This medicines product information is available in all official EU languages.Select available languages to access the language you need. Health Care at Home or similar. Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu. if you or the child have an infection of any kind. The mean serum steady-state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48. The expiry date refers to the last day of thatmonth. Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with etanercept during pregnancy. Good luck. In the toxicological studies with etanercept, no dose-limiting or target organ toxicity was evident. when other widely used treatments have not worked well enough or are not suitable forthem. In studies when adult patients received concurrent treatment with etanercept plus anakinra, a higher rate of serious infections compared to etanercept alone was observed and 2% of patients (3/139) developed neutropenia (absolute neutrophil count < 1,000/mm3). Women of childbearing potential should be advised to use appropriate contraception to avoid becoming pregnant during Benepali therapy and for three weeks after discontinuation of therapy. Store in a refrigerator (2C 8C). For more information about treatment with Benepali, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist. Vaccinations: Some vaccines, such as oral polio vaccine, should not be given during Benepali therapy. Benepali works by reducing the inflammation associated with certain diseases. Do not remove the needle cover until you are ready to inject. Instead, the safety and efficacy of etanercept were assessed in four randomised, double-blind, placebo-controlled studies. Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. Administration of live vaccines to infants for 16 weeks after the mother's last dose of Benepali is generally not recommended. (symptoms may include persistent rash, fever, joint pain, and tiredness); skin rash, which may lead to severe blistering and peeling of the skin; inflammation of the liver caused by the body'sown immune system (autoimmune hepatitis; in patients also receiving methotrexate treatment, the frequency is uncommon); immune disorder that can affect the lungs, skin and lymph nodes (sarcoidosis); inflammation or scarring of the lungs (in patients also receiving methotrexate treatment, the frequency of inflammation or scarring of the lungs is uncommon); lichenoid reactions (itchy reddish-purple skin rash and/or threadlike white-grey lines on mucous membranes), opportunistic infections (which include tuberculosis and other infections that occur when resistance to disease is lowered), erythema multiforme (inflammatory skin rash), cutaneous vasculitis (inflammation of blood vessels in the skin); damage to nerves, including Guillain-Barre syndrome (a serious condition which can affect breathing and damage body organs). Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept. Opportunistic infections have been reported in association with etanercept, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections. a sore throat feeling sick or vomiting a mild fever headaches dizziness a rash stomach pain. Do not use the pre-filled syringe if the needle cover is missing or not securely attached. For th e full list of all side effects reported with Benepali, see the package leaflet. Reports of various malignancies (including breast and lung carcinoma and lymphoma) have also been received in the postmarketing period. Adult patients with non-radiographic axial spondyloarthritis. Serious allergic reactions are rare. Talk to your doctor before taking Benepali. 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. The effect of etanercept on radiographic progression was maintained in patients who continued on treatment during the second year. You can let go of the skin that you are pinching after the needle is completely inserted. Abbreviations: ACR, American College of Rheumatology; ACR20/50/70, American College of Rheumatology 20%/50%/70% response criteria; oETN, originator etanercept. Treatment should be discontinued in patients who show no response after 12 weeks. I thought I had done my reading around (even the pack that came with the meds) the subject. Thank You Carol Written by CFergie 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. Patients in this study received a dose of 25 mg or 50 mg etanercept, or placebo twice a week for 12 weeks and then all patients received open-label 25 mg etanercept twice weekly for an additional 24 weeks. The Benepali pre-filled syringe is for a subcutaneous injection. Do not touch this area again before giving the injection. Infections/monitoring: Tell your doctor of any recent travel outside the European region. Enbrel (etanercept) is a prescription medication used to treat five chronic diseases including moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), and moderate to severe polyarticular juvenile idiopathic arthritis (JIA). The mechanism of action of etanercept is thought to be its competitive inhibition of TNF binding to cell surface TNFR, preventing TNF-mediated cellular responses by rendering TNF biologically inactive. Doses of 10 mg or 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months. Physicians should use caution when considering combination therapy with sulfasalazine. Like all medicines, this medicine can cause side effects, although not everybody getsthem. After a single subcutaneous dose of 25 mg etanercept, the average maximum serum concentration observed in healthy volunteers was 1.65 0.66 g/ml, and the area under the curve was 235 96.6 g hr/ml. 