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    / Megapharm


    Active Ingredient
    Miltefosine 10 mg , 50 mg

    Status in Israel
    RX

    Presentation and Status in Health Basket

    Presentation Basket Yarpa Pharmasoft

    Hard Capsules

    56 X 10 mg

    partial basket chart 32907 9902

    Hard Capsules

    56 X 50 mg

    partial basket chart 32908

    Related information


    Dosage

    Visceral leishmaniasis:
    Bodyweight  30 – 31 kg: 60 mg  daily (6 hard capsules of 10 mg).
    Bodyweight  32 – 39 kg: 80 mg daily (8 hard capsules 10 mg).
    Bodyweight 40 kg and above: 100 mg daily (2 hard capsules of 50 mg).
    No data from clinical studies are available for patients with a bodyweight higher than 67 kg. An increase of the daily dosage to 150 mg (3 hard capsules of 50 mg) could be considered in patients with a bodyweight above 67 kg under monitoring of the tolerability.
    Cutaneous leishmaniasis: The daily dosage for children aged 12 years and older with a body weight of at least 30 kg, adolescents and adults with a body weight of lower than 45 kg is 100 mg miltefosine (2 hard capsules of 50 mg). Patients with a bodyweight higher than 45 kg receive 150 mg miltefosine daily (3 hard capsules 50 mg). No data from clinical studies are available for patients with a bodyweight lower than 30 kg. The hard capsules should be taken with meals. Dosages of 2 – 8 hard capsules per day should be divided into 2 -3 individual doses to be taken either in the morning and in the evening or in the morning, at noon and in the evening. The duration of treatment is 28 days. Immuno-compromised patients may require prolonged treatment.


    Indications

    Treatment of visceral Leishmaniasis caused by Leishmania donovani, indicated in adults and adolescents ≥12 years of age weighing ≥30 kg (66 lbs).
    Treatment of cutaneous Leishmaniasis caused by Leishmania brasiliensis complex or Leishmania mexicana complex, indicated in adults and adolescents ≥12 years of age weighing ≥30 kg (66 lbs).


    Contra-Indications

    Hypersensitivity to the active substance or any of the excipients.
    Pre-existing severe damage of liver or kidney function.
    Sjögren – Larsson Syndrome.
    Pregnancy and women of childbearing potential who do not use a reliable contraception during and up to 5 months after treatment.
    Women who can become pregnant and have not had a pregnancy test. Women who can get pregnant must have a urine or blood pregnancy test before taking this drug.


