They are way more knowledgeable than the rheumy nurse. Some vaccines, such as oral polio vaccine, should not be given while using Benepali. There have been rare reports of lupus, lupus-related conditions, and vasculitis. 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. Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanercept. Benepali should be discarded if not used within four weeks of removal from refrigeration. The proportion of patients treated with etanercept who developed anticardiolipin antibodies was similarly increased compared to placebo-treated patients. Undesirable effects in paediatric patients with juvenile idiopathic arthritis. Infections/monitoring: Tell your doctor of any recent travel outside the European region. Comprehensive instructions for administration are given in the package leaflet, section 7, Instructions for use. Radiographic progression at 12 months was significantly less in the etanercept group than in the methotrexate group, while the combination was significantly better than either monotherapy at slowing radiographic progression (see figure below). The differences in TSS and JSN were not statistically significant between methotrexate and etanercept 25 mg. Among patients with psoriatic arthritis who received etanercept, the clinical responses were apparent at the time of the first visit (4 weeks) and were maintained through 6 months of therapy. Benepali is also indicated in the treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate. For th e full list of all side effects reported with Benepali, see the package leaflet. 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). Immediate use is then recommended. In the double-blind period, patients received etanercept 50 mg weekly or placebo for 12 weeks. 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). 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 use of etanercept in combination with other systemic therapies or phototherapy for the treatment of psoriasis has not been studied. During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three etanercept doses. The nurse went through all the risks and what to be aware of. Patients developing a serious infection should stop Benepali treatment. Some of these patients have been under 50 years of age. Compared to placebo, treatment with etanercept resulted in significant improvements in the ASAS 20, ASAS 50 and ASAS 70 as early as 2 weeks after the initiation of therapy. This includes any possible side effects not listed in this leaflet. manufacturing authorisationholder responsible for batch release (annex IIA). Infections/diabetes: Tell your doctor if you or the child have a history of recurrent infections or suffer from diabetes or other conditions that increase the risk of infection. Week 12 results are shown in the table below. 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. In lactating rats following subcutaneous administration, etanercept was excreted in the milk and detected in the serum of pups. It is important that you tell the babysdoctors and other healthcare professionals about the use of Benepali during pregnancy before the baby receives any vaccine (for more information see section 2, Vaccinations). A study was carried out to show that Benepali produces similar levels of the active substance in the body to Enbrel. These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice-weekly. Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept. Results are summarised in the table below. Adult patients with non-radiographic axial spondyloarthritis. Approximately half the cases were lymphomas. These include rare reports of pancytopenia and very rare reports of aplastic anaemia. The recommended dose of etanercept is 50 mg administered once weekly. The solution should be clear to slightly opalescent, colourless or pale yellow and may contain small translucent or white particles of protein. 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. These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa). I will start treatment tomorrow and discuss with my dentist. Benepali is not recommended for the treatment of Wegener's granulomatosis. Doses of 10 mg or 25 mg etanercept or placebo were administered subcutaneously twice a week for 6 consecutive months. Benepali is administered by an injection under the skin (subcutaneoususe). 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. Do not use heat sources, such as a microwave or hot water, to warm Benepali. Patients also had plaque psoriasis with a qualifying target lesion > 2 cm in diameter. Paediatric plaque psoriasis (age 6 years and above). If needed, cover the injection site with a plaster. One hundred and twenty-nine (129) new malignancies of various types were observed in 4,114 rheumatoid arthritis patients treated in clinical trials with etanercept for up to approximately 6 years, including 231 patients treated with etanercept in combination with methotrexate in the 2-year active-controlled study. b Values for Disease Activity Score (DAS) are means. The solution is clear to slightly opalescent, colourless or pale yellow, and is formulated at pH 6.2 0.3. The efficacy of etanercept was assessed in a randomised, double-blind, placebo-controlled study. In adults (aged 18 and over), Benepali can be used for: moderate or severe rheumatoid arthritis; psoriatic arthritis; Radiographic progression: Comparison of etanercept vs. methotrexate vs. etanercept in combination with methotrexate in patients with RA of 6 months to 20 years duration (12 month results). You can let go of the skin that you are pinching after the needle is completely inserted. The youngest children (4 years of age) had reduced clearance (increased clearance when normalised by weight) compared with older children (12 years of age) and adults. Patients developing a serious infection should stop Benepali treatment. Do not inject into areas that are red, hard, bruised, or tender. Continuous therapy beyond 24 weeks may be appropriate for some adult patients. It allows continued monitoring of the benefit/risk balance of the medicinal product. 