Pharmacokinetics and bioequivalence of a liquid formulation of hydroxyurea in children with sickle cell anemia

Journal of Clinical Pharmacology

Volumn 56, Issue 3, 2016, Pages 298-306

  Estepp, Jeremie H ^a   Melloni, Chiara ^b   Thornburg, Courtney D ^c   Wiczling, Paweł ^d   Rogers, Zora ^e   Rothman, Jennifer A ^b   Green, Nancy S ^f   Liem, Robert ^g   Brandow, Amanda M ^h   Crary, Shelley E ⁱ   Howard, Thomas H ^j   Morris, Maurine H ^k   Lewandowski, Andrew ^l   Garg, Uttam ^m   Jusko, William J ⁿ   Neville, Kathleen A ⁱ  

^a ST JUDE CHILDREN S RESEARCH HOSPITAL   (United States)

^b DUKE UNIVERSITY MEDICAL CENTER   (United States)

^c UNIVERSITY OF CALIFORNIA SAN DIEGO   (United States)

^d MEDICAL UNIVERSITY OF GDANSK   (Poland)

^e UNIVERSITY OF TEXAS SOUTHWESTERN MEDICAL CENTER   (United States)

^f Department of Medicine   (United States)

^g NORTHWESTERN UNIVERSITY   (United States)

^h MEDICAL COLLEGE OF WISCONSIN   (United States)

ⁱ ARKANSAS CHILDREN S HOSPITAL   (United States)

^j UNIVERSITY OF ALABAMA SCHOOL OF MEDICINE   (United States)

^k DUKE CLINICAL RESEARCH INSTITUTE   (United States)

^l EMMES CORPORATION   (United States)

^m CHILDREN S MERCY HOSPITAL   (United States)

ⁿ UNIVERSITY AT BUFFALO   (United States)

more..

Author keywords

bioequivalent; hydroxyurea. children; sickle cell anemia

Indexed keywords

HYDROXYUREA; ANTISICKLING AGENT; MICROCAPSULE; SOLUTION AND SOLUBILITY;

ABSENCE OF SIDE EFFECTS; ADOLESCENT; AGE; AREA UNDER THE CURVE; ARTICLE; BIOEQUIVALENCE; BODY WEIGHT; CHILD; CLINICAL ARTICLE; CLINICAL EVALUATION; CONTROLLED STUDY; CROSSOVER PROCEDURE; DRUG BIOAVAILABILITY; DRUG BLOOD LEVEL; DRUG CAPSULE; DRUG CLEARANCE; DRUG DISPOSITION; DRUG DOSAGE FORM COMPARISON; DRUG EFFICACY; DRUG EXPOSURE; DRUG FORMULATION; DRUG HALF LIFE; DRUG SAFETY; ELIMINATION HALF-LIFE; ELIMINATION RATE CONSTANT; FEMALE; HUMAN; LIQUID; MALE; MAXIMUM PLASMA CONCENTRATION; MEAN TRANSIT TIME; MULTICENTER STUDY; OPEN STUDY; PEDIATRICS; PROSPECTIVE STUDY; RANDOMIZED CONTROLLED TRIAL; SICKLE CELL ANEMIA; SICKLE CELL BETA THALASSEMIA; SINGLE DRUG DOSE; TIME TO MAXIMUM PLASMA CONCENTRATION; TODDLER; BLOOD; CHEMISTRY; CLINICAL TRIAL; MICROCAPSULE; PRESCHOOL CHILD; SOLUTION AND SOLUBILITY; THERAPEUTIC EQUIVALENCE;

ADOLESCENT; ANEMIA, SICKLE CELL; ANTISICKLING AGENTS; CAPSULES; CHILD; CHILD, PRESCHOOL; FEMALE; HUMANS; HYDROXYUREA; MALE; PROSPECTIVE STUDIES; SOLUTIONS; THERAPEUTIC EQUIVALENCY;

EID: 84958113265     PISSN: 00912700     EISSN: 15524604     Source Type: Journal    
DOI: 10.1002/jcph.598     Document Type: Article

References (25)

