Amphotericin B lipid complex (ABLC)
Sigma Tau Pharm.
100 mg (5mg/mL 20 mL)
$240 per vial
*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.
Not removed in dialysis, no supplement needed post HD. Usual dose.
Active against most fungi with the notable exceptions of Candida lusitaniae, Trichosporon beigelii, Aspergillus terreus (some isolates), Pseudallescheria boydii, Scedosporium prolificans, Malassezia furfur and many 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.
Slow renal excretion. Approximately 0.9% of dose excreted in the first day.
0.9-2.5 mcg/ml after 5mg/kg IV dose administration.
Attains lower serum concentration but has greater volume of distribution compared to conventional amphotericin. Increased uptake by the liver and spleen and decreased kidney concentration. Poor fat distribution (animal data).
B- There is limited data on the use of Amphotericin B lipid 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: Abelcet dosed at 2.5-5 mg/kg/day is recommended in neonates for the treatment of invasive candidiasis.
Comment: This is a prospective, randomized trial comparing the safety and efficacy of Abelcet vs. Ambisome for the treatment of suspected or documented fungal infections in 82 patients with leukemia. The overall response to therapy was 27/43 (63%) for Abelcet and 15/39 (39%) for Ambisome (p=0.03). It is important to note that patients in the Ambisome arm were sicker (i.e more with Fusarium spp .). Patients receiving Abelcet had more infusion related toxicity, whereas patients receiving Ambisome had a higher incidence of bilirubin elevation.
Comment: In this prospective, randomized trial, nephrotoxicity (3x above baseline) was noted in 6.2% and 26.9% of patients receiving Ambisome and Abelcet, respectively (p<0.001). Chills and rigors were reported in 50.5% in the Abelcet arm and 24.3% in the ambisome arm(p<0.001)). Ambisome, at a higher cost, has a lower incidence of nephrotoxicity and infusion related toxicity. It is however interesting to note that ADR reported with Abelcet in this trial is 2-fold higher than historical rates.
Comment: Abelcet at a dosage of 5 mg/kg/day was well tolerated in 111 pediatric patients who were enrolled in this open label compassionate use protocol.
Comment: Clinical improvement occurred in 86% of patients treated with Abelcet even though CSF sterilization was achieved in 42% after 2 weeks of therapy. This small study suggests that there may be a role for Abelcet in the treatment of cryptococcal meningitis , however larger trials need to be conducted.
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