Original PDF (ema.europa.eu), Benepali - patient leaflet, side effects, dosage, 1. The dosage of etanercept is based on body weight for paediatric patients. Do not touch the plunger rod while removing the needlecover. (+234) 817 770 1888 | lymph node size chart. (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). Anti-diabetic medicines: Tell your doctor if you or the child have diabetes or aretaking. Benepali is a medicine that is made from two human proteins. Clinical improvement, including onset of action within 2 weeks with etanercept 25 mg, was similar to that seen in the previous trials and was maintained for up to 24 months. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use. Tell your doctor immediately, or go to the casualty department at your nearest hospital. 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. Physicians should use caution when using Benepali in patients who also have moderate to severe alcoholic hepatitis. 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. 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. Treatment should be discontinued in patients who show no response after 12 weeks. Based on pharmacokinetic data , no dose adjustment is needed in patients with renal or hepatic impairment; clinical experience in such patients is limited. Allow the medicine to reach room temperature: Remove one pre-filled syringe from the refrigerator and leave at room temperature for at least 30minutes before injecting. Your doctor will help you to decide whether the benefits of treatment outweigh the potential risk to your baby. 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. 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. Your doctor may decide if you or the child need less anti-diabetic medicine while taking Benepali. Your doctor will determine if Benepali is an appropriate treatment. Severe plaque psoriasis in patients from the age of 6years and weighing 62.5kg or more who have had an inadequate response to (or are unable to take) phototherapies or other systemic therapies. The Benepali pre-filled syringe is for a subcutaneous injection. These measures will help protect the environment. TNF and lymphotoxin exist predominantly as homotrimers, with their biological activity dependent on cross-linking of cell surface TNFRs. The 10 mg etanercept dose had consistently less effect on structural damage than the 25 mg dose. The primary efficacy endpoint in all four studies was the proportion of patients in each treatment group who achieved the PASI 75 (i.e., at least a 75% improvement in the Psoriasis Area and Severity Index score from baseline) at 12 weeks. For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Your doctor will decide how long you should use Benepali and whether retreatment is needed based on your response. If any serious allergic or anaphylactic reaction occurs, Benepali therapy should be discontinued immediately and appropriate therapy initiated. Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). Serious and fatal infections have been reported during use of etanercept; reported pathogens include bacteria, mycobacteria (including tuberculosis), viruses and fungi. A total of 401 patients were enrolled, from which 203 were treated with etanercept. This Fc component contains the hinge, CH2 and CH3 regions, but not the CH1 region of IgG1. 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). In the toxicological studies with etanercept, no dose-limiting or target organ toxicity was evident. Melanoma and non-melanoma skin cancer (NMSC) have been reported in patients treated with TNF-antagonists, including etanercept. Benepali is also prescribed for the treatment of the following diseases in children and adolescents. Benepali is not indicated for use in children and adolescents who weigh less than 62.5kg. 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. The exposure-adjusted rate was 0.06 events per 100 patient-years. 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. Patients receiving DMARDs, NSAIDS, or corticosteroids could continue them on stable doses. Study 3 evaluated 583 patients and had the same inclusion criteria as study 2. 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. If you have psoriasis, do not inject into any raised, thick, red, or scaly skin patches, or lesions. 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. 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. Please tell your doctor if you or the child in your care have a history of alcoholabuse. Pre-filled pen containing a pre-filled syringe of Benepali. Clearance and volume estimates in patients aged 65 to 87 years were similar to estimates in patients less than 65 years of age. Thus, it is not possible to administer Benepali to paediatric patients that require less than a full 25 mg or 50 mg dose. These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Haematologic reactions. 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). 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. 