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Benepali is a brand name for Etanercept. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: Rheumatoid arthritis 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. Benepali can be given as…
Verbatim from this product's EMA label. Tap a section to expand.
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.
Patients treated with Benepali should be given the Patient Card. Benepali is available in strengths of 25 and 50 mg. Posology Rheumatoid arthritis 25 mg etanercept administered twice weekly is the recommended dose. 1). Psoriatic arthritis, ankylosing spondylitis and non-radiographic axial spondyloarthritis The recommended dose is 25 mg etanercept administered twice weekly, or 50 mg administered once weekly.
For all of the above indications, available data suggest that a clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be carefully reconsidered in a patient not responding within this time period.
Plaque psoriasis 4 The recommended dose of etanercept is 25 mg administered twice weekly or 50 mg administered once weekly. Alternatively, 50 mg given twice weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg twice weekly or a dose of 50 mg once weekly.
Treatment with Benepali should continue until remission is achieved, for up to 24 weeks. 1). Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Benepali is indicated, the same guidance on treatment duration should be followed.
The dose should be 25 mg twice weekly or 50 mg once weekly. Special populations Renal and hepatic impairment No dose adjustment is required. Elderly No dose adjustment is required. Posology and administration are the same as for adults 18-64 years of age.
Paediatric population Benepali is only available as 25 mg pre-filled syringe, 50 mg pre-filled syringe and 50 mg pre-filled pen. Thus, it is not possible to administer Benepali to paediatric patients that require less than a full 25 mg or 50 mg dose.
Paediatric patients who require a dose other than a full 25 mg or 50 mg should not receive Benepali. If an alternate dose is required, other etanercept products offering such an option should be used. The dosage of etanercept is based on body weight for paediatric patients.
Summary of the safety profile 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), headache, allergic reactions, development of autoantibodies, itching, and fever.
Serious adverse reactions have also been reported for etanercept. TNF-antagonists, such as etanercept, affect the immune system and their use may affect the body’s defenses against infection and cancer. Serious infections affect fewer than 1 in 100 patients treated with etanercept.
Reports have included fatal and life-threatening infections and sepsis. Various malignancies have also been reported with use of etanercept, including cancers of the breast, lung, skin and lymph glands (lymphoma). Serious haematological, neurological and autoimmune reactions have also been reported.
These include rare reports of pancytopenia and very rare reports of aplastic anaemia. Central and peripheral demyelinating events have been seen rarely and very rarely, respectively, with etanercept use. There have been rare reports of lupus, lupus-related conditions, and vasculitis.
12 Tabulated list of adverse reactions The following list of adverse reactions is based on experience from clinical trials and on post- marketing experience. Within the System Organ Class, adverse reactions are listed under headings of frequency (number of patients expected to experience the reaction), using the following categories: very common (≥ 1/10); common (≥ 1/100 to < 1/10); uncommon (≥ 1/1,000 to < 1/100); rare (≥ 1/10,000 to < 1/1,000); very rare (< 1/10,000); not known (cannot be estimated from the available data).
System Organ Class Very common ≥ 1/10 Common ≥ 1/100 to < 1/10 Uncommon ≥ 1/1,000 to < 1/100 Rare ≥ 1/10,000 to < 1/1,000 Very rare < 1/10,000 Not known (cannot be estimated from available data) Infections and infestations Infection (including upper respiratory tract infection, bronchitis, cystitis, skin infection)* Serious infections (including pneumonia, cellulitis, arthritis bacterial, sepsis and parasitic infection)* Tuberculosis, opportunistic infection (including invasive fungal, protozoal, bacterial, atypical mycobacterial, viral infections and Legionella)* Hepatitis B reactivation, listeria Neoplasms benign, malignant and unspecified (incl.
Traceability In order to improve the traceability of biological medicinal products, the brand name and batch number of the administered product should be clearly recorded. Infections Patients should be evaluated for infections before, during, and after treatment with Benepali, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
8). These infections were due to bacteria, mycobacteria, fungi, viruses and parasites (including protozoa). In some cases, particular fungal and other opportunistic infections have not been recognised, resulting in delay of appropriate treatment and sometimes death.
, exposure to endemic mycoses) should be considered. Patients who develop a new infection while undergoing treatment with Benepali should be monitored closely. Administration of Benepali should be discontinued if a patient develops a serious infection.
The safety and efficacy of etanercept in patients with chronic infections have not been evaluated. 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.
Tuberculosis 6 Cases of active tuberculosis, including miliary tuberculosis and tuberculosis with extra-pulmonary location, have been reported in patients treated with etanercept. Before starting treatment with Benepali, all patients must be evaluated for both active and inactive (‘latent’) tuberculosis.
This evaluation should include a detailed medical history with personal history of tuberculosis or possible previous contact with tuberculosis and previous and/or current immunosuppressive therapy. , tuberculin skin test and chest X-ray, should be performed in all patients (local recommendations may apply).
1. Sepsis or risk of sepsis. Treatment with Benepali should not be initiated in patients with active infections, including chronic or localised infections.
