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Abciximab (Systemic)

Introductory Information

Platelet aggregation inhibitor; a platelet glycoprotein (GP IIb/IIIa)-receptor inhibitor.1, 2, 4, 5

Class: 20:12.18 Platelet-Aggregation Inhibitors

Brands: ReoPro®

Generic Name: Abciximab

CAS Number: 143653-53-6
Chemical Name: Human mouse monoclonal c7E3 clone p7E3VHhCgamma4 Fab fragment anti-human
glycoprotein IIb/IIIa receptor immunoglobulin G disulfide with human-mouse monoclonal c7E3 clone
p7E3vkhCk light chain
Investigational Drug Number: c7E3

Uses

Acute Ischemic Complications of PCI

Adjunct to anticoagulant therapy (e.g., unfractionated heparin, low molecular weight heparin), aspirin,
and/or clopidogrel to prevent acute cardiac ischemic complications in patients undergoing PCI or in
patients with non-ST-segment acute coronary syndromes (i.e., unstable angina or non-ST-segment-
elevation MI) not responding to conventional medical therapy in whom PCI is planned within 24
hours.1, 2, 4, 5, 7, 10, 11, 71, 85, 91, 95, 96, 98, 107, 108, 113

Adjunctive therapy with a GP IIb/IIIa-receptor inhibitor can reduce the incidence of cardiac ischemic
events, including subsequent MI and death, in patients with non-ST-segment-elevation acute coronary
syndromes undergoing PCI and in patients without these conditions undergoing PCI.10, 11, 17, 42, 47, 48,
49, 50, 51, 52, 84, 85, 108

The American College of Chest Physicians (ACCP), ACC, and AHA recommend that therapy with a GP
IIb/IIIa-receptor inhibitor be considered in all patients undergoing PCI, particularly those with refractory
non-ST-segment elevation acute coronary syndromes or other high-risk features.83, 84, 85, 86, 96
ACC/AHA/SCAI recommend a GP IIb/IIIa-receptor inhibitor (i.e., abciximab, eptifibatide, tirofiban)
without clopidogrel in patients with non-ST-segment-elevation acute coronary syndromes undergoing
PCI;85, 103, 104 however, ACCP recommends a GP IIb/IIIa inhibitor with clopidogrel in such patients.
108

Abciximab or eptifibatide recommended for patients with at least moderate risk factors for an ischemic
event undergoing PCI, provided a GP IIb/IIIa-receptor inhibitor has not been initiated previously (at
presentation or diagnosis ["upstream"]).108 In patients with non-ST-segment-elevation acute coronary
syndromes in whom PCI is planned and coronary anatomy is known, initiation of abciximab within 24
hours prior to PCI is recommended.108

ACCP recommends bivalirudin with provisional use of a GP IIb/IIIa-receptor inhibitor or unfractionated

heparin and a GP IIb/IIIa-receptor inhibitor in patients who are at a low to moderate risk for an ischemic
event and who are undergoing PCI.108 In patients undergoing elective PCI with stent placement, ACC

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and AHA consider the use of GP IIb/IIIa-receptor inhibitors (abciximab, eptifibatide, tirofiban) to be
reasonable.85

GP IIb/IIIa-receptor inhibitors also have been used in patients with ST-segment-elevation MI

undergoing PCI.85, 97, 107 ACCP recommends abciximab for patients with ST-segment-elevation MI
undergoing primary PCI with or without stenting to reduce the incidence of ischemic complications.107
ACC, ACCP, SCAI, and AHA suggest initiating abciximab as soon as possible before primary PCI (e.g.,
before coronary angiography) in such patients.85, 97, 107

Unstable Angina and Non-ST-Segment Elevation MI

Abciximab is not recommended as initial treatment (at presentation or diagnosis ["upstream"]) in

patients with non-ST-segment-elevation acute coronary syndromes, except when the coronary anatomy
is known and PCI is planned within 24 hours.1, 98, 108 Other GP IIb/IIIa-receptor inhibitors (eptifibatide,
tirofiban) are recommended for initial use as an adjunct to standard therapeutic measures for managing
non-ST-segment-elevation acute coronary syndromes.1, 57, 71, 86, 95, 96, 98, 113 Manufacturer and some
clinicians state that safety and efficacy of abciximab not established in such patients who are not
undergoing PCI.1, 108

Adjunctive Therapy during Thrombolysis to Prevent Reocclusion

Has been used concomitantly with a thrombolytic agent (e.g., reteplase, tenecteplase) and IV heparin to
prevent coronary artery reocclusion after an acute MI.97, 102 Some clinicians state that combined
therapy with abciximab and a thrombolytic agent (at half the standard thrombolytic dosage) may be
considered in selected patients (anterior MI, age <75 years, no risk factors for bleeding).97 However,
ACCP does not recommend use of abciximab in combination with half-dose reteplase or tenecteplase
over standard therapy with these thrombolytic agents alone.102, 107

