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  • BIMZELX
    / Neopharm


    Active Ingredient
    Bimekizumab 160 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Pre-filled Pen (Solution for Injection)

    1 X 160 mg/ml

    partial basket chart

    Dosage

    The recommended dose for adult patients with plaque psoriasis is 320 mg (given as 2 subcutaneous injections of 160 mg each) at week 0, 4, 8, 12, 16 and every 8 weeks thereafter.


    Indications

    This medical product is indicated for the treatment of moderate to severe plaque psoriasis in adults who are candidates for systemic therapy.


    Contra-Indications

    * Hypersensitivity to the active substance or any other ingredient
    * Active infections
    See prescribing information for full details


    Special Precautions

    Infections
    Bimekizumab may increase the risk of infections such as upper respiratory tract infections and oral candidiasis. Caution should be exercised when considering the use of bimekizumab in patients with a chronic infection or a history of recurrent infection. Treatment with bimekizumab must not be initiated in patients with any clinically important active infection until the infection resolves or is adequately treated
    Pre-treatment evaluation for tuberculosis (TB)
    Bimekizumab should not be given in patients with active TB. Prior to initiating treatment with bimekizumab, patients should be evaluated for TB infection, therapy should be considered.
    Inflammatory bowel disease
    Bimekizumab is not recommended in patients with inflammatory bowel disease. If a patient develops signs and symptoms of inflammatory bowel disease or experiences an exacerbation of pre-existing inflammatory bowel disease, this medical product should be discontinued and appropriate medical management should be initiated.
    Hypersensitivity
    Serious hypersensitivity reactions including anaphylactic reactions have been observed with IL-17 inhibitors. If a serious hypersensitivity reaction occurs, administration of bimekizumab should be discontinued immediately and appropriate therapy initiated.
    Vaccinations
    Prior to initiating therapy with bimekizumab, completion of all age appropriate immunizations according to current immunization guidelines should be considered.
    Live vaccines should not be given in patients treated with bimekizumab, may receive inactivated or non-live vaccinations.
    See prescribing information for full details.


    Side Effects

    Very common: Upper respiratory tract infections
    Common: Oral candidiasis, Tinea infections, Ear infections, Herpes simplex infections, Oropharyngeal candidiasis, Gastroenteritis, Folliculitis, Headache, Dermatitis and eczema, Acne, Injection site reactions, Fatigue
    See prescribing information for full details


    Drug interactions

    No interaction studies have been performed.
    See prescribing information for full details


    Pregnancy and Lactation

    Pregnancy: There is a limited amount of data on the use of bimekizumab in pregnant women.
    Lactation
    : It is unknown whether bimekizumab is excreted in human milk. A risk to the newborn/infant cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from bimekizumab therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman


    Overdose

    : Single doses of 640 mg intravenously or 640 mg subcutaneously, followed by 320 mg subcutaneously every two weeks for five doses have been administered in clinical studies without dose-limiting toxicity. In the event of overdose, it is recommended that the patient be monitored for any signs and symptoms of adverse reactions and appropriate symptomatic treatment be instituted immediately.


    Manufacturer
    UCB Pharma SA
    Licence holder
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