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. In a population pharmacokinetics analysis in ankylosing spondylitis patients, the etanercept steady state AUCs were 466 g hr/ml and 474 g hr/ml for 50 mg etanercept once weekly (n = 154) and 25 mg twice weekly (n = 148), respectively. Such symptoms may point to the existence of potentially life-threatening blood disorders, which may require discontinuation of Benepali. Evidence of efficacy for the once-weekly dosing regimen in this patient population has been based on data from the study in patients with ankylosing spondylitis. The reference medicine for Benepali is Enbrel. Patients who take Benepali must be given the special alert card that summarises important safety information about the medicine so they can recognise any serious side effects and know when to seek urgent attention from their doctor. Each pre-filled pen contains 50 mg of etanercept. I think this with the meds surprised me 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. . 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. Live vaccines should not be given concurrently with Benepali. Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA). If you or the child in your care have Wegenersgranulomatosis, talk to your doctor. Dose and frequency of dosing for the child or adolescent will depend on body weight and disease. 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. Some have occurred within a few weeks after initiating treatment with etanercept in patients who have underlying conditions (e.g., diabetes, congestive heart failure, history of active or chronic infections) in addition to their rheumatoid arthritis. It is also used to treat plaque psoriasis in adults and polyarticular juvenile idiopathic arthritis in children who are at least 2 years old. Patients treated with Benepali should be given the Patient Alert Card. Benepali 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 contraindicated), has been inadequate. Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Benepali. If you are injecting into the abdomen, choose a site that is at least 5cm away from the belly button. By blocking TNF, etanercept reduces the inflammation and other symptoms of the diseases. The results are shown in the figure below. Original PDF (ema.europa.eu), 1. No formal clinical trials have been conducted in children aged 2 to 3 years. In an open-label, single-dose, two-treatment, crossover study in healthy volunteers, etanercept administered as a single 50 mg/ml injection was found to be bioequivalent to two simultaneous injections of 25 mg/ml. Benepali is a biosimilar medicinal product. Always use this medicine exactly as your doctor has told you. The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients. It allows continued monitoring of the benefit/risk balance of the medicinal product. For polyarthritis or extended oligoarthritis in patients from the age of 2years and weighing 62.5kg or more, or enthesitis-related arthritis or psoriatic arthritis in patients from the age of 12years and weighing 62.5kg or more, the usual dose is 25mg given twice a week or 50mg given once aweek. Among patients who completed a full 24 months of therapy in the study, the non-progression rates were 78%, 70%, and 61%, respectively. The study evaluated 215 adult patients (modified intent-to-treat population) with active nr-AxSpa (18 to 49 years of age), defined as those patients meeting the ASAS classification criteria of axial spondyloarthritis but did not meet the modified New York criteria for AS. 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 clinical trials that allowed concomitant treatment with etanercept and methotrexate, the frequency (incidence proportion) of interstitial lung disease was 0.47% (frequency uncommon). Blood disorders: Seek medical advice immediately if you or the child have any signs or symptoms such as persistent fever, sore throat, bruising, bleeding or paleness. The medicine can only be obtained with a prescription. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-) inhibitors, ATC code: L04AB01. Benepali controls disease activity as well as oETN 2,3 Adapted from: Emery P, et al. Benepali is also used to associated treatment for these conditions: Ankylosing Spondylitis (AS), Graft Versus Host Disease (GVHD), Polyarticular Juvenile Idiopathic Arthritis, Psoriasis Vulgaris (Plaque Psoriasis), Psoriatic Arthritis, Pyoderma Gangrenosum, Rheumatoid Arthritis, Stevens-Johnson Syndrome How Benepali works Do not inject into areas that are red, hard, bruised, or tender. IT SHOULD BE INJECTED INTO THE THIGH, ABDOMEN, OR BACK OF THE UPPER ARM. Look at the medicine in the pre-filled syringe. Methotrexate doses were escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial and continued for up to 24 months. Gently pinch a fold of skin at the cleaned injection site. It is recommended that paediatric patients, if possible, be brought up to date with all immunisations in agreement with current immunisation guidelines prior to initiating etanercept therapy (see Vaccinations, above). The nurse went through all the risks and what to be aware of. I contacted my RA nurse (everything has to go through them before the consultant) and she said -. Similar results were obtained in the 2 smaller ankylosing spondylitis trials. Benepali must not be used in patients who have or are at risk of sepsis (when bacteria and toxins circulate in the blood and start to damage the organs), or in patients with infections. 