The European Commission granted a marketing authorisation valid throughout the European Union for Benepali on 14 January 2016. 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. 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. 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. 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). 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! Chickenpox: Tell your doctor if you or the child are exposed to chickenpox when using Benepali. martin31040. Radiographic changes were assessed in the psoriatic arthritis study. The incidence of non-cutaneous malignancies of various types was significantly higher in patients treated with etanercept than in the control group. A total of 401 patients were enrolled, from which 203 were treated with etanercept. Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose. Serum concentration profiles were similar to those seen in adult rheumatoid arthritis patients. I will start treatment tomorrow and discuss with my dentist. If you are injecting into the abdomen, choose a site that is at least 5 cm away from the belly button. No formal clinical trials have been conducted in children aged 2 to 3 years. Do not inject into areas that are red, hard, bruised, or tender. Benepali, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Thus, the combined use of Benepali and anakinra is not recommended. Do not warm in any other way. The following list of adverse reactions is based on experience from clinical trials in adults and on postmarketing experience. Ive been on methotrexate for 5 years and can remember feeling overwhelmed at the beginning- over the years it became part n parcel of life! If I was you I'd phone your specialist nurse for advice though. Psoriatic arthritis in patients from the age of 12years and weighing 62.5kg ormore. 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. All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g., persistent cough, wasting/weight loss, low-grade fever) appear during or after Benepali treatment. Any unused medicinal product or waste material should be disposed of in accordance with local requirements. Always consult to a doctor or pharmacist before using pills or medicines. Children and adults taking Benepali may have an increased risk of developing lymphoma or another cancer. Doses of 10 mg or 25 mg etanercept or placebo were administered subcutaneously twice a week for 6 consecutive months. After taking a syringe from the refrigerator, wait approximately 30minutes to allow the Benepali solution in the syringe to reach room temperature. Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present. Haematologic reactions. One of my great start with biologic treatment, I was told it would be Etanercept then when I saw the biologic nurse have inflammatory arthritis and will start Benepali treatment soon. I ask the Hospital of course . Treatment with Benepali may result in reactivation of hepatitis B in patients who have previously been infected with the hepatitis B virus. 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. It is very important that you tell your doctor if you or the child have ever had tuberculosis, or have been in close contact with someone who has had tuberculosis. gilbert lani kauhi net worth; porto's parisian cake calories Benepali treatment may increase mortality in patients with established sepsis. Benepali works by reducing the inflammation associated with certain diseases. If there is bleeding at the injection site, press a gauze pad over the injectionsite. Patients developing a serious infection should stop Benepali treatment. In the Phase 3 studies in rheumatoid arthritis, psoriatic arthritis, and ankylosing spondylitis, no overall differences in adverse events, serious adverse events, and serious infections in patients age 65 or older who received etanercept were observed compared with younger patients. I have had root fillings in the past and have to say theyve never been an issue. This is a summary of the European public assessment report (EPAR) for Benepali. It hits you that th we meds are not so straight forward! Two large clinical trials evaluating the use of etanercept in the treatment of CHF were terminated early due to lack of efficacy. Study 4 evaluated 142 patients and had similar inclusion criteria to studies 2 and 3. Treatment with Benepali should continue until remission is achieved, for up to 24 weeks. The side effects and their frequencies seen in children and adolescents are similar to those describedabove. The combination etanercept and anakinra has not demonstrated increased clinical benefit, and is therefore not recommended. Do not mix the Benepali solution with any other medicine. 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. 3. Each pre-filled pen contains 50 mg of etanercept. If active tuberculosis is diagnosed, Benepali therapy must not be initiated. If re-treatment with Benepali is indicated, the same guidance on treatment duration should be followed. It is recommended that you record the date that Benepali is removed from the refrigerator and the date after which Benepali should be discarded (no more than 4weeks following the removal from the refrigerator). Preclinical data about peri- and postnatal toxicity of etanercept and of effects of etanercept on fertility and general reproductive performance are not available. I am due to have a new bridge started on Saturday which involves one root canal. Compared to placebo, treatment with etanercept resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6. 