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  • Mycamine
    / Astellas


    Active Ingredient
    Micafungin (as Sodium) 50 mg, 100 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Vial

    1 X 10 ml X 50 mg

    partial basket chart 33078 13789

    Vial

    1 X 10 ml X 100 mg

    partial basket chart 33077 13788

    Dosage

    The dose regimen of Micafungin depends on the body weight of the patient as given in the following tables: Use in adults, adolescents ≥ 16 years of age and elderly, Body weight > 40 kg, Body weight ≤ 40 kg.
    Treatment of invasive candidiasis:  100 mg/day*.
    Body weight ≤ 40 kg: 2 mg/kg/day*.
    Treatment of oesophageal candidiasis: 150 mg/day.
    Body weight ≤ 40 kg : 3 mg/kg/day.
    Prophylaxis of Candida infection:  50 mg/day.
    Body weight ≤ 40 kg:   1 mg/kg/day.
    *If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients ≤ 40 kg.
    Treatment duration
    Invasive candidiasis: The treatment duration of Candida infection should be a minimum of 14 days. The antifungal treatment should continue for at least one week after two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.
    Oesophageal candidiasis: For the treatment of oesophageal candidiasis, Micafungin should be administered for at least one week after resolution of clinical signs and symptoms.
    Prophylaxis of Candida infections: For prophylaxis of Candida infection, Micafungin should be administered for at least one week after neutrophil recovery.
    Use in children (including neonates) and adolescents < 16 years of age, Body weight > 40 kg, Body weight ≤ 40 kg
    Treatment of invasive candidiasis : 100 mg/day*.
    Body weight ≤ 40 kg: 2 mg/kg/day*.
    Prophylaxis of Candida infection:  50 mg/day.
    Body weight ≤ 40 kg: 1 mg/kg/day.
    *If the patient’s response is inadequate, e.g. persistence of cultures or if clinical condition does not improve, the dose may be increased to 200 mg/day in patients weighing > 40 kg or 4 mg/kg/day in patients weighing ≤ 40 kg.
    Treatment duration
    Invasive candidiasis: The treatment duration of Candida infection should be a minimum of 14 days. The antifungal treatment should continue for at least one week a fter two sequential negative blood cultures have been obtained and after resolution of clinical signs and symptoms of infection.
    Prophylaxis of Candida infections: For prophylaxis of Candida infection, Micafungin should be administered for at least one week after neutrophil recovery. Experience with Micafungin in patients less than 2 years of age is limited.


    Indications

    Adults, adolescents ≥ 16 years of age and elderly: Treatment of invasive candidiasis. Treatment of oesophageal candidiasis in patients for whom intravenous therapy is appropriate. Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation. Children (including neonates) and adolescents < 16 years of age: Treatment of invasive candidiasis. Prophylaxis of Candida infection in patients undergoing allogeneic haematopoietic stem cell transplantation. The decision to use Micafungin should take into account a potential risk for the development of liver. Micafungin should therefore only be used if other antifungals are not appropriate.


    Contra-Indications

    Hypersensitivity to the active substance, to other echinocandins or to any of the excipients.


    Special Precautions

    Hepatic effect: The development of foci of altered hepatocytes (FAH) and hepatocellular tumours after a treatment period of 3 months or longer were observed in rats. The assumed threshold for tumour development in rats is approximately in the range of clinical exposure. The relevance of this finding for the therapeutic use in patients can not be excluded. Liver function should be carefully monitored during micafungin treatment. To minimise the risk of adaptive regeneration and potentially subsequent liver tumour formation, early discontinuation in the presence of significant and persistent elevation of ALT/AST is recommended. Micafungin treatment should be conducted on a careful risk/benefit basis, particularly in patients having severe liver function impairment or chronic liver diseases known to represent preneoplastic conditions, such as advanced liver fibrosis, cirrhosis, viral hepatitis, neonatal liver disease or congenital enzyme defects, or receiving a concomitant therapy including hepatotoxic and/or genotoxic properties. Micafungin treatment was associated with significant impairment of liver function (increase of ALT, AST or total bilirubin > 3 times ULN) in both healthy volunteers and patients. In some patients more severe hepatic dysfunction, hepatitis, or hepatic failure including fatal cases have been reported. Paediatric patients < 1 year of age might be more prone to liver injury.
    Anaphylactic reactions: During administration of micafungin, anaphylactic/anaphylactoid reactions including shock may occur. If these reactions occur, micafungin infusion should be discontinued and appropriate treatment administered.
    Skin reactions: Exfoliative cutaneous reactions, such as Stevens-Johnson syndrome and toxic epidermal necrolysis have been reported. If patients develop a rash they should be monitored closely and micafungin discontinued if lesions progress.
    Haemolysis: Rare cases of haemolysis including acute intravascular haemolysis or haemolytic anaemia have been reported in patients treated with micafungin. Patients who develop clinical or laboratory evidence of haemolysis during micafungin therapy should be monitored closely for evidence of worsening of these conditions and evaluated for the risk/benefit of continuing micafungin therapy.
    Renal effects: Micafungin may cause kidney problems, renal failure, and abnormal renal function test. Patients should be closely monitored for worsening of renal function.
    See prescribing information for full details.


    Side Effects

    Nausea, blood alkaline phosphatase increased, phlebitis, primarily in HIV infected patients with peripheral lines), vomiting, and aspartate aminotransferase increased.
    See prescribing information for full details.


    Drug interactions

    Interactions with other medicinal products: Co-administration of micafungin and amphotericin B desoxycholate should only be used when the benefits clearly outweigh the risks, with close monitoring of amphotericin B desoxycholate toxicities. Patients receiving sirolimus, nifedipine or itraconazole in combination with Micafungin should be monitored for sirolimus, nifedipine or itraconazole toxicity and the sirolimus, nifedipine or itraconazole dosage should be reduced if necessary.
    See prescribing information for full details.


    Pregnancy and Lactation

    Pregnancy: There are no data from the use of micafungin in pregnant women.
    Lactation: It is not known whether micafungin is excreted in human breast milk.
    See prescribing information for full details.


    Overdose

    Repeated daily doses up to 8 mg/kg (maximum total dose 896 mg) in adult patients have been administered in clinical trials with no reported dose-limiting toxicity. One case of mis-dosage of 7.8 mg/kg/day for 7 days was reported in a newborn patient. No adverse reactions associated with this high dose were noted. There is no experience with overdoses of micafungin. In case of overdose, general supportive measures and symptomatic treatment should be administered. Micafungin is highly proteinbound and not dialyzable.


    Important notes

    Storage: Unopened vials: store below 25°C. Micafungin contains no preservatives. From a microbiological point of view, the reconstituted and diluted solutions should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 to 8°C, unless the reconstitution and dilution have taken place in controlled and validated aseptic conditions.


    Manufacturer
    Astellas Pharma International B.V., Israel
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