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  • Humira 20, 40, 80 mg
    / AbbVie


    Active Ingredient
    Adalimumab 20 mg / 0.2 ml, 40 mg / 0.4 ml, 80 mg / 0.8 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    2 X 20 mg / 0.2 ml

    partial basket chart 4211 8447

    Pre-filled Syringe (solution for injection)

    2 X 40 mg / 0.4 ml

    partial basket chart 73626

    Pre-filled Pen

    1 X 80 mg / 0.8 ml

    partial basket chart

    Pre-filled Pen

    2 X 40 mg / 0.4 ml

    partial basket chart

    Pre-filled Pen

    1 X 80 mg / 0.8 ml

    partial basket chart

    Related information


    Dosage

    Humira treatment should be initiated and supervised by specialist physicians experienced in the diagnosis and treatment of conditions for which Humira is indicated. Ophthalmologists are advised to consult with an appropriate specialist before initiation of treatment with Humira.
    Patients treated with Humira should be given the ‘Patient safety information card’.
    After proper training in injection technique, patients may self-inject with Humira if their physician determines that it is appropriate and with medical follow-up as necessary.
    During treatment with Humira, other concomitant therapies (e.g., corticosteroids and/or immunomodulatory agents) should be optimised.
    Rheumatoid arthritis: The recommended dose of Humira ml for adult patients with rheumatoid arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection. Methotrexate should be continued during treatment with Humira.
    Glucocorticoids, salicylates, nonsteroidal anti-inflammatory drugs, or analgesics can be continued during treatment with Humira. Regarding combination with disease modifying anti-rheumatic drugs other than methotrexate see sections 4.4 and 5.1 at the attached doctor’s leaflet.
    In monotherapy, some patients who experience a decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg adalimumab every week or 80 mg every other week.
    Available data suggest that the clinical response is usually achieved within 12 weeks of treatment. Continued therapy should be reconsidered in a patient not responding within this time period.
    Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis: The recommended dose of Humira for patients with ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and for patients with psoriatic arthritis is 40 mg adalimumab administered every other week as a single dose via subcutaneous injection.
    Psoriasis: The recommended dose of Humira for adult patients is an initial dose of 80 mg administered subcutaneously, followed by 40 mg subcutaneously given every other week starting one week after the initial dose.
    Hidradenitis suppurativa: The recommended Humira dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at Day 1 (given as four 40 mg or two 80mg injections in one day or as two 40 mg or one 80 mg injections per day for two consecutive days), followed by 80 mg two weeks later at Day 15 (given as two 40 mg or one 80 mg injections in one day). Two weeks later (Day 29) continue with a dose of 40 mg every week or 80 mg every other week (given as two 40 mg or one 80 mg injections in one day). Antibiotics may be continued during treatment with Humira if necessary. It is recommended that the patient should use a topical antiseptic wash on their HS lesions on a daily basis during treatment with Humira.
    Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period.
    Should treatment be interrupted, Humira 40 mg every week or 80 mg every other week may be reintroduced.
    Crohn’s disease: The recommended Humira induction dose regimen for adult patients with moderately to severely active Crohn’s disease is 160 mg at Week 0 (given as four 40 mg or two 80 mg injections in one day or as two 40 mg or one 80 mg injections per day for two consecutive days), 80 mg at Week 2 (given as two 40 mg or one 80 mg injections in one day), followed by a maintenance dose of 40 mg every other week via subcutaneous injection beginning at Week 4.
    Aminosalicylates, corticosteriods and/or immunomodulatory agents (e.g. 6-mercaptopurine and azathioprine) may be continued during treatment with Humira.
    Some patients who experience decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg Humira every week or 80 mg every other week.
    Some patients who have not responded by Week 4 may benefit from continued maintenance therapy through Week 12. Continued therapy should be carefully reconsidered in a patient not responding within this time period.
    Ulcerative colitis: The recommended Humira induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at Week 0 (given as four 40mg or two 80mg injections in one day or as two 40mg or one 80 mg injections per day for two consecutive days) and 80 mg at Week 2 (given as two 40mg or one 80mg injections in one day). After induction treatment, the recommended dose is 40 mg every other week via subcutaneous injection.
    During maintenance treatment, corticosteroids may be tapered in accordance with clinical practice guidelines.
    Some patients who experience decrease in their response to Humira 40 mg every other week may benefit from an increase in dosage to 40 mg Humira every week or 80 mg every other week.
    Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment.
    Humira therapy should not be continued in patients failing to respond within this time period.
    Uveitis: The recommended dose of Humira for adult patients with uveitis is an initial dose of 80 mg, followed by 40 mg given every other week starting one week after the initial dose. There is limited experience in the initiation of treatment with Humira alone. Treatment with Humira can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents.
    Intestinal Behcet’s disease: The initial dose of Humira for adult intestinal Behcet’s disease patients is 160 mg as subcutaneous injection. The initial dose is followed by 80 mg two weeks later. Four weeks after the initial dose begin 40 mg every other week.
    See prescribing information for full details.


