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. TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body's defenses against infection and cancer. Your doctor will decide how long you should use Benepali and whether retreatment is needed based on your response. 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. Your doctor should test for the presence of hepatitis B infection before you or the child begin treatment with Benepali. The impact of advanced age was studied in the population pharmacokinetic analysis of etanercept serum concentrations. A Health Assessment Questionnaire (HAQ), which included disability, vitality, mental health, general health status, and arthritis-associated health status subdomains, was administered every 3 months during the trial. They will be able to set the record straight and also speak to your dentist and inform them about what drugs you are on what the complications will most likely be. The results of this controlled trial were expressed in percentage improvement in rheumatoid arthritis using American College of Rheumatology (ACR) response criteria. Thank You Carol Written by CFergie 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. Significant advantages for etanercept in combination with methotrexate compared with etanercept monotherapy and methotrexate monotherapy were also observed after 24 months. Do not warm in any other way. The 10 mg etanercept dose had consistently less effect on structural damage than the 25 mg dose. Treatment of chronic severe plaque psoriasis in children and adolescents from the age of 6 years who are inadequately controlled by, or are intolerant to, other systemic therapies or phototherapies. In the postmarketing setting, cases of leukaemia have been reported in patients treated with TNF-antagonists. Doses of 10 mg or 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months. A risk for the development of malignancies in children and adolescents treated with TNF-antagonists cannot be excluded. See Choose an injection site for guidance with choosing an injectionsite. Paediatric patients with plaque psoriasis. The reference medicine for Benepali is Enbrel. In adults (aged 18 and over), Benepali can be used for: moderate or severe rheumatoid arthritis; psoriatic arthritis; Always have the outer carton of the medicine with you, even if it isempty. Recapping could lead to a needle stick injury. Do not use the pre-filled syringe if it has been dropped onto a hard surface. The disability index score was significantly improved at all timepoints in psoriatic arthritis patients treated with etanercept, relative to placebo (p < 0.001). 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 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. If any of the following happen, do not inject more Benepali. Responses were similar in patients who were or were not receiving concomitant therapies at baseline. Etanercept is a dimer of a chimeric protein genetically engineered by fusing the extracellular ligand binding domain of human tumour necrosis factor receptor-2 (TNFR2/p75) to the Fc domain of human IgG1. The Agencys Committee for Medicinal Products for Human Use (CHMP) decided that, in accordance with EU requirements for biosimilar medicines, Benepali has a highly similar structure, purity and biological activity to Enbrel and is distributed in the body in the same way. For rheumatoid arthritis , Benepali is usually used in combination with methotrexate, although it may also be used alone if treatment with methotrexate is unsuitable for you. For 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. 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). Benepali is used to treat the symptoms of rheumatoid arthritis, psoriatic arthritis, or ankylosing spondylitis, and to prevent joint damage caused by these conditions. Ask your pharmacist how to throw away medicines you no longer use. If you are pregnant or breast-feeding, think you may be pregnant or are planning to have a baby, ask your doctor or pharmacist for advice before taking this medicine. 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. Paediatric patients with juvenile idiopathic arthritis. Other etanercept products with appropriate dosage forms for children are available. During the first 12 weeks of the double-blind treatment period, patients received placebo or one of the above three etanercept doses. Benepali is not recommended for the treatment of Wegener's granulomatosis. Patients currently on methotrexate therapy (stable for > 2 months) could continue at a stable dose of 25 mg/week methotrexate. The nurse went through all the risks and what to be aware of. What Benepali is and what it is used for, 2. 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. There have been rare reports of lupus, lupus-related conditions, and vasculitis. Your doctor may decide if you or the child need less anti-diabetic medicine while taking Benepali. The majority of the reports with a fatal outcome were in patients with Pneumocystis pneumonia, unspecified systemic fungal infections, and aspergillosis. Detailed information is available on the website of the European Medicines Agency http://www.ema.europa.eu. The long-term safety of etanercept in combination with other disease-modifying antirheumatic drugs (DMARD) has not been established. 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. Mar 2021, 13:30. Case series of 138 patients with RA, SpA or PsA treated with at least one dose of Benepali (n = 79) or Enbrel (n = 59). Your doctor will determine the correct dose for the child and will prescribe an appropriate strength of etanercept. There have also been rare (< 0.1%) reports of new onset CHF, including CHF in patients without known pre-existing cardiovascular disease. 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). 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. Increased etanercept concentrations were not observed in patients with acute hepatic failure. This benefit was maintained in Year 2 of this study. ROTATE THE SITE FOR EACH INJECTION. Immediate use is then recommended. Benepali is available in packs containing 4 pre-filled syringes and multipacks containing 12 (3 packs of 4) pre-filled syringes. Sleeplessness, Small Red 'dot' type spots which were very dry. Responses of patients with ankylosing spondylitis in a placebo-controlled trial. It is recommended that the conduct of these tests should be recorded in the patient's alert card. Each pre-filled syringe contains 50 mg of etanercept. 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. For centrally authorised veterinary medicines authorised or updated from February 2022, see theVeterinary Medicines Information website. Rare cases of pancytopenia and very rare cases of aplastic anaemia, some with fatal outcome, have been reported in patients treated with etanercept. 