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
Enbrel Online, Description, Chemistry, Ingredients - Etanercept
Enbrel Online, Description, Chemistry, Ingredients - Etanercept
DESCRIPTION
ENBREL® (etanercept) is a dimeric fusion protein
consisting of the extracellular ligand-binding portion of the human 75 kilodalton
(p75) tumor necrosis factor receptor (TNFR) linked to the Fc portion of human
IgG1. The Fc component of etanercept contains the CH2 domain, the
CH3 domain and hinge region, but not the CH1 domain of
IgG1. Etanercept is produced by recombinant DNA technology in a Chinese hamster
ovary (CHO) mammalian cell expression system. It consists of 934 amino acids
and has an apparent molecular weight of approximately 150 kilodaltons.
ENBREL® is supplied in a single-use prefilled
1 mL syringe as a sterile, preservative-free solution for subcutaneous injection.
The solution of ENBREL® is clear and colorless and is formulated
at pH 6.3 ± 0.2. Each ENBREL®
single-use prefilled syringe contains 0.98 mL of a 50 mg/mL solution of etanercept
with 10 mg/mL sucrose, 5.8 mg/mL sodium chloride, 5.3 mg/mL L-arginine hydrochloride,
2.6 mg/mL sodium phosphate, monobasic, monohydrate, and 0.9 mg/mL sodium phosphate,
dibasic, anhydrous. Administration of one 50 mg/mL prefilled syringe of ENBREL®
provides a dose equivalent to two 25 mg vials of lyophilized ENBREL®,
when vials are reconstituted and administered as recommended.
ENBREL® multiple-use vial contains sterile,
white, preservative-free, lyophilized powder. Reconstitution with 1 mL of the
supplied Sterile Bacteriostatic Water for Injection (BWFI), USP (containing
0.9% benzyl alcohol) yields a multiple-use, clear, and colorless solution with
a pH of 7.4 ± 0.3 containing 25 mg etanercept, 40 mg mannitol, 10 mg sucrose,
and 1.2 mg tromethamine.
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