REOPRO abciximab injection solution

国家: 美国

语言: 英文

来源: NLM (National Library of Medicine)

有效成分:

abciximab (UNII: X85G7936GV) (abciximab - UNII:X85G7936GV)

可用日期:

Eli Lilly and Company

INN（国际名称）:

abciximab

组成:

abciximab 2 mg in 1 mL

处方类型:

PRESCRIPTION DRUG

授权状态:

Biologic Licensing Application

产品特点

REOPRO- ABCIXIMAB INJECTION, SOLUTION
ELI LILLY AND COMPANY
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REOPRO
ABCIXIMAB
FOR INTRAVENOUS ADMINISTRATION
DESCRIPTION:
Abciximab, ReoPro
, is the Fab fragment of the chimeric human-murine monoclonal antibody
7E3.
Abciximab binds to the glycoprotein (GP) IIb/IIIa receptor of human
platelets and inhibits platelet
aggregation. Abciximab also binds to the vitronectin (α β ) receptor
found on platelets and vessel wall
endothelial and smooth muscle cells.
The chimeric 7E3 antibody is produced by continuous perfusion in
mammalian cell culture. The 47,615
dalton Fab fragment is purified from cell culture supernatant by a
series of steps involving specific
viral inactivation and removal procedures, digestion with papain and
column chromatography.
ReoPro
is a clear, colorless, sterile, non-pyrogenic solution for intravenous
(IV) use. Each single use
vial contains 2 mg/mL of Abciximab in a buffered solution (pH 7.2) of
0.01 M sodium phosphate, 0.15
M sodium chloride and 0.001% polysorbate 80 in Water for Injection. No
preservatives are added.
CLINICAL PHARMACOLOGY:
GENERAL- Abciximab binds to the intact platelet GPIIb/IIIa receptor,
which is a member of the integrin
family of adhesion receptors and the major platelet surface receptor
involved in platelet aggregation.
Abciximab inhibits platelet aggregation by preventing the binding of
fibrinogen, von Willebrand factor,
and other adhesive molecules to GPIIb/IIIa receptor sites on activated
platelets. The mechanism of
action is thought to involve steric hindrance and/or conformational
effects to block access of large
molecules to the receptor rather than direct interaction with the RGD
(arginine-glycine-aspartic acid)
binding site of GPIIb/IIIa.
Abciximab binds with similar affinity to the vitronectin receptor,
also known as the α β integrin. The
vitronectin receptor mediates the procoagulant properties of platelets
and the proliferative properties
of vascular endothelial and smooth muscle cells. In _in vitro_ studies
using a model cell line derived from
mela