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  • Cosentyx 150 mg
    / Novartis


    Active Ingredient
    Secukinumab 150 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 6 ml X 150 mg

    partial basket chart

    Pre-filled Syringe

    2 X 1 ml X 150 mg

    partial basket chart 18478 9850

    Pre-filled Pen

    2 X 1 ml X 150 mg

    partial basket chart 18479 9851

    Related information


    Dosage

    Plaque psoriasis: The recommended dose is 300 mg of secukinumab by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as two subcutaneous injections of 150 mg.
    Psoriatic arthritis: For patients with concomitant moderate to severe plaque psoriasis or who are anti-TNFα inadequate responders (IR), the recommended dose is 300 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing. Each 300 mg dose is given as two subcutaneous injections of 150 mg.
    For other patients, the recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
    Ankylosing spondylitis: The recommended dose is 150 mg by subcutaneous injection with initial dosing at Weeks 0, 1, 2, 3 and 4, followed by monthly maintenance dosing.
    For all of the above indications, available data suggest that a clinical response is usually achieved within 16 weeks of treatment. Consideration should be given to discontinuing treatment in patients who have shown no response by 16 weeks of treatment. Some patients with an initial partial response may subsequently improve with continued treatment beyond 16 weeks.
    Elderly patients (aged 65 years and over): No dose adjustment is required.
    Renal impairment / hepatic impairment: Secukinumab has not been studied in these patient populations. No dose recommendations can be made.
    Paediatric population: The safety and efficacy of secukinumab in children below the age of 18 years have not yet been established. No data are available.
    Method of administration: Secukinumab is to be administered by subcutaneous injection. If possible, areas of the skin that show psoriasis should be avoided as injection sites. The powder for solution for injection must be reconstituted before use. For instructions on reconstitution of the medicinal product before administration: See prescribing information for full details.


    Indications

    Plaque psoriasis: Treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.
    Psoriatic arthritis: Alone or in combination with methotrexate (MTX), is indicated for the treatment of active psoriatic arthritis in adult patients when the response to previous disease-modifying anti-rheumatic drug (DMARD) therapy has been inadequate.
    Ankylosing spondylitis: Treatment of active ankylosing spondylitis in adults who have responded inadequately to conventional therapy.


    Contra-Indications

    Severe hypersensitivity reactions to the active substance or to any of the excipients.
    Clinically important, active infection (e.g. active tuberculosis).


    Special Precautions

    Infections: Secukinumab has the potential to increase the risk of infections. Serious infections have been observed in patients receiving secukinumab. in the post-marketing setting. Caution should be exercised when considering the use of secukinumab. in patients with a chronic infection or a history of recurrent infection.
    Patients should be instructed to seek medical advice if signs or symptoms suggestive of an infection occur. If a patient develops a serious infection, the patient should be closely monitored and secukinumab  should not be administered until the infection resolves.
    In clinical studies, infections have been observed in patients receiving secukinumab. Most of these were mild or moderate upper respiratory tract infections such as nasopharyngitis and did not require treatment discontinuation.
    Related to the mechanism of action of secukinumab, non-serious mucocutaneous candida infections were more frequently reported for secukinumab than placebo in the psoriasis clinical studies (3.55 per 100 patient years for secukinumab 300 mg versus 1.00 per 100 patient years for placebo).
    No increased susceptibility to tuberculosis was reported from clinical studies. However, secukinumab  should not be given to patients with active tuberculosis. Anti-tuberculosis therapy should be considered prior to initiation of secukinumab in patients with latent tuberculosis.
    Inflammatory bowel disease: Cases of new or exacerbations of Crohn’s disease and ulcerative colitis have been reported. Caution should be exercised when prescribing secukinumab  to patients with inflammatory bowel disease, including Crohn’s disease and ulcerative colitis. Patients should be closely monitored.
    Hypersensitivity reactions: In clinical studies, rare cases of anaphylactic reactions have been observed in patients receiving secukinumab. If an anaphylactic or other serious allergic reactions occur, administration of secukinumab should be discontinued immediately and appropriate therapy initiated.
    Vaccinations: Live vaccines should not be given concurrently with secukinumab.
    Concomitant immunosuppressive therapy: In psoriasis studies, the safety and efficacy of secukinumab in combination with immunosuppressants, including biologics, or phototherapy have not been evaluated.
    See prescribing information for full details.


    Side Effects

    Upper respiratory tract infections (most frequently nasopharyngitis, rhinitis).
    See prescribing information for full details.


    Drug interactions

    Live vaccines should not be given concurrently with secukinumab.
    In a study in subjects with plaque psoriasis, no interaction was observed between secukinumab and midazolam (CYP3A4 substrate).
    No interaction was seen when secukinumab was administered concomitantly with methotrexate (MTX) and/or corticosteroids in arthritis studies (including in patients with psoriatic arthritis and ankylosing spondylitis).
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no adequate data from the use of secukinumab in pregnant women.
    Lactation: It is not known whether secukinumab is excreted in human milk.
    See prescribing information for full details.


    Overdose

    No cases of overdose have been reported in clinical studies.
    Doses up to 30 mg/kg (approximately 2000 to 3000 mg) have been administered intravenously in clinical studies without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs or symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.


    Important notes

    Storage: Store in a refrigerator (2°C – 8°C).


    Manufacturer
    Novartis Pharma Stein AG Switzerland
    Licence holder
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