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    / GSK


    Active Ingredient
    Mepolizumab 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 10ml

    not in the basket chart 59906

    Vial

    3 X 10ml

    not in the basket chart

    Dosage

    The recommended dose of mepolizumab is 100 mg administered subcutaneously once every 4 weeks. Mepolizumab is intended for long-term treatment. The need for continued therapy should be considered at least on an annual basis as determined by physician assessment of the patient’s disease severity and level of control of exacerbations. The safety and efficacy of Mepolizumab in children and adolescents under 18 years of age has not yet been established. Very limited data are currently available in children 12 to 18 years old. Therefore no recommendations can be made. No dose adjustment is required for elderly patients No dose adjustment is required in patients with renal or hepatic impairment.


    Indications

    Mepolizumab is indicated as an add-on treatment for severe refractory eosinophilic asthma in adult patients.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients.


    Special Precautions

    Mepolizumab should not be used to treat acute asthma exacerbations. Asthma-related adverse events or exacerbations may occur during treatment. Patients should be instructed to seek medical advice if their asthma remains uncontrolled or worsens after initiation of treatment. Abrupt discontinuation of corticosteroids after initiation of Mepolizumab therapy is not recommended. Reduction in corticosteroid doses, if required, should be gradual and performed under the supervision of a physician.
    Hypersensitivity and administration-related reactions: Acute and delayed systemic reactions, including hypersensitivity reactions (e.g. anaphylaxis, urticaria, angioedema, rash,  bronchospasm, hypotension), have occurred following administration of Mepolizumab. These reactions generally occur within hours of administration, but in some instances have a delayed onset (i.e., typically within several days). These reactions may occur for the first time after a long duration of treatment.
    Parasitic infections: Eosinophils may be involved in the immunological response to some helminth infections. Patients with preexisting helminth infections should be treated before starting therapy. If patients become infected whilst receiving treatment with Mepolizumab and do not respond to anti-helminth treatment, temporary discontinuation of therapy should be considered.
    Sodium content: This medicinal product contains less than 1 mmol sodium (23 mg) per dose, i.e. essentially ‘sodium- free’.
    See prescribing information for full details.


    Side Effects

    Headache, Lower respiratory tract infection, Urinary tract infection, Pharyngitis, Hypersensitivity reactions (systemic allergic), Nasal congestion, Abdominal pain upper, Eczema, Back pain, Administration-related reactions (systemic non allergic, Local injection site reactions, Pyrexia.
    See prescribing information for full details.


    Drug interactions

    No interaction studies have been performed. Cytochrome P450 enzymes, efflux pumps and protein-binding mechanisms are not involved in the clearance of mepolizumab. Increased levels of pro-inflammatory cytokines (e.g. IL-6), via interaction with their cognate receptors on hepatocytes, have been shown to suppress the formation of CYP450 enzymes and drug transporters, however, elevation of systemic pro-inflammatory markers in severe asthma is minimal and there is no evidence of IL-5 receptor alpha expression on hepatocytes. The potential for drug-drug interactions with mepolizumab is therefore considered low.


    Pregnancy and Lactation

    Pregnancy: There is a limited amount of data (less than 300 pregnancy outcomes) from the use of mepolizumab in pregnant women.
    Lactation: There are no data regarding the excretion of mepolizumab in human milk.
    See prescribing information for full details.


    Overdose

    There is no clinical experience with overdose of mepolizumab. Single doses of up to 1500 mg were administered intravenously in a clinical trial to patients with eosinophilic disease without evidence of dose-related toxicities. There is no specific treatment for an overdose with mepolizumab. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary. Further management should be as clinically indicated or as recommended by the national poisons centre, where available.


    Important notes

    Storage: Store below 25°C. Do not freeze. Keep the vial in the outer carton in order to protect from light.
    Compatibility: This medicinal product must not be mixed with other medicinal products.


    Manufacturer
    GlaxoSmithKline
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