Miltefosine

(Impavido®)

Miltefosine

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Drug updated on 4/16/2024

Dosage FormCapsule (oral: 50 mg)
Drug ClassAntileishmanials
Ongoing and
Completed Studies
ClinicalTrials.gov

Indication

  • 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.
  • 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.
  • 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.

Summary
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  • Miltefosine (Impavido) is indicated for the treatment of visceral, cutaneous, and mucosal leishmaniasis in adults and pediatric patients 12 years of age or older weighing at least 30 kg. It has demonstrated effectiveness against various forms of Leishmania species.
  • Seven systematic reviews/meta-analyses provided a comprehensive comparison between Impavido (miltefosine) and other treatments used for different types of leishmaniasis.
  • The efficacy of miltefosine in treating cutaneous leishmaniasis was notable, showing a significantly greater proportion of patients achieving complete cure compared to control treatments, such as parenteral pentamidine.
  • Regarding the safety profile, miltefosine was comparable to other therapeutic options for Visceral Leishmaniasis, with serious adverse events reported being proportional across all treatment groups, including this drug.
  • For Post-kala-azar Dermal Leishmaniasis (PKDL), miltefosine was preferred due to its convenience of oral administration and minimal toxicity risk in comparison with sodium stibogluconate or other combination therapies.
  • An additional advantage of miltefosine is its capacity for immunomodulation, particularly in inducing a Th1 response crucial for successful leishmaniasis treatment, suggesting an enhanced therapeutic value beyond direct antiparasitic activity.

Product Monograph / Prescribing Information

Document TitleYearSource
Impavido (miltefosine) prescribing information.2021FDA

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines