• Home
  • A-B index
  • Pharmacological Index
  • Drug Classes
  • Active Ingredients
  • Companies
  • News
  • Enbrel
    / Pfizer


    Active Ingredient
    Etanercept 25, 50 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial -powder and solvent

    4 X 25 mg

    partial basket chart 28907 5211

    Pre-filled Syringe (solution for injection)

    4 X 25 mg

    partial basket chart 15838 5507

    Pre-filled Syringe (solution for injection)

    4 X 50 mg

    partial basket chart 15837 5506

    Solution for injection in pre-filled pen.

    4 X 50 mg

    partial basket chart 50125

    Related information


    Dosage

    Pre-Filles Syringe:
    Enbrel 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.
    Enbrel pre filled syringe is available in strengths of 25 and 50 mg.
    The Enbrel pre-filled pen is available in a 50 mg strength.
    Rheumatoid arthritis: 25 mg Enbrel administered twice weekly is the recommended dose. Alternatively, 50 mg administered once weekly has been shown to be safe and effective.
    Psoriatic arthritis ,ankylosing spondylitis and non-radiographic axial spondyloarthritis: The recommended dose is 25 mg Enbrel 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: The recommended dose of Enbrel 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 50 mg once weekly. Treatment with Enbrel should continue until remission is achieved, for up to 24 weeks. Continuous therapy beyond 24 weeks may be appropriate for some adult patients (see section 5.1). Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment with Enbrel 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.
    The dosage of Enbrel is based on body weight for paediatric patients. Patients weighing less than 62.5 kg should be accurately dosed on a mg/kg basis using Enbrel 25 mg powder and solvent for solution for injection presentation (see below for dosing for specific indications). Patients weighing 62.5 kg or more, may be dosed using a fixed-dose pre-filled syringe or pre-filled pen.
    Juvenile idiopathic arthritis: The recommended dose is 0.4 mg/kg (up to a maximum of 25 mg per dose), given twice weekly as a subcutaneous injection with an interval of 3-4 days between doses or 0.8 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. No formal clinical trials have been conducted in children aged 2 to 3 years. 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. There is generally no applicable use of Enbrel in children aged below 2 years in the indication juvenile idiopathic arthritis.
    Paediatric plaque psoriasis (age 6 years and above): The recommended dose is 0.8 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.
    If re-treatment with Enbrel is indicated, the above guidance on treatment duration should be followed. The dose should be 0.8 mg/kg (up to a maximum of 50 mg per dose) once weekly. There is generally no applicable use of Enbrel in children aged below 6 years in the indication plaque psoriasis.
    Method of administration: Enbrel is administered by subcutaneous injection.

    Vial:
    Treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of rheumatoid arthritis and psoriatic arthritis, ankylosing spondylitis and plaque psoriasis.
    Adults (18-64 years): 25 mg reconstituted in 1 ml of water for injection administered 2 x weekly as a S.C. injection, is recommended for optimal therapeutic response. In rheumatoid arthritis, 25 mg administered 1 x weekly gives a slower response and may be less effective. In psoriatic arthritis, ankylosing spondylitis and plaque psoriasis, doses other than 25 mg 2 x weekly have not been studied.
    Rheumatoid Arthritis: 25 mg 2 x weekly. Alternatively, 50 mg 1 x weekly has been shown to be safe and effective Psoriatic arthritis and ankylosing spondylitis 25 mg 2 x weekly, or 50 mg 1 x weekly.
    Plaque Psoriasis: 25 mg 2 x weekly. Alternatively, 50 mg 2 x weekly may be used for up to 12 weeks followed, if necessary, by a dose of 25 mg 2 x weekly. Treatment should continue until remission is achieved, for up to 24 weeks. Treatment should be discontinued in patients who show no response after 12 weeks. If re-treatment is indicated, the above guidance on treatment duration should be followed, and dose should be 25 mg 2 x weekly.
    Elderly: No dose adjustment is required.
    Children & Adolescents (4-18 years)(not including plaque psoriasis):
    0.4 mg/kg up to a maximum of 25 mg/dose, after reconstititution in 1 ml of water for injection, given 2 x weekly as a S.C. injection with an interval of 3-4 days between doses.
    Renal and hepatic impairment: No dose adjustment is required.


