No

Platelet Aggregation Inhibitor

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

C

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

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

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.

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)

The antiplatelet effects can be quickly reversed with the administration of platelets

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).

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

Fab antibody fragment of the chimeric human-murine monoclonal antibody 7E3; this agent binds to platelets resulting in steric hindrance, thus inhibiting platelet aggregation

Half-life: ~30 minutes

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

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

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.

None reported

None reported

No information available to require special precautions

No effects or complications reported

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.

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.

Injection: 2 mg/mL (5 mL)

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.