Clinical Pharmacokinetics

8/18/99


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Table of Contents

PPT Slide

Clinical Pharmacokinetics

Sirolimus Pharmacokinetics

Rapid Absorption Rate After Single Oral Doses in Stable Renal Transplant Patients

Time to Steady State and Terminal Half-Life Are Consistent Among Ascending Multiple Oral Dose Regimens of RAPAMUNE

Whole Blood Sirolimus Dose Proportionality in Stable Renal Transplant Patients After Single Oral Doses of RAPAMUNE

Sirolimus Distribution

Sirolimus Metabolism and Elimination

Demographic Factors Have No Substantial Effect on Sirolimus Pharmacokinetics

Other Factors Affecting Sirolimus Pharmacokinetics

Effect of Other Drugs on the Exposure (AUC) of Sirolimus

Increases in Sirolimus AUC After Administration of Cyclosporine

Whole Blood Sirolimus Pharmacokinetic Parameters* in De Novo Renal Transplant Patients

Whole Blood Sirolimus AUC Versus Cmin* for Combined RAPAMUNE 2-mg and 5-mg Dose Groups

Equal Exposure to Sirolimus in Black and Non-Black Patients

Sirolimus Exposure in De Novo Renal Transplant Patients Remains Constant Over Time

Mean Cyclosporine Levels Were Not Different Between Treatment Groups

RAPAMUNE Reduces Dose Requirements of Cyclosporine

Clinical Pharmacokinetics Conclusions I

Clinical Pharmacokinetics Conclusions II

Well Defined Pharmacokinetic Behavior in Renal Transplant Recipients

Author: Maureen Galie