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. The specific activity of etanercept is 1.7 106 units/mg. Benepali contains the active substance etanercept. Because baricitinib affects your immune system, it can make you more likely to pick up infections. If you received Benepali during pregnancy, your baby may have a higher risk of getting an infection. The dose should be 50 mg once weekly. Patients in this study received a dose of 50 mg etanercept or placebo once weekly for 12 weeks and then all patients received open-label 50 mg etanercept once weekly for an additional 12 weeks. This protein is found at high levels in patients with the diseases that Benepali is used to treat. The safety and efficacy of etanercept in patients with chronic infections have not been evaluated. There have been reports of IBD and uveitis in JIA patients being treated with etanercept. I would ask to speak to the Rheumatologist and get their opinion. Haematologic reactions. Do not inject into scars or stretch marks. Allergic reactions have included angioedema and urticaria; serious reactions have occurred. For more information on biosimilar medicines, see related information. In general, the adverse events in paediatric patients with juvenile idiopathic arthritis were similar in frequency and type to those seen in adult patients. In evaluating patients for infections, the patient's risk for relevant opportunistic infections (e.g., exposure to endemic mycoses) should be considered. Each pre-filled syringe contains 25mg of etanercept. There is no known antidote to etanercept. These reactions should stop appearing after a month of treatment. It is advisable to refrain from the injection till after the Dental treatment as it could impair wound healing. In lactating rats following subcutaneous administration, etanercept was excreted in the milk and detected in the serum of pups. Your doctor may decide if you or the child need less anti-diabetic medicine while taking Benepali. *see Description of selected adverse reactions, below. 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). Patients were between 18 and 70 years of age and had active psoriatic arthritis (> 3 swollen joints and > 3 tender joints) in at least one of the following forms: (1) distal interphalangeal (DIP) involvement; (2) polyarticular arthritis (absence of rheumatoid nodules and presence of psoriasis); (3) arthritis mutilans; (4) asymmetric psoriatic arthritis; or (5) spondylitis-like ankylosis. Im positive I was told that if your having any invasive dental treatment i.e. At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients. Pillintrip.com does not provide medical or pharmacological advice, diagnosis or treatment. weight loss , and feeling Anxious. moderate to severe rheumatoid arthritis (an immune-system disease causing inflammation of the joints) in adults (aged 18 years or over). These reactions were generally transient and did not recur with treatment. In the double-blind periods of controlled clinical trials of etanercept across all indications, the frequency (incidence proportion) of adverse events of elevated liver enzymes in patients receiving etanercept without concomitant methotrexate was 0.54% (frequency uncommon). This means that Benepali is highly similar to a biological medicine (also known as the reference medicine) that is already authorised in the European Union (EU). Phone calls . There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis. Etanercept 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months. In a double-blind, placebo-controlled, randomised clinical study in adult patients with psoriatic arthritis, 184 patients also received a multivalent pneumococcal polysaccharide vaccine at week 4. Please see Indications and Important Safety Information. medicines to treat diabetes. The recommended dose of etanercept is 50 mg administered once weekly. 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. Benepali is used in patients who have not responded to or cannot receive other treatments for this disease. The doctor will provide you with detailed directions for preparing and measuring the appropriatedose. Treatment with Benepali should continue until remission is achieved, for up to 24 weeks. The efficacy of etanercept in ankylosing spondylitis was assessed in 3 randomised, double-blind studies comparing twice-weekly administration of 25 mg etanercept with placebo. 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. Require discontinuation of Benepali trials have been conducted in children who are least. A fold of skin at the cleaned injection site, the safety and efficacy of etanercept assessed. Tnf- ) inhibitors, ATC code: L04AB01 lactating rats following subcutaneous administration etanercept! 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