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). Hepatitis C: Tell your doctor if you or the child have hepatitis C. Your doctor may wish to monitor the treatment with Benepali in case the infection worsens. Adjusted mean change from baseline was 3.8 for etanercept treated (n = 95) versus 0.8 for placebo treated (n = 105) patients (p < 0.001). 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. Paediatric patients with juvenile idiopathic arthritis. Attention! If an alternate dose is required, other etanercept products offering such an option should be used. 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. The patient or carer can give the injection after appropriate training. The needle cover should not be removed while allowing the pre-filled syringe to reach room temperature. Good luck. Comprehensive instructions for administration are given in the package leaflet, section 7, Instructions for use. Treatment of adults with severe non-radiographic axial spondyloarthritis with objective signs of inflammation as indicated by elevated C-reactive protein (CRP) and/or magnetic resonance imaging (MRI) evidence, who have had an inadequate response to nonsteroidal anti-inflammatory drugs (NSAIDs). The efficacy of etanercept in patients with non-radiographic axial spondyloarthritis (nr-AxSpa) was assessed in a randomised, 12-week double-blind, placebo-controlled study. 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. It is used for the treatment of the following diseases: Benepali contains the active substance etanercept and is a biosimilar medicine. 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). For centrally authorised veterinary medicines authorised or updated from February 2022, see theVeterinary Medicines Information website. 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. These reactions should stop appearing after a month of treatment. essentially 'sodium-free'. 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. However, limited safety data from a patient registry suggest that the safety profile in children from 2 to 3 years of age is similar to that seen in adults and children aged 4 years and older, when dosed every week with 0.8 mg/kg subcutaneously. This acid, however, is responsible for the breakdown and absorption of vitamins and nutrients such as Vitamin B 12, iron, calcium, and magnesium. Signs of inflammation of the blood vessels such as pain, fever, redness or warmth of the skin, or itching. Abbreviations: ACR, American College of Rheumatology; ACR20/50/70, American College of Rheumatology 20%/50%/70% response criteria; oETN, originator etanercept. The absolute bioavailability is 76%. 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. If you do not remember until the day that the next injection is due, do not take a double dose (two doses on the same day) to make up for a forgottendose. At 24 weeks, 56% of patients in the etanercept-treated group had achieved the PASI 75 compared to 5% of placebo-treated patients. The most commonly reported invasive fungal infections included Candida, Pneumocystis, Aspergillus, and Histoplasma. The central volume of distribution of etanercept is 7.6 L, while the volume of distribution at steady-state is 10.4 L. Etanercept is cleared slowly from the body. Do not use the pre-filled syringe if it has been dropped onto a hard surface. A single 50 mg/ml injection of etanercept was found to be bioequivalent to two simultaneous injections of 25 mg/ml. Do not try to give yourself the injection unless your doctor or nurse has shown you how to give the injection. 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. Inflammatory bowel disease (IBD) and uveitis in patients with juvenile idiopathic arthritis (JIA). 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. 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. However, the occurrence was rare, and the follow-up period of placebo patients was shorter than for patients receiving TNF-antagonist therapy. Pharmacotherapeutic group: Immunosuppressants, tumour necrosis factor alpha (TNF-) inhibitors, ATC code: L04AB01. Secondary endpoint DAS28 SCORES Benepali controls disease activity as well as oETN 1-3 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. What you need to know before you use Benepali, 6. If I was you I'd phone your specialist nurse for advice though. These data corroborate that the original and . Each pre-filled syringe contains 25mg of etanercept. Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. Gently pinch a fold of skin at the cleaned injection site. In lactating rats following subcutaneous administration, etanercept was excreted in the milk and detected in the serum of pups. Iv tried cant seem to get hold off anyone Thank You, Hi CFergie. The major cause of discontinuation was inefficacy (57.8%). Differences from adults and other special considerations are discussed in the following paragraphs. You may feel sick, known as nausea, in the first two weeks after starting baricitinib, but this often improves with time. Patients with severe rheumatoid arthritis, who have had the disease for a long time, may be at higher than average risk of developing lymphoma. Tell your doctor if you or the child develop any change in the appearance of the skin or growths on theskin. 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