Reopro

Country: Australia

Language: English

Source: Department of Health (Therapeutic Goods Administration)

Active ingredient:

Abciximab

Available from:

Eli Lilly Australia Pty Ltd

Class:

Medicine Registered

Patient Information leaflet

REOPRO(R)
1
REOPRO(R)
_abciximab_
CONSUMER MEDICINE INFORMATION
WHAT IS IN THIS LEAFLET
This leaflet answers some common
questions about REOPRO. It does
not contain all the available
information.  It does not take the
place of talking with your doctor or
nurse.
All medicines have risks and
benefits.
Your doctor has weighed the risks of
you being given REOPRO against
the benefits they expect it will have
for you.
IF YOU HAVE ANY CONCERNS ABOUT
BEING GIVEN THIS MEDICINE, ASK YOUR
DOCTOR OR NURSE.
KEEP THIS LEAFLET.
You may need to read it again.
WHAT REOPRO IS USED
FOR
REOPRO belongs to a class of
medicines called antithrombotics
which help to prevent blood clots.
REOPRO inhibits the aggregation of
blood-clotting cells (called platelets)
in the blood.
REOPRO is used in patients with
heart disease caused by poor blood
flow in the arteries of the heart
(known as ischaemic cardiac
complications).
REOPRO prevents the formation of
blood clots in the heart that may
occur during procedures to open
blocked arteries in the heart (known
as percutaneous coronary
intervention). Examples of
percutaneous coronary intervention
procedures include balloon
angioplasty, atherectomy and stent
placement.
REOPRO is also used in patients
who have severe chest pain with
heart disease (known as unstable
angina), when percutaneous coronary
intervention is planned.  REOPRO
may be started 18 to 24 hours prior to
the planned intervention.
ASK YOUR DOCTOR IF YOU HAVE ANY
QUESTIONS ABOUT WHY THIS MEDICINE
HAS BEEN PRESCRIBED FOR YOU.  YOUR
DOCTOR MAY HAVE PRESCRIBED IT FOR
ANOTHER REASON.
There is not enough information to
recommend the use of this medicine
in children under the age of 18 years.
BEFORE YOU HAVE
REOPRO
_WHEN YOU MUST NOT HAVE IT_
DO NOT HAVE REOPRO IF YOU HAVE
AN ALLERGY TO:
*
any medicine containing
abciximab
*
any of the ingredients listed at the
end of this leaflet
*
specific disease-fighting protein
substances (calle

Summary of Product characteristics

1 
ReoPro (abciximab)- Product Information v3.0 
REOPRO
®

(ABCIXIMAB RMC)

NAME OF THE MEDICINE 
ReoPro
® 
(abciximab) 

The active ingredient is abciximab. 

DESCRIPTION

ReoPro (abciximab rmc) is
the Fab fragment of the chimeric monoclonal antibody 7E3 (c7E3 
Fab).  The chemical description of abciximab is: 

Immunoglobulin G (human-mouse monoclonal c7E3 clone p7E3V
H
hC
H
 Fab 
fragment anti-human glycoprotein IIb/IIIa receptor), disulfide with human-
mouse monoclonal c7E3 clone p7E3V
_K_
hC
_K_
 light chain. 

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.  

Each 5 mL single-use vial
contains 10 mg abciximab, 6.75 mg dibasic sodium phosphate 
dihydrate, 1.65 mg monobasic sodium phosphate (monohydrate),
43.85 mg sodium chloride, 
0.05 mg polysorbate 80 and water for injections, qs
to 5.0 mL.  No preservatives are added.  

PHARMACOLOGY

ReoPro 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. ReoPro
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. 

ReoPro binds with similar affinity to the related integrin, 
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