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
Reopro Indications, Dosage, Storage, Stability - Abciximab
Reopro Indications, Dosage, Storage, Stability - Abciximab
INDICATIONS AND USAGE
Abciximab is indicated as an adjunct to percutaneous coronary
intervention for the prevention of cardiac ischemic complications
• in patients undergoing percutaneous coronary intervention
• in patients with unstable angina not responding to conventional medical
therapy when percutaneous coronary intervention is planned within 24 hours
Safety and efficacy of Abciximab use in patients not undergoing
percutaneous coronary intervention have not been established.
Abciximab is intended for use with aspirin and heparin
and has been studied only in that setting, as described in CLINICAL
STUDIES.
DOSAGE AND ADMINISTRATION
The safety and efficacy of Abciximab have only been investigated
with concomitant administration of heparin and aspirin as described in
CLINICAL STUDIES.
In patients with failed PCls, the continuous infusion of Abciximab
should be stopped because there is no evidence for Abciximab efficacy in that
setting.
In the event of serious bleeding that cannot be controlled
by compression, Abciximab and heparin should be discontinued immediately.
The recommended dosage of Abciximab in adults is a 0.25 mg/kg
intravenous bolus administered 10-60 minutes before the start of PCI, followed
by a continuous intravenous infusion of 0. 125 m
g/kg/min (to a maximum of 10 m g/min) for 12
hours.
Patients with unstable angina not responding to conventional
medical therapy and who are planned to undergo PCI within 24 hours may be treated
with an Abciximab 0.25 mg/kg intravenous bolus followed by an 18- to 24-hour
intravenous infusion of 10 m g/min, concluding
one hour after the PCI.
Instructions for Administration
1. Parenteral drug products should be inspected visually for
particulate matter prior to administration. Preparations of Abciximab containing
visibly opaque particles should NOT be used.
2. Hypersensitivity reactions should be anticipated whenever
protein solutions such as Abciximab are administered. Epinephrine, dopamine,
theophylline, antihistamines and corticosteroids should be available for immediate
use. If symptoms of an allergic reaction or anaphylaxis appear, the infusion
should be stopped and appropriate treatment given.
3. As with all parenteral drug products, aseptic procedures
should be used during the administration of Abciximab.
4. Withdraw the necessary amount of Abciximab for bolus
injection into a syringe.
Filter the bolus injection using a sterile, non-pyrogenic,
low protein-binding 0.2 or 0.22 m m filter (Millipore
SLGV025LS or equivalent).
5. Withdraw the necessary amount of Abciximab for the continuous
infusion into a syringe. Inject into an appropriate container of sterile 0.9%
saline or 5% dextrose and infuse at the calculated rate via a continuous infusion
pump. The continuous infusion should be filtered either upon admixture using
a sterile, non-pyrogenic, low protein-binding 0.2 or 0.22 m
m syringe filter (Millipore SLGV025LS or equivalent) or upon administration
using an in-line, sterile, non-pyrogenic, low protein-binding 0.2 or 22 m
m filter (Abbott #4524 or equivalent). Discard the unused portion at the end
of the infusion.
6. No incompatibilities have been shown with intravenous infusion
fluids or commonly used cardiovascular drugs. Nevertheless, Abciximab should
be administered in a separate intravenous line whenever possible and not mixed
with other medications.
7. No incompatibilities have been observed with glass bottles
or polyvinyl chloride bags and administration sets.
HOW SUPPLIED
Abciximab (ReoPro ) 2 mg/mL is supplied in 5 mL vials containing
10 (NDC 0002-7140-01).
Vials should be stored at 2 to 8 oC (36 to 46 OF). Do not freeze.
Do not shake. Do not use beyond the expiration date. Discard any unused portion
left in the vial.
REFERENCES
1. Reverter JC, Beguin S, Kessels H, Kumar R, Hemmer HC, Coller
BS. Inhibition of platelet-mediated, tissue-factor-induced thrombin generation
by the mouse/human chimeric 7E3 antibody; potential implications for the effect
of c7E3 Fab treatment on acute thrombosis and "clinical restenosis J Clin Invest.
1996;98:863-874.
2. Alteri D, Edgington T, A monoclonal antibody reacting with
distinct adhesion molecules defines a transition in the functional state of
the receptor CD 11 b/CD 18 (Mac-1). The Journal of Immunology. 1988;141:2656-2660.
3. Simon DI, Xu H, Ortlepp S, Rogers C, Rao NK. 7E3 monoclonal
antibody directed against the platelet glycoprotein IIb/IIIa cross-reacts with
the leukocyte integrin Mac-and blocks adhesion to fibrinogen and ICAM- 1. Arterioscler
Thromb Vase BioI. 1997;17:528-535.
4. Mickelson JK, Ali MN, Kleiman NS, Lakkis NM, Chow TW, Hughes
BJ. Chimeric 7E3 Fab (ReoPro) decreases detectable CDllb on neutrophils from
patients undergoing coronary angioplasty. J Am CoIl Cardioi. 1999;33:97- 106.
5. Tcheng J, Ellis SG, George BS. Pharmacodynamics of chimeric
glycoprotein IIb/IIIa integrin antiplatelet antibody Fab 7E3 in high risk coronary
angioplasty. Circulation. 1994;90:1757- 1764.
6. Simoons ML, de Boer MJ, van der Brand MJBM, et al. Randomized
trial of a GPIIb/illa platelet receptor blocker in refractory unstable angina.
Circulation. 1994;89:596-603.
7. EPIC Investigators. Use of a monoclonal antibody directed
against the platelet glycoprotein IIb/IIIa receptor in high-risk coronary angioplasty.
Engl J Med. 1994;330:956-961.
8. Topol EJ, Califf RM, Weisman HF, et al. Randomised trial
of coronary intervention with antibody against platelet IIb/IIIa integrin for
reduction of clinical restenosis: results at six months. Lancet. 1994;343:881-886.
Updated Jan 30, 2004
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