Table of Contents
Concentration-Controlled Trials and Therapeutic Drug Monitoring
Key Messages in This Presentation
Currently Approved RAPAMUNE Regimen
Concentration-Controlled RAPAMUNE Administration
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Sirolimus Pharmacokinetics Influences the Implementation of Concentration-Controlled Dosing
Four Studies Contributed Data for RAPAMUNE Concentration-Controlled Regimens
Sirolimus Target Concentration Ranges after Cyclosporine Withdrawal in Studies 212 and 310
Outcomes of Sirolimus Concentration Control Among Studies (RAPA Group)
Sirolimus and Cyclosporine Trough Levels for Study 310 (RAPA Group)
Comments Regarding the Rate of Cyclosporine Withdrawal in Study 310
A Mean RAPAMUNE Dose of 8 mg/day Maintained Sirolimus in the Target Range for Study 310
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Distributions of Average Sirolimus Trough Levels Among Non-Rejectors in Studies 310 and 212 (RAPAMUNE Groups)
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Sirolimus TDM Considerably Reduced Intersubject Variability in Study 310 Compared to a Predicted 8-mg Fixed-dose Regimen
Recommended Sirolimus TDM Range
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Guidance In Using Sirolimus TDM
Conclusions (I)
Conclusions (II)
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