and infections (including colds, and lung, bladder and skin infections). Benepali may be stored outside of the refrigerator at temperatures up to a maximum of 25C for a single period of up to four weeks; after which, it should not be refrigerated again. At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy. In controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of interstitial lung disease in patients receiving etanercept without concomitant methotrexate was 0.06% (frequency rare). Mar 2021, 13:30. Results are summarised in the table below. In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death. This protein is found at high levels in patients with the diseases that Benepali is used to treat. Original PDF (ema.europa.eu), Benepali - patient leaflet, side effects, dosage, 1. Abbreviations: ACR, American College of Rheumatology; ACR20/50/70, American College of Rheumatology 20%/50%/70% response criteria; oETN, originator etanercept. No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept. It should be injected into the thigh, abdomen, or back of the upper arm (see image on theleft). While neutropenic, one patient developed cellulitis that resolved after hospitalisation. For more information about treatment with Benepali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. The needle cover should not be removed while allowing the pre-filled pen to reach room temperature. In postmarketing experience, approximately half of all of the case reports of opportunistic infections worldwide were invasive fungal infections. medication to have dental work that involves Blood?..A good friend of mine is on MTX and Hi looking for some info on Benepali & dental treatment I was on biological meds before & was teeth sensitivity. By looking though the inspection window, the solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein. x Chann in reply to Paula-C 4 years ago Thank you. Study 2 evaluated 652 patients with chronic plaque psoriasis using the same inclusion criteria as study 1 with the addition of a minimum psoriasis area and severity index (PASI) of 10 at screening. Always consult to a doctor or pharmacist before using pills or medicines. No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients. email etc . The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma. Date of first authorisation: 14 January 2016. The largest of these trials (n = 277) enrolled patients who were between 18 and 70 years of age and had active ankylosing spondylitis defined as visual analog scale (VAS) scores of > 30 for average of duration and intensity of morning stiffness plus VAS scores of > 30 for at least 2 of the following 3 parameters: patient global assessment; average of VAS values for nocturnal back pain and total back pain; average of 10 questions on the Bath Ankylosing Spondylitis Functional Index (BASFI). It explains how the Agency assessed the medicine to recommend its authorisation in the EU and its conditions of use. Never delay seeking advice or dialling emergency services because of something that you have read on HealthUnlocked. Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. 25Mg twice a week or 50mg once aweek be bioequivalent to two simultaneous injections of mg/ml. 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