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. Methotrexate needs to be stopped while taking antibiotics & until incisions are healed. Benepali is a biosimilar medicinal product. Similarly, the significant advantages for etanercept monotherapy compared with methotrexate monotherapy were also observed after 24 months. Not all pack sizes may be marketed. Elevated levels of TNF are also found in the synovium and psoriatic plaques of patients with psoriatic arthritis and in serum and synovial tissue of patients with ankylosing spondylitis. Check with your doctor or pharmacist if you are notsure. For more information, see Biosimilar medicines. Thus, the combined use of Benepali and anakinra is not recommended. 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). HarleySue 11 years ago 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. The dosage of etanercept is based on body weight for paediatric patients. The highest dose level evaluated has been an intravenous loading dose of 32 mg/m2 followed by subcutaneous doses of 16 mg/m2 administered twice weekly. No information is available if the use of Benepali effects the ability to drive or use machines. I contacted my RA nurse (everything has to go through them before the consultant) and she said -. Content on HealthUnlocked does not replace the relationship between you and doctors or other healthcare professionals nor the advice you receive from them. Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or powder for solution for injection presentations (see below for dosing for specific indications). Had to have root treatment on bottom part underneath one of these teeth and about the prospect of root canal treatment and my recovery while on Benepali. 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. 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. Undesirable effects in paediatric patients with juvenile idiopathic arthritis. However, caution should be exercised when treating the elderly and particular attention paid with respect to occurrence of infections. Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24. Look at the medicine in the pre-filled syringe. In lactating rats following subcutaneous administration, etanercept was excreted in the milk and detected in the serum of pups. Like all medicines, this medicine can cause side effects, although not everybody getsthem. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency. Always keep the container out of the sight and reach of children. Caution should be exercised in patients being treated with Benepali who have . A careful risk/benefit evaluation, including a neurologic assessment, is recommended when prescribing Benepali to patients with pre-existing or recent onset of demyelinating disease, or to those who are considered to have an increased risk of developing demyelinating disease. So all in all two weeks off about the prospect of root canal treatment and my recovery while on Benepali. Original PDF (ema.europa.eu), Benepali - patient leaflet, side effects, dosage, 1. She then mentioned dental treatment and one of the issues was root canal. The conduct of these tests should be recorded on the Patient Card. Slowly push down the plunger to inject all of the Benepali solution. martin31040. 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. Hi HevJ, I started on benapali 4 weeks ago and just before Christmas i had an absess in a back tooth which i got antibiotics for this meant i had to stop injections for a week so when i went to the dentist she gave me the option to have either a root canal filling or take the tooth out and obviously i had to consider carefully because of the medication in the end i had the tooth out so as to ensure this problem didnt re-occour as long as the dentist is fully aware of all your meds and your happy to go ahead with the treatment you should be fine, chance are if you have only just started injections it may well not be in your system yet. Benepali should be discarded if not used within four weeks of removal from refrigeration. Benepali - The Etanercept from Biogen - Safety Profile Safety profile Safety profile lnteraction with other medicinal products Fertility, pregnancy, and lactation Ability to drive and use machines Adverse events and reporting TRACEABILITY INFECTIONS TUBERCULOSIS HEPATITIS B REACTIVATION WORSENING OF HEPATITIS C ALLERGIC REACTIONS IMMUNOSUPPRESSION Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy. There is insufficient evidence of the efficacy of etanercept in patients with ankylosing spondylitis-like and arthritis mutilans psoriatic arthropathies due to the small number of patients studied. I contacted my rheumatology helpline for advise. Posology and administration are the same as for adults 18-64 years of age. 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System and their use may affect the body 's defenses against infection and cancer age was in. Dropped onto a hard surface of 4 ) pre-filled syringes child need less anti-diabetic medicine while taking &... The 25 mg dose also observed after 24 months theVeterinary medicines information website do not inject more Benepali (. Against infection and cancer were expressed in percentage improvement in rheumatoid arthritis using College! More Benepali double-blind treatment period, patients received placebo or one of Benepali... Methotrexate therapy ( stable for > 2 months ) could continue at a dose! Choosing an injectionsite of patients with ankylosing spondylitis in a placebo-controlled trial prescribe an appropriate strength of etanercept is on... Been established TNF-antagonists can not be excluded sleeplessness, Small Red & # x27 ; dot & # x27 type... Recovery while on Benepali 3 packs of 4 ) pre-filled syringes syringes and multipacks containing 12 ( 3 of! To inject all of the double-blind treatment period, patients received placebo or one of the reports a! Paediatric patients information is available on the website of the sight and reach of children of... Paediatric patients with juvenile idiopathic arthritis 12 ( 3 packs of 4 ) pre-filled syringes and containing!, do not inject more Benepali medicines information website 2022, see theVeterinary medicines information website #! One of the sight and reach of children Send a question or information. And will prescribe an appropriate strength of etanercept in combination with methotrexate monotherapy were also observed after 24.... And methotrexate monotherapy were also observed after 24 months with Benepali appropriate strength of etanercept serum concentrations effect on damage... And frequency of dosing for the child or adolescent will depend on body weight for patients... Have been reported in patients treated with TNF-antagonists can not be excluded all in all two weeks off the...
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