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. Administration of Benepali should be discontinued if a patient develops a serious infection. 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. The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis. Benepali was also compared with Enbrel in one main study involving 596 adult patients with moderate to severe rheumatoid arthritis despite treatment with methotrexate. Vaccinations: Some vaccines, such as oral polio vaccine, should not be given during Benepali therapy. You or the child should not use Benepali with medicines that contain the active substance anakinra or abatacept. Benepali & Dental Treatment meds before dental treatment was 3 weeks but I'm unsure of the time scale prior to dental. The medicine can only be obtained with a prescription. 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. Increased etanercept concentrations were not observed in patients with acute hepatic failure. No information is available if the use of Benepali effects the ability to drive or use machines. The expiry date refers to the last day of thatmonth. Treatment with etanercept 25 mg resulted in substantial improvement at 12 months, with about 44% of patients achieving a normal HAQ score (less than 0.5). 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. The swelling and inflammation has been a lot better. Posology and administration are the same as for adults 18-64 years of age. Benepali is also prescribed for the treatment of the following diseases in children and adolescents. Tumour necrosis factor (TNF) is a dominant cytokine in the inflammatory process of rheumatoid arthritis. Treatment with Benepali should not be initiated in patients with active infections, including chronic or localised infections. Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby. Paediatric patients with plaque psoriasis. Benepali may be stored 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. Improvements in health-related quality of life and physical function were also maintained through 2 years of therapy. Responses of patients with psoriasis in studies 2, 3 and 4. What you need to know before you use Benepali, 6. If Benepali has no effect on the childscondition after 12weeks, your doctor may tell you to stop using this medicine. To view profiles and participate in discussions please. 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. In the 2-year active-controlled study where patients were treated with either etanercept alone, methotrexate alone or etanercept in combination with methotrexate, the rates of serious infections were similar among the treatment groups. Efficacy response in placebo-controlled nr-AxSpa study: Percent of patients achieving endpoints, Double-Blind Clinical Responses at Week 12, *Some patients did not provide complete data for each endpoint, **ASAS=Assessments in Spondyloarthritis International Society, ***Bath Ankylosing Spondylitis Disease Activity Index, a: p < 0.001, b: < 0.01 and c: < 0.05, respectively between etanercept and placebo. Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF-antagonist therapy are not available. I was told there was no need to stop sulfasalazine or hydoroxychloroquine. Malignancies and lymphoproliferative disorders, Solid and haematopoietic malignancies (excluding skin cancers). (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). 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). 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. In patients who develop HBV infection, Benepali should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated. The types and proportion of adverse events in juvenile idiopathic arthritis patients were similar to those seen in trials of etanercept in adult patients with rheumatoid arthritis, and the majority were mild. The specific activity of etanercept is 1.7 106 units/mg. 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. Adult patients treated with etanercept and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either etanercept or anakinra alone (historical data). Additionally, there have been rare reports of peripheral demyelinating polyneuropathies (including Guillain-Barr syndrome, chronic inflammatory demyelinating polyneuropathy, demyelinating polyneuropathy, and multifocal motor neuropathy). Original PDF (ema.europa.eu), 1. Alcohol abuse: Benepali should not be used for the treatment of hepatitis related to alcohol. No data are available on the secondary transmission of infection by live vaccines in patients receiving etanercept. These mean concentrations in patients with paediatric plaque psoriasis were similar to the concentrations observed in patients with juvenile idiopathic arthritis (treated with 0.4 mg/kg etanercept twice weekly, up to maximum dose of 50 mg per week). Hope this is of some help, would advise you check with your rheumatology team as this advise was a few years ago. 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. For the full list of restrictions, see the package leaflet. My experience is that dentists have little knowledge about rheumatology drugs. Benepali is only available as 25 mg pre-filled syringe, 50 mg pre-filled syringe and 50 mg pre-filled pen. 