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  • Simponi
    / Janssen


    Active Ingredient
    Golimumab 50 mg/0.5 ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Syringe (solution for injection)

    0.5 ml

    not in the basket chart 31568 19969

    Auto-Injector Pen

    1 ml x 100 mg

    not in the basket chart 85391 9845

    Related information


    Dosage

    Psoriatic arthritis: Simponi 50 mg given once a month, on the same date each month.
    Ankylosing spondylitis: Simponi 50 mg given once a month, on the same date each month. Available data suggest that clinical response is usually achieved within 12 to 14 weeks of treatment (after 3-4 doses). Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit within this time period. In patients weighing more than 100 kg who do not achieve an adequate clinical response after 3 or 4 doses, increasing the dose of golimumab to 100 mg once a month may be considered, taking into account the increased risk of certain serious adverse drug reactions with the 100 mg dose compared with the 50 mg dose. Continued therapy should be reconsidered in patients who show no evidence of therapeutic benefit after receiving 3 to 4 additional doses of 100 mg.
    Missed dose: If a patient forgets to inject Simponi on the planned date, the forgotten dose should be injected as soon as the patient remembers. Patients should be instructed not to inject a double dose to make up for the forgotten dose. The next dose should be administered based on the following guidance: – if the dose is less than 2 weeks late, the patient should inject his/her forgotten dose and stay on his/her original monthly schedule. – if the dose is more than 2 weeks late, the patient should inject his/her forgotten dose and a new once-monthly schedule should be established from the date of this injection.
    Elderly patients (≥ 65 years): No dose adjustment is required in the elderly.
    Renal and hepatic impairment: Simponi has not been studied in these patient populations. No dose recommendations can be made.


    Indications

    Rheumatoid arthritis: In combination with methotrexate, for the treatment of adult patients with moderately-severely active rheumatoid arthritis when the response to disease-modifying anti-rheumatic drug (DMARD) therapy including MTX has been inadequate.
    Psoriatic arthritis: Alone or in combination with methotrexate, for the treatment of adult patients with active and progressive psoriatic arthritis when the response to previous disease-modifying antirheumatic drug (DMARD) therapy has been inadequate.
    Ankylosing spondylitis: Treatment of adult patients with severe active ankylosing spondylitis who have responded inadequately to conventional therapy.


