Generic vancomycin products: Analysis of serum concentrations in patients with acute myeloid leukemia.
Concerns have recently emerged about the quality of generic vancomycin products. Our aim is to analyze serum vancomycin concentrations measured 48 hours after the start of an empirical treatment regimen in patients with acute myeloid leukemia (AML) who received one of the two generic vancomycin products available in France.


METHODS
Seventy-nine AML patients treated with vancomycin during two study periods were included in the study. Our vancomycin dosing regimen was based on the patients' total body weight adjusted for renal clearance.


RESULTS
A total of 93 serum vancomycin concentrations were collected: 31 in period 1 and 62 in period 2. In bivariate analysis, the mean serum vancomycin concentrations were not significantly different (19.9 ± 11.2 mg/L in period 1 vs 18.9 ± 6.0 mg/L in period 2, P=0.64). In the final generalized estimating equations model, serum vancomycin concentrations correlated statistically with a positive coefficient for age (P<0.001) and with negative coefficients for male sex (P=0.001) and hemoglobin level (P=0.021).


CONCLUSIONS
Serum vancomycin concentrations measured 48 hours after the start of an empirical treatment were not influenced by the nature of the generic product but correlated with age, sex and hemoglobin level in AML patients.
Department of Pharmacy, University Hospital, 14, rue Gaffarel, 21000 Dijon, France.
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Monnier
Department of Pharmacy, University Hospital, 14, rue Gaffarel, 21000 Dijon, France.
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Malbranche
Department of Pharmacy, University Hospital, 14, rue Gaffarel, 21000 Dijon, France; University of Burgundy, EA4184, BP 87900, 21079 Dijon, France.
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Fagnoni
Department of Epidemiology, University Hospital, 14, rue Gaffarel, 21000 Dijon, France.
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Serge Aho
Department of Pharmacology-Toxicology, University Hospital, 2, rue Angélique-Ducoudray, 21000 Dijon, France.
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Guerard
Department of Pharmacovigilance, University Hospital, 14, rue Gaffarel, 21000 Dijon, France.
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Sgro
Department of Pharmacy, University Hospital, 14, rue Gaffarel, 21000 Dijon, France.
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Guignard
Department of Infectious Diseases and Vivexia, University Hospital, 14, rue Gaffarel, 21000 Dijon, France.
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Croisier-Bertin
Department of Infectious Diseases and Vivexia, University Hospital, 14, rue Gaffarel, 21000 Dijon, France.
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Chavanet
Department of Hematology, University Hospital, 14, rue Gaffarel, 21000 Dijon, France.
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Chrétien
Department of Hematology, University Hospital, 14, rue Gaffarel, 21000 Dijon, France.
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Caillot
Department of Pharmacy, University Hospital, 14, rue Gaffarel, 21000 Dijon, France; University of Burgundy, EA4184, BP 87900, 21079 Dijon, France. Electronic address: mathieu.boulin@chu-dijon.fr.
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Boulin
D000293:Adolescent; D000328:Adult; D000368:Aged; D000900:Anti-Bacterial Agents / Q000097:blood* / Q000493:pharmacokinetics; D016568:Drugs, Generic; D005260:Female; D006801:Humans; D007668:Kidney / Q000378:metabolism; D015470:Leukemia, Myeloid, Acute / Q000378:metabolism*; D008297:Male; D008875:Middle Aged; D012189:Retrospective Studies; D014640:Vancomycin / Q000097:blood* / Q000493:pharmacokinetics; D055815:Young Adult
D000900:Anti-Bacterial Agents; D016568:Drugs, Generic; D014640:Vancomycin
Acute myeloid leukemia; Concentration sérique; Generic product; Leucémie aiguë myéloïde; Médicament générique; Serum concentration; Vancomycin; Vancomycine