    Indications

    Rheumatoid arthritis
    Humira in combination with methotrexate is indicated for:
    – The treatment of moderate to severe, active rheumatoid arthritis in adult patients when the response to disease-modifying anti-rheumatic drugs including methotrexate has been inadequate.
    – The treatment of severe, active and progressive rheumatoid arthritis in adults not previously treated with methotrexate.
    Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate.
    Humira has been shown to reduce the rate of progression of joint damage as measured by X-ray and to improve physical function, when given in combination with methotrexate.
    Juvenile idiopathic arthritis
    Polyarticular juvenile idiopathic arthritis: Humira in combination with methotrexate is indicated for the treatment of active polyarticular juvenile idiopathic arthritis, in patients from the age of 2 years who have had an inadequate response to one or more disease-modifying anti-rheumatic drugs (DMARDs). Humira can be given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. Humira has not been studied in patients aged less than 2 years.
    Enthesitis-related arthritis: Humira is indicated for the treatment of active enthesitis-related arthritis in patients, 6 years of age and older, who have had an inadequate response to, or who are intolerant of, conventional therapy.
    Axial spondyloarthritis
    Ankylosing spondylitis (AS): Humira is indicated for the treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
    Axial spondyloarthritis without radiographic evidence of AS: Humira is indicated for the treatment of adults with severe axial spondyloarthritis without radiographic evidence of AS, but with objective signs of inflammation by radiological and/or laboratory tests including MRI and serum CRP levels , who have had an inadequate response to, or are intolerant to, non – steroidal anti-inflammatory drugs.
    Psoriatic arthritis
    Humira is indicated for the treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Humira has been shown to reduce the rate of progression of peripheral joint damage as measured by X-ray in patients with polyarticular symmetrical subtypes of the disease and to improve physical function.
    Psoriasis
    Humira is indicated for the treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
    Paediatric plaque psoriasis
    Humira is indicated for the treatment of severe chronic plaque psoriasis in children and adolescents from 4 years of age who have had an inadequate response to or are inappropriate candidates for topical therapy and phototherapies.
    Hidradenitis suppurativa (HS)
    Humira is indicated for the treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult and adolescents from 12 years of age with an inadequate response to conventional systemic HS therapy.
    Crohn’s disease
    Humira is indicated for reducing signs and symptoms and inducing and maintaining clinical remission in adult patients with moderately to severely active Crohn’s disease who have had an inadequate response to conventional therapy. Humira is indicated for reducing signs and symptoms and inducing clinical remission in these patients if they have also lost response to or are intolerant to infliximab.
    Paediatric Crohn’s disease
    Humira is indicated for the treatment of moderately to severely active Crohn’s disease in paediatric patients (from 6- years of age) who have had an inadequate response to conventional therapy including primary nutrition therapy and corticosteroid, and/or an immunomodulator, or who are intolerant to or have contraindications for such therapies
    Ulcerative colitis
    Humira is indicated for treatment of moderately to severely active ulcerative colitis in adult patients who have had an inadequate response to conventional therapy including corticosteroids and 6-mercaptopurine (6-MP) or azathioprine (AZA), or who are intolerant to or have medical contraindications for such therapies.
    Uveitis
    Humira is indicated for the treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroidsparing, or in whom corticosteroid treatment is inappropriate.
    Intestinal Behcet’s disease
    Humira is indicated for the treatment of intestinal Behcet’s disease in patients who have had an inadequate response to conventional therapy.
    Paediatric Uveitis
    Humira is indicated for the treatment of chronic non-infectious uveitis in paediatric patients from 2 years of age who have had an inadequate response to or are intolerant to conventional therapy, or in whom conventional therapy is inappropriate.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.
    Active tuberculosis or other severe infections such as sepsis, and opportunistic infections.
    Moderate to severe heart failure (NYHA class III/IV).


    Special Precautions

    Infections, serious infections, tuberculosis and other opportunistic infections, hepatitis B reactivation, neurological events (demyelinating  disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease), allergic reactions, immunosuppression, malignancies and lymphoproliferative disorders, hematologic reactions, vaccinations (no live vaccines, e.g, BCG vaccine ), congestive heart failure, autoimmune processes, concurrent administration of biologic DMARDS or TNF-antagonists, surgery, small bowel obstruction in patients with Crohn’s disease, elderly (higher risk for serious infections), Paediatric population.
    See prescribing information for full details.


    Side Effects

    The most commonly reported adverse reactions are infections and infestations such as respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral), leucopenia (including neutropenia and agranulocytosis), anaemia, lipids increased, rash (including exfoliative rash), injection site reactions (including erythema), headache and musculoskeletal pain, abdominal pain, nausea and vomiting, elevated liver enzymes.
    See prescribing information for full details.


    Drug interactions

    Humira has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking Humira as monotherapy and those taking concomitant methotrexate. Antibody formation was lower when Humira was given together with methotrexate in comparison with use as monotherapy. Administration of Humira without methotrexate resulted in increased formation of antibodies, increased clearance and reduced
    efficacy of adalimumab.
    The combination of Humira and anakinra is not recommended.
    The combination of Humira and abatacept is not recommended.


    Pregnancy and Lactation

    Women of child bearing potential and Pregnancy: Women of childbearing potential should consider the use of adequate contraception to prevent pregnancy and continue its use for at least five months after the last Humira treatment.
    Breast feeding: Humira can be used during breastfeeding.


    Overdose

    No dose-limiting toxicity was observed during clinical trials. The highest dose level evaluated has been multiple intravenous doses of 10 mg/kg, which is approximately 15 times the recommended dose.


    Manufacturer
    AbbVie Ltd., UK
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