Hieronder vindt u een aantal relevante studies voor Tacrolimus Sandoz® (Adport®, Adoport® and Tacrolimus Hexal®). Deze zijn onderverdeeld naar orgaan en voor de novo of conversie patiënten. 

 

Nier – de novo patiënten

  1. Arns W, Huppertz A, Rath T, Ziefle S, Rump LC, Hansen A, et al. Pharmacokinetics and Clinical Outcomes of Generic Tacrolimus (Hexal) Versus Branded Tacrolimus in De Novo Kidney Transplant Patients: A Multicenter, Randomized Trial. Transplantation. 2017. doi:10.1097/TP.0000000000001843.
  2. Rickman H, Hull R, Popoola J, MacPhee I. Intrapatient variability in trough drug concentrations in renal transplant patients receiving branded (prograf) and generic (adoport) tacrolimus: A retrospective cohort analysis. Transplantation. 2014;98:476-7. doi:http://dx.doi.org/10.1097/01.tp.0000452133.17661.04.
  3. Qazi Y, Bolonesi R, Monis T, Smogorzewski M, Sheikh R, Alexopoulus S, et al. Effect of generic tacrolimus on the incidence of acute rejection in kidney transplant recipients-a single center experience. American Journal of Transplantation. 2012;12:205-6. http://dx.doi.org/http://dx.doi.org/10.1111/j.1600-6143.2012.04112.x. |
  4. Dick TB, Raines AA, Van Der Werf W, Alonso D, Fujita S, Stinson JB. Comparison of dose requirements of SandozTM generic tacrolimus with brand Prograf in kidney transplant recipients. American Journal of Transplantation. 2011;11:354. doi:http://dx.doi.org/10.1111/j.1600-6143.2011.03534.x.
  5. Siddiqi N, Lu A, Jones T, Akalin E, Marfo K. Clinical and economic outcomes: De novo use of FDA-approved bioequivalent formulation of generic tacrolimus versus brand tacrolimus (Prograf). American Journal of Transplantation. 2011;11:242. http://dx.doi.org/http://dx.doi.org/10.1111/j.1600-6143.2011.03534.x.

 

Nier – substitutie

  1. Alloway R, Trofe-Clark J, Christians U, Wiland A, McCague K, Bloom R. Application of new bioequivalence testing procedures to tacrolimus formulations in stable kidney recipients: Global regulatory impact. Transplantation. 2014;98:847. doi:http://dx.doi.org/10.1097/01.tp.0000452136.10038.a6.
  2. Jogia P, Oskiera D, Booth S, McKane W. Generic switch of tacrolimus in prevalent kidney transplant recipients. American Journal of Transplantation. 2013;13:226. doi:http://dx.doi.org/10.1111/ajt.12266.
  3. Storey R, Hossain MA, Shrivastava S, Popoola J, Heap S, MacPhee I. Tacrolimus dosing in renal transplant recipients following introduction of a generic preparation. Transplant International. 2013;26:82. doi:http://dx.doi.org/10.1111/tri.12210.
  4. Alloway RR, Sadaka B, Trofe-Clark J, Wiland A, Bloom RD. A randomized pharmacokinetic study of generic tacrolimus versus reference tacrolimus in kidney transplant recipients. American Journal of Transplantation. 2012;12:2825-31. doi:http://dx.doi.org/10.1111/j.1600-6143.2012.04174.x.
  5. Crowther BR, Dobie H, Brady R, Hall R, Maxwell P. Conversion of prograf to generic tacrolimus in stable renal transplant recipients. American Journal of Transplantation. 2012;12:203. doi:http://dx.doi.org/10.1111/j.1600-6143.2012.04112.x.  

 

Lever - de novo patiënten

  1. Dannhorn E, Cheung M, Rodrigues S, Cooper H, Thorburn D, Patch D, et al. De novo use of generic tacrolimus in liver transplantation - A single center experience with one-yr follow-up. Clinical Transplantation. 2014;28:1349-57. doi:http://dx.doi.org/10.1111/ctr.12455.
  2. Pasangulapati S, Featherstone B, Allison MED. Retrospective study comparing safety and efficacy of generic preparation of tacrolimus with prograf as primary immunosuppression after liver transplantation. Journal of Hepatology. 2014;1):S382-S3. doi:http://dx.doi.org/10.1016/S0168-8278%2814%2961084-9.

 

Lever - substitutie

  1. Del Gaudio M, Cescon M, Bertuzzo V, Amaduzzi A, Ravaioli M, Cucchetti A, et al. The impact of conversion from prograf to generic tacrolimus in liver transplant recipients with stable graft function. Liver Transplantation. 2017.
  2. Olausson M, Cowlrick I. Are generic formulations of tacrolimus therapeutically equivalent to the innovator product in liver transplant recipients? Transplantation. 2016;100 (5 Supplement 1):S137. doi:http://dx.doi.org/10.1097/01.tp.0000483259.57907.d4.
  3. Venkataramanan R, Raghu V, Momper J, Schonder K, Shapiro R, Humar A. The effect of generic substitution of tacrolimus in liver and kidney transplant recipients. Transplantation. 2012;94:748. http://ovidsp.ovid.com/ovidweb.cgi?T=JS&CSC=Y&NEWS=N&PAGE=fulltext&D=eme....
  4. Momper JD, Ridenour TA, Schonder KS, Shapiro R, Humar A, Venkataramanan R. The impact of conversion from Prograf to generic tacrolimus in liver and kidney transplant recipients with stable graft function. American Journal of Transplantation. 2011;11:1861-7. doi:http://dx.doi.org/10.1111/j.1600-6143.2011.03615.x.

 

Hart – de novo patiënten

  1. Dhungel V, Colvin-Adams MM, Eckman PM. Short-term outcomes in heart transplant recipients treated with generic tacrolimus compared to Prograf. Open J Organ Transpl Surg 2013;3:19.

 

Hart - substitutie

  1. Soderlund C, Radegran G. Safety and efficacy of the switch to generic mycophenolate mofetil and tacrolimus in heart transplant patients. Clinical Transplantation. 2015;29:619-28. doi:http://dx.doi.org/10.1111/ctr.12564.
  2. Spence MM, Nguyen LM, Hui RL, Chan J. Evaluation of clinical and safety outcomes associated with conversion from brand-name to generic tacrolimus in transplant recipients enrolled in an integrated health care system. Pharmacotherapy. 2012;32:981-7. doi:http://dx.doi.org/10.1002/phar.1130.

 

Hart en Long – substitutie

  1. Fitzsimons S, Gibbs H, Wasywich C, McWilliams T, Ruygrok P. Obligatory tacrolimus formulation substitution in heart and lung transplant recipients: A national bioequivalence audit. Heart, Lung and Circulation. 2015;24, Supplement 2:S108. http://dx.doi.org/http://doi.org/10.1016/j.hlc.2015.04.148.
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