28
Treatment
Table 3c. Approach to Syndromic Treatment of Visceral
Leishmaniasis (VL)
5
in North America
1,2
Treatment
Classification
Generic (Brand)
Source and Availability Regimen
Treatment of
choice
Liposomal amphotericin B6
(AmBisome
®
)
Astellas
FDA-approved regimen, if
immunocompetent
5,7
:
• 3 mg/kg/day IV on days 1–5,
14, and 21 (total dose 21 mg/kg )
FDA-approved regimen, if
immunosuppressed
8
:
• 4 mg/kg/day IV on days 1–5,
10, 17, 24, 31, and 38
(total dose 40 mg/kg )
Alternatives
9
Miltefosine
10
(Impavido
®
)
• In US: Knight Therapeutics,
via Profounda, the US
marketer.
• In Canada: via Special
Access Program
FDA- approved regimen:
• 30–44 kg : 50 mg bid for 28
days PO
• ≥45 kg : 50 mg tid for 28 days8
PO
Pentavalent antimonials
4,11
Sodium stibogluconate
(Pentostam
®
)
GlaxoSmithKline
• via CDC Drug Service or
USAMMDA for military
health care beneficiaries
13
• via Special Access Program
in Canada
• 20 mg Sb
V
/kg/day for 28 days
8
IV, IM (IV preferred in North
America
1
)
Meglumine antimoniate
(Glucantime
®
) Sanofi
• via Special Access In Canada
As per Pentostam
®
Amphotericin B deoxycholate
6
(Fungizone
®
)
Bristol Myers Squibb
1 mg/kg per dose IV daily or every
other day for a total of 15–20 doses
8
Amphotericin B lipid complex
(Abelcet
®
)
Sigma-Tau Pharmaceuticals
Immunocompetent
5,7
:
• 2–3 mg/kg/day IV for
5–10 days
Immunosuppressed
8
:
• 3–5 mg/kg/day IV for
10 days
12
Lesser
alternative
Pentamidine isethionate
(Pentam 300
®
)
APP Pharmaceuticals
4 mg/kg every other day or 3 × per
week for ~15– 30 doses
8
IV, IM
(IV preferred in North America
1
)
