Etanercept is slowly absorbed from the site of subcutaneous injection, reaching maximum concentration approximately 48 hours after a single dose. This protein is found at high levels in patients with the diseases that Benepali is used to treat. Doses of 10 mg or 25 mg etanercept were administered subcutaneously (SC) twice a week for up to 24 months. Undesirable effects in paediatric patients with plaque psoriasis. If this occurs, you should stop using Benepali. Both TNFRs exist naturally in membrane-bound and soluble forms. 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. Patients should be tested for HBV infection before initiating treatment with Benepali. If any of the following happen, do not inject more Benepali. The other cases represented a variety of different malignancies and included rare malignancies typically associated with immunosuppression. All subdomains of the HAQ were improved in patients treated with etanercept compared to controls at 3 and 6 months. If you want to ask a question or request information from EMA, please Send a question to the European Medicines Agency. 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. At week 104, 8 subjects had progressed to a score of bilateral Grade 2 on spinal X-ray according to the modified New York Radiological Grade, indicative of axial spondyloarthropathy. Phone calls . Hope this is of some help, would advise you check with your rheumatology team as this advise was a few years ago. Comprehensive instructions for administration are given in the package leaflet, section 7, Instructions for use. Wipe the skin at the injection site with an alcohol swab. It allows continued monitoring of the benefit/risk balance of the medicinal product. Benepali should be discarded if not used within four weeks after removal from the refrigerator. Contents of the pack and other information. 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. Adult patients had serum samples tested for autoantibodies at multiple timepoints. The impact of long-term treatment with etanercept on the development of autoimmune diseases is unknown. Like all medicines, this medicine can cause side effects, although not everybody getsthem. What Benepali is and what it is used for, 2. 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. 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. Etanercept 25 mg was significantly superior to methotrexate for erosion scores at both 12 and 24 months. Benepali can also be used in patients with severe rheumatoid arthritis who have not taken methotrexate before; certain forms of juvenile idiopathic arthritis (a rare childhood disease causing inflammation of joints) in the following groups: patients aged two to 17 years with disease that affects many joints (polyarthritis which is rheumatoid-factor-positive or -negative) and disease that starts in a few joints and then extends to many (oligoarthritis) and have not responded adequately to or cannot take methotrexate; adolescents aged 12 to 17 years who have psoriatic arthritis (a disease causing red, scaly patches on the skin and inflammation of the joints) and who have not responded adequately to or cannot take methotrexate; adolescents aged 12 to 17 years who have enthesitis-related arthritis and have not responded adequately to or cannot take standard treatment; psoriatic arthritis in adults who have not responded adequately to other treatments; severe ankylosing spondylitis (a disease causing inflammation of the joints of the spine) who have not responded adequately to other treatments; severe non-radiographic axial spondyloarthritis (a chronic inflammatory disease of the spine) when there are objective signs of inflammation but no abnormalities seen on x-ray; plaque psoriasis (a disease causing red, scaly patches on the skin) with moderate to severe disease in adults and in patients from the age of six years with long-term severe disease. 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. Abbreviations: ACR, American College of Rheumatology; ACR20/50/70, American College of Rheumatology 20%/50%/70% response criteria; oETN, originator etanercept. Radiographs of hands and wrists were obtained at baseline and months 6, 12, and 24. For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Opportunistic infections have been reported in association with etanercept, including invasive fungal, parasitic (including protozoal), viral (including herpes zoster), bacterial (including Listeria and Legionella), and atypical mycobacterial infections. Treatment should be discontinued in patients who show no response after 12 weeks. 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. Methotrexate doses were escalated from 7.5 mg/week to a maximum of 20 mg/week over the first 8 weeks of the trial and continued for up to 24 months. Immediate use is then recommended. Benepali is used either in combination with methotrexate (a medicine that acts on the immune system) in adults with moderate or severe disease who have not responded adequately to other treatments, or on its own if methotrexate is not suitable for the patient. IT SHOULD BE INJECTED INTO THE THIGH, ABDOMEN, OR BACK OF THE UPPER ARM. The clinical impact of this is unknown, however, infants may be at increased risk of infection. Benepali can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Olof Palmestraat 102616 LR DelftThe Netherlands, 06/01/2023 Benepali - EMEA/H/C/004007 - IB/0072. It should be clear to slightly opalescent, colourless or pale yellow, and may contain small white or almost transparent particles of protein. I contacted my RA nurse (everything has to go through them before the consultant) and she said -. Doses of 25 mg of etanercept (based on dose-finding studies in patients with rheumatoid arthritis) or placebo were administered subcutaneously twice a week for 6 months in 138 patients. Dose and frequency of dosing for the child or adolescent will depend on body weight and disease. Compared to placebo, treatment with etanercept resulted in statistically significant improvement in the ASAS 40, ASAS 20 and ASAS 5/6. In the double-blind period, patients received etanercept 50 mg weekly or placebo for 12 weeks. This medicines product information is available in all official EU languages.Select available languages to access the language you need. Alcohol abuse: Benepali should not be used for the treatment of hepatitis related to alcohol. Please do not include any personal data, such as your name or contact details. Similarly, the significant advantages for etanercept monotherapy compared with methotrexate monotherapy were also observed after 24 months. 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. 50 mg solution for injection in pre-filled pen. Patients developing a serious infection should stop Benepali treatment. Contents of the pack and other information. Secondary endpoint DAS28 SCORES Benepali controls disease activity as well as oETN 1-3 The absolute bioavailability is 76%. The needle cover should not be removed while allowing the pre-filled pen to reach room temperature. Enbrel (etanercept) is a prescription medication used to treat five chronic diseases including moderate to severe rheumatoid arthritis (RA), psoriatic arthritis (PsA), moderate to severe plaque psoriasis (PsO), ankylosing spondylitis (AS), and moderate to severe polyarticular juvenile idiopathic arthritis (JIA). 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. The presence of hepatic impairment should not require a change in dosage. Comprehensive instructions for administration are given in the package leaflet, section 7, Instructions for use. PPIs are used to treat acid-related conditions such as esophageal/duodenal/stomach ulcers and GERD. This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative. Undesirable effects in paediatric patients with juvenile idiopathic arthritis. There may be new information. However, it cannot be excluded that the combination of etanercept with methotrexate could be associated with an increase in the rate of infections. Has it been successful for injection today of benepali, although easy to do I found it very painful. All patients and parents/caregivers should be advised that if the patient develops signs and symptoms suggestive of blood dyscrasias or infections (e.g., persistent fever, sore throat, bruising, bleeding, and paleness) whilst on Benepali, they should seek immediate medical advice. Do not use the solution if it is discoloured, cloudy, or if particles other than those described above are present. Caution should be exercised when administering Benepali in patients previously infected with HBV. There have been postmarketing reports of interstitial lung disease (including pneumonitis and pulmonary fibrosis), some of which had fatal outcomes. 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