Biology Reference
In-Depth Information
Table 5. Single-dose pharmacokinetic parameters for subcutaneously (SC) administered rHuEPO in
rHuEPO-naive nephrology patients
Ref
SC Dose (U/kg)
n
T
max
(hr)
t
1/2,z
(hr)
F (%)
[28]
15, 150
8-12
NA
NA
5
[epoetin alfa]
[26]
120
27.7
a
21.5
8
18
[epoetin beta]
(11.3-36.0)
[25]
40
18.0
b
11.16
b
25%
c
9
[epoetin beta]
[6.0-24.1]
[5.31-13.98]
24-36
18.2
d
[10]
300
6
NA
[epoetin alfa]
(SEM 2.1)
[32]
100
12
28.0 (SEM 5.0)
30.2 (SEM 5.3)
14.9
[epoetin beta]
(SEM 4.8)
[14]
25-225
21.7
NA
48.8
e
15
[epoetin alfa]
(SEM 2.2)
(14.5-96.3)
[8]
50 (non-naive)
4
27.3 (8.6)
NA
14.1
[epoetin beta]
150 (naive)
2
19.5
46.2
31.7
[epoetin beta]
[33]
100
NA
NA
23
6
[epoetin beta]
100
NA
6
NA
24
[epoetin beta]
[1]
50
43.7 (6.7)
12
NA
NA
[epoetin alfa]
[28-100]
3000 U
23.4 (SEM 4.3)
23.28 (SEM 5.09)
36.3
[34]
5
[epoetin beta]
6000 U
24.0 (SEM 5.4)
26.12 (SEM 5.28)
31.0
5
[epoetin beta]
[13]
100
8
17.1 (5.0)
24.4 (27)
22.8 (14)
[epoetin alfa]
[5]
60
8
17.2 (6.5)
21.9 (9.7)
NA
[epoetin beta]
[8.1-30.8]
[10.3-35.8]
19.3
25.1
20.8
[18]
100
12
median/
[epoetin beta]
[8-24]
[14.0-40.1]
[11.6-35.6]
range
Values given as mean (SD) [range] unless otherwise indicated. F given for cross-over studies unless
otherwise indicated. F, bioavailability; NA, not available; SEM, standard error of the mean.
a
estimated as ln2/k
el
where k
el
given as 0.025h
-1
.
b
median.
c
estimated from parallel arms with dif-
ferent doses.
d
likely an underestimate as AUC
(0-72)
for SC dose.
e
unknown if cross-over study.
In summary, after subcutaneous dosing of rHuEPO to nephrology patients,
the absorption rate is slow, resulting in an extended terminal half-life with
bioavailability ranging from 20% to 40%. Dose- or time-dependencies are not
apparent.
