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  • CABLIVI
    / Sanofi


    Active Ingredient
    Caplacizumab 10 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Powder and Diluent for Solution for Injection

    1 x 10 mg

    partial basket chart

    Powder and Diluent for Solution for Injection

    7 x 10 mg

    partial basket chart

    Related information


    Dosage

    Treatment with Cablivi should be initiated and supervised by physicians experienced in the management of patients with thrombotic microangiopathies.
    First dose
    Intravenous injection of 10 mg of caplacizumab prior to plasma exchange.
    Subsequent doses
    Daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.
    If after initial treatment course, sign(s) of persistent underlying disease such as suppressed ADAMTS13 activity levels remain present, treatment may be extended for a maximum of 28 days.
    In the clinical development program, caplacizumab has been administered daily for up to 65 days. No data on re-treatment with caplacizumab are available.
    See prescribing information for full details.


    Indications

    Treatment for adults and adolescents aged 12 years and older, weighing at least 40 kg, experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients


    Special Precautions

    Bleeding
    Cablivi increases the risk of bleeding. Cases of major bleeding, including life-threatening and fatal bleeding have been reported in patients receiving caplacizumab, mainly in those using concomitant anti-platelet agents or anticoagulants. Caplacizumab should be used with caution in patients with underlying conditions that may predispose them to a higher risk of bleeding.
    In case of, clinically significant bleeding, treatment with Cablivi should be interrupted. If needed, the use of von Willebrand Factor concentrate could be considered to correct hemostasis. If Cablivi is restarted, monitor closely for signs of bleeding.
    In the setting of concomitant use of oral anticoagulants, anti-platelet agents, thrombolytic agents or heparin
    The risk of bleeding is increased with concomitant use of Cablivi with other medicinal products affecting hemostasis and coagulation. Initiation or continuation of treatment with oral anticoagulants (e.g., vitamin K antagonists or direct oral anticoagulants [DOAC] such as thrombin inhibitors or factor Xa inhibitors), anti-platelet agents, thrombolytic agents such as urokinase, tissue plasminogen activator (t-PA) (e.g. alteplase) or heparin requires careful consideration and close clinical monitoring.
    In patients with coagulopathies
    Due to a potential increased risk of bleeding, use of Cablivi in patients with underlying coagulopathies (e.g. hemophilia, other coagulation factor deficiencies) must be accompanied by close clinical monitoring.
    In patients undergoing surgery
    If a patient is to undergo elective surgery, an invasive dental procedure or other invasive interventions, the patient must be advised to inform the physician or dentist that they are using caplacizumab, and it is recommended to withhold treatment for at least 7 days before the planned intervention. After the risk of surgical bleeding has resolved, and caplacizumab is resumed, the patient should be monitored closely for signs of bleeding.
    If emergency surgery is needed, the use of von Willebrand Factor concentrate is recommended to correct haemostasis.
    Severe hepatic impairment
    No formal study with caplacizumab has been conducted in patients with severe acute or chronic hepatic impairment and no data regarding the use of caplacizumab in these populations are available. Use of Cablivi in this population requires a benefit/risk assessment and close clinical monitoring.
    See prescribing information for full details.


    Side Effects

    Very common: headache, epistaxis, gingival bleeding, urticarial, pyrexia, fatigue.
    Common: cerebral infarction, eye haemorrhage, haematoma, dyspnoea, haemoptysis, haematemesis, haematochezia, melaena, upper gastrointestinal, haemorrhage,  haemorrhoidal haemorrhage, rectal haemorrhage, abdominal wall haematoma, myalgia, haematuria, menorrhagia, vaginal haemorrhage, injection site haemorrhage, injection site pruritus, injection site erythema, injection site reaction, subarachnoid haemorrhage.
    See prescribing information for full details.


    Drug interactions

    No interaction studies evaluating use of caplacizumab with oral anticoagulants (e.g. vitamin K antagonists, direct oral anticoagulants [DOAC] such as thrombin inhibitors or factor Xa inhibitors), antiplatelet agents, thrombolytic agents such as urokinase, tPA (e.g. alteplase) or heparin have been performed.


    Pregnancy and Lactation

    Pregnancy: There are no data on the use of caplacizumab in pregnant women. As a precautionary measure, it is preferable to avoid the use of caplacizumab during pregnancy.
    Lactation
    : There are no data on the use of caplacizumab in breastfeeding women. It is unknown whether caplacizumab is excreted in human milk. A risk to the child cannot be excluded. A decision must be made whether to discontinue breastfeeding or to abstain/discontinue from therapy, taking into account the benefit of breastfeeding for the child and the benefit of therapy for the woman.


    Overdose

    In case of overdose, based on the pharmacological action of caplacizumab, there is the potential for an increased risk of bleeding. Close monitoring for signs and symptoms of bleeding is recommended.


    Manufacturer
    Ablynx nv., Belgium
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