23
FDA Approval Comments
For cases of CL associated with increased
risk for ML,
3
the choices include
miltefosine, amphotericin B formulations,
and pentavalent antimonials.
Yes, but not for CL (off-label use)
No, but available in the US under a CDC-
sponsored IND protocol (CDC Drug
Service: 404-639-3670).
• Supplied as 100 mg Sb
V
/mL.
• Dilute dose in D5W (~50–100 mL) for
IV, ~10–30-minute infusion.
• Use of an in-line filter is recommended.
No. In US, would require investigator-
sponsored IND protocol.
• Supplied as 81 mg Sb
V
/mL.
• Dilute dose in D5W (~50–100 mL) for
IV, ~10–30-minute infusion.
Yes, but not for CL (off-label use) • No standard dosage regimens have been
established.
• Other regimens have been described in
case reports/series from various settings.
Yes, but not for CL (off-label use) L. (V.) panamensis/guyanensis: an
alternative regimen is 2 mg/kg every other
day for 7 doses.
Yes, but not for CL (off-label use) See Recs. 35–37 regarding preliminary
data for therapy with higher daily doses.
Yes, but not for CL (off-label use) Take with acidic drink (eg, coke or citric
juice).
Yes, for CL caused by Viannia species (off-
label use for other species)
Target dose is ~2.5 mg/kg/day, but doses
>150 mg/day have not been studied.
• GI side effects may limit higher doses.
See Table 4 and Recs. 78-79.