Not medical advice. Always read the patient information leaflet and follow your prescriber or pharmacist.
Other brands of Etanercept in European Union.
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Brand names are compiled from public regulatory records for active-ingredient mapping only. Drugvu is not affiliated with any manufacturer. This is not medical advice.
5 kg should be accurately dosed on a mg/kg basis using the powder and solvent for solution for injection presentations or the powder for solution for injection presentations (see below for dosing for specific indications). 5 kg or more may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
The safety and efficacy of etanercept in children aged less than 2 years has not been established. 8 mg/kg (up to a maximum of 50 mg per dose) given once weekly. Discontinuation of treatment should be considered in patients who show no response after 4 months.
A 10 mg vial strength may be more appropriate for administration to children with JIA below the weight of 25 kg. No formal clinical trials have been conducted in children aged 2 to 3 years. 1). There is generally no applicable use of etanercept in children aged below 2 years in the indication juvenile idiopathic arthritis.
8 mg/kg (up to a maximum of 50 mg per dose) once weekly for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks. 5 If re-treatment with Benepali is indicated, the above guidance on treatment duration should be followed.
8 mg/kg (up to a maximum of 50 mg per dose) once weekly. There is generally no applicable use of etanercept in children aged below 6 years in the indication plaque psoriasis. 6). Comprehensive instructions for administration are given in the package leaflet, section 7, “Instructions for use”.
Detailed instructions on unintentional dosing or scheduling variations, including missed doses, are provided in section 3 of the package leaflet.
4) Respiratory, thoracic and mediastinal disorders Interstitial lung disease (including pneumonitis and pulmonary fibrosis)* Gastrointestinal disorders Inflammatory bowel disease Hepatobiliary disorders Elevated liver enzymes* Autoimmune hepatitis* Skin and subcutaneous tissue disorders Pruritus, rash Angioedema, psoriasis (including new onset or worsening and pustular, primarily palms and soles), urticaria, psoriasiform rash Stevens-Johnson syndrome, cutaneous vasculitis (including hypersensitivity vasculitis), erythema multiforme, lichenoid reactions Toxic epidermal necrolysis Musculoskeletal and connective tissue disorders Cutaneous lupus erythematosus, subacute cutaneous lupus erythematosus, lupus-like syndrome Renal and urinary disorders Glomerulonephri tis General disorders and administration site conditions Injection site reactions (including bleeding, bruising, erythema, itching, pain, swelling)* Pyrexia *see Description of selected adverse reactions, below.
14 Description of selected adverse reactions Malignancies and lymphoproliferative disorders 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.
The observed rates and incidences in these clinical trials were similar to those expected for the population studied. A total of 2 malignancies were reported in clinical studies of approximately 2 years duration involving 240 etanercept-treated psoriatic arthritis patients.
In clinical studies conducted for more than 2 years with 351 ankylosing spondylitis patients, 6 malignancies were reported in etanercept-treated patients. 5 years, 30 malignancies and 43 nonmelanoma skin cancers were reported. In a group of 7,416 patients treated with etanercept in rheumatoid arthritis, psoriatic arthritis, ankylosing […]
It is recommended that the conduct of these tests should be recorded in the Patient Card. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromised.
If active tuberculosis is diagnosed, Benepali therapy must not be initiated. 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.
In this situation, the benefit/risk balance of Benepali therapy should be very carefully considered. , persistent cough, wasting/weight loss, low-grade fever) appear during or after Benepali treatment. Hepatitis B reactivation 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.
This includes reports of reactivation of hepatitis B in patients who were anti-HBc positive but HBsAg negative. Patients should be tested for HBV infection before initiating treatment with Benepali. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
Caution should be exercised when administering Benepali in patients previously infected with HBV. These patients should be monitored for signs and symptoms of active HBV infection throughout therapy and for several weeks following termination of therapy.
Adequate data from treating patients infected with HBV with anti-viral therapy in conjunction with TNF- antagonist therapy are not available. In patients who develop HBV infection, Benepali should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.
Worsening of hepatitis C There have been reports of worsening of hepatitis C in patients receiving etanercept. Benepali should be used with caution in patients with a history of hepatitis C. Concurrent treatment with anakinra Concurrent administration of etanercept and anakinra has been associated with an increased risk of serious infections and neutropenia compared to etanercept alone.
This combination has not demonstrated increased clinical benefit. 8). Concurrent treatment with abatacept In clinical studies, concurrent administration of abatacept and etanercept resulted in increased incidences of serious adverse events.
5). Allergic reactions 7 Allergic reactions associated with etanercept administration have been reported commonly. Allergic reactions have included angioedema and urticaria; serious reactions have occurred. If any serious allergic or anaphylactic reaction occurs, Benepali therapy should be discontinued immediately and appropriate therapy initiated.
Immunosuppression 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 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.
Two juvenile idiopathic arthritis patients developed varicella infection and signs and symptoms of aseptic meningitis, which resolved without sequelae. Patients with a […]