    Special Precautions

    In immunocompromised patients  Miltefosine  may only be used after failure of standard therapy as only limited experience is available on therapeutic use of  Miltefosine  in such patients. In 39 HIV co-infected patients with a mean body weight of 59 kg (range 43 – 99 kg)  Miltefosine  was used at a dosage of 100 mg per day for treatment of visceral Leishmaniasis that was recurrent after or refractory to drug therapy. After a mean treatment duration of 55 days (median: 30 days, range 4 – 732 days) 25 patients (65 %) responded to therapy; of these, 16 patients (43 %) showed negative parasitology. 22 patients received at least one further treatment course with similar response rate and tolerability. The results of a clinical study in cutaneous Leishmaniasis caused by Leishmania brasiliensis indicate, that the efficacy of  Miltefosine  against this pathogen may be somewhat lower than against other Leishmania species. Patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose- galactose malabsorption should not take this medicine.
    Embryo-Fetal Toxicity: Miltefosine may cause fetal harm. Embryo-fetal toxicity, including death and teratogenicity, was observed in animals administered miltefosine prior to mating, during early pregnancy, and during organogenesis at doses lower than the maximum recommended human dose (MRHD). Do not use Miltefosine in pregnant women. Obtain a urine or serum pregnancy test prior to prescribing Miltefosine to females of reproductive potential. Advise females of reproductive potential to use effective contraception during Miltefosine therapy and for 5 months after completion of therapy Data should be collected regarding pregnancy outcomes for 10 years after approval of Miltefosine in women who become pregnant while taking Miltefosine or during 5 months after end of Miltefosine therapy.
    Reproductive Effects: Females: Effects on human female fertility have not been formally studied.
    Males: The effects of Miltefosine on human male fertility have not been adequately studied. See prescribing information for full details. Elevations of serum creatinine (Cr) were noted in clinical trials evaluating Miltefosine in the treatment of cutaneous, mucosal and visceral leishmaniasis. Monitor renal function weekly in patients receiving Miltefosine during therapy and for 4 weeks after end of therapy. Elevations in liver transaminases (ALT, AST) and bilirubin were noted in clinical trials evaluating Miltefosine in the treatment of visceral leishmaniasis. Monitor liver transaminases (ALT, AST) and bilirubin during therapy in patients receiving this drug. In patients with clinically significant abnormality in kidney function monitoring should be continued until normalization Patients with severe damage of liver and kidney functions were not investigated Sufficient data of patients with mild and moderate impairment of liver and kidney function are not available. Patients with liver values (GOT, GPT, alkaline phosphatase) 3 times and kidney values (serum creatinine, BUN) 1.5 times above the normal range, were excluded from the clinical study.
    Gastrointestinal Effects: Vomiting and diarrhea are possible side effects of a therapy with Miltefosine. The patients must be instructed that in case of prolonged persistance of these symptoms a sufficient fluid intake must be ensured, to avoid dehydration and consequently the risk of an impaired renal function.
    Thrombocytopenia: Thrombocytopenia during therapy has been reported in patients treated for visceral leishmaniasis. Monitor platelet count during therapy for visceral leishmaniasis.
    Absorption of Oral Contraceptives: Vomiting and/or diarrhea occurring during Miltefosine therapy may affect the absorption of oral contraceptives, and therefore compromise their efficacy. If vomiting and/or diarrhea occur during. Miltefosine therapy, advice females to use additional non-hormonal or alternative method(s) of effective contraception.
    Stevens – Johns on Syndrome: Stevens-Johnson syndrome has been reported during therapy. Discontinue this drug if an exfoliative or bullous rash is noted during therapy.
    QT interval: Data should be collected regarding QT interval in leishmaniasis patients receiving Miltefosine treatment to evaluate the effects of Miltefosine on the QT interval. ECGs and PK samples will be obtained to identify potential effects of Miltefosine on the QT interval or other ECG parameters.
    See prescribing information for full details. 


    Side Effects

    Vomiting, diarrhea, nausea, increase in liver enzymes (SGOT, SGPT, AP), anorexia increase of BUN and creatinine.
    See prescribing information for full details.


    Drug interactions

    In vitro investigations have shown that interactions are unlikely with medications that are metabolised by cytochrome P450 or glucuronised or conjugated otherwise. However, the possibility of interactions with commonly used medicinal products cannot entirely be excluded.


    Pregnancy and Lactation

    Pregnancy: The use of this drug in pregnant women is contraindicated.
    Lactation: It is not known whether miltefosine is excreted in the milk. Miltefosine must not be used during lactation; Breastfeeding should be avoided for 5 months after Miltefosine therapy.
    See prescribing information for full details. 


    Overdose

    A specific antidote against miltefosine is not known.
    Gastrointestinal symptoms (nausea, vomiting, loss of appetite) are to be expected in case of acute overdose. Adverse effects on liver, kidney, and retinal function cannot be excluded in case of substantial overdose.
    Institute adequate hydration to prevent the risk of impaired renal function, and replace electrolytes as necessary. Because Miltefosine is only slightly excreted in the urine, forced diuresis will not increase Miltefosine excretion. Gastrointestinal lavage is of unknown value.  


    Important notes

    Storage: Store below 30°C. Store in the original package in order to protect from moisture.  

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