Miltefosine

Antiprotozoal agent that can be described as hexadecylphosphocholine (alkylphosphocholine) 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 agent.

Miltefosine impairs the biosynthesis of ether lipids and phsopholipids in the cell membranes of Leishmania.

Approved as a systemic therapeutic agent for visceral leishmaniasis caused by the L. donovani group and for cutaneous leishmaniasis of the New World. According to recent reports also effective in cutaneous leishmaniasis of the Old World.

Topical (Miltex solution) Malignant skin lesions in breast cancer (flat and/or small nodular metastases in or outside the area of the initial operation), if surgery, radiation, hormone therapy or chemotherapy on the skin has not been successful or is not expected to be successful, or if there are contraindications for the aforementioned therapies.

According to the EMA, orphan drug status exists for the treatment of cutaneous T-cell lymphoma.

• ^Impavido®: Adults and children > 3 LJ: 1.5-2.5 mg/kg bw/day p.o. over 28 days. Max. TD: 150 mg. Take 1-3 doses at mealtimes

  , please note! Longer treatment may be necessary in immunocompromised patients.

• ^Miltex®: 6% solution: Initially apply 1 time/day for 1 week, then apply thinly 2 times/day to the affected skin areas.

Note! Effective contraception must be used during treatment and for up to 6 months afterwards!

Local therapy: Itching, reddening of the skin, dryness of the skin, scaling of the skin, burning in the area of 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, diarrhea and vomiting occur relatively frequently.

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.

1. Fischer T et al. (2024)Treatment of mucocutaneous leishmaniasis- a systematic review. JDDG 22:763-774

2. Jacobs S (2002) An oral drug for leishmaniasis. N Engl J Med. 2002 Nov 28;347(22): 1737-1738
3. Jha TK et al. (1999) Miltefosine, an oral agent, for the treatment of Indian visceral leishmaniasis. N Engl J Med 341: 1795-1800
4. Roca B (2003) Miltefosine for Indian visceral leishmaniasis. N Engl J Med 2003 348: 857-858
5. Von Stebut E et al (2007) Cutaneous leishmaniasis. Dermatology 58: 445-459