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Pronunciation |
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(ab
SIK si
mab) |
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U.S. Brand
Names |
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ReoPro® |
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Generic
Available |
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No |
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Synonyms |
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C7E3; 7E3 |
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Pharmacological Index |
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Platelet Aggregation Inhibitor |
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Use |
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Abciximab in for the prevention of acute cardiac ischemic complications in
patients at high risk for abrupt closure of the treated coronary vessel; an
adjunct with heparin to prevent cardiac ischemic complications in patients with
unstable angina not responding to conventional therapy when a percutaneous
coronary intervention is scheduled within 24 hours
Acute evolving myocardial infarction (MI) within 12 hours of onset of
symptoms requiring rescue PTCA
Early postinfarction angina or unstable angina with at least 2 episodes of
angina associated with EKG changes during previous 24 hours
Non-Q-wave myocardial infarction
Clinical or angiographic characteristic indicating high risk (see
"Characteristics of Type A, B, and C Lesions" below)
Unfavorable anatomy (ie, 2 or more Type B lesions) or
One or more Type B lesions with diabetes or
One or more Type B lesions and a female and over the age of 65 or
One Type C lesion
Thrombus score is based upon angiographic evidence
Characteristics of Type A, B, and C Lesions
Type A lesions (minimally complex)
Discrete (length <10 mm)
Concentric
Readily accessible
Nonangulated segment (<45°)
Smooth contour
Little or no calcification
Less than totally occlusive
Not ostial in location
No major side branch involvement
No thrombus
Type B lesions (moderately complex)
Tubular (length 10-20 mm)
Eccentric
Moderate tortuosity of proximal segment
Moderate angulated segment (>45°,
<90°)
Irregular contour
Moderate or heavy calcification
Total occlusions <3 months old
Ostial in location
Bifurcation lesions requiring double lead wires
Some thrombus present
Type C lesions (severely complex)
Diffuse (length >20 mm)
Excessive tortuosity of proximal segment
Extremely angulated segments >90°
Total occlusions >3 months old and/or bridging collaterals
Inability to protect major side branches
Degenerated vein grafts with friable lesions |
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Pregnancy Risk
Factor |
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C |
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Pregnancy/Breast-Feeding
Implications |
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Clinical effects on the fetus: It is not known whether abciximab can cause
fetal harm when administered to a pregnant woman or can affect reproduction
capacity |
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Contraindications |
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Hypersensitivity to abciximab or to murine proteins; active internal
hemorrhage or recent (within 6 weeks) clinically significant GI or GU bleeding;
history of cerebrovascular accident within 2 years or cerebrovascular accident
with significant neurological deficit; clotting abnormalities or administration
of oral anticoagulants within 7 days unless prothrombin time (PT) is less than
or equal to 1.2 times control PT value; thrombocytopenia (<100,000
cells/mL); recent (within 6 weeks) major surgery or
trauma; intracranial tumor, arteriovenous malformation, or aneurysm; severe
uncontrolled hypertension; history of vasculitis; use of dextran before PTCA or
intent to use dextran during PTCA; concomitant use of another parenteral GP
IIb/IIIa inhibitor |
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Warnings/Precautions |
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Administration of abciximab is associated with increased frequency of major
bleeding complications including retroperitoneal bleeding, spontaneous GI or GU
bleeding, and bleeding at the arterial access site and in the following:
patients weighing <75 kilograms, elderly patients (>65 years of age),
history of previous GI disease, recent thrombolytic therapy.
Increased risk of hemorrhage during or following angioplasty is associated
with unsuccessful PTCA, PTCA procedure >70 minutes duration, or PTCA
performed within 12 hours of symptom onset for acute myocardial infarction.
There is no data concerning the safety or efficacy of readministration of
abciximab. Administration of abciximab may result in human antichimeric antibody
formation that can cause hypersensitivity reactions (including anaphylaxis),
thrombocytopenia, or diminished efficacy. Anticoagulation, such as with heparin,
may contribute to the risk of bleeding. |
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Adverse
Reactions |
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As with all drugs which may affect hemostasis, bleeding is associated with
abciximab. Hemorrhage may occur at virtually any site. Risk is dependent on
multiple variables, including the concurrent use of multiple agents which alter
hemostasis and patient susceptibility.
Cardiovascular: Hypotension (14.4%), chest pain (11.4%)
Gastrointestinal: Nausea (13.6%)
Hematologic: Minor bleeding (4.0% to 16.8%)
Neuromuscular & skeletal: Back pain (17.6%)
1% to 10%:
Cardiovascular: Bradycardia (4.5%), peripheral edema (1.6%)
Central nervous system: Headache (6.45)
Gastrointestinal: Vomiting (7.3%), abdominal pain (3.1%)
Hematologic: Major bleeding (1.1% to 14%), thrombocytopenia: <100,000
cells/mm3 (2.5% to 5.6%); <50,000 cells/mm3 (0.4% to
1.7%)
Local: Injection site pain (3.6%)
<1% (Limited to important or life-threatening symptoms): Stroke,
intracranial hemorrhage, ventricular tachycardia, pseudoaneurysm, palpitation,
arteriovenous fistula, incomplete AV block, nodal arrhythmia, complete AV block,
embolism, thrombophlebitis, dyspepsia, diarrhea, ileus, gastroesophageal reflux,
anemia, leukocytosis, petechiae, dizziness, agitation, anxiety, abnormal
thinking, hypesthesia, confusion, muscle contractions, coma, hypertonia,
diplopia, pneumonia, pleural effusion, bronchitis, bronchospasm, pulmonary
embolism, myalgia, urinary retention, dysuria, urinary incontinence, crystalgia,
prostatitis, pain, increased sweating, weakness, pruritus, abnormal vision,
cellulitis, peripheral coldness, xerostomia, hyperkalemia, diabetes mellitus,
bullous eruption, inflammation, allergic reactions/anaphylaxis (possible)
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Overdosage/Toxicology |
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The antiplatelet effects can be quickly reversed with the administration of
platelets |
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Drug
Interactions |
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Heparin and aspirin: Use with aspirin and heparin may increase bleeding over
aspirin and heparin alone. However, aspirin and heparin were used concurrently
in the majority of patients in the major clinical studies of abciximab.
