Primary amoebic meningoencephalitis future or investigational therapies

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]

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Overview

Recently, an investigational drug, miltefosine, a breast cancer and anti-leishmania drug, has shown some promise against the free-living amoebae in combination with some other drugs. Miltefosine has shown in vitro and mouse model amebicidal activity against Balamuthia, Naegleria fowleri, and Acanthamoeba.

Future or Investigational Therapies

Miltefosine (oral): The standard miltefosine dosing in adults is as follows:

• Up to 45 kg body weight: 100 mg daily (i.e., one 50 mg cap po BID, given with food if possible to reduce gastrointestinal side effects)
• 45 kg body weight and higher: 150 mg daily (i.e., one 50 mg cap po TID, given with food if possible to reduce gastrointestinal side effects )

These standard doses are the maximal tolerated with respect to gastrointestinal symptoms. A higher dose would lead to increased nausea, vomiting, or diarrhea. Miltefosine is mildly nephrotoxic and the dosing might need to be adjusted for patients with impaired kidney function. However, because few data are available about the effective dose for amebic infection, the risk for nephrotoxicity should be balanced with the risk for mortality from PAM. Miltefosine has not been approved by the U.S. Food and Drug Administration (FDA) for use in the U.S. and requires granting of an emergency Investigational New Drug (IND) request from the FDA before being ordered from the manufacturer. CDC is currently working on an expanded access IND protocol which would allow for CDC to acquire and distribute miltefosine for treatment of confirmed cases of Naegleria fowleri infection. Until that protocol is approved, CDC has individual emergency IND request paperwork available upon request that has been pre-filled as much as possible to facilitate clinicians obtaining miltefosine for treatment of PAM and other free-living amoeba infections.