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  • Eraxis
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    Active Ingredient
    Anidulafungin 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 100 mg

    partial basket chart 21260 5494

    Related information


    Dosage

    Treatment with Anidulafungin should be initiated by a physician experienced in the management of invasive fungal infections. Specimens for fungal culture should be obtained prior to therapy. Therapy may be initiated before culture results are known and can be adjusted accordingly once they are available.
    Posology: A single 200 mg loading dose should be administered on Day 1, followed by 100 mg daily thereafter. Duration of treatment should be based on the patient’s clinical response. In general, antifungal therapy should continue for at least 14 days after the last positive culture.
    Duration of treatment: There are insufficient data to support the 100 mg dose for longer than 35 days of treatment.
    Patients with renal and hepatic impairment: No dosing adjustments are required for patients with mild, moderate, or severe hepatic impairment. No dosing adjustments are required for patients with any degree of renal insufficiency, including those on dialysis. Anidulafungin can be given without regard to the timing of haemodialysis.
    Other special populations: No dosing adjustments are required for adult patients based on gender, weight, ethnicity, HIV positivity, or elderly.
    Paediatric population: The safety and efficacy of anidulafungin in children below 18 years have not been established.
    Method of administration: For intravenous use only. Anidulafungin should be reconstituted with water for injections to a concentration of 3.33 mg/mL and subsequently diluted to a concentration of 0.77 mg/mL. It is recommended that anidulafungin be administered at a rate of infusion that does not exceed 1.1 mg/min (equivalent to 1.4 mL/min when reconstituted and diluted per instructions). Infusion associated reactions are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min. Anidulafungin must not be administered as a bolus injection.         


    Indications

    Treatment of invasive candidiasis in adult patients.


    Contra-Indications

    Hypersensitivity to the active substance or to any of the excipients. Hypersensitivity to other medicinal products of the echinocandin class.      


    Special Precautions

    Anidulafungin. has not been studied in patients with Candida endocarditis, osteomyelitis or meningitis. The efficacy of anidulafungin.has only been evaluated in a limited number of neutropenic patients.
    Hepatic effects: Increased levels of hepatic enzymes have been seen in healthy subjects and patients treated with anidulafungin. In some patients with serious underlying medical conditions who were receiving multiple concomitant medicines along with anidulafungin, clinically significant hepatic abnormalities have occurred. Cases of significant hepatic dysfunction, hepatitis, and hepatic failure were uncommon in clinical trials. Patients with increased hepatic enzymes during anidulafungin therapy should be monitored for evidence of worsening hepatic function and evaluated for risk/benefit of continuing anidulafungin therapy.
    Anaphylactic reactions: Anaphylactic reactions, including shock, were reported with the use of anidulafungin. If these reactions occur, anidulafungin should be discontinued and appropriate treatment administered.
    Infusion-related reactions: Infusion-related adverse events have been reported with anidulafungin, including rash, urticaria, flushing, pruritus, dyspnea, bronchospasm and hypotension. Infusion-related adverse events are infrequent when the rate of anidulafungin infusion does not exceed 1.1 mg/min.
    Fructose content: Patients with rare hereditary problems of fructose intolerance should not take this medicine.
    See prescribing information for full details. 


    Side Effects

    Very Common: Hypokalaemia, diarrhoea, nausea.
    Common: Hyperglycaemia, convulsion, headache, hypotension, hypertension, bronchospasm, dyspnoea, vomiting, alanine aminotransferase increased,
    blood alkaline phosphatase increased, aspartate aminotransferase increased, blood bilirubin increased, cholestasis, rash, pruritus, blood creatinine increased.
    See prescribing information for full details.


    Drug interactions

    Anidulafungin is not a clinically relevant substrate, inducer, or inhibitor of cytochrome P450 isoenzymes (1A2, 2B6, 2C8, 2C9, 2C19, 2D6, 3A). Of note, in vitro studies do not fully exclude possible in vivo interactions. Drug interaction studies were performed with anidulafungin and other medicinal products likely to be co-administered. No dosage adjustment of either medicinal product is recommended when anidulafungin is co-administered with ciclosporin, voriconazole or tacrolimus, and no dosage adjustment for anidulafungin is recommended when co-administered with amphotericin B or rifampicin. 


    Pregnancy and Lactation

    Pregnancy: There are no data from the use of anidulafungin in pregnant women. Studies in animals have shown reproductive toxicity.
    ERAXIS® is not recommended during pregnancy unless the benefit to the mother clearly outweighs the potential risk to the foetus.
    Lactation: It is unknown whether anidulafungin is excreted in human milk. Available pharmacodynamic/toxicological data in animals have shown excretion of anidulafungin in milk.
    A risk to the suckling child cannot be excluded. A decision must be made whether to discontinue breast-feeding or to discontinue/abstain from Eraxis® therapy taking into account the benefit of breast-feeding for the child and the benefit of therapy for the woman.


    Overdose

    As with any overdose, general supportive measures should be utilized as necessary. ERAXIS is not dialysable.
    See prescribing information for full details.


    Important notes

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


    Manufacturer
    Pharmacia Upjohn
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