Liposomal amphotericin B does not induce nephrotoxicity or renal function impairment in premature neonates.
BACKGROUND
Liposomal amphotericin B (LAMB) is frequently administered in NICU to preterm infants <1500 g at birth (VLBW) for treatment of systemic fungal infections (SFI). Concerns exist on safety and tolerability of such drug in patients who are at risk for renal function impairment due to their prematurity.


OBJECTIVE
To assess the occurrence of renal function impairment related to LAMB in a 10-year cohort of VLBW neonates treated with this drug.


METHODS
Through database search of clinical charts, all VLBW neonates admitted to a 3(rd) level NICU in the years 1998-2007 and undergoing treatment with LAMB were identified. The occurrence of LAMB-attributable renal toxicity was investigated; infants withdrawn from treatment for development of adverse effects or toxicity were identified.


RESULTS
In the study period, 71 of 792 admitted VLBW neonates (8.9%) underwent antifungal treatment with LAMB administered at the recommended dosages (3-to-5 mg/kg/day). Mean duration of treatment was 14 (±9) days, mean cumulative dose given was 58 (±25) mg/kg per infant. Renal compromise, defined as hypokalaemia, and/or elevated creatinine serum levels, and/or decreased urine output, occurred in 2 of 71 (2.8%) treated patients, by 5 (±3) mean days after treatment initiation. In both patients LAMB was withdrawn; renal function impairment was only mild and transient, and normal renal function was restored at discharge. No other significant adverse effects were recorded in any treated neonate.


CONCLUSIONS
LAMB is generally safe and well tolerated in VLBW neonates. The occurrence of LAMB-related nephrotoxicity appears to be uncommon, mild and transient.
Neonatology and NICU, Sant'Anna Hospital, Azienda Ospedaliera OIRM - S Anna, Torino, Italy. paolomanzoni@hotmail.com
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Manzoni
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Galletto
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Rizzollo
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Franco
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Gallo
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Antonucci
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Fanos
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Farina
D000666:Amphotericin B / Q000009:adverse effects* / Q000627:therapeutic use*; D000935:Antifungal Agents / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D002177:Candidiasis / Q000188:drug therapy; D015331:Cohort Studies; D003404:Creatinine / Q000097:blood; D015725:Fluconazole / Q000627:therapeutic use; D006801:Humans; D007008:Hypokalemia / Q000139:chemically induced; D007231:Infant, Newborn; D007235:Infant, Premature, Diseases / Q000188:drug therapy*; D019102:Infant, Very Low Birth Weight; D007668:Kidney / Q000187:drug effects; D007674:Kidney Diseases / Q000139:chemically induced*; D007677:Kidney Function Tests; D009181:Mycoses / Q000188:drug therapy*; D047928:Premature Birth; D012189:Retrospective Studies; D018805:Sepsis / Q000188:drug therapy
D000935:Antifungal Agents; C068538:liposomal amphotericin B; D000666:Amphotericin B; D015725:Fluconazole; D003404:Creatinine