Zortress (Page 8 of 12)

12.8 Cyclosporine Concentrations Observed in Kidney Transplant Patients

In the kidney transplant clinical trial [ s ee Clinical Studies (14.1) ] , the target cyclosporine whole blood trough concentration for the Zortress treatment arm of 0.75 mg twice daily were 100 to 200 ng/mL through Month 1 posttransplant, 75 to 150 ng/mL at Months 2 and 3 posttransplant, 50 to 100 ng/mL at Month 4 posttransplant, and 25 to 50 ng/mL from Month 6 through Month 12 posttransplant. Table 5 below provides a summary of the observed cyclosporine whole blood trough concentrations during the study.

Table 5. Cyclosporine Trough Concentrations Over 12 Months Posttransplant – Kidney Study Median Values (ng/mL) with 10th and 90th Percentiles
Treatment Group Visit N Target (ng/mL) Median 10 th Percentile 9 0 th Percentile
Zortress0.75 mg twice daily Day 3 242 100-200 172 46 388
Day 7 265 100-200 185 75 337
Day 14 243 100-200 182 97 309
Month 1 245 100-200 161 85 274
Month 2 232 75-150 140 84 213
Month 3 220 75-150 111 68 187
Month 4 208 50-100 99 56 156
Month 6 200 25-50 75 43 142
Month 7 199 25-50 59 36 117
Month 9 194 25-50 49 28 91
Month 12 186 25-50 46 25 100

12.9 Tacrolimus Concentrations in Liver Transplant

In the liver transplant clinical trial [ s ee Clinical Studies (14. 2 ) ] , the target tacrolimus whole blood trough concentrations were greater than or equal to 8 ng/mL in the first 30 days posttransplant. The protocol required that patients had a tacrolimus trough concentration of at least 8 ng/mL in the week prior to initiation of Zortress. Zortress was initiated after 30 days posttransplant. At that time, the target tacrolimus trough concentrations were reduced to 3 to 5 ng/mL. Table 6 below provides a summary of the tacrolimus whole blood trough concentrations observed during the study through Month 24 posttransplant.

Table 6. Tacrolimus Trough Concentrations Over 24 Months Posttransplant – Liver Study Median Values (ng/mL) With 10th and 90th Percentiles
Treatment Group Visit N Target (ng/mL) Median 10 th Percentile 90 th Percentile
Pre-dose groupZortress1 mg twice daily (initiated at Month 1) Week 4 234 3-5 9.5 5.8 14.6
Week 5 219 3-5 8.1 4.5 13.8
Week 6 233 3-5 7.0 4.1 12.0
Month 2 219 3-5 5.6 3.4 10.3
Month 3 218 3-5 5.2 3.1 9.7
Month 4 196 3-5 4.9 2.9 7.7
Month 5 195 3-5 4.8 2.7 7.3
Month 6 200 3-5 4.6 3.0 7.5
Month 9 186 3-5 4.4 2.9 8.0
Month 12 175 3-5 4.3 2.6 7.3
Month 24 109 3-5 3.8 2.3 5.5

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