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Clinical Pharmacology
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Clinical Pharmacology

PBPCs from patients treated at the 250 mcg/m2/day dose had significantly higher number of granulocyte-macrophage colony-forming units (CFU-GM) than those collected without mobilization. The mean value after thawing was 11.41 x 104 CFU-GM/kg for all Leukine mobilized patients, compared to 0.96 x 104/kg for the non-mobilized group. A similar difference was observed in the mean number of erythrocyte burst-forming units (BFU-E) collected (23.96 x 104/kg for patients mobilized with 250 mcg/m2 doses of Leukine administered SC vs. 1.63 x 104/kg for non-mobilized patients).

After transplantation, mobilized subjects had shorter times to myeloid engraftment, and fewer days between transplantation and the last platelet transfusion compared to non-mobilized subjects. Neutrophil recovery (ANC >500/mm3) was more rapid in patients administered Leukine following PBPC transplantation with Leukine-mobilized cells (see table below). Mobilized patients also had fewer days to the last platelet transfusion and last RBC transfusion, and a shorter duration of hospitalization than did non-mobilized subjects.


Route for Mobilization

Post-transplant Leukine

ENGRAFTMENT (median value in days)

ANC>500/mm3 

Last platelet transfusion

No mobilization

-

no

29

28

Leukine
250 mcg/m2

IV

no

21

24

IV

yes

12

19

SC

yes

12

17


A second retrospective review of data from patients undergoing PBPC at another single transplant center was also conducted. Leukine was given SC at 250 mcg/m2/day once a day (n=10) or twice a day (n=21) until completion of the phereses. Phereses were begun on day 5 of Leukine administration and continued until the targeted MNC count of 9 x 108/kg or CD34+ cell count of 1 x 106/kg was reached. There was no difference in CD34+ cell count in patients receiving Leukine once or twice a day. The median time to ANC>500/mm3 was 12 days and to platelet recovery (>25,000/mm3) was 23 days.

Brand Name: Leukine
Generic Name: Sargramostim
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