A1,
A2,
B,
C1,
C2,
D,
E,
F,
G-H,
I-K,
L,
M,
N,
O,
P1,
P2,
Q-R,
S,
T,
U-V,
W-Z
Rituxan Online, Description, Chemistry, Ingredients - Rituximab
Rituxan Online, Description, Chemistry, Ingredients - Rituximab
DESCRIPTION
The RITUXAN (Rituximab) antibody
is a genetically engineered chimeric murine/human monoclonal
antibody directed against
the CD20 antigen found
on the surface of normal
and malignant B lymphocytes.
The antibody is an
IgG1 kappa immunoglobulin
containing murine light-
and heavy- chain variable
region sequences and
human constant
region sequences. Rituximab
is composed of two heavy chains of 451 amino acids and two light
chains of 213 amino acids (based on cDNA analysis) and has an approximate
molecular weight of 145 kD. Rituximab has a binding affinity
for the CD20 antigen of approximately 8.0 nM.
The chimeric anti-CD20 antibody
is produced by mammalian cell
(Chinese Hamster Ovary) suspension
culture in a nutrient
medium containing the
antibiotic gentamicin. Gentamicin is not detectable in the final
product. The anti-CD20 antibody is purified by affinity
and ion exchange
chromatography. The purification process includes specific
viral inactivation
and removal procedures. Rituximab drug product
is manufactured from either bulk
drug substance
manufactured by Genentech, Inc. (US License No. 1048), or utilizing
formulated bulk Rituximab supplied by IDEC Pharmaceuticals Corporation
(US License No. 1235) under a shared manufacturing arrangement.
RITUXAN is a sterile,
clear, colorless, preservative-free liquid
concentrate for intravenous
(IV) administration. RITUXAN is supplied at a concentration of 10
mg/mL in either 100 mg (10
mL) or 500 mg (50 mL) single-use
vials. The product is
formulated for IV administration
in 9.0 mg/mL sodium chloride,
7.35 mg/mL sodium citrate
dihydrate, 0.7 mg/mL polysorbate 80, and Sterile Water for Injection.
The pH is adjusted to 6.5.
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