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  • AMGEVITA
    / Amgen


    Active Ingredient
    Adalimumab 50 mg/ml.

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe

    2×(20 mg/0.4 mL, 40mg/0.8ml)

    not in the basket chart

    Pre-filled Pen

    2×(40mg /0.8 ml)

    not in the basket chart

    Dosage

    Rheumatoid arthritis: The recommended dose of AMGEVITA 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 AMGEVITA. Glucocorticoids, salicylates, non-steroidal anti-inflammatory drugs, or analgesics can be continued during treatment with AMGEVITA.
    In monotherapy, some patients who experience a decrease in their response to AMGEVITA 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 adalimumab 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.
    Dose interruption
    There may be a need for dose interruption, for instance before surgery or if a serious infection occurs. Available data suggest that re-introduction of AMGEVITA after discontinuation for 70 days or longer should result in the same magnitudes of clinical response and similar safety profile as before dose interruption.
    Ankylosing spondylitis, axial spondyloarthritis without radiographic evidence of AS and psoriatic arthritis: The recommended dose of AMGEVITA 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. 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.
    Psoriasis
    The recommended dose of AMGEVITA 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. Continued therapy beyond 16 weeks should be carefully reconsidered in a patient not responding within this time period. Beyond 16 weeks, patients with inadequate response to AMGEVITA 40 mg every other week may benefit from an increase in dosage to 40 mg every week or 80 mg every other week. The benefits and risks of continued 40 mg weekly or 80 mg every other week therapy should be carefully reconsidered in a patient with an inadequate response after the increase in dosage. If adequate response is achieved with 40 mg every week or 80 mg every other week, the dosage may subsequently be reduced to 40 mg every other week.
    Hidradenitis suppurativa The recommended AMGEVITA dose regimen for adult patients with hidradenitis suppurativa (HS) is 160 mg initially at day 1 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days), followed by 80 mg two weeks later at day 15 (given as two 40 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 injections in one day).
    Antibiotics may be continued during treatment with AMGEVITA 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 AMGEVITA.
    Continued therapy beyond 12 weeks should be carefully reconsidered in a patient with no improvement within this time period. Should treatment be interrupted, AMGEVITA 40 mg every week or 80 mg every other week may be re-introduced.
    Crohn’s disease:  The recommended AMGEVITA 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 injections in one day or as two 40 mg injections per day for two consecutive days), 80 mg at Week 2 (given as two 40 mg injections in one day), followed by a maintenance dose of 40 mg every other week via subcutaneous injection beginning at Week 4. Aminosalicylates, corticosteroids and/or immunomodulatory agents (e.g. 6-mercaptopurine and azathioprine) may be continued during treatment with Amgevita. Some patients who experience decrease in their response to AMGEVITA 40 mg every other week may benefit from an increase in dosage to 40 mg AMGEVITA 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 AMGEVITA induction dose regimen for adult patients with moderate to severe ulcerative colitis is 160 mg at week 0 (given as four 40 mg injections in one day or as two 40 mg injections per day for two consecutive days) and 80 mg at week 2 (given as two 40 mg 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 AMGEVITA 40 mg every other week may benefit from an increase in dosage to 40 mg AMGEVITA every week or 80 mg every other week. Available data suggest that clinical response is usually achieved within 2-8 weeks of treatment. AMGEVITA therapy should not be continued in patients failing to respond within this time period.
    Uveitis: The recommended dose of AMGEVITA 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 adalimumab alone. Treatment with AMGEVITA can be initiated in combination with corticosteroids and/or with other non-biologic immunomodulatory agents. Concomitant corticosteroids may be tapered in accordance with clinical practice starting two weeks after initiating treatment with AMGEVITA. It is recommended that the benefit and risk of continued long-term treatment should be evaluated on a yearly basis.
    Intestinal Behcet’s disease: The initial dose of AMGEVITA 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. AMGEVITA should be used when the signs and symptoms caused by intestinal Behcet’s  disease remain clearly evident after appropriate treatment with existing drug (steroids or  immunosuppressant, etc.).


    Indications

    Rheumatoid arthritis: 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,  given as monotherapy in case of intolerance to methotrexate or when continued treatment with methotrexate is inappropriate. AMGEVITA 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.
    Axial spondyloarthritis Ankylosing spondylitis (AS): treatment of adults with severe active ankylosing spondylitis who have had an inadequate response to conventional therapy.
    Axial spondyloarthritis without radiographic evidence of AS: 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: treatment of active and progressive psoriatic arthritis in adults when the response to previous disease-modifying anti-rheumatic drug therapy has been inadequate. Adalimumab 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: treatment of moderate to severe chronic plaque psoriasis in adult patients who are candidates for systemic therapy.
    Hidradenitis suppurativa (HS): treatment of active moderate to severe hidradenitis suppurativa (acne inversa) in adult patients with an inadequate response to conventional systemic HS therapy.
    Crohn’s disease: 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. AMGEVITA 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.
    Ulcerative colitis: 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: treatment of non-infectious intermediate, posterior and panuveitis in adult patients who have had an inadequate response to corticosteroids, in patients in need of corticosteroid-sparing, or in whom corticosteroid treatment is inappropriate.
    Intestinal Behcet’s disease:  treatment of intestinal Behcet’s disease in patients who have had an inadequate response to conventional therapy.


    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

    Traceability In order to improve traceability of biological medicinal products, the name and the batch number of the administered product should be clearly recorded.
    Infections
    Patients taking TNF-antagonists are more susceptible to serious infections. Impaired lung function may increase the risk for developing infections. Patients must therefore be monitored closely for infections, including tuberculosis, before, during and after treatment with AMGEVITA. Because the elimination of adalimumab may take up to four months, monitoring should be continued throughout this period. Treatment with AMGEVITA should not be initiated in patients with active infections including chronic or localized infections until infections are controlled. In patients who have been exposed to tuberculosis and patients who have travelled in areas of high risk of tuberculosis or endemic mycoses, such as histoplasmosis, coccidioidomycosis, or blastomycosis, the risk and benefits of treatment with AMGEVITA should be considered prior to initiating therapy. Patients who develop a new infection while undergoing treatment with AMGEVITA, should be monitored closely and undergo a complete diagnostic evaluation. Administration of AMGEVITA should be discontinued if a patient develops a new serious infection or sepsis, and appropriate antimicrobial or antifungal therapy should be initiated until the infection is controlled. Physicians should exercise caution when considering the use of AMGEVITA in patients with a history of recurring infection or with underlying conditions which may predispose patients to infections, including the use of concomitant immunosuppressive medications.
    Serious infections:
     Serious infections, including sepsis, due to bacterial, mycobacterial, invasive fungal, parasitic, viral, or other opportunistic infections such as listeriosis, legionellosis and pneumocystis have been reported in patients receiving adalimumab. Other serious infections seen in clinical trials include pneumonia, pyelonephritis, septic arthritis and septicaemia. Hospitalization or fatal outcomes associated with infections have been reported.
    Tuberculosis
    Tuberculosis, including reactivation and new onset of tuberculosis, has been reported in patients receiving adalimumab. Reports included cases of pulmonary and extra-pulmonary (i.e. disseminated) tuberculosis.
    Before initiation of therapy with AMGEVITA, all patients must be evaluated for both active or inactive (“latent”) tuberculosis infection. This evaluation should include a detailed medical assessment of patient history of tuberculosis or possible previous exposure to people with active tuberculosis and previous and/or current immunosuppressive therapy. Appropriate screening tests (i.e. tuberculin skin test and chest x-ray) should be performed in all patients (local recommendations may apply). It is recommended that the conduct and results of these tests are recorded in the ‘Patient safety information card’. Prescribers are reminded of the risk of false negative tuberculin skin test results, especially in patients who are severely ill or immunocompromized.
    If active tuberculosis is diagnosed, AMGEVITA therapy must not be initiated
    Hepatitis B reactivation
    Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including adalimumab, who are chronic carriers of this virus (i.e. surface antigen positive). Some cases have had a fatal outcome. Patients should be tested for HBV infection before initiating treatment with AMGEVITA. For patients who test positive for hepatitis B infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended.
    Neurological events
    TNF-antagonists including adalimumab have been associated in rare instances with new onset or exacerbation of clinical symptoms and/or radiographic evidence of central nervous system demyelinating disease including multiple sclerosis and optic neuritis, and peripheral demyelinating disease, including Guillain-Barré syndrome. Prescribers should exercise caution in considering the use of AMGEVITA in patients with pre-existing or recent-onset central or peripheral nervous system demyelinating disorders; discontinuation of AMGEVITA should be considered if any of these disorders develop. There is a known association between intermediate uveitis and central demyelinating disorders. Neurologic evaluation should be performed in patients with non-infectious intermediate uveitis prior to the initiation of AMGEVITA therapy and regularly during treatment to assess for pre-existing or developing central demyelinating disorders.
    Allergic reactions
    Serious allergic reactions associated with adalimumab were rare during clinical trials. Non-serious allergic reactions associated with adalimumab were uncommon during clinical trials. Reports of serious allergic reactions including anaphylaxis have been received following adalimumab administration. If an anaphylactic reaction or other serious allergic reaction occurs, administration of AMGEVITA should be discontinued immediately and appropriate therapy initiated.
    Dry natural rubber for AMGEVITA 40 mg solution for injection in pre-filled pen
    The needle cover of the pre-filled pen is made from dry natural rubber (a derivative of latex), which may cause allergic reactions.
    Immunosuppression
    In a study of 64 patients with rheumatoid arthritis that were treated with adalimumab, there was no evidence of depression of delayed-type hypersensitivity, depression of immunoglobulin levels, or change in enumeration of effector T-, B-, NK-cells, monocyte/macrophages, and neutrophils.
    Malignancies and lymphoproliferative disorders
    In the controlled portions of adalimumab clinical trials of TNF-antagonists, more cases of malignancies including lymphoma have been observed among patients receiving a TNF-antagonist compared with control patients. However, the occurrence was rare. In the post-marketing setting, cases of leukemia have been reported in patients treated with a TNF-antagonist. There is an increased background risk for lymphoma and leukemia in rheumatoid arthritis patients with long-standing highly active, inflammatory disease, which complicates the risk estimation.
    Hematologic reactions
    Rare reports of pancytopenia including aplastic anemia have been reported with TNF-antagonists. Adverse events of the hematologic system, including medically significant cytopenia (e.g. thrombocytopenia, leukopenia) have been reported with adalimumab. All patients should be advised to seek immediate medical attention if they develop signs and symptoms suggestive of blood dyscrasias (e.g. persistent fever, bruising, bleeding, pallor) while on AMGEVITA. Discontinuation of AMGEVITA therapy should be considered in patients with confirmed significant hematologic abnormalities.
    Vaccinations
    Similar antibody responses to the standard 23-valent pneumococcal vaccine and the influenza trivalent virus vaccination were observed in a study in 226 adults.
    Congestive heart failure
    In a clinical trial with another TNF-antagonist worsening congestive heart failure and increased mortality due to congestive heart failure have been observed. Cases of worsening congestive heart failure have also been reported in patients receiving adalimumab. AMGEVITA should be used with caution in patients with mild heart failure (NYHA class I/II). AMGEVITA is contraindicated in moderate to severe heart failure. Treatment with AMGEVITA must be discontinued in patients who develop new or worsening symptoms of congestive heart failure.
    Autoimmune processes
    Treatment with AMGEVITA may result in the formation of autoimmune antibodies. The impact of long-term treatment with AMGEVITA on the development of autoimmune diseases is unknown. If a patient develops symptoms suggestive of a lupus-like syndrome following treatment with AMGEVITA and is positive for antibodies against double-stranded DNA, further treatment with AMGEVITA should not be given.
    Concurrent administration of biologic DMARDs or TNF-antagonists
    Serious infections were seen in clinical studies with concurrent use of anakinra and another TNF-antagonist, etanercept, with no added clinical benefit compared to etanercept alone. Because of the nature of the adverse events seen with the combination of etanercept and anakinra therapy, similar toxicities may also result from the combination of anakinra and other TNF-antagonists. Therefore, the combination of AMGEVITA and anakinra is not recommended.
    Concomitant administration of AMGEVITA with other biologic DMARDs (e.g. anakinra and abatacept) or other TNF-antagonists is not recommended based upon the possible increased risk for infections, including serious infections and other potential pharmacological interactions.
    Surgery
    There is limited safety experience of surgical procedures in patients treated with adalimumab. The long half-life of adalimumab should be taken into consideration if a surgical procedure is planned. A patient who requires surgery while on AMGEVITA should be closely monitored for infections, and appropriate actions should be taken. There is limited safety experience in patients undergoing arthroplasty while receiving adalimumab.
    Small bowel obstruction
    Failure to respond to treatment for Crohn’s disease may indicate the presence of fixed fibrotic stricture that may require surgical treatment. Available data suggest that adalimumab does not worsen or cause strictures.
    Elderly
    The frequency of serious infections among adalimumab-treated subjects over 65 years of age (3.7%) was higher than for those under 65 years of age (1.5%). Some of those had a fatal outcome. Particular attention regarding the risk for infection should be paid when treating the elderly.  Please refer to the license holder for further details.


    Side Effects

    Respiratory tract infections (including lower and upper respiratory tract infection, pneumonia, sinusitis, pharyngitis, nasopharyngitis and pneumonia herpes viral)
    Systemic infections (including sepsis, candidiasis and influenza),
    Intestinal infections (including gastroenteritis viral),
    Skin and soft tissue infections (including paronychia, cellulitis, impetigo, necrotizing fasciitis and herpes zoster), Ear infections,
    Oral infections (including herpes simplex, oral herpes and tooth infections).
    Reproductive tract infections (including vulvovaginal mycotic infection), Urinary tract infections (including pyelonephritis),Fungal infections, Joint infections,
    Skin cancer excluding melanoma (including basal cell carcinoma and squamous cell carcinoma),Benign neoplasm, Hypersensitivity, Allergies (including seasonal allergy),Lipids increased, Hypokalemia, Uric acid increased, Blood sodium abnormal.
    Hypocalcemia, Hyperglycemia, Hypophosphatemia, Dehydration, Mood alterations (including depression), Anxiety, Insomnia, Headache, Paresthesias (including hypoesthesia),Migraine,Nerve root compression, Visual impairment, Conjunctivitis, Blepharitis, Eye swelling.
    Please refer to the license holder for further details.


    Drug interactions

    Adalimumab has been studied in rheumatoid arthritis, polyarticular juvenile idiopathic arthritis and psoriatic arthritis patients taking adalimumab as monotherapy and those taking concomitant methotrexate. Antibody formation was lower when adalimumab was given together with methotrexate in comparison with use as monotherapy. Administration of adalimumab without methotrexate resulted in increased formation of antibodies, increased clearance and reduced efficacy of adalimumab.
    The combination of AMGEVITA and anakinra is not recommended.
    The combination of AMGEVITA and abatacept is not recommended.
    Please refer to the license holder for further details.


    Pregnancy and Lactation

    Pregnancy:
    A large number (approximately 2,100) of prospectively collected pregnancies exposed to adalimumab resulting in live birth with known outcomes, including more than 1,500 exposed during the first trimester, does not indicate an increase in the rate of malformation in the newborn.
    Please refer to the license holder for further details.
    Lactation:

    Limited information from the published literature indicates that adalimumab is excreted in breast milk at very low concentrations with the presence of adalimumab in human milk at concentrations of 0.1% to 1% of the maternal serum level. Given orally, immunoglobulin G proteins undergo intestinal proteolysis and have poor bioavailability. No effects on the breastfed newborns/infants are anticipated. Consequently, AMGEVITA can be used during breast-feeding.
    Please refer to the license holder for further details.


    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.


    Important notes

    Storage: store in a refrigerator (2°C – 8°C).
    Do not freeze.
    Keep AMGEVITA in the outer carton in order to protect from light.
    The pre-filled syringe or pre-filled pen may be stored at temperatures up to a maximum of
    25°C for a period of up to 14 days. The pre-filled syringe or pre-filled pen must be protected
    from light, and discarded if not used within the 14-day period.
    Compatibilities:
    In the absence of compatibility studies, this medicinal product must not be mixed with other medicinal products.


    Manufacturer
    Amgen Europe
    Licence holder
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