Pharmacokinetic and pharmacodynamic basis for effective argatroban dosing in pediatrics

Journal of Clinical Pharmacology

Volumn 51, Issue 1, 2011, Pages 19-28

  Madabushi, Rajanikanth ^a   Cox, Donna S ^b   Hossain, Mohammad ^b   Boyle, Duane A ^b   Patel, Bela R ^b   Young, Guy ^c   Choi, Young Moon ^a   Gobburu, Jogarao V S ^a  

^a CENTER FOR DRUG EVALUATION AND RESEARCH   (United States)

^b GLAXOSMITHKLINE   (United States)

^c CHILDREN S HOSPITAL LOS ANGELES   (United States)

Author keywords

activated plasma thromboplastin time (aPTT); argatroban; Heparin induced thrombocytopenia; pediatrics; pharmacodynamics; pharmacokinetics; simulation

Indexed keywords

ARGATROBAN;

ADOLESCENT; ARTICLE; BILIRUBIN BLOOD LEVEL; BLEEDING; BODY WEIGHT; CHILD; CLINICAL ARTICLE; DRUG CLEARANCE; DRUG DOSE TITRATION; HUMAN; INFANT; MULTICENTER STUDY; NEWBORN; PEDIATRICS; PHARMACODYNAMICS; POPULATION MODEL; PRESCHOOL CHILD; RECOMMENDED DRUG DOSE; SCHOOL CHILD; THROMBOPLASTIN TIME;

ADOLESCENT; BILIRUBIN; BODY WEIGHT; CHILD; CHILD, PRESCHOOL; COMPUTER SIMULATION; DOSE-RESPONSE RELATIONSHIP, DRUG; FEMALE; HEMORRHAGE; HUMANS; INFANT; INFANT, NEWBORN; MALE; MODELS, BIOLOGICAL; PARTIAL THROMBOPLASTIN TIME; PIPECOLIC ACIDS; PLATELET AGGREGATION INHIBITORS;

EID: 78650808350     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1177/0091270010365550     Document Type: Article

References (27)

1. Warkentin TE History of heparin-induced thrombocytopenia. In: Warkentin TE, Greinacher A, eds. Heparin-Induced Thrombocytopenia. 2 nd ed. New York, NY: Marcel Dekker ; 2001: 1-18.
2. Warkentin TE, Greinacher A., Koster A., Lincoff AM ; American College of Chest Physicians. Treatment and prevention of heparin-induced thrombocytopenia: American College of Chest Physicians evidence-based clinical practice guidelines (8th ed). Chest. 2008 ; 133: 340S - 380S.
3. Keeling D., Davidson S., Watson H. The management of heparin-induced thrombocytopenia. Br J Haematol. 2006 ; 133: 259-269.
4. Young G. Current and future antithrombotic agents in children. Expert Rev Cardiovasc Ther. 2004 ; 2: 523-534.
5. Monagle P., Chan A., Massicotte P., Chalmers E., Michelson AD Antithrombotic therapy in children: the seventh ACCP conference on antithrombotic and thrombolytic therapy. Chest. 2004 ; 126: 645S - 687S.
6. Kearns GL, Abdel-Rahman SM, Alander SW, Blowey DL, Leeder JS, Kauffman RE Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med. 2003 ; 349: 1157-1167.
7. Guidance for industry. Qualifying for pediatric exclusivity under section 505A of the Federal Food, Drug, and Cosmetic Act. Center for Drug Evaluation and Research, United States Food and Drug Administration. http://www.fda.gov/ downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/UCM080558.pdf. Accessed March 7, 2010
8. Powell JR, Gobburu JVS. Pharmacometrics at FDA: evolution and impact on decisions. Clin Pharmacol Ther. 2007 ; 82: 97-102. 9. Bhattaram VA, Booth BP, Ramchandani RP, et al. Impact of pharmacometrics on drug approvals and labeling decisions: survey of 42 new drug applications. AAPS J. 2005 ; 7: E503 - E512.
9. Bhattaram VA, Bonapace C., Chilukuri DM, et al. Impact of pharmacokinetic review on new drug approval and labeling decisions-a survey of 31 new drug applications submitted between 2005 and 2006. Clin Pharmacol Ther. 2007 ; 81: 213-221.
10. Young G., Boshkov LK Prospective study of direct thrombin inhibition with argatroban in pediatric patients requiring non-heparin anticoagulation [abstract]. Blood. 2007 ; 110 (pt 1). 553a.
11. Swan SK, St Peter JV, Lambrecht LJ, Hursting MJ Comparison of anticoagulant effects and safety of argatroban and heparin in healthy subjects. Pharmacotherapy. 2000 ; 20: 756-770.
12. Swan SK, Hursting MJ The pharmacokinetics and pharmacodynamics of argatroban: effects of age, gender, and hepatic or renal dysfunction. Pharmacotherapy. 2000 ; 20: 318-329.
13. Brown PM, Hursting MJ Lack of pharmacokinetic interactions between argatroban and warfarin. Am J Health Syst Pharm. 2002 ; 59: 2078-2083.
14. Tran JQ, Di Cicco RA, Sheth SB, et al. Assessment of the potential pharmacokinetic and pharmacodynamic interactions between erythromycin and argatroban. J Clin Pharmcol. 1999 ; 39: 513-519.
15. Beal SL, Boeckman A., Sheiner LB NONMEM Users' Guides, Version V. San Francisco, Calif: NONMEM Project Group, University of California ; 1992.
16. NONMEM Users' Guides. Beal SL, Sheiner LB, eds. San Francisco, Calif: NONMEM Project Group, University of California ; 1992.
17. Prescribing information for Argatroban Injection as of 05/05/2008. http://www.accessdata.fda.gov/drugsatfda-docs/label/2008/020883s014lbl.pdf. Accessed March 7, 2010
18. Klenner AF, Lubenow N., Raschke R., Greinacher A. Heparin-induced thrombocytopenia in children: 12 new cases and review of literature. Thromb Haemost. 2004 ; 91: 719-724.
19. Risch L., Fischer JE, Herklotz R., Huber AR Heparin-induced thrombocytopenia in paediatrics: clinical characteristics, therapy and outcomes. Intensive Care Med. 2004 ; 30: 1615-1624.
20. Prescribing information for Refludan as of 11/07/2006. http://www.accessdata.fda.gov/drugsatfda-docs/label/2006/020807s011lbl.pdf. Accessed March 7, 2010
21. West GB, Brown JH, Enquist BJ A general model for the origin of allometric scaling laws in biology. Science. 1997 ; 276: 5309: 122-126.
22. Hunt A., Joel S., Dick G., Goldmann A. Population pharmacokinetics of oral morphine and its glucuronides in children receiving morphine as immediate-release liquid or sustained-release tablets for cancer pain. J Pediatr. 1999 ; 135: 47-55.
23. Massicotte P., Adams M., Marzinotto V., Brookder LA, Andrew M. Low-molecular-weight heparin in pediatric patients with thrombotic disease: a dose finding study. J Pediatr. 1996 ; 128: 313-318.
24. Booth BP, Rahman A., Dagher R., et al. Population pharmacokinetic-based dosing of intravenous busulfan in pediatric patients. J Clin Pharmacol. 2007 ; 47: 101-111.
25. Prescribing information for Zosyn as of 04/17/2008. www.accessdata.fda. gov/drugsatfda-docs/label/2008/050684s051s052lbl.pdf. Accessed March 7, 2010
26. Tornoe CW, Tworzyanski JJ, Imoisili MA, Alexander JJ, Korth-Bradley JM, Gobburu JV Optimising piperacillin/tazobactam dosing in paediatrics. Int J Antimicrob Agents. 2007 ; 30: 320-324.
27. Prescribing information for Betapace as of 10/01/2001. http://www.accessdata.fda.gov/drugsatfda-docs/nda/2001/19-865S010-Betapace- prntlbl.pdf. Accessed March 7, 2010