Amphotericin B cholesteryl sulfate complex (ABCD)
(Ben Venue Laboratories)
*Prices represent cost per unit specified, are representative of "Average Wholesale Price" (AWP).
^Dosage is indicated in mg unless otherwise noted.
No renal dosage adjustment in patients with renal insufficiency
Usual dose. Monitor closely for worsening renal function.
Not removed in dialysis, no supplement needed post HD. Usual dose.
Aspergillus spp (A. fumigatus, A. flavus), Candida spp (C. albicans, C. krusei, C. parapsilosis, C. tropicalis), Cryptococcus neoformans, and Blastomyces dermatitidis. Active against most fungi with the notable exceptions of Candida lusitaniae, Trichosporon beigelii, Aspergillus terreus (some isolates), Pseudallescheria boydii, Malassezia furfur and Fusarium spp.
Amphotericin binds to ergosterol in fungal cell membrane, resulting in the disruption of the cell membrane. As a result the cell membrane is no longer able to function as a selective barrier and leakage of intracellular contents occurs. The lipid formulations are designed to reduce binding of amphotericin to mammalian cell membranes, therefore reducing toxicities.
Not absorbed from the GI tract.
2-9 mcg/ml after 4mg/kg IV dose administration.
Attains lower serum concentration but has greater volume of distribution (vd = 4 L/kg) compared to conventional amphotericin. Increased uptake by the liver and spleen and decreased kidney concentration. Poor fat distribution (animal data)
No data. Usual dose likely in mild/moderate hepatic insufficiency
B- There is limited data on the use of Amphotericin B cholesteryl sulfate complex in pregnancy; therefore the use should be limited to patients where the benefit outweighs the risk.
No data available.
Comment: The IDSA guidelines recommend Ambisome (3â??5 mg/kg/day IV) or Abelcet (5 mg/ kg/day IV) as alternatives to voriconazole for the treatment of invasive aspergillosis.
Comment: Previous data suggested higher rates of infusion related reactions with ABCD as compared to conventional amphotericin as well as the other lipid formulations. This was largely due to lack of the use of premedications, which have now become routine in clinical practice. This data suggests that the incidence of infusion related reactions is lower than previously thought when corticosteroids are used prior to ABCD administration; acetaminophen and antihistamine use, though, had no effect.
Comment: This is a multicenter randomized, double-blind trial of Amphotec (ABCD)6 mg/kg/day vs. Amphotericin B 1.0-1.5 mg/kg/day for treatment of invasive aspergillosis in 174 patients. The results of this trial showed Amphotec and Amphotericin B are comparable in therapeutic efficacy for invasive aspergillosis. The study was under powered to detect a potential difference, nevertheless,overall responses was poor in both groups (17% in the ABCD group vs.23% in the ampho B group).The advantage of ABCD is the reduced rate of nephrotoxicity, but this advantage is offset by a comparable rate of complications requiring discontinuation due to infusion-related adverse reactions.
Comment: This trial demonstrated that Amphotec was equivalent to standard amphotericin B for the empiric treatment of febrile neutropenia. The frequency of renal dysfunction was decreased with Amphotec, but more infusion related-reaction was seen. The rate of infusion-related reactions seen in this study is consistent with that seen with historical controls where Amphotec demonstrated the highest incidence of infusion related reaction compared to all other forms of amphotericin including standard Amphotericin B.
Comment: Amphotec (ABCD) dosed at 4 mg/kg/day (up to 7.5mg/kg/day) was well tolerated in children.
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