Concentration-Controlled Trials and Therapeutic Drug Monitoring

2/6/02


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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)

Author: Maureen Galie