1. Brousseau DC, Panepinto A, Nimmer M, Hoffmann RG., The number of people with sickle-cell disease in the United States: national and state estimates. Am J Hematol. 2010; 85 (1): 77-78.
2. Charache S, Terrin ML, Moore RD, et al., Effect of hydroxyurea on the frequency of painful crises in sickle cell anemia. N Engl J Med. 1995; 332 (20): 1317-1322.
3. Hankins JS, Ware RE, Rogers ZR, et al., Long-term hydroxyurea therapy for infants with sickle cell anemia: the HUSOFT extension study. Blood. 2005; 106 (7): 2269-2275.
4. Kinney TR, Helms RW, O'Branski EE, et al., Safety of hydroxyurea in children with sickle cell anemia: results of the HUG-KIDS study, a phase I/II trial. Blood. 1999; 94 (5): 1550-1554.
5. Lopes de, Castro Lobo C, Pinto JFC, Nascimento EM, et al., The effect of hydroxcarbamide therapy on survival of children with sickle cell disease. Br J Haematol. 2013; 161 (6): 852-860.
6. Thornburg C, Dixon N, Burgett S, et al., A pilot study of hydroxyurea to prevent chronic organ damage in young children with sickle cell anemia. Pediatr Blood Cancer. 2009; 52 (5): 609-615.
7. Wang WC, Wynn LW, Rogers ZR, et al., A two-year pilot trial of hydroxyurea in very young children with sickle-cell anemia. J Pediatr. 2001; 139 (6): 790-796.
8. Wang WC, Ware RE, Miller ST, et al., Hydroxycarbamide in very young children with sickle-cell anaemia: a multicentre, randomised, controlled trial (BABY HUG). Lancet. 2011; 377 (9778): 1663-1672.
9. Zimmerman SA, Schultz WH, Davis JS, et al., Sustained long-term hematologic efficacy of hydroxyurea at maximum tolerated dose in children with sickle cell disease. Blood. 2004; 103 (6): 2039-2045.
10. Yawn BP, Buchanan GR, Afenyi-Annan AN., Management of sickle cell disease: summary of the 2014 evidence-based report by expert panel members. JAMA. 2014; 312 (10): 1033-1048.
11. McGann PT, Howard TA, Flanagan JM, Lahti JM, Ware RE., Chromosome damage and repair in children with sickle cell anaemia and long-term hydroxycarbamide exposure. Br J Haematol. 2011; 154 (1): 134-140.
12. McGann PT, Flanagan JM, Howard TA, et al., Genotoxicity associated with hydroxyurea exposure in infants with sickle cell anemia: results from the BABY-HUG phase III clinical trial. Pediatr Blood Cancer. 2012; 59 (2): 254-257.
13. Scott DK, Neville K, Garg U., Determination of hydroxyurea in serum or plasma using gas chromatography-mass spectrometry (GC-MS). Methods Mol Biol. 2010; 603: 279-287.
14. Garg U, Scott D, Frazee C, Kearns G, Neville K., Isotope dilution gas chromatography-mass spectrometry (GC-MS) method for the analysis of hydroxyurea. Ther Drug Monit. 2015; 37 (3): 325-330.
15. Food and Drug Administration. Statistical Approaches to Establishing Bioequivalence. 2001. http://www.fda.gov/downloads/Drugs/GuidanceComplianceRegulatoryInformation/Guidances/ucm070244.pdf. Accessed March 25, 2015.
16. Rogers ZR, Thompson B, Ware RE, et al., Pharmacokinetics of hydroxyurea in young children with sickle cell anemia: a report from the BABY HUG trial. Blood (ASH Annual Meeting Abstracts). 2005; 106: 3184.
17. Ware RE, Despotovic J, Mortier NA, et al., Pharmacokinetics, pharmacodynamics, and pharmacogenetics of hydroxyurea treatment for children with sickle cell anemia. Blood. 2011; 118 (18): 4985-4991.
18. de Montalembert M, Bachir D, Hulin A, et al., Pharmacokinetics of hydroxyurea 1000 mg coated breakable tablets and 500 mg capsules in pediatric and adult patients with sickle cell disease. Haematologica. 2006; 91 (12): 1685-1688.
19. Yan JH, Ataga K, Kaul S, et al., The influence of renal function on hydroxyurea pharmacokinetics in adults with sickle cell disease. J Clin Pharmacol. 2005; 45 (4): 434-445.
20. Oyeku SO, Driscoll MC, Cohen HW, et al., Parental and other factors associated with hydroxyurea use for pediatric sickle cell disease. Pediatr Blood Cancer. 2013; 60 (4): 653-658.
21. Bekele E, Thornburg C, Brandow AM, et al., Do difficulties in swallowing medication impede the use of hydroxyurea in children ? Pediatr Blood Cancer. 2014; 61 (9): 1536-1539.
22. Kearns GL, Abdel-Rahman SM, Alander SW, et al., Developmental pharmacology-drug disposition, action, and therapy in infants and children. N Engl J Med. 2003; 349 (12): 1157-1167.
23. Rodriguez GI, Kuhn JG, Weiss GR, et al., A bioavailability and pharmacokinetic study of oral and intravenous hydroxyurea. Blood. 1998; 91 (5): 1533-1541.
24. Wiczling P, Liem RI, Panepinto JA, et al., Population pharmacokinetics of hydroxyurea for children and adolescents with sickle cell disease. J Clin Pharmacol. 2014; 54 (9): 1016-1022.
25. Walker AL, Lancaster CS, Finkelstein D, Ware RE, Sparreboom A. Organic anion transporting polypeptide 1B transporters modulate hydroxyurea pharmacokinetics. Am J Physiol Cell Physiol. 2013; 305 (12): C1223-C1229.