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
RAPTIVA Online, Description, Chemistry, Ingredients - Efalizumab
RAPTIVA Online, Description, Chemistry, Ingredients - Efalizumab
RAPTIVA [efalizumab]
For injection, subcutaneous
DESCRIPTION
RAPTIVA (efalizumab) is an
immunosuppressive recombinant humanized IgG1 kappa isotype monoclonal antibody
that binds to human CD11a (1). Efalizumab has a molecular weight of approximately
150 kilodaltons and is produced in a Chinese hamster ovary mammalian cell expression
system in a nutrient medium containing the antibiotic gentamicin. Gentamicin
is not detectable in the final product.
RAPTIVA is supplied as a sterile, white to off-white, lyophilized
powder in single-use glass vials for subcutaneous (SC) injection. Reconstitution
of the single-use vial with 1.3 mL of the supplied sterile water for injection
(non-USP) yields approximately 1.5 mL of solution to deliver 125 mg per 1.25
mL (100 mg/mL) of RAPTIVA. The sterile water for injection supplied does
not comply with USP requirement for pH. After reconstitution, RAPTIVA
is a clear to pale yellow solution with a pH of approximately 6.2. Each single-use
vial of RAPTIVA contains 150 mg of efalizumab, 123.2 mg of sucrose, 6.8 mg of
L-histidine hydrochloride monohydrate, 4.3 mg of L-histidine and 3 mg of polysorbate
20 and is designed to deliver 125 mg of efalizumab in 1.25 mL.
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