DefinitionThis section has been translated automatically.
Antiprotozoal agent which can be called hexadecylphosphocholine according to its chemical structure. Miltefosine has been shown to be effective against Leishmania donovani and L. infantum in human and animal studies. Miltefosine was discovered at the Max Planck Institute for Biophysical Chemistry in Göttingen (H. Eibl and C. Unger) and was primarily developed as a cytostatic drug.
IndicationThis section has been translated automatically.
- Approved as a systemic therapeutic agent for visceral leishmaniasis by the L. Donovani group and for cutaneous leishmaniasis in the New World. According to recent reports also effective for cutaneous leishmaniasis of the Old World.
- Topical (Miltex solution) Malignant skin changes in breast cancer (extensive and/or small-nodular metastases in the area or outside the area of the initial operation), if surgery, radiation, hormone therapy or chemotherapy on the skin shows no success or is expected to show success, or if there are contraindications for the above-mentioned therapies.
- According to the EMA, orphan drug status exists for the treatment of cutaneous T-cell lymphoma.
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Dosage and method of useThis section has been translated automatically.
- Impavido: Adults and children > 3 LJ: 1,5-2,5 mg/kg bw/day p.o. over 28 days. Max. TD: 150 mg. To be taken at 1-3 times a day with meals.
Remember! In immunocompromised patients a longer treatment may be necessary.
- Miltex: 6% solution: Apply initially once/day for 1 week, then apply thinly twice/day to the affected areas.
Notice! During the therapy and up to 6 months afterwards, effective contraception must be used!
Undesirable effectsThis section has been translated automatically.
- Local therapy: Itching, reddening, dry skin, scaling, burning in open, weeping areas.
- Systemic therapy: Orally administered miltefosine may cause mild to moderate gastrointestinal discomfort. There may be a reversible increase in transaminases and creatinine. In addition, diarrhoea and vomiting occur relatively frequently.
PreparationsThis section has been translated automatically.
Impavido; Miltex solution
Note(s)This section has been translated automatically.
Remember! Miltefosine is a new preparation for the oral therapy of visceral leishmaniasis. Compared to the substances recommended as standard therapeutics, the new preparation apparently shows a better benefit-risk ratio.
LiteratureThis section has been translated automatically.
- Jacobs S (2002) An oral drug for leishmaniasis. N Engl J Med. 2002 Nov 28;347(22): 1737-1738
- Jha TK et al (1999) Miltefosine, an oral agent, for the treatment of Indian visceral leishmaniasis. N Engl J Med 341: 1795-1800
- Roca B (2003) Miltefosine for Indian visceral leishmaniasis. N Engl J Med 2003 348: 857-858
- From Stebut E et al (2007) Cutaneous leishmaniasis. dermatologist 58: 445-459
Prof. Dr. med. Peter Altmeyer