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. The dose should be 50 mg once weekly. In addition, use of an immunoglobulin Fc region as a fusion element in the construction of a dimeric receptor imparts a longer serum half-life. 8. The packaging for Benepali is beautiful and as good as Apples BUT is extremely painful and difficult for RA people to open.Also injecting into thigh I found was agony but lying flat on my back and into the abdo no problem (but not near tummy button) and no pain.Wait for the click,count to ten and remove. Physicians should exercise caution when considering the use of Benepali in patients with a history of recurring or chronic infections or with underlying conditions that may predispose patients to infections, such as advanced or poorly controlled diabetes. a sore throat feeling sick or vomiting a mild fever headaches dizziness a rash stomach pain. Serious allergic reactions are rare. Similarly, the significant advantages for etanercept monotherapy compared with methotrexate monotherapy were also observed after 24 months. Undesirable effects in paediatric patients with juvenile idiopathic arthritis. Last updated on 12.03.2020. Feeling full after eating a small amount , then indigestion.Hair Loss. The mean serum steady-state trough concentrations ranged from 1.6 to 2.1 mcg/ml at weeks 12, 24, and 48. Sharps disposal containers may be purchased at your local pharmacy. This may include a thorough medical history, a chest X-ray and a tuberculin test. Gently pinch a fold of skin at the cleaned injection site. Adult patients with non-radiographic axial spondyloarthritis. In the double-blind period, patients received etanercept 50 mg weekly or placebo for 12 weeks. Benepali is an anti-inflammatory medicine. A placebo-controlled trial, in which 89 adult patients were treated with etanercept in addition to standard therapy (including cyclophosphamide or methotrexate, and glucocorticoids) for a median duration of 25 months, has not shown etanercept to be an effective treatment for Wegener's granulomatosis. There is no known antidote to etanercept. Allergic reactions; fever; rash; itching; antibodies directed against normal tissue (autoantibody formation). The recommended dose is 50 mg etanercept administered once weekly. Caution should be exercised when considering TNF-antagonist therapy for patients with a history of malignancy or when considering continuing treatment in patients who develop a malignancy. If inactive ('latent') tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Benepali, and in accordance with local recommendations. Ask your pharmacist how to throw away medicines you no longer use. Benepali controls disease activity as well as oETN 2,3 Adapted from: Emery P, et al. Allergic reactions: If you or the child experience allergic reactions such as chest tightness, wheezing, dizziness or rash, do not inject more Benepali, and contact your doctor immediately. Benepali contains the active substance etanercept. Although not conclusive, data from one of these trials suggest a possible tendency toward worsening CHF in those patients assigned to etanercept treatment. Do not use this medicine after the expiry date which is stated on the carton and the label of the prefilled syringe after EXP. The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma. If you feel that the effect of Benepali is too strong or too weak, talk to your doctor or pharmacist. In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with etanercept and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with etanercept. You can findproduct informationdocuments for centrally authorised human medicines on this website. In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change 0.5) at 12 months was higher in the etanercept group compared with the placebo group (73% vs. 47%, respectively, p 0.001). Long-term studies to assess the safety of the combination are ongoing. Original PDF (ema.europa.eu), Benepali - patient leaflet, side effects, dosage, 1. 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. Week 12 results are shown in the table below. Therefore, the CHMPs view was that, as for Enbrel, the benefits outweighs the identified risks. The most commonly reported adverse reactions are injection site reactions (such as pain, swelling, itching, reddening and bleeding at the puncture site), infections (such as upper respiratory infections, bronchitis, bladder infections and skin infections), allergic reactions, development of autoantibodies, itching, and fever. Paediatric patients with juvenile idiopathic arthritis. There have been post-marketing reports of worsening of CHF, with and without identifiable precipitating factors, in patients taking etanercept. For more information on biosimilar medicines, see related information. Asingle-use pre-filled syringe contains one 25mg dose of Benepali. The clinical significance of this is unknown. 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. The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature. Drug retention time was the primary efficacy endpoint compared to the biosimilar and the original. Postmarketing cases of Merkel cell carcinoma have been reported very infrequently in patients treated with etanercept. In adults (aged 18 and over), Benepali can be used for: moderate or severe rheumatoid arthritis; psoriatic arthritis; No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin. Do not remove the needle cover until you are ready to inject. The study evaluated 234 adult patients with active rheumatoid arthritis who had failed therapy with at least one but no more than four disease-modifying antirheumatic drugs (DMARDs). 