29
FDA Approval Comments
Yes, for this indication • See Recs. 51–52 regarding other regimens that have
been used in various settings.
• For treatment of VL in immunocompetent
7
persons
with VL acquired in East Africa, regimens with total
doses ≥40 mg/kg may be needed.
Yes, for VL caused by
L. donovani
• On the basis of anecdotal experience in Europe and Brazil,
not as effective for VL caused by L. infantum-chagasi.
• In general, 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 VL
(off-label use)
Yes, but not for VL
(off-label use)
• Liposomal amphotericin B (L-AmB) is the treatment
of choice for VL.
• Bioequivalence between amphotericin B lipid complex
(ABLC) and L-AmB for treatment of VL has not been
established.
• ABCL has been less well studied in VL treatment
trials and, anecdotally, may not be as effective as
AmBisome
®
(rough conversion: 3 mg/kg of liposomal
amphotericin B is about 5 mg/kg of ABLC).
Yes, but not for VL
(off-label use)
Considered second-line therapy because of toxicity (see
Table 4) and lower efficacy.