Monoclonal antibodies: Allergic reactions may be increased in patients who
have received diagnostic or therapeutic monoclonal antibodies due to the
presence of HACA antibodies.
Thrombolytic agents theoretically may increase the risk of hemorrhage; use
with caution.
Warfarin and oral anticoagulants: Risk of bleeding may be increased during
concurrent therapy.
Other IIb/IIIa antagonists: Avoid concomitant use of other glycoprotein
IIb/IIIa antagonists (see Contraindications). |
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Stability |
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Vials should be stored at 2°C to
8°C, do not freeze; after admixture, the prepared solution
is stable for 12 hours; abciximab should be administered in a separate
intravenous line; no incompatibilities have been observed with glass bottles or
PVC bags |
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Mechanism of
Action |
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Fab antibody fragment of the chimeric human-murine monoclonal antibody 7E3;
this agent binds to platelets resulting in steric hindrance, thus inhibiting
platelet aggregation |
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Pharmacodynamics/Kinetics |
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Half-life: ~30 minutes |
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Usual Dosage |
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I.V.: 0.25 mg/kg bolus administered 10-60 minutes before the start of
intervention followed by an infusion of 0.125 mcg/kg/minute (to a maximum of 10
mcg/minute) for 12 hours |
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Monitoring
Parameters |
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Prothrombin time, activated partial thromboplastin time, hemoglobin,
hematocrit, platelet count, fibrinogen, fibrin split products, transfusion
requirements, signs of hypersensitivity reactions, guaiac stools, and
Hemastix® urine |
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Cardiovascular
Considerations |
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Abciximab and other IIb/IIIa inhibitors appear to have a beneficial effect in
decreasing cardiovascular death and the need for revascularization when used in
patients with coronary artery disease. This is not necessarily a class effect.
Some IIb/IIIa inhibitors (eg, sibrafiban) have not demonstrated clear
cardiovascular benefit. Specifically, the benefits of IIb/IIIa inhibitors are
evident when used with aspirin either with or in comparison to heparin in
patients with unstable angina. IIb/IIIa inhibitors also decrease the frequency
of cardiovascular presentations when used prior to angioplasty or arthrectomy.
The benefits in terms of cardiovascular event reduction need to be balanced
against a small but significantly increased risk of
bleeding. |
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Mental Health: Effects
on Mental Status |
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None reported |
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Mental Health:
Effects on Psychiatric
Treatment |
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None reported |
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Dental Health: Local
Anesthetic/Vasoconstrictor
Precautions |
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No information available to require special precautions |
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Dental Health:
Effects on Dental Treatment |
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No effects or complications reported |
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Patient
Information |
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This medication can only be administered I.V. You will have a tendency to
bleed easily following this medication; use caution to prevent injury (use
electric razor, use soft toothbrush, and use caution with sharps). If bleeding
occurs, apply pressure to bleeding spot until bleeding stops completely. Report
unusual bruising or bleeding; blood in urine, stool, or vomitus; bleeding gums;
or changes in vision. Breast-feeding precautions: Consult prescriber if
breast-feeding. |
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Nursing
Implications |
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Do not shake the vial; maintain bleeding precautions, avoid unnecessary
arterial and venous punctures, use saline or heparin lock for blood drawing,
assess sheath insertion site and distal pulses of affected leg every 15 minutes
for the first hour and then every 1 hour for the next 6 hours. Arterial access
site care is important to prevent bleeding. Care should be taken when attempting
vascular access that only the anterior wall of the femoral artery is punctured,
avoiding a Seldinger (through and through) technique for obtaining sheath
access. Femoral vein sheath placement should be avoided unless needed. While the
vascular sheath is in place, patients should be maintained on complete bed rest
with the head of the bed at a 30° angle and the affected
limb restrained in a straight position. |
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Dosage Forms |
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Injection: 2 mg/mL (5 mL) |
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References |
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Aguirre FV, Topol EJ, and Ferguson JJ,
"Bleeding Complications With the Chimeric Antibody to Platelet Glycoprotein IIb/IIIa Integrin in Patients Undergoing Percutaneous Coronary Intervention. EPIC Investigators,"
Circulation, 1995, 91(12):2882-90.
Azrin MA, "The Use of Antibodies in Clinical Cardiology," Am Heart J,
1992, 124(3):753-68.
Berkowitz SD, Harrington RA, Rund MM, et al,
"Acute Profound Thrombocytopenia After C7E3 Fab (Abciximab) Therapy,"
Circulation, 1997, 95(4):809-13.
The EPIC Investigators,
"Use of a Monoclonal Antibody Directed Against the Platelet Glycoprotein IIb/IIIa Receptor in High-Risk Coronary Angioplasty,"
N Engl J Med, 1994, 330(14):956-61.
Weitz J and Hirsh J, "New Anticoagulant Strategies," J Lab Clin Med,
1993, 122(4):364-73. |
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