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. a Patients who did not complete 12 months in the study were considered to be non-responders. Update on my rantings of bad dental work and RA. Serious infections affect fewer than 1 in 100 patients treated with etanercept. Kaposissarcoma most commonly appears as purple lesions on the skin); excessive activation of white blood cells associated with inflammation (macrophage activation syndrome); recurrence of hepatitis B (a liver infection); worsening of a condition called dermatomyositis (muscle inflammation and weakness with an accompanying skin rash); listeria (a bacterial infection). Swelling of the face, throat, hands, or feet, Feeling nervous or anxious, throbbing sensations, sudden reddening of the skin and/or a warm feeling, Severe rash, itching, or hives (elevated patches of red or pale skin that oftenitch), Signs of serious infections (including pneumonia, deep skin infections, joint infectionsand. The presence of hepatic impairment should not require a change in dosage. During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three etanercept doses. I'm on enbrel, Benepali is the biosimilar drug. If. The medicine should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein. Signs of heart failure or worsening heart failure, such as fatigue or shortness of breath with activity, swelling in the ankles, a feeling of fullness in the neck or abdomen, night-time shortness of breath or coughing, bluish colour of the nails or thelips; Signs of cancers: Cancers may affect any part of the body including the skin and blood, and possible signs will depend on the type and location of the cancer. After taking a syringe or a pen from the refrigerator, wait approximately 30 minutes to allow the Benepali solution in the syringe or the pen to reach room temperature. Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept. In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products. Your doctor may decide if you or the child need less anti-diabetic medicine while taking Benepali. If re-treatment with Benepali is indicated, the same guidance on treatment duration should be . 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. Hi Guys wee update on my dental treatment firstly can I just say I went to my last appointment on my own (massive achievement) I wont say I wasnt scared I was petrified but felt the need to do this & did. The double-blind period was followed by an open-label period during which all patients receive etanercept 50 mg weekly for up to an additional 92 weeks. One rheumatoid arthritis patient mistakenly self-administered 62 mg etanercept subcutaneously twice weekly for 3 weeks without experiencing undesirable effects. Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months. Congestive heart failure: Tell your doctor if you or the child have a history of congestive heart failure, because Benepali needs to be used with caution under these circumstances. PPIs are used to treat acid-related conditions such as esophageal/duodenal/stomach ulcers and GERD. Appropriate screening tests, i.e., tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply). Slowly push down the plunger to inject all of the Benepali solution. Clinical responses among nr-AxSpa patients who received etanercept were apparent at the time of the first visit (2 weeks) and were maintained through 2 years of therapy. Also the side effects not as bad, compared to Methotrexate which made me feel ill. Patients developing a serious infection should stop Benepali treatment. The long-term safety of etanercept in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established. In a group of 2,711 plaque psoriasis patients treated with etanercept in double-blind and open-label studies of up to 2.5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported. The recommended dose of etanercept is 50 mg administered once weekly. I contacted my rheumatology helpline for advise. In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death. There have been reports of hypoglycaemia following initiation of etanercept in patients receiving medicinal products for diabetes, necessitating a reduction in anti-diabetic medicinal products in some of these patients. Hepatitis B: Tell your doctor if you or the child have or have ever had hepatitis B. 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. Each pre-filled syringe contains 50 mg of etanercept. 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. These reactions should stop appearing after a month of treatment. Wipe the skin at the injection site with an alcohol swab. If you notice any of the following, you or the child may need urgent medical attention. In an analysis in which all patients who dropped out of the study for any reason were considered to have progressed, the percentage of patients without progression (TSS change 0.5) at 24 months was higher in the etanercept in combination with methotrexate group compared with the etanercept alone and methotrexate alone groups (62%, 50%, and 36%, respectively; p < 0.05). Benepali should be used with caution in patients with a history of hepatitis C. Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone. You can let go of the skin that you are pinching after the needle is completely inserted. Benepali is administered by an injection under the skin (subcutaneoususe). 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. FUJIFILM Diosynth Biotechnologies Denmark ApS. Tell your doctor or pharmacist if you or the child are taking, have recently taken or might take any other medicines (including sulfasalazine). If you have any further questions on the use of this medicine, ask your doctor or pharmacist. Similar results were obtained in the 2 smaller ankylosing spondylitis trials. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease. sighI had so much hope that I was one of the \\"lucky ones\\" who was methotraxate tablets verses methotrexate injection to stop m Do biologics (and other RA meds) frequently stop working? Allergic reactions have included angioedema and urticaria; serious reactions have occurred. 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. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency. At my pre biological methotraxate tablets verses methotrexate injection to stop m Do biologics (and other RA meds) frequently stop working? These mean concentrations were similar to those seen in adult patients with plaque psoriasis treated with 25 mg etanercept twice-weekly. Tell your doctor immediately, or go to the casualty department at your nearest hospital. In study 1, the etanercept-treated group had a significantly higher proportion of patients with a PASI 75 response at week 12 (30%) compared to the placebo-treated group (2%) (p < 0.0001). Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Biogen - 112923. Compared to placebo, patients with rheumatic diseases treated with etanercept had a significantly higher incidence of injection site reactions (36% vs. 9%). THE BENEPALITMPRE-FILLED SYRINGE IS FOR A SUBCUTANEOUS INJECTION. In this study, structural joint damage was assessed radiographically and expressed as change in Total Sharp Score (TSS) and its components, the erosion score and Joint Space Narrowing (JSN) score. Keep the pre-filled syringes in the outer carton in order to protect fromlight. The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly. If an alternate dose is required, other etanercept products offering such an option should be used. IT SHOULD BE INJECTED INTO THE THIGH, ABDOMEN, OR BACK OF THE UPPER ARM. essentially 'sodium-free'. Date of first authorisation: 14 January 2016. Physicians should use caution when using Benepali in patients who have congestive heart failure (CHF). Etanercept may also modulate biologic responses controlled by additional downstream molecules (e.g., cytokines, adhesion molecules, or proteinases) that are induced or regulated by TNF. Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma. This includes any possible side effects not listed in this leaflet. I was advised to have a gap of at least 10days from abatacept, 1week antibiotics & then a further week until the next infusion. 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. Patients treated with Benepali should be given the Patient Alert Card. Serious and fatal infections have been reported during use of etanercept; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi. 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 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. Do not use heat sources, such as a microwave or hot water, to warm Benepali. Clearance is approximately 0.066 l/hr in patients with rheumatoid arthritis, somewhat lower than the value of 0.11 l/hr observed in healthy volunteers. It should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein. Benepali 50 mg solution for injection in pre-filled syringe. Doses of 10 mg or 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months. Dose and frequency of dosing for the child or adolescent will depend on body weight and disease. 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). 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. I've had a root canal on it no problem. Adult patients with ankylosing spondylitis. 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). 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. Patients weighing 62.5 kg or more, may be dosed using a fixed-dose pre-filled syringe or pre-filled pen. Anyone on Benepali had root canal treatment? A biexponential curve is required to describe the concentration time curve of etanercept. 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 Hypoglycaemia in patients treated for diabetes. Please consult your doctor before you or the child receive any vaccines. Do not freeze. Mean duration was approximately 3 to 5 days. Vaccinations: If possible, children should be up to date with all vaccinations before using 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. It is advisable to refrain from the injection till after the Dental treatment as it could impair wound healing. If you or the child develop symptoms of an infection such as fever, chills or cough, notify your doctor immediately. 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. Your doctor will determine if Benepali is an appropriate treatment. Pre-filled pen containing a pre-filled syringe of Benepali. Do not twist or bend the needle cover while removing it, as this may damage the needle. If you are not sure, please talk to your doctor. Other etanercept products with appropriate dosage forms for children are available. These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa). Physicians should use caution when using Benepali in patients who also have moderate to severe alcoholic hepatitis. moderate to severe rheumatoid arthritis (an immune-system disease causing inflammation of the joints) in adults (aged 18 years or over). 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. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Benepali. The educational materials also include a reminder that Benepali is not for use in children and adolescents who weigh less than 62.5 kg. The exposure-adjusted rate was 0.06 events per 100 patient-years. 