September 4, 2015
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"The U.S. Food and Drug Administration today approved Impavido (miltefosine) to treat a tropical disease called leishmaniasis.

Leishmaniasis is a disease caused by Leishmania, a parasite which is transmitted to humans through sand fly bites."...




The common adverse effects of vomiting, diarrhea, and abdominal pain are likely in case of overdose. Institute adequate hydration to prevent the risk of impaired renal function, and replace electrolytes as necessary. Because miltefosine is only slightly excreted in the urine, forced diuresis will not increase miltefosine excretion. Gastrointestinal lavage is of unknown value. A specific antidote to treat miltefosine overdose is not known.



IMPAVIDO may cause fetal harm. IMPAVIDO is contraindicated in pregnant women. Obtain a urine or serum pregnancy test prior to prescribing IMPAVIDO [see BOXED WARNING and Use in Specific Populations].


IMPAVIDO is contraindicated in patients who have Sjögren-Larsson-Syndrome [see CLINICAL PHARMACOLOGY].


IMPAVIDO is contraindicated in patients who are hypersensitive to miltefosine or any IMPAVIDO excipients.

Last reviewed on RxList: 3/31/2014
This monograph has been modified to include the generic and brand name in many instances.


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