Dosage and Administration

General

• Discontinue infusion in patients in whom PCI has failed.1

• Optimal time to initiate treatment with GP IIb/IIIa-receptor inhibitors prior to PCI not established.109
In patients with non-ST-segment-elevation acute coronary syndromes, ACC/AHA/SCAI recommend
administering abciximab prior to diagnostic angiogram or just before PCI.85 ACCP recommends
initiating abciximab after coronary anatomy is known in patients with non-ST-segment-elevation
acute coronary syndromes who are to undergo PCI.108 In patients with acute ST-segment-elevation
MI who are to undergo primary PCI, ACCP suggests administration of the IV loading dose of
abciximab prior to coronary angiography;107 ACC, AHA, and SCAI state that it is reasonable to
administer abciximab as early as possible in such patients.85

Adjunctive Antithrombotic Therapy: General Considerations

• Used in conjunction with aspirin and heparin in clinical studies.1

• Dosage of heparin required to maintain an appropriate activated clotting time (ACT) during
concomitant therapy with abciximab may be lower than with heparin monotherapy.19, 107, 109 (See

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Specific Drugs under Interactions.)

• Dosage of fondaparinux in conjunction with heparin required to maintain adequate anticoagulation
during concomitant therapy with abciximab is lower than that required with anticoagulants alone.108

Adjunctive Antithrombotic Therapy When Used to Prevent Acute Ischemic Complications of PCI

• Aspirin: In clinical studies, patients received 325 mg 2 hours prior to PCI and daily thereafter.1, 77
ACC/AHA/SCAI recommend 300-325 mg ≥2 hours, preferably 24 hours, prior to PCI in patients not
already receiving maintenance therapy with aspirin.85, 109 In patients already receiving maintenance
therapy with aspirin, give 75-325 mg before the procedure.85, 109 ACCP recommends long-term
treatment after PCI with aspirin 75-100 mg daily.111
• Clopidogrel in patients with acute coronary syndromes undergoing PCI: 300-600 mg generally
recommended as a loading dose prior to or at the time of the procedure.107, 108, 109
• Heparin: In clinical studies, patients received 70 units/kg if baseline ACT <150 seconds, 50 units/kg if
baseline ACT was 150-199 seconds, or no heparin if baseline ACT ≥200 seconds.1 ACCP, ACC, and
AHA recommend 50-70 units/kg 6 hours prior to PCI with dosage adjusted to maintain an ACT of
≥200 seconds.10, 12, 16, 18, 19, 45, 46, 77, 85, 96, 107, 108 Administer additional injections (e.g., 20
units/kg) to maintain an ACT of ≥200 seconds during the procedure.1 (See Laboratory Monitoring
under Cautions.) Postprocedural use of heparin not generally recommended.1, 10, 18, 22, 77, 96
Consider a lower dosage of heparin in women and geriatric patients receiving a GP IIb/IIIa-receptor
inhibitor to decrease the risk of minor bleeding.85
• Fondaparinux: In patients managed initially with fondaparinux at presentation or diagnosis
("upstream"), a GP IIb/IIIa-receptor inhibitor, and a delayed invasive strategy, ACCP recommends
additional IV injections of fondaparinux sodium (2.5 mg) and heparin sodium (e.g., 50-60 units/kg)
be given at the time of the procedure.108

Administration

IV Administration
For solution and drug compatibility information, see Compatibility under Stability.

Administer by IV injection followed by IV infusion using a controlled-infusion device (e.g., pump).1

Do not shake vial.1

Filter injection upon dilution, prior to IV administration, or during IV infusion using a sterile,
nonpyrogenic, low-protein-binding filter (0.2 or 5 mcm).1, 7

For IV injection, withdraw appropriate dose into syringe and filter injection prior to administration.1

Discard unused portion.1

Do not admix or administer other drugs in the same IV line with abciximab injection or infusion.1

Dilution
For IV infusion, withdraw appropriate dose into syringe and inject into an appropriate container of 0.9%
sodium chloride or 5% dextrose injection.1

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Rate of Administration
For IV injection, administer over at least 1 minute.1, 7

Dosage

Adults
Acute Ischemic Complications of PCI
>IV
Patients undergoing PCI: 0.25 mg/kg by IV injection 10-60 minutes prior to PCI,1, 7, 96, 107, 108
followed by IV infusion of 0.125 mcg/kg per minute (maximum of 10 mcg/minute) for 12 hours.1, 96,
107
Patients scheduled to receive PCI within 24 hours: 0.25 mg/kg by IV injection, followed by IV infusion
of 10 mcg/minute for 18-24 hours, concluding 1 hour after procedure.1, 4

Prescribing Limits

Adults
Acute Ischemic Complications of PCI
>IV
Patients undergoing PCI: Maximum 10 mcg/minute (as IV infusