27
FDA Approval Comments
Yes, but not for ML (off-label use)
Yes, but not for ML (off-label use)
Yes, approved for ML caused by L. (V.)
braziliensis
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.
No, but available in the US under a CDC-
sponsored IND protocol.
• 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 ML (off-label use)