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). The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression. The differences in TSS and JSN were not statistically significant between methotrexate and etanercept 25 mg. European Medicines AgencyDomenico Scarlattilaan61083 HS AmsterdamThe Netherlands. This appearance is normal for Benepali. For the United Kingdom, as of 1 January 2021, European Union law applies only to the territory of Northern Ireland (NI) to the extent foreseen in the Protocol on Ireland / NI. blood infection), such as high fever that may be accompanied by cough, shortness of breath, chills, weakness, or a hot, red, tender, sore area on the skin or joints; These are rare or uncommon side effects, but are serious conditions (some of which may rarely be fatal). 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. There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation. Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of etanercept. 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. This is a biosimilar medicine, which is a biological medicine highly similar to another already approved biological medicine called the reference medicine. Please tell your doctor if you or the child in your care have a history of alcoholabuse. Etanercept serum values were determined by an Enzyme-Linked Immunosorbent Assay (ELISA) method, which may detect ELISA-reactive degradation products, as well as the parent compound. With twice-weekly doses, it is anticipated that steady-state concentrations are approximately twice as high as those observed after single doses. The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria. Treatment should be discontinued in patients who show no response after 12 weeks. Benepali 50 mg solution for injection in pre-filled pen. The doctor will provide you with detailed directions for preparing and measuring the appropriatedose. Allergic reactions associated with etanercept administration have been reported commonly. I dont see it as a wound and its for precaution. See Choose an injection site for guidance with choosing an injectionsite. 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. Methotrexate needs to be stopped while taking antibiotics & until incisions are healed. The conduct of these tests should be recorded on the Patient Card. With a quick, dart-like motion, insert the needle fully into the skin. If I am honest I was really taken aback by the nurse of Wednesday. A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. If you forget a dose, you should inject it as soon as you remember, unless the next scheduled dose is the next day; in which case you should skip the missed dose. 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. Significant improvement was also observed for the ASAS partial remission and BASDAI 50. For more information, see Biosimilar medicines. Caution should be exercised when administering Benepali in patients previously infected with HBV. 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. Paediatric plaque psoriasis (age 6 years and above). Benepali should not normally be used in children with polyarthritis or extended oligoarthritis below the age of 2years or weighing less than 62.5kg, or in children with enthesitis-related arthritis or psoriatic arthritis below the age of 12years or weighing less than 62.5kg, or in children with psoriasis below the age of 6years or weighing less than 62.5kg. In a 48-week study in 211 children aged 4 to 17 years with paediatric plaque psoriasis, the adverse events reported were similar to those seen in previous studies in adults with plaque psoriasis. The clinical significance of this interaction is unknown. 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. So does that mean As I am having the treatment on Saturday I miss Wednesday dose and is all ok I start back the following week?? No dose adjustment is required. For centrally authorised veterinary medicines authorised or updated from February 2022, see theVeterinary Medicines Information website. 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). Reactivation of hepatitis B in patients who were previously infected with the hepatitis B virus (HBV) and had received concomitant TNF-antagonists, including etanercept, has been reported. ROTATE THE SITE FOR EACH INJECTION. Responses of patients with ankylosing spondylitis in a placebo-controlled trial. Treatment of polyarthritis (rheumatoid factor positive or negative) and extended oligoarthritis in children and adolescents from the age of 2 years who have had an inadequate response to, or who have proved intolerant of, methotrexate. No studies on the effects on the ability to drive and use machines have been performed. Benepali should be discarded if not used within four weeks of removal from refrigeration. Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept. This benefit was maintained in Year 2 of this study. However, any of the above symptoms may indicate an allergic reaction to Benepali, so you should seek immediate medical attention. Patients with paediatric plaque psoriasis (aged 4 to 17 years) were administered 0.8 mg/kg (up to a maximum dose of 50 mg per week) of etanercept once weekly for up to 48 weeks. 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. Benepali, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. Etanercept crosses the placenta and has been detected in the serum of infants born to female patients treated with etanercept during pregnancy. Mean (SE) annualized change from baseline in total sharp score. I think it best if you contact your Rheumy nurse for advice. You must be present to . Do not use the pre-filled syringe if it has been dropped onto a hard surface. For enthesitis-related arthritis in patients from the age of 12years and weighing 62.5kg ormore. So if you're going on a two-week holiday, take two pens in a FRIO pouch. TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs. Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Benepali, alone or in combination with methotrexate, has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function. 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. The usual dose is 25mg twice a week or 50mg once aweek. The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001). I thought I had done my reading around (even the pack that came with the meds) the subject. Serious infections occurred in 6.3% of rheumatoid arthritis patients treated with etanercept for up to 48 months. Benepali is not recommended during pregnancy. Tell your doctor if you or the child develop any change in the appearance of the skin or growths on theskin. email etc . 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). Do not warm in any other way. If any of the above occurs, tell your doctor immediately, or visit the casualty department at your nearest hospital. Only take the pens you'll need for your stay. There is generally no applicable use of etanercept in children aged below 6 years in the indication plaque psoriasis. For th e full list of all side effects reported with Benepali, see the package leaflet. Thus, it is not possible to administer Benepali to paediatric patients that require less than a full 25 mg or 50 mg dose. Benepali is not for use in children weighing less than 62.5 kg, as Benepali does not have low-dose formulations. Additionally, some patients developed recall injection site reactions characterised by a skin reaction at the most recent site of injection, along with the simultaneous appearance of injection site reactions at previous injection sites. 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. 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 Various malignancies have also been reported with use of etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma). 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. 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. In adults (aged 18and over), Benepali can be usedfor: In each case Benepali is used, usually when other widely used treatments have not worked well enough or are not suitable foryou. Combining the results of controlled clinical trials, more cases of NMSC were observed in patients receiving etanercept compared with control patients, particularly in patients with psoriasis. Phone calls . There may be new information. Please do not include any personal data, such as your name or contact details. Your doctor will determine if preventive treatment for chickenpox is appropriate. No change in the rate of spontaneous abortion, stillbirth, or minor malformations was observed. 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). 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). inside the pre-filled syringe may be broken. Pairwise comparison p-values: * = p < 0.05 for comparisons of etanercept vs.methotrexate, = p < 0.05 for comparisons of etanercept + methotrexate vs. methotrexate and = p < 0.05 for comparisons of etanercept + methotrexate vs. etanercept. Each pre-filled syringe contains 25mg of etanercept. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. if you or the child have an infection of any kind. 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. Case series of 138 patients with RA, SpA or PsA treated with at least one dose of Benepali (n = 79) or Enbrel (n = 59). I have emailed in to clarify this, however being short staffed can take a day or two (or three) for a rely! When the syringe is empty, remove the needle from the skin at the same angle as inserted. In a study of 49 adult patients with rheumatoid arthritis treated with etanercept, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector cell populations. weight loss , and feeling Anxious. 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. Recapping could lead to a needle stick injury. A single 50 mg/ml injection of etanercept was found to be bioequivalent to two simultaneous injections of 25 mg/ml. x Chann in reply to Paula-C 4 years ago Thank you. If Benepali has no effect on your condition after 12weeks, your doctor may tell you to stop using this medicine. For the full list of all side effects reported with Benepali, see the package leaflet. Instead, the safety and efficacy of etanercept were assessed in four randomised, double-blind, placebo-controlled studies. 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. Benepali should only be used during pregnancy if clearly needed. The primary measure of efficacy (ASAS 20) was a > 20% improvement in at least 3 of the 4 Assessment in Ankylosing Spondylitis (ASAS) domains (patient global assessments, back pain, BASFI, and inflammation) and absence of deterioration in the remaining domain. Treatment should be discontinued in patients who show no response after 12 weeks. There have been reports of worsening of hepatitis C in patients receiving etanercept. The safety and efficacy profiles of the two etanercept treatment regimens were comparable at week 8 in their effect on signs and symptoms of RA; data at week 16 did not show comparability (non-inferiority) between the two regimens. 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.

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