Pharmacokinetics in stable kidney transplant recipients after conversion from twice-daily to once-daily tacrolimus formulations

Therapeutic Drug Monitoring

Volumn 34, Issue 1, 2012, Pages 46-52

  Van Hooff, Johannes ^a   Van Der Walt, Isak ^b   Kallmeyer, Jeffrey ^c   Miller, Derek ^d   Dawood, Shabbir ^c   Moosa, M Rafique ^e   Christiaans, Maarten ^a   Karpf, Carmen ^f   Undre, Nasrullah ^g  

^a MAASTRICHT UNIVERSITY MEDICAL CENTER   (Netherlands)

^b Jacaranda Hospital   (South Africa)

^c St Augustine's Hospital   (South Africa)

^d Christiaan Barnard Memorial Hospital   (South Africa)

^e STELLENBOSCH UNIVERSITY   (South Africa)

^f Astellas GmbH   (Germany)

^g ASTELLAS PHARMA EUROPE LTD   (United Kingdom)

Author keywords

kidney; once daily tacrolimus; prolonged release; tacrolimus; therapeutic drug monitoring; transplant

Indexed keywords

AZATHIOPRINE; CORTICOSTEROID; MYCOPHENOLIC ACID 2 MORPHOLINOETHYL ESTER; TACROLIMUS;

ADULT; AGED; ARTICLE; CONNECTIVE TISSUE DISEASE; CONTUSION; CROSSOVER PROCEDURE; DRUG FORMULATION; DRUG INDUCED HEADACHE; DRUG TOLERABILITY; EVENING DOSAGE; FEMALE; FLU LIKE SYNDROME; FOLLOW UP; GASTROINTESTINAL DISEASE; GRAFT RECIPIENT; HUMAN; HYPERTENSION; INFECTION; INFESTATION; INFLUENZA; KIDNEY GRAFT; MAJOR CLINICAL STUDY; MALE; MEDIASTINUM DISEASE; MULTICENTER STUDY; MUSCULOSKELETAL DISEASE; NEUROLOGIC DISEASE; OPEN STUDY; PHASE 2 CLINICAL TRIAL; PRIORITY JOURNAL; PROSPECTIVE STUDY; RESPIRATORY TRACT DISEASE; SKIN DISEASE; THORAX DISEASE; VASCULAR DISEASE;

ADULT; AGED; AREA UNDER CURVE; CROSS-OVER STUDIES; DELAYED-ACTION PREPARATIONS; DRUG ADMINISTRATION SCHEDULE; FEMALE; HALF-LIFE; HUMANS; IMMUNOSUPPRESSIVE AGENTS; KIDNEY TRANSPLANTATION; MALE; MIDDLE AGED; TACROLIMUS; YOUNG ADULT;

EID: 84862945395     PISSN: 01634356     EISSN: 15363694     Source Type: Journal    
DOI: 10.1097/FTD.0b013e318244a7fd     Document Type: Article

References (13)

1. Scott LJ, McKeage K, KeamSJ, et al. Tacrolimus: A further update of its use in the management of organ transplantation. Drugs. 2003;63:1247-1297. (Pubitemid 36750952)
2. Staatz CE, Tett SE. Clinical pharmacokinetics and pharmacodynamics of tacrolimus in solid organ transplantation. Clin Pharmacokinet. 2004;43: 623-653. (Pubitemid 38981845)
3. Wallemacq P, Armstrong VW, Brunet M, et al. Opportunities to optimize tacrolimus therapy in solid organ transplantation: Report of the European consensus conference. Ther Drug Monit. 2009;31:139-152.
4. Alak AM, Moy S, Cook M, et al. An HPLC/MS/MS assay for tacrolimus in patient blood samples. Correlation with results of an ELISA assay. J Pharm Biomed Anal. 1997;16:7-13. (Pubitemid 27462682)
5. Baraldo M, Furlanut M. Chronopharmacokinetics of ciclosporin and tacrolimus. Clin Pharmacokinet. 2006;45:775-788. (Pubitemid 44182275)
6. Katsakiori PF, Papapetrou EP, Sakellaropoulos GC, et al. Factors affecting the long-term response to tacrolimus in renal transplant patients: Pharmacokinetic and pharmacogenetic approach. Int J Med Sci. 2010;7: 94-100.
7. Singh R, Srivastava A, Kapoor R, et al. Do drug transporter (ABCB1) SNPs influence cyclosporine and tacrolimus dose requirements and renal allograft outcome in the posttransplantation period? J Clin Pharmacol. 2011;51:603-615.
8. Capron A, Mourad M, De Meyer M, et al. CYP3A5 and ABCB1 polymorphisms influence tacrolimus concentrations in peripheral blood mononuclear cells after renal transplantation. Pharmacogenomics. 2010; 11:703-714.
9. Florman S, Alloway R, Kalayoglu M, et al. Conversion of stable liver transplant recipients from a twice-daily Prograf-based regimen to a oncedaily modified release tacrolimus-based regimen. Transplant Proc. 2005; 37:1211-1213. (Pubitemid 40590839)
10. Heffron TG, Pescovitz MD, Florman S, et al. Once-daily tacrolimus extended-release formulation: 1-year post-conversion in stable pediatric liver transplant recipients. Am J Transplant. 2007;7:1609-1615. (Pubitemid 46776251)
11. Alloway R, Steinberg S, Khalil K, et al. Conversion of stable kidney transplant recipients from a twice daily Prograf-based regimen to a once daily modified release tacrolimus-based regimen. Transplant Proc. 2005; 37:867-870.
12. Food and Drug Administration (FDA). Guidance for Industry. Bioavailability and Bioequivalence Studies for Orally Administered Drug Products-General Considerations. US Department of Health and Human Services, Food and Drugs Administration, Center for Drug Evaluation and Research (CDER). March 2003. Available at: Www.fda.gov/ downloads/Drugs/ GuidanceComplianceRegulatoryInformation/Guidances/ UCM070124.pdf. Accessed October 1, 2010.
13. Musuamba FT, Rousseau A, Bosmans JL, et al. Limited sampling models and Bayesian estimation for mycophenolic acid area under the curve prediction in stable renal transplant patients co-medicated with ciclosporin or sirolimus. Clin Pharmacokinet. 2009;48:745-758.