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    Active Ingredient
    Reslizumab 10 mg/ml

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 10 ml

    partial basket chart 64880

    Vial

    1 X 100 ml

    partial basket chart 89850

    Related information


    Dosage

    Intravenous infusion only. Do not administer as an intravenous push or bolus. The recommended dosage regimen is 3 mg/kg once every 4 weeks administered by intravenous infusion over 20-50 minutes.
    Discontinue the infusion immediately if the patient experiences a severe systemic reaction, including anaphylaxis.
    See prescribing information for full details.


    Indications

    Indicated for the add-on maintenance treatment of patients with severe asthma aged 18 years and older with an eosinophilic phenotype.


    Contra-Indications

    Patients who have known hypersensitivity to reslizumab or any of its excipients.


    Special Precautions

    Anaphylaxis: Anaphylaxis to Reslizumab was reported in 0.3% of asthma patients in placebo-controlled clinical studies. These events were observed during or within 20 minutes after completion of the Reslizumab infusion and reported as early as the second dose of Reslizumab. Manifestations included dyspnea, decreased oxygen saturation, wheezing, vomiting, and skin and mucosal involvement, including urticaria. In all 3 cases, Reslizumab was discontinued. Anaphylaxis can be life-threatening. Reslizumab should be administered in a healthcare setting by a healthcare professional prepared to manage anaphylaxis. Patients should be observed for an appropriate period of time after Reslizumab administration. If severe systemic reactions, including anaphylaxis, occur, stop administration of Reslizumab immediately and provide appropriate medical treatment. Prior to discharge, inform patients of the signs and symptoms of anaphylaxis and instruct them to seek immediate medical care if symptoms occur. Discontinue Reslizumab use permanently if the patient experiences signs or symptoms of anaphylaxis.
    Acute Asthma Symptoms or Deteriorating Disease: The drug  should not be used to treat acute asthma symptoms or acute exacerbations. Not for use  of  acute bronchospasm or status asthmaticus.
    Malignancy: In placebo-controlled clinical studies, 6/1028 (0.6%) patients receiving 3 mg/kg Reslizumab had at least 1 malignant neoplasm reported compared to 2/730 (0.3%) patients in the placebo group. The observed malignancies in Reslizumab -treated patients were diverse in nature and without clustering of any particular tissue type. The majority of malignancies were diagnosed within less than six months of exposure to Reslizumab.
    Reduction of Corticosteroid Dosage: No clinical studies have been conducted to assess reduction of maintenance corticosteroid dosages following administration of Reslizumab. Do not discontinue systemic or inhaled corticosteroids abruptly upon initiation of therapy with Reslizumab. Reductions in corticosteroid dose, if appropriate, should be gradual and performed under the supervision of a physician. Reduction in corticosteroid dose may be associated with systemic withdrawal symptoms and/or unmask conditions previously suppressed by systemic corticosteroid therapy.
    Parasitic (Helminth) Infection: Eosinophils may be involved in the immunological response to some helminth infections. Patients with known parasitic infections were excluded from participation in clinical studies. It is unknown if Reslizumab will influence the immune response against parasitic infections. Treat patients with preexisting helminth infections before initiating Reslizumab. If patients become infected while receiving treatment with Reslizumab and do not respond to anti-helminth treatment, discontinue treatment with Reslizumab until infection resolves.
    See prescribing information for full details.


    Side Effects

    Anaphylaxis, musculo-skeletal chest pain, neck pain, muscle spasms, extremity pain, muscle fatigue, and musculoskeletal pain.
    See prescribing information for full details.


    Drug interactions

    No formal clinical drug interaction studies have been performed with this drug.


    Pregnancy and Lactation

    Pregnancy: The data on pregnancy exposure from the clinical trials are insufficient to inform on drug-associated risk. Monoclonal antibodies, such as reslizumab, are transported across the placenta in a linear fashion as pregnancy progresses; therefore, potential effects on a fetus are likely to be greater during the second and third trimester of pregnancy.
    Lactation: It is not known whether reslizumab is present in human milk, and the effects of reslizumab on the breast fed infant and on milk production are not known.
    See prescribing information for full details.


    Overdose

    Single doses of up to 732 mg have been administered intravenously to subjects in clinical trials without evidence of dose-related toxicities.There is no specific treatment for an overdose with this drug. If overdose occurs, the patient should be treated supportively with appropriate monitoring as necessary.


    Important notes

    Storage: 2°C to 8°C. Do not freeze. Do not shake. Protect the vials from light by storing in the original package until time of use.


    Manufacturer
    Teva Pharmaceutical Industries Ltd, Israel
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