1339. Intravenous Voriconazole Administration is Not Associated with a Decline in Renal Function in Patients with Moderate to Severe Renal Impairment
Session: Oral Abstract Session: Fungal Pathogenesis, Virulence, and Anti-fungal Therapy
Saturday, October 22, 2011: 3:00 PM
Room: 151AB
Background: Intravenous voriconazole (IV-VOR) is an important antifungal agent in the immunocompromised host population. According to the prescribing information, patients with creatinine clearance (CrCl) <50 mL/min (moderate to severe renal dysfunction) should use oral rather than IV-VOR due to the potential accumulation of the cyclodextrin solubilizing agent. However, studies in small numbers of volunteers have suggested that serum creatinine (Cr) elevation does not occur even in patients with renal dysfunction. We reviewed pharmacy records at our institution to evaluate if IV-VOR was more likely to result in renal impairment in patients with baseline renal dysfunction than those with normal renal function.

Methods: We identified 494 episodes of >=3 days of IV-VOR administration from 2007-2009. Statistical analysis was performed using Fisher exact for categorical and Mann-Whitney U test for continuous variables.

Results: Patients with CrCl<50 were older than those with normal function (55.5 versus 49.5 yrs, p=.001). Both hematology and hematopoietic cell transplant patients were equally represented; however, significantly more solid organ transplant recipients had renal dysfunction. Dosing was weight-based and not adjusted for CrCl. Patients with renal dysfunction received a higher dose (mean 4.5 v. 4.2 mg/kg, p=.041) for a shorter median length of treatment (6 v. 8 days, p<.001).

Clinically significant increases in Cr were defined as (1) > 2.0 or 1.5 x baseline or (2) an increase of >= 0.3 mg/dl. Patients with renal dysfunction were not more likely to have a rise in Cr than patients with normal renal function. In a multivariate analysis including age, ICU admission, and renal dysfunction, only ICU admission was associated with an increase in Cr by > 0.3 mg/dl. (OR 2.49, 95% CI 1.68-3.69).

Impact of IV-VOR on Renal Function

 

CrCl<50

n=89

CrCl>=50

n=405

p-value

 

2.0 x baseline Cr

6 (7.0%)

51 (12.7%)

.335

1.5 x baseline Cr

20 (23.3%)

102 (25.3%)

.822

Increase Cr of >0.3

45 (52.3%)

166 (41.2%)

  .072  

 Conclusion: Renal dysfunction was not associated with an increased risk for further renal impairment during IV-VOR administration. Our data suggest that renal dysfunction should not be an absolute contraindication for IV-VOR use and may not necessitate dose reduction


Subject Category: O. Transplant infectious diseases

Joanna Schaenman, MD PhD, Divsion of Infectious Diseases, Department of Medicine, Stanford University School of Medicine, Stanford, CA, Chanu Rhee, MD, Department of Medicine, Stanford University School of Medicine, Stanford, CA, Marisa Holubar, MD, Division of Infectious Diseases, Department of Medicine, Stanford University School of Medicine, Stanford, CA, Richard Lafayette, MD, Division of Nephrology, Department of Medicine, Stanford University School of Medicine, Palo Alto, CA and Janice M. Brown, MD, Division of Blood and Marrow Transplant and Division of Infectious Diseases, Department of Medicine, Stanford University School of Medicine, Stanford, CA

Disclosures:

J. Schaenman, None

C. Rhee, None

M. Holubar, None

R. Lafayette, None

J. M. Brown, None

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