Limits...
Therapeutic drug monitoring of modified release once daily tacrolimus in de novo renal transplant with conversion to a twice daily generic in the stable period.

Mathew BS, Prabha R, Basu G, Rajkumar P, Tamilarasi V, Fleming DH - J Pharmacol Pharmacother (2015 Jul-Sep)

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology and Clinical Pharmacology, Clinical Pharmacology Unit, Christian Medical College Hospital, Vellore, Tamil Nadu, India.

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

Comparable clinical outcome, trough concentration and tacrolimus area under concentration time curve (AUC0–24) between twice a day, tacrolimus innovator (Prograf) and tacrolimus MR in renal transplant recipients have been reported... Studies used Prograf as de novo and found a comparable AUC0–24 after patients were converted later to tacrolimus MR (Advagraf)... The mobile phase was 2 mM ammonium acetate in water, with 0.1% formic acid and 2 mM ammonium acetate in methanol, with 0.1% formic acid, at a flow rate of 0.4 ml/min... It was run using a gradient where the organic phase was increased from 50% to 100% at 0.6 min and reduced back to 50% at 1.2 min of each run... The second AUC0–24 determination on Advagraf was done in all patients at 3 months after transplantation (visit 2) and the range of tacrolimus AUC0–24 was from 280.9 µg.h/L (this unit is correct to the best of our knowledge) to 454.6 µg.h/L... In visit 2, based on earlier tacrolimus trough concentrations, case no. 1, 2 and 4 had a dose reduction of 47.1%, 50.5% and 58.0% compared to visit 1 (except case no. 3 whose dose was increased by 1.9% in visit 2)... The Cmax with Advagraf was lower by 6.4% to 50.5% compared to PanGraf... Three patients showed a lower tacrolimus trough and AUC0–24 with Advagraf compared to PanGraf... None of the above-mentioned patients experienced any significant serious adverse events while on Advagraf or after conversion to PanGraf... But a high tacrolimus AUC0–24 in case no. 2 would imply that we need to exercise caution in initiating higher dose of Advagraf for all de novo renal transplant patients... In the stable 3 month post renal transplant period, tacrolimus AUC0–24 with Advagraf measured between 280.9 and 454.6 μg.h/L... Based on the recommended AUC0–12 of tacrolimus of 125 μg.h/L by Scholten et al. in the stable post transplant period, the dose of Advagraf could be further reduced when used in our patients in this period... In patients without financial constraints and where compliance is an issue, Advagraf tacrolimus MR may be used with strict monitoring both in the early and stable post transplant period.

No MeSH data available.


Area under concentration time profile with tacrolimus MR Visit 1, tacrolimus MR prior to conversion and tacrolimus twice daily generic post conversion—four cases (dimensions: 1195 × 754)
© Copyright Policy - open-access
Related In: Results  -  Collection

License
getmorefigures.php?uid=PMC4544138&req=5

Figure 2: Area under concentration time profile with tacrolimus MR Visit 1, tacrolimus MR prior to conversion and tacrolimus twice daily generic post conversion—four cases (dimensions: 1195 × 754)

Mentions: After which the patient was immediately changed to PanGraf®, tacrolimus BD generic on an equivalent milligram to milligram basis total daily dose, after obtaining written informed consent from the patient. The next sampling was performed 7–10 days after initiating PanGraf® (visit 3) and the sampling time points were trough, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 12 hours, performed both after morning and evening tacrolimus doses. Case no. 2 was unwilling to discontinue tacrolimus MR at 3 months and was converted to PanGraf® at 6 months post transplant. So this patient had an additional AUC0–24 done on Advagraf®, at 6 months and thereafter repeated again after conversion to PanGraf®. Figure 2 demonstrates the area under concentration time profile during all three visits.


Therapeutic drug monitoring of modified release once daily tacrolimus in de novo renal transplant with conversion to a twice daily generic in the stable period.

Mathew BS, Prabha R, Basu G, Rajkumar P, Tamilarasi V, Fleming DH - J Pharmacol Pharmacother (2015 Jul-Sep)

Area under concentration time profile with tacrolimus MR Visit 1, tacrolimus MR prior to conversion and tacrolimus twice daily generic post conversion—four cases (dimensions: 1195 × 754)
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC4544138&req=5

Figure 2: Area under concentration time profile with tacrolimus MR Visit 1, tacrolimus MR prior to conversion and tacrolimus twice daily generic post conversion—four cases (dimensions: 1195 × 754)
Mentions: After which the patient was immediately changed to PanGraf®, tacrolimus BD generic on an equivalent milligram to milligram basis total daily dose, after obtaining written informed consent from the patient. The next sampling was performed 7–10 days after initiating PanGraf® (visit 3) and the sampling time points were trough, 0.5, 1, 1.5, 2, 2.5, 4, 6, 8 and 12 hours, performed both after morning and evening tacrolimus doses. Case no. 2 was unwilling to discontinue tacrolimus MR at 3 months and was converted to PanGraf® at 6 months post transplant. So this patient had an additional AUC0–24 done on Advagraf®, at 6 months and thereafter repeated again after conversion to PanGraf®. Figure 2 demonstrates the area under concentration time profile during all three visits.

View Article: PubMed Central - PubMed

Affiliation: Department of Pharmacology and Clinical Pharmacology, Clinical Pharmacology Unit, Christian Medical College Hospital, Vellore, Tamil Nadu, India.

AUTOMATICALLY GENERATED EXCERPT
Please rate it.

Comparable clinical outcome, trough concentration and tacrolimus area under concentration time curve (AUC0–24) between twice a day, tacrolimus innovator (Prograf) and tacrolimus MR in renal transplant recipients have been reported... Studies used Prograf as de novo and found a comparable AUC0–24 after patients were converted later to tacrolimus MR (Advagraf)... The mobile phase was 2 mM ammonium acetate in water, with 0.1% formic acid and 2 mM ammonium acetate in methanol, with 0.1% formic acid, at a flow rate of 0.4 ml/min... It was run using a gradient where the organic phase was increased from 50% to 100% at 0.6 min and reduced back to 50% at 1.2 min of each run... The second AUC0–24 determination on Advagraf was done in all patients at 3 months after transplantation (visit 2) and the range of tacrolimus AUC0–24 was from 280.9 µg.h/L (this unit is correct to the best of our knowledge) to 454.6 µg.h/L... In visit 2, based on earlier tacrolimus trough concentrations, case no. 1, 2 and 4 had a dose reduction of 47.1%, 50.5% and 58.0% compared to visit 1 (except case no. 3 whose dose was increased by 1.9% in visit 2)... The Cmax with Advagraf was lower by 6.4% to 50.5% compared to PanGraf... Three patients showed a lower tacrolimus trough and AUC0–24 with Advagraf compared to PanGraf... None of the above-mentioned patients experienced any significant serious adverse events while on Advagraf or after conversion to PanGraf... But a high tacrolimus AUC0–24 in case no. 2 would imply that we need to exercise caution in initiating higher dose of Advagraf for all de novo renal transplant patients... In the stable 3 month post renal transplant period, tacrolimus AUC0–24 with Advagraf measured between 280.9 and 454.6 μg.h/L... Based on the recommended AUC0–12 of tacrolimus of 125 μg.h/L by Scholten et al. in the stable post transplant period, the dose of Advagraf could be further reduced when used in our patients in this period... In patients without financial constraints and where compliance is an issue, Advagraf tacrolimus MR may be used with strict monitoring both in the early and stable post transplant period.

No MeSH data available.