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Similar MPA exposure on modified release and regular tacrolimus.
- Source :
-
Therapeutic drug monitoring [Ther Drug Monit] 2014 Jun; Vol. 36 (3), pp. 353-7. - Publication Year :
- 2014
-
Abstract
- Concomitant immunosuppression may affect the mycophenolate mofetil exposure. Astellas developed a once-daily modified release formulation of tacrolimus (TacMR) with the potential to reduce the likelihood of nonadherence. It is unknown whether mycophenolic acid (MPA) area under the concentration-time curve (AUC) differs between the 2 tacrolimus (Tac) formulations. In a 2-by-2 crossover design, 20 stable renal transplant recipients on twice-daily Tac either continued their usual Tac therapy (n = 10, group 1) or switched to TacMR for a 12-week period (n = 10, group 2), after which the patients crossed over to the other formulation for another 12-week period. Pharmacokinetic profiles using limited sampling strategies were obtained before randomization (visit 1), and at 12 (visit 2) and 24 weeks (visit 3) at steady state. MPA AUC was calculated using the Pawinski formula. When analyzing visits on Tac, TacMR, and back on Tac combined, the MPA AUC for all 20 patients at baseline was 42.24 (16.98), 37.18 (13.75), and 40.09 (16.69) mg·h·L(-1), respectively, which was not statistically significant using repeated measures (P = 0.1327, R(2) = 0.1109). We conclude that MPA pharmacokinetic profiles are not altered when converting patients from Tac to TacMR.
- Subjects :
- Adult
Aged
Area Under Curve
Cross-Over Studies
Delayed-Action Preparations
Drug Therapy, Combination
Female
Humans
Immunosuppressive Agents administration & dosage
Male
Middle Aged
Mycophenolic Acid pharmacokinetics
Immunosuppressive Agents pharmacokinetics
Immunosuppressive Agents pharmacology
Kidney Transplantation
Mycophenolic Acid analogs & derivatives
Tacrolimus administration & dosage
Tacrolimus pharmacology
Subjects
Details
- Language :
- English
- ISSN :
- 1536-3694
- Volume :
- 36
- Issue :
- 3
- Database :
- MEDLINE
- Journal :
- Therapeutic drug monitoring
- Publication Type :
- Academic Journal
- Accession number :
- 24365986
- Full Text :
- https://doi.org/10.1097/FTD.0000000000000021