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. The medicine should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 50 mg once weekly. 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 specific activity of etanercept is 1.7 106 units/mg. This protein is found at high levels in patients with the diseases that Benepali is used to treat. Serious haematological, neurological and autoimmune reactions have also been reported. Biogen - 112923. Attention! There is no apparent pharmacokinetic difference between males and females. 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). 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. Your symptoms may return upon discontinuation. Etanercept 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. The reason they tell you this is because of all the bacteria in your mouth. These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy. In one study in children with juvenile idiopathic arthritis aged 4 to 17 years, 43 of 69 (62%) children experienced an infection while receiving etanercept during 3 months of the study (part 1, open-label), and the frequency and severity of infections was similar in 58 patients completing 12 months of open-label extension therapy. The medicine can only be obtained with a prescription. Etanercept was administered at doses of 25 mg once a week, 25 mg twice a week or 50 mg twice a week for 6 consecutive months. For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder: Detailed information on this medicine is available on the European Medicines Agency website: Read the instructions for use before you start using Benepali and each time you get a refill of your prescription. You can buy a FRIO pouch for this purpose. In adults (18 years and older) Benepali can be used for: moderate or severe rheumatoid arthritis ; psoriatic arthritis severe axial spondylarthritis including ankylosing spondylitis ; moderate or severe plaque psoriasis. Alcohol abuse: Benepali should not be used for the treatment of hepatitis related to alcohol. Additionally, the pharmacokinetics of etanercept in rheumatoid arthritis patients, ankylosing spondylitis and plaque psoriasis patients are similar. (+234) 817 770 1888 | lymph node size chart. Good luck with the dentist hope it all goes ok, Hi,I also was due to start benepali,but due to root canal X 2 couldn't start,then following untold infections still haven't! There have been post-marketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking etanercept. Mean (SE) annualized change from baseline in total sharp score. I am due to have a new bridge started on Saturday which involves one root canal. The safety and efficacy of 50 mg etanercept (two 25 mg SC injections) administered once weekly were evaluated in a double-blind, placebo-controlled study of 420 patients with active RA. 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. This site is intended for EU healthcare professionals only. The possibility exists for TNF-antagonists, including etanercept, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses. Consequently, Benepali should not be used in patients for the treatment of alcoholic hepatitis. Very common (may affect more than 1in 10people), Very rare (may affect up to 1in 10,000people), Not known (frequency cannot be estimated from availabledata). Some people may have reactions at the spot of the injection, such as redness, swelling or pain. The results are shown in the figure below. Pull the needle cover straight off and dispose of it in the bin or sharps container. It should be injected into the thigh, abdomen, or back of the upper arm (see image on theleft). Benepali is available in packs containing 4 pre-filled pens and multipacks containing 12 (3 packs of 4) pre-filled pens. If I am honest I was really taken aback by the nurse of Wednesday. The other ingredients are sucrose, sodium chloride, sodium dihydrogen phosphate monohydrate, disodium hydrogen phosphate heptahydrate, and water for injections (see section 2 Benepali contains sodium). Clinical responses were expressed as percentages of patients achieving the ACR 20, 50, and 70 response and percentages with improvement in Psoriatic Arthritis Response Criteria (PsARC). 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. A dose response was seen; results with 10 mg were intermediate between placebo and 25 mg. Etanercept was significantly better than placebo in all components of the ACR criteria, as well as other measures of rheumatoid arthritis disease activity not included in the ACR response criteria, such as morning stiffness. Serious infections, sepsis, tuberculosis, and opportunistic infections, including invasive fungal infections, listeriosis and legionellosis, have been reported with the use of etanercept. If you or the child in your care have Wegenersgranulomatosis, talk to your doctor. 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. Compared to placebo, patients with rheumatic diseases treated with etanercept had a significantly higher incidence of injection site reactions (36% vs. 9%). ), 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. Vaccinations: Some vaccines, such as oral polio vaccine, should not be given during Benepali therapy. Before starting treatment with Benepali, all patients must be evaluated for both active and inactive ('latent') tuberculosis. A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg. Her weight was far below the 62.5 klg , by the way . Responses of patients with ankylosing spondylitis in a placebo-controlled trial. It should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein. Your doctor may decide if you or the child need less anti-diabetic medicine while taking Benepali. Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients. For psoriatic arthritis patients with multiple joint involvement, Benepali can improve your ability to do normal daily activities. Olof Palmestraat 102616 LR DelftThe Netherlands, 06/01/2023 Benepali - EMEA/H/C/004007 - IB/0072. 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. Of severe, active and inactive ( 'latent ' ) tuberculosis Benepali can improve your to. 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