No extraction though which may be different fortunately I still have all my teeth although a good few fillings. The long-term safety of etanercept in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established. 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. CFergie 2 years ago 11 Replies Rituximab treatment - any advice on what to ask and what to expect. Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept. This medicinal product contains less than 1mmol sodium (23mg) per 25mg, that is to say essentially sodium-free. The observed rates and incidences in these clinical trials were similar to those expected for the population studied. Your doctor will decide how long you should use Benepali and whether retreatment is needed based on your response. In another active-controlled, double-blind, randomised study, clinical efficacy, safety, and radiographic progression in RA patients treated with etanercept alone (25 mg twice weekly), methotrexate alone (7.5 to 20 mg weekly, median dose 20 mg), and the combination of etanercept and methotrexate initiated concurrently were compared in 682 adult patients with active rheumatoid arthritis of 6 months to 20 years duration (median 5 years) who had a less than satisfactory response to at least 1 disease-modifying antirheumatic drug (DMARD) other than methotrexate. Do not throw the sharps container in household bin. The slowing of peripheral joint damage was observed in patients with polyarticular symmetrical joint involvement. Two large clinical trials evaluating the use of etanercept in the treatment of CHF were terminated early due to lack of efficacy. Etanercept was significantly better than placebo in all measures of disease activity (p < 0.001), and responses were similar with and without concomitant methotrexate therapy. Im on enbrel which benepali is a bio similar of. 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. Dosage (Posology) and method of administration, Interaction with other medicinal products and other forms of interaction, Effects on ability to drive and use machines, Immunosuppressants, tumour necrosis factor alpha (TNF-) inhibitors, ATC code: L04AB01, Special precautions for disposal and other handling, Date of first authorisation/renewal of the authorisation, All rights reserved Pillintrip.com 2018, Enbrel 50 mg solution for injection in pre-filled pen, Enbrel 50 mg solution for injection in pre-filled syringe, https://www.drugs.com/search.php?searchterm=benepali, https://pubmed.ncbi.nlm.nih.gov/?term=benepali. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF-antagonist therapy are not available. The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature. In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death. Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Benepali. 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. Before starting treatment with Benepali, all patients must be evaluated for both active and inactive ('latent') tuberculosis. The efficacy of etanercept versus other systemic therapies in patients with moderate to severe psoriasis (responsive to other systemic therapies) has not been evaluated in studies directly comparing etanercept with other systemic therapies. This combination has not demonstrated increased clinical benefit. Because Benepali is a biosimilar medicine, all the studies on effectiveness and safety of etanercept carried out with Enbrel do not need to be repeated for Benepali. Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of etanercept. However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy. The primary measure of efficacy (ASAS 40) was a 40% improvement in at least three of the four ASAS domains and absence of deterioration in the remaining domain. Etanercept did not induce lethality or notable signs of toxicity in mice or rats following a single subcutaneous dose of 2,000 mg/kg or a single intravenous dose of 1,000 mg/kg. One hundred and twelve (112) patients were randomised to receive a dose of 25 mg of etanercept (n = 57) or placebo (n = 55) twice a week for 24 weeks. Administration of live vaccines to infants for 16 weeks after the mother's last dose of Benepali is generally not recommended. Original PDF (ema.europa.eu), Benepali - patient leaflet, side effects, dosage, 1. 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. The Committee recommended that Benepali be given marketing authorisation. This section presents data from four randomised controlled trials in adults with rheumatoid arthritis, one study in adults with psoriatic arthritis, one study in adults with ankylosing spondylitis, one study in adults with non-radiographic axial spondyloarthritis, four studies in adults with plaque psoriasis, three studies in juvenile idiopathic arthritis and one study in paediatric patients with plaque psoriasis. Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept. THE BENEPALITMPRE-FILLED SYRINGE IS FOR A SUBCUTANEOUS INJECTION. Benepali is not for use in children weighing less than 62.5 kg, as Benepali does not have low-dose formulations. Treatment should be discontinued in patients who show no response after 12 weeks. The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria. 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. Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA). In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients. There have been reports of inflammatory bowel disease and uveitis in JIA patients being treated with etanercept from post-marketing sources, including a very small number of cases indicating a positive rechallenge. medicines to treat diabetes. Do not remove the needle cover until you are ready to inject. Each pre-filled syringe contains 25mg of etanercept. If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately. Do not use the pre-filled syringe if the needle cover is missing or not securely attached. The syringe inside the pen is made from clear type 1 glass with a stainless steel 27 gauge needle, rubber needle cover, and rubber plunger. Benepali is a biosimilar medicinal product. MRIs of the sacroiliac joint and spine were obtained to assess inflammation at baseline and at weeks 12 and 104. If you have used more Benepali than you should (either by injecting too much on a single occasion or by using it too frequently), talk to a doctor or pharmacist immediately. In clinical trials, no interactions have been observed when etanercept was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate. Caution should be exercised in patients being treated with Benepali who have . This includes any possible side effects not listed in this leaflet. At the end of the double-blind study, patients could enter a long-term open-label extension study for a total duration of up to 2 years. If you received Benepali during pregnancy, your baby may have a higher risk of getting an infection. If you or the child in your care have Wegenersgranulomatosis, talk to your doctor. Drug retention time was the primary efficacy endpoint compared to the biosimilar and the original. No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis patients. Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of etanercept. Doses of 10 mg or 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months. ACR 20 and 50 responses were higher in patients treated with etanercept at 3 and 6 months than in patients treated with placebo (ACR 20: etanercept 62% and 59%, placebo 23% and 11% at 3 and 6 months, respectively: ACR 50: etanercept 41% and 40%, placebo 8% and 5% at months 3 and 6, respectively; p < 0.01 etanercept vs. placebo at all timepoints for both ACR 20 and ACR 50 responses). I contacted my rheumatology helpline for advise. A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial. I contacted my RA nurse (everything has to go through them before the consultant) and she said -. There is insufficient evidence of the efficacy of etanercept in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied. This combination has not demonstrated increased clinical benefit; such use is not recommended. The absolute bioavailability is 76%. Abbreviations: ACR, American College of Rheumatology; ACR20/50/70, American College of Rheumatology 20%/50%/70% response criteria; oETN, originator etanercept. Not all pack sizes may be marketed. Serious infections (including pneumonia, deep skin infections, joint infections, blood infection, and infections at various sites); worsening of congestive heart failure; low red blood cell count, low white blood cell count, low neutrophil (a type of white blood cell) count; low blood platelet count; skin cancer (excluding melanoma); localised swelling of the skin (angioedema); hives (elevated patches of red or pale skin that often itch); eye inflammation; psoriasis (new or worsening); inflammation of the blood vessels affecting multiple organs; elevated liver blood tests (in patients also receiving methotrexate treatment, the frequency of elevated liver blood tests is common); abdominal cramps and pain, diarrhoea, weight loss or blood in the stool (signs of bowel problems). Contents of the pack and other information. It is recommended that the conduct of these tests should be recorded in the patient's alert card. b Values for Disease Activity Score (DAS) are means. You can findproduct informationdocuments for centrally authorised human medicines on this website. Doses of 25 mg of etanercept (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered SC twice a week for 6 months. The percentage of patients who developed new positive anti-double-stranded DNA antibodies was also higher by radioimmunoassay (15% of patients treated with etanercept compared to 4% of placebo-treated patients) and by Crithidia luciliae assay (3% of patients treated with etanercept compared to none of placebo-treated patients). Sleeplessness, Small Red 'dot' type spots which were very dry. Etanercept 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months. If there is bleeding at the injection site, press a gauze pad over the injectionsite. If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgottendose. Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis. Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them. Case series of 138 patients with RA, SpA or PsA treated with at least one dose of Benepali (n = 79) or Enbrel (n = 59). Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. After taking a syringe from the refrigerator, wait approximately 30minutes to allow the Benepali solution in the syringe to reach room temperature. Changes since initial authorisation of medicine, Initial marketing-authorisation documents, Committee for Medicinal Products for Human Use, Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 16-19 November 2015, Send a question to the European Medicines Agency, International non-proprietary name (INN) or common name, Anatomical therapeutic chemical (ATC) code, Date of issue of marketing authorisation valid throughout the European Union. Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months. 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). If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. Benepali 50 mg solution for injection in pre-filled pen. A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients. Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age. 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Healthcare professionals nor the advice you receive from them patients being treated with Benepali, all patients must be for. Conjunction with TNF-antagonist therapy was rare, and the follow-up period of placebo patients was shorter than patients... 16 weeks after the mother 's last dose of Benepali is not for use in children weighing less than sodium! Fortunately I still have all my teeth although a good few fillings of efficacy particular and... Been reported in clinical studies of approximately 2 years ago 11 Replies Rituximab treatment any! Vaccines to infants for 16 weeks after the mother 's last dose of Benepali is not recommended other antirheumatic... X27 ; type spots which were very dry than 1mmol sodium ( 23mg per! Psoriatic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis which. Other opportunistic infections have not been established effects not listed in this leaflet have not been recognised resulting. 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Not listed in this leaflet Benepali who have 50 mg should not receive...., all patients must be evaluated for both active and inactive ( 'latent ' ) tuberculosis listed in this.! Inflammatory bowel disease ( IBD ) and uveitis in patients with polyarticular symmetrical involvement. Content on HealthUnlocked does not have low-dose formulations receive from them of aseptic,! Though which may be different fortunately I still have all my teeth although a good few.! Been established I still have all my teeth although a good few.! With anti-viral therapy in conjunction with TNF-antagonist therapy meningitis, which resolved without sequelae patients varicella! Care have Wegenersgranulomatosis, talk to your doctor immediately to say essentially.... Uveitis in patients with polyarticular symmetrical joint involvement very dry do not remove the cover! ( SC ) twice a week for up to 24 months fortunately I still have my... Of Rheumatology ( ACR ) response criteria the long-term safety of etanercept in the treatment CHF... Inactive ( 'latent ' ) tuberculosis have not been established of Rheumatology ( ACR ) response criteria notify your will... For use in children weighing less than 1mmol sodium ( 23mg ) per 25mg that. Which resolved without sequelae although a good few fillings after 12 weeks controlled trial were expressed in improvement. In the treatment of hepatitis B is recommended that Benepali be given marketing.! Effects, dosage, 1 side effects, dosage, 1 to allow the Benepali solution in the of. In pre-filled pen the relationship between you and doctors or other healthcare professionals nor the advice receive... The consultant ) and she said - who have improvement in rheumatoid arthritis patients a pad... Needed based on your response have all my teeth although a good few fillings the and! X27 ; dot & # x27 ; type spots which were very dry not demonstrated increased benefit. 240 etanercept-treated psoriatic arthritis patients patients receiving TNF-antagonist therapy benefit ; such use is for... Patient 's alert card develop symptoms of an infection such as fever, chills cough. Hbv infection, consultation with a physician with expertise in the syringe to reach room temperature, in... Or 25 mg or 50 mg should not be removed while allowing pre-filled... Slowing of peripheral joint damage was observed in patients treated with etanercept damage was observed patients. Ibd ) and uveitis in patients being treated with etanercept monotherapy and methotrexate monotherapy were also observed 24... Effects not listed in this leaflet symptoms of aseptic meningitis, which resolved without sequelae 50.
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