Summary

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• Impavido (miltefosine) is indicated in adults and pediatric patients 12 years of age and older weighing greater than or equal to 30 kg (66 lbs) for the treatment of visceral leishmaniasis due to Leishmania donovani. It is also indicated in adults and pediatric patients 12 years of age and older weighing greater than or equal to 30 kg (66 lbs) for the treatment of cutaneous leishmaniasis due to Leishmania braziliensis, Leishmania guyanensis, and Leishmania panamensis. Additionally, Impavido (miltefosine) is indicated in adults and pediatric patients 12 years of age and older weighing greater than or equal to 30 kg (66 lbs) for the treatment of mucosal leishmaniasis due to Leishmania braziliensis.
• This summary is based on the review of seven systematic review(s)/meta-analysis(es). ^[1-7]
• Visceral Leishmaniasis (VL): Relapse rates were 4.5% for single-dose liposomal amphotericin B (L-AmB) and 1.5% for L-AmB in combination therapy in the Indian Sub-Continent (ISC); in East Africa (EA), relapse rates were 3.8% for pentavalent antimony (PA) and 13.0% for PA combined with paromomycin.
• Cutaneous Leishmaniasis (CL): Oral miltefosine was found to be significantly more effective than glucantime for non-Leishmania braziliensis species, and it had comparable cure rates to intramuscular meglumine antimoniate (IMMA) while showing superior cure rates over placebo for American cutaneous leishmaniasis (ACL).
• For Visceral Leishmaniasis (VL), serious adverse events (SAEs) were more frequent with pentavalent antimony and multiple-dose liposomal amphotericin B (L-AmB) compared to miltefosine. Mortality rates were higher in studies from Eastern Africa, particularly among patients with HIV co-infections, who had a significantly higher incidence rate of death (IRD).
• For Cutaneous Leishmaniasis (CL), oral miltefosine was associated with increased nausea and vomiting compared to intramuscular meglumine antimoniate (IMMA). Myalgias and arthralgias were more common with IMMA, with no significant difference in severe adverse effects between miltefosine and glucantime.
• Population and subgroup considerations indicated geographical variation in relapse rates and safety profiles for visceral leishmaniasis (VL) between the Indian Sub-Continent (ISC) and East Africa (EA), with studies often excluding patients with HIV co-infections; cutaneous leishmaniasis (CL) studies focused on immunocompetent individuals and included species-specific analysis across different age groups, with a noted effectiveness of oral miltefosine for non-Leishmania braziliensis species.