    Indications

    Rheumatoid Arthritis: Active rhematoid arthritis in adults when the response to disease-modifying antirheumatic drugs (DMARDs) including methotrexate (unless contraindicated) has been inadequate. Enbrel can be used in combination with methotrexate in patients who do not respond adequately to methotrexate alone. Reducing signs and symptoms and inhibiting the progression of structural damage in patients with moderately to severely active rheumatoid arthritis. Enbrel, 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.
    Juvenile idiopathic arthritis: 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. 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.
    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. Enbrel has not been studied in children aged less than 2 years.
    Psoriatic Arthritis: Treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying antirheumatic drug therapy has been inadequate. Enbrel 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.
    Ankylosing Spondylitis: Treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
    Non-radiographic axial spondyloarthritis: 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).
    Plaque Psoriasis: Treatment of adults patients (18 years or older) with moderate to severe plaque psoriasis who are candidates for systemic therapy or phototherapy.
    Paediatric Plaque Psoriasis: 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.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Sepsis or risk of sepsis. Treatment with Enbrel should not be initiated in patients with active infections including chronic or localised infections.


    Special Precautions

    In order to improve the traceability of biological medicinal products, the trademark and the batch number of the administered product should be clearly recorded (or stated) in the patient file.
    Infections: Patients should be evaluated for infections before, during, and after treatment with Enbrel, taking into consideration that the mean elimination half-life of etanercept is approximately 70 hours (range 7 to 300 hours).
    Tuberculosis: Cases of active tuberculosis including miliary tuberculosis and tuberculosis with extra-pulmonary location have been reported in patients treated with Enbrel. Before starting treatment with Enbrel, all patients must be evaluated for both active and inactive (‘latent’) tuberculosis.
    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 Enbrel, has been reported. Patients should be tested for HBV infection before initiating treatment with Enbrel. 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 Enbrel 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.
    Worsening of hepatitis C: There have been reports of worsening of hepatitis C in patients receiving Enbrel. Enbrel should be used with caution in patients with a history of hepatitis C.
    Concurrent treatment with anakinra: Concurrent administration of Enbrel and anakinra has been associated with an increased risk of serious infections and neutropenia.
    Allergic reactions: The needle cover of the pre-filled syringe and the needle cap of the pre-filled pen contains latex (dry natural rubber) that may cause hypersensitivity reactions when handled by, or when Enbrel is administered to, persons with known or possible latex sensitivity.
    Immunosuppression: The possibility exists for TNF-antagonists, including Enbrel, to affect host defences against infections and malignancies since TNF mediates inflammation and modulates cellular immune responses.
    For full details see prescribing information.


    Side Effects

    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.
    See prescribing information for full details.


    Drug interactions

    Concurrent treatment with anakinra: Adult patients treated with Enbrel and anakinra were observed to have a higher rate of serious infection when compared with patients treated with either Enbrel or anakinra alone (historical data). In addition, in a double-blind, placebo-controlled trial in adult patients receiving background methotrexate, patients treated with Enbrel and anakinra were observed to have a higher rate of serious infections (7%) and neutropenia than patients treated with Enbrel. The combination Enbrel and anakinra has not demonstrated increased clinical benefit,
    and is therefore not recommended.
    Concurrent treatment with abatacept: In clinical studies, concurrent administration of abatacept and Enbrel resulted in increased incidences of serious adverse events. This combination has not demonstrated increased clinical benefit; such use is not recommended.
    Concurrent treatment with sulfasalazine: In a clinical study of adult patients who were receiving established doses of sulfasalazine, to which Enbrel was added, patients in the combination group experienced a statistically significant decrease in mean white blood cell counts in comparison to groups treated with Enbrel or sulfasalazine alone. The clinical significance of this interaction is unknown. Physicians should use caution when considering combination therapy with sulfasalazine.
    Non-interactions: In clinical trials, no interactions have been observed when Enbrel was administered with glucocorticoids, salicylates (except sulfasalazine), nonsteroidal anti-inflammatory drugs (NSAIDs), analgesics, or methotrexate. No clinically significant pharmacokinetic drug-drug interactions were observed in studies with methotrexate, digoxin or warfarin.


    Pregnancy and Lactation

    Pregnancy: Enbrel is not recommended during pregnancy.
    Breast-feeding: Etanercept has been reported to be excreted in human milk following subcutaneous administration. Because immunoglobulins, in common with many medicinal products, can be excreted in human milk, a decision must be made whether to discontinue breast-feeding or to discontinue Enbrel therapy, taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.


    Overdose

    No dose-limiting toxicities were observed during clinical trials of rheumatoid arthritis 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. One rheumatoid arthritis patient mistakenly self-administered 62 mg Enbrel subcutaneously twice weekly for 3 weeks without experiencing undesirable effects. There is no known antidote to Enbrel.


    Important notes

    Incompatibilities: In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.
    Storage: Store in a refrigerator (2°C – 8°C). Do not freeze. Protect from light.
    Shelf-life (Vial): Chemical and physical in-use stability has been demonstrated for 6 hours at temperatures of up to 25°C after reconstitution. From a microbiological point of view, the reconstituted medicinal product should be used immediately.
    See prescribing information for full details.


    Manufacturer
    John Wyeth and Brother Limited: Trading as Wyeth Pharmaceuticals, UK
    CLOSE