    Contra-Indications

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


    Special Precautions

    Infections: Patients must be monitored closely for infections including tuberculosis before, during and after treatment with Simponi. Because the elimination of golimumab may take up to 5 months, monitoring should be continued throughout this period. Further treatment with Simponi must not be given if a patient develops a serious infection or sepsis. Simponi should not be given to patients with a clinically important, active infection. Caution should be exercised when considering the use of Simponi in patients with a chronic infection or a history of recurrent infection. Patients should be advised of, and avoid exposure to, potential risk factors for infection as appropriate. Patients taking TNF-blockers are more susceptible to serious infections. Bacterial (including sepsis and pneumonia), mycobacterial (including TB), invasive fungal and opportunistic infections, including fatalities, have been reported in patients receiving Simponi. Some of these serious infections have occurred in patients on concomitant immunosuppressive therapy that, in addition to their underlying disease, could predispose them to infections. Patients who develop a new infection while undergoing treatment with Simponi should be monitored closely and undergo a complete diagnostic evaluation. Administration of Simponi 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. For patients who have resided in or travelled to regions where invasive fungal infections such as histoplasmosis, coccidioidomycosis, or blastomycosis are endemic, the benefits and risks of Simponi treatment should be carefully considered before initiation of Simponi therapy.
    Tuberculosis: There have been reports of tuberculosis in patients receiving Simponi. It should be noted that in the majority of these reports, tuberculosis was extrapulmonary presenting as either local or disseminated disease. Before starting treatment with Simponi, 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. Appropriate screening tests, i.e. tuberculin skin or blood test and chest X-ray, should be performed in all patients (local recommendations may apply). 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, Simponi therapy must not be initiated. If latent tuberculosis is suspected, a physician with expertise in the treatment of tuberculosis should be consulted. In all situations described below, the benefit/risk balance of Simponi therapy should be very carefully considered. If inactive (‘latent’) tuberculosis is diagnosed, treatment for latent tuberculosis must be started with anti-tuberculosis therapy before the initiation of Simponi, and in accordance with local recommendations.In patients who have several or significant risk factors for tuberculosis and have a negative test for latent tuberculosis, anti-tuberculosis therapy should be considered before the initiation of Simponi. Use of anti-tuberculosis therapy should also be considered before the initiation of Simponi in patients with a past history of latent or active tuberculosis in whom an adequate course of treatment cannot be confirmed.Cases of active tuberculosis have occurred in patients treated with Simponi during and after treatment for latent tuberculosis. Patients receiving Simponi should be monitored closely for signs and symptoms of active tuberculosis, including patients who tested negative for latent tuberculosis, patients who are on treatment for latent tuberculosis, or patients who were previously treated for tuberculosis infection All patients should be informed to seek medical advice if signs/symptoms suggestive of tuberculosis (e.g. persistent cough, wasting/weight loss, low-grade fever) appear during or after Simponi treatment.
    Hepatitis B virus reactivation: Reactivation of hepatitis B has occurred in patients receiving a TNF-antagonist including Simponi, who are chronic carriers of this virus (i.e., surface antigen positive). Some cases have had fatal outcome. Patients should be tested for HBV infection before initiating treatment with Simponi. For patients who test positive for HBV infection, consultation with a physician with expertise in the treatment of hepatitis B is recommended. Carriers of HBV who require treatment with Simponi should be closely monitored for signs and symptoms of active HBV infection throughout therapy and for several months following termination of therapy. Adequate data of treating patients who are carriers of HBV with anti-viral therapy in conjunction with TNF-antagonist therapy to prevent HBV reactivation are not available. In patients who develop HBV reactivation, Simponi should be stopped and effective anti-viral therapy with appropriate supportive treatment should be initiated.Paediatric malignancy Malignancies, some fatal, have been reported among children, adolescents and young adults (up to 22 years of age) treated with TNF-blocking agents (initiation of therapy ≤ 18 years of age) in the post marketing setting. Approximately half the cases were lymphomas. The other cases represented a variety of different malignancies and included rare malignancies usually associated with immunosuppression. A risk for the development of malignancies in children and adolescents treated with TNF-blockers cannot be excluded.
    Lymphoma and leukaemia: In the controlled portions of clinical trials of all the TNF-blocking agents including Simponi, more cases of lymphoma have been observed among patients receiving anti-TNF treatment compared with control patients. During the Simponi Phase IIb and Phase III clinical trials, the incidence of lymphoma in Simponi-treated patients was higher than expected in the general population. In the post-marketing setting, cases of leukaemia have been reported in patients treated with a TNFantagonist. There is an increased background risk for lymphoma and leukaemia in rheumatoid arthritis patients with long-standing, highly active, inflammatory disease, which complicates risk estimation. Rare post-marketing cases of hepatosplenic T-cell lymphoma (HSTCL) have been reported in patients treated with other TNF-blocking agents. This rare type of T-cell lymphoma has a very aggressive disease course and is usually fatal. Nearly all of the reported TNF-blocker cases have occurred in patients with Crohn’s disease with some occurring in ulcerative colitis patients. The majority were in adolescent and young adult males. Almost all these patients had received treatment with azathioprine (AZA) or 6-mercaptopurine (6–MP) concomitantly with a TNFblocker at or prior to diagnosis. The potential risk with the combination of AZA or 6-MP and TRADENAME should be carefully considered. A risk for the development for hepatosplenic T-cell lymphoma in patients treated with TNF-blockers cannot be excluded.
    Malignancies other than lymphoma: In the controlled portions of the Simponi Phase IIb and Phase III clinical trials in RA, PsA, and AS, the incidence of non-lymphoma malignancies (excluding non-melanoma skin cancer) was similar between the Simponi and the control groups. In an exploratory clinical trial evaluating the use of Simponi in patients with severe persistent asthma, more malignancies were reported in patients treated with Simponi compared with controlpatients. The significance of this finding is unknown. In an exploratory clinical trial evaluating the use of another anti-TNF agent, infliximab, in patients with moderate to severe chronic obstructive pulmonary disease (COPD), more malignancies, mostly in the lung or head and neck, were reported in infliximab-treated patients compared with control patients. All patients had a history of heavy smoking. Therefore, caution should be exercised when using any TNF-antagonist in COPD patients, as well as in patients with an increased risk of malignancy due to heavy smoking.
    Colon dysplasia/carcinoma: It is not known if Simponi treatment influences the risk for developing dysplasia or colon cancer. All patients with ulcerative colitis who are at increased risk for dysplasia or colon carcinoma (for example, patients with long-standing ulcerative colitis or primary sclerosing cholangitis), or who had a prior history of dysplasia or colon carcinoma should be screened for dysplasia at regular intervals before therapy and throughout their disease course. This evaluation should include colonoscopy and biopsies per local recommendations. In patients with newly diagnosed dysplasia treated with Simponi, the risks and benefits to the individual patient must be carefully reviewed and consideration should be given to whether therapy should be continued.
    Skin cancers: Melanoma has been reported in patients treated with TNF blocking agents, including SIMPONI. Merkel cell carcinoma has been reported in patients treated with other TNF- blocking agents. Periodic skin examination is recommended for all patients, particularly those with risk factors for skin cancer.
    See prescribing information for full details.


