Original PDF (ema.europa.eu), Benepali - patient leaflet, side effects, dosage, 1. The reason they tell you this is because of all the bacteria in your mouth. Immediate use is then recommended. Quality of life in psoriatic arthritis patients was assessed at every timepoint using the disability index of the HAQ. Please tell your doctor if you or the child in your care have a history of alcoholabuse. Benepali 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. Similarly, the significant advantages for etanercept monotherapy compared with methotrexate monotherapy were also observed after 24 months. These included headache (19% of patients, 1.7 events per patient year), nausea (9%, 1.0 event per patient year), abdominal pain (19%, 0.74 events per patient year), and vomiting (13%, 0.74 events per patient year). Instead, the safety and efficacy of etanercept were assessed in four randomised, double-blind, placebo-controlled studies. After previously using other drugs such as Methotrexate, sulfazalazine and another drug with awful side effects and not much improvement I can say I have improved a lot since starting Benepali. While neutropenic, one patient developed cellulitis that resolved after hospitalisation. Patients should be evaluated for infections before, during, and after treatment with Benepali, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours). Do not mix the Benepali solution with any other medicine. Had to have root treatment on bottom part underneath one of these teeth and about the prospect of root canal treatment and my recovery while on Benepali. Each pre-filled syringe contains 25mg of etanercept. With twice-weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses. The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients. In a controlled clinical trial of two years duration in rheumatoid arthritis patients, the combination of etanercept and methotrexate did not result in unexpected safety findings, and the safety profile of etanercept when given in combination with methotrexate was similar to the profiles reported in studies of etanercept and methotrexate alone. Has it been successful for injection today of benepali, although easy to do I found it very painful. In a phase II randomised placebo-controlled study of 48 hospitalised patients treated with etanercept or placebo for moderate to severe alcoholic hepatitis, etanercept was not efficacious, and the mortality rate in patients treated with etanercept was significantly higher after 6 months. inside the pre-filled syringe may be broken. In adults (aged 18 and over), Benepali can be used for: moderate or severe rheumatoid arthritis; psoriatic arthritis; Do not use heat sources, such as a microwave or hot water, to warm Benepali. Hi, is it possible to receive Benepali prescriptions from your GP as I do have continual delivery problems receiving them direct, my MTX injections I can pick up from my local pharmacy, I am aware that Benepali has to be refrigerated so maybe that is the reason for direct deliveries. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Benepali. A higher rate of major birth defects was observed in an observational study comparing pregnancies exposed to etanercept during the first trimester, with pregnancies not exposed to etanercept or other TNF-antagonists (adjusted odds ratio 2.4, 95% CI: 1.0-5.5). For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Comprehensive instructions for administration are given in the package leaflet, section 7, Instructions for use. In plaque psoriasis, infiltration by inflammatory cells, including T-cells, leads to increased TNF levels in psoriatic lesions compared with levels in uninvolved skin. Whether used alone or in combination with methotrexate, Benepali can slow down the damage to your joints caused by the rheumatoid arthritis and improve your ability to do normal daily activities. During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three etanercept doses. Responses of patients with psoriatic arthritis in a placebo-controlled trial. Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including sulfasalazine). 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. If this occurs, you should stop using Benepali. Several adverse events were reported more commonly in 69 juvenile idiopathic arthritis patients receiving 3 months of etanercept compared to the 349 adult rheumatoid arthritis patients. This appearance is normal for Benepali. Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age. At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients. Wegenersgranulomatosis: Benepali is not recommended for the treatment of Wegenersgranulomatosis, a rare inflammatory disease. Benepali is a biosimilar medicinal product. severe axial spondyloarthritis including ankylosing spondylitis; For the following types of juvenile idiopathic arthritis when treatment with methotrexate has not worked well enough or is not suitable forthem: Polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in patients from the age of 2years and weighing 62.5kg ormore. This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative. a Patients who did not complete 12 months in the study were considered to be non-responders. Treatment should be discontinued in patients who show no response after 12 weeks. The safety and efficacy of etanercept in patients with immunosuppression have not been evaluated. This site is intended for EU healthcare professionals only. Two large clinical trials evaluating the use of etanercept in the treatment of CHF were terminated early due to lack of efficacy. Carcinogenicity studies, and standard assessments of fertility and postnatal toxicity, were not performed with etanercept due to the development of neutralising antibodies in rodents. Continuous therapy beyond 24 weeks may be appropriate for some adult patients. 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. Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available. Laboratory studies comparing Benepali with Enbrel have shown that the active substance in Benepali is highly similar to that in Enbrel in terms of structure, purity and biological activity. Administration of Benepali should be discontinued if a patient develops a serious infection. The types of major birth defects were consistent with those most commonly reported in the general population and no particular pattern of abnormalities was identified. These reactions were generally transient and did not recur with treatment. For psoriasis in patients from the age of 6years and weighing 62.5kg or more, the usual dose is 50mg and should be given once weekly. If you have psoriasis, do not inject into any raised, thick, red, or scaly skin patches, or lesions. The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study in 205 patients with psoriatic arthritis. If you type it in you may find a post or two there. Your doctor may decide if you or the child need less anti-diabetic medicine while taking Benepali. Infections/surgery: If you or the child develop a new infection, or are about to have any major surgery, your doctor may wish to monitor the treatment with Benepali. You or the child should not use Benepali with medicines that contain the active substance anakinra or abatacept. Your doctor may decide to continue to monitor you or the child for the presence of infections after you stop using Benepali. Psoriatic arthritis in patients from the age of 12years and weighing 62.5kg ormore. Vaccinations: If possible, children should be up to date with all vaccinations before using Benepali. There is no known antidote to etanercept. Alternatively, 50mg may be given twice a week for up to 12weeks, followed by 25mg twice a week or 50mg once aweek. There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis. I'm on enbrel, Benepali is the biosimilar drug. Etanercept is a competitive inhibitor of TNF binding to its cell surface receptors, and thereby inhibits the biological activity of TNF. After discontinuation of etanercept, symptoms of arthritis generally returned within a month. Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. The presence of hepatic impairment should not require a change in dosage. Look at the medicine in the pre-filled syringe. Today I have started on Benepali. For more information on biosimilar medicines, see related information. For rheumatoid arthritis , Benepali is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you. For more information about treatment with Benepali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Key results of studies 2, 3 and 4 are shown below. 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. Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Benepali. 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. See Choose an injection site for guidance with choosing an injectionsite. 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). There have been rare reports of patients, including rheumatoid factor positive patients, who have developed other autoantibodies in conjunction with a lupus-like syndrome or rashes that are compatible with subacute cutaneous lupus or discoid lupus by clinical presentation and biopsy. The nurse went through all the risks and what to be aware of. Sounds like a plan, you are quite right after so long the meds become a major part of our lifes and its only then that we realise what an important part they play in giving us back some normality and quality of life. 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. 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. The modified TSS at 12 months is presented in the table below. Tell your doctor immediately, or go to the casualty department at your nearest hospital. Do not twist or bend the needle cover while removing it, as this may damage the needle. Some patients receiving Benepali have developed skin cancers. At week 12, there was a statistically significant improvement in the SPARCC (Spondyloarthritis Research Consortium of Canada) score for the sacroiliac joint (SIJ) as measured by MRI for patients receiving etanercept. Developmental toxicity studies performed in rats and rabbits have revealed no evidence of harm to the foetus or neonatal rat due to etanercept. No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept. Date of first authorisation: 14 January 2016. Etanercept showed statistically significantly greater improvement from baseline to week 12 compared to placebo in most health-related quality of life and physical function assessments, including BASFI (Bath Ankylosing Spondylitis Functional Index), EuroQol 5D Overall Health State Score and SF-36 Physical Component Score.
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