Indications and Orphan Designations
Impavido is the first and only FDA-approved drug to treat cutaneous or mucosal leishmaniasis, in addition to Viceral leishmaniasis.
Impavido (Miltefosine) is promising with an orphan designation for the treatment of free-living ameba (FLA) infections caused by Naegleria fowleri, Balamuthia mandrillaris, Amebiasis, Schistosomiasis, Granulomatous Amebic
Encephalitis (GAE) and Acanthamoeba species. Use of Impavido with these Orphan Designations is considered "off-label" use at this time.
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Impavido® (miltefosine) is an FDA-approved treatment for cutaneous, mucosal and visceral leishmaniasis in patients 12 years of age and older. PLEASE SEE FULL PRESCRIBING INFO