    Side Effects

    Very common: Upper respiratory tract infection (nasopharyngitis, pharyngitis, laryngitis and rhinitis).
    Common: Bacterial infections (such as cellulitis), viral infections (such as influenza and herpes), bronchitis, sinusitis, superficial fungal infections. Anemia, allergic reactions (bronchospasm, hypersensitivity, urticaria), autoantibody positive. Depression, insomnia, dizziness, paresthesia, headache, hypertension. Constipation, dyspesia, GI and abdominal pain. Increased alanine aminotransferase, increased aspartate aminotransferase. Alopecia, dermatitis, pruritis, rash. Pyrexia, asthenia, injection site reaction (such as injection site erythema, urticaria, induration, pain, bruising, pruritus, irritation and paraesthesia), impaired healing, chest discomfort.
    See prescribing information for full details.


    Drug interactions

    No interaction studies have been performed. Concurrent use with other Biological Therapeutics The combination of Simponi with other biological therapeutics used to treat the same conditions as Simponi, including anakinra and abatacept is not recommended. Live vaccines /Therapeutic Infectious Agents Live vaccines should not be given concurrently with Simponi. Therapeutic infectious agents should not be given concurrently with Simponi Methotrexate Although concomitant use of MTX results in higher steady-state trough concentrations of Simponi in patients with RA, PsA or AS, the data do not suggest the need for dose adjustment of either Simponi or MTX.
    See prescribing information for full details.


    Pregnancy and Lactation

    Women of childbearing potential: Women of childbearing potential must use adequate contraception to prevent pregnancy and continue its use for at least 6 months after the last golimumab treatment.
    Pregnancy: There are no adequate data on the use of golimumab in pregnant women. Due to its inhibition of TNF, golimumab administered during pregnancy could affect normal immune responses in the newborn. Studies in animals do not indicate direct or indirect harmful effects with respect to pregnancy, embryonal/foetal development, parturition or postnatal development. The use of golimumab in pregnant women is not recommended; golimumab should be given to a pregnant woman only if clearly needed. Golimumab crosses the placenta. Following treatment with a TNF-blocking monoclonal antibody during pregnancy, the antibody has been detected for up to 6 months in the serum of the infant born by the treated woman. Consequently, these infants may be at increased risk of infection. Administration of live vaccines to infants exposed to golimumab in utero is not recommended for 6 months following the mother’s last golimumab injection during pregnancy.
    Breastfeeding: It is not known whether golimumab is excreted in human milk or absorbed systemically after ingestion. Golimumab was shown to pass over to breast milk in monkeys, and because human immunoglobulins are excreted in milk, women must not breast feed during and for at least 6 months after golimumab treatment.
    Fertility: No animal fertility studies have been conducted with golimumab. A fertility study in mice, using an analogous antibody that selectively inhibits the functional activity of mouse TNFα, showed no relevant effects on fertility.


    Overdose

    Single doses up to 10 mg/kg intravenously have been administered in a clinical study without dose-limiting toxicity. In case of an overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse effects and appropriate symptomatic treatment be instituted immediately.


    Manufacturer
    Cilag AG
    Licence holder
    CLOSE