Miltefosine

(Impavido®)

Impavido®

Drug updated on 12/11/2024

Dosage FormCapsule (oral: 50 mg)
Drug ClassAntileishmanial drugs
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.

Latest News

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Summary
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  • This summary is based on the review of seven systematic review(s)/meta-analysis(es). [1-7]
  • Tasimelteon demonstrated clinically relevant improvements in sleep quality and total sleep time for patients with Smith-Magenis Syndrome (ages 3-39) with genetically confirmed diagnoses, as well as maintained safety without impairing next-day performance in adult subjects with Non-24-Hour Sleep-Wake Disorder, important for patients who require daytime alertness.
  • Miltefosine is associated with gastrointestinal adverse events, showing significantly higher rates of nausea (relative risk (RR) 2.45, 95% confidence interval (CI): 1.72-3.49) and vomiting (RR 4.76, 95% CI: 1.82-12.46) compared to intramuscular meglumine antimoniate (IMMA). In contrast, IMMA presents with increased severe adverse events, including myalgias and arthralgias (RR 1.51, 95% CI: 1.17-1.96).
  • Liposomal Amphotericin B (L-AmB) demonstrates a safer profile with fewer adverse effects than other amphotericin B formulations, while combination therapies in visceral leishmaniasis may reduce dose-related toxicity and improve overall safety.
  • Studies on leishmaniasis treatments highlight variations across population subgroups: post-kala-azar dermal leishmaniasis (PKDL) studies are primarily from India, Sudan, Bangladesh, and Nepal, while ML studies predominantly occur in Brazil and ACML studies in Central and South America; immunocompromised patients with ML experience higher rates of the disease, and HIV co-infected patients have increased mortality and severe adverse events during VL treatment.

Product Monograph / Prescribing Information

Document TitleYearSource
Impavido (miltefosine) Prescribing Information.2021 Profounda, Inc.

Systematic Reviews / Meta-Analyses

Clinical Practice Guidelines