Effect of Weight and Maturation on Busulfan Clearance in Infants and Small Children Undergoing Hematopoietic Cell Transplantation Radojka M. Savic, Morton.

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Presentation transcript:

Effect of Weight and Maturation on Busulfan Clearance in Infants and Small Children Undergoing Hematopoietic Cell Transplantation Radojka M. Savic, Morton J. Cowan, Christopher C. Dvorak, Sung-Yun Pai, Luis Pereira, Imke H. Bartelink, Jaap J. Boelens, Robbert G.M. Bredius, Rob F. Wynn, Geoff D.E. Cuvelier, Peter J. Shaw, Mary A. Slatter, Janel Long-Boyle Biology of Blood and Marrow Transplantation Volume 19, Issue 11, Pages 1608-1614 (November 2013) DOI: 10.1016/j.bbmt.2013.08.014 Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 1 Fraction of busulfan clearance for infants compared to an average 2-year-old child by change in busulfan clearance versus weight (A) and change in busulfan clearance versus age (B). Biology of Blood and Marrow Transplantation 2013 19, 1608-1614DOI: (10.1016/j.bbmt.2013.08.014) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 2 Visual predictive check for every 6-hour dosing (A) and once-daily administration (B). The solid line represents the data median. The upper and lower dashed lines are 97.5th and 2.5th data percentiles, respectively. The upper, middle, and lower shaded areas are simulated 97.5th percentile, median, and 2.5th percentile with uncertainty, respectively. An appropriate model fit is indicated if lines are contained within shaded areas. Biology of Blood and Marrow Transplantation 2013 19, 1608-1614DOI: (10.1016/j.bbmt.2013.08.014) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 3 Model-based estimated dose (mg/kg) required to achieve a therapeutic Css of 600-900 ng/mL (solid line). For comparison, the dashed line represents conventional dosing of 1.1 mg/kg in children weighing <12 kg. Biology of Blood and Marrow Transplantation 2013 19, 1608-1614DOI: (10.1016/j.bbmt.2013.08.014) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions

Figure 4 Plot demonstrating estimated Css with conventional dosing versus the model-based algorithm for achieving a therapeutic target of 600-900 ng/mL by age. The currently recommended dose (1.1 mg/kg) is shown for reference (horizontal dashed line). Biology of Blood and Marrow Transplantation 2013 19, 1608-1614DOI: (10.1016/j.bbmt.2013.08.014) Copyright © 2013 American Society for Blood and Marrow Transplantation Terms and Conditions