Revision of Miltefosine from Sep 1, 2023

Monitoring: 

Do not use in pregnant individuals. Obtain a urine or serum pregnancy test prior to initiation of therapy. Advise use of effective contraception in females of reproductive potential

Dosing: Adult Antimicrobial Dosing, Non-dialysis

Indication Dose  Notes 
Amebic meningoencephalitis

< 45 kg:  50 mg PO twice daily with food

>= 45 kg:  50 mg PO three times daily with food 

No renal adjustment
Leishmaniasis

30-44 kg:  50 mg PO twice daily with food

>= 45 kg:  50 mg PO three times daily with food 

No renal adjustment

Dosing: Antimicrobial Dosing in Intermittent & Continuous Hemodialysis

Indication

Intermittent Hemodialysis

Continuous Hemodialysis
Amebic meningoencephalitis

< 45 kg:  50 mg PO twice daily with food

>= 45 kg:  50 mg PO three times daily with food 

(no adjustment for hemodialysis)

< 45 kg:  50 mg PO twice daily with food

>= 45 kg:  50 mg PO three times daily with food 

(no adjustment for hemodialysis)

Leishmaniasis

30-44 kg:  50 mg PO twice daily with food

>= 45 kg:  50 mg PO three times daily with food 

(no adjustment for hemodialysis)

30-44 kg:  50 mg PO twice daily with food

>= 45 kg:  50 mg PO three times daily with food 

(no adjustment for hemodialysis)

Dialysis Notes

Intermittent HD assumes high-flux hemodialysis. CRRT assumes CVVHD with ultrafiltration rate 2L/h and residual native GFR < 10 mL/min.  For detailed view of dialysis dosing and evidence, see Dosing in Hemodialysis document.

Restricted to ID or Antimicrobial Stewardship with exceptions:

1) Continuation of therapy 

ZSFG: Non-formulary

References:

https://www.accessdata.fda.gov/drugsatfda_docs/label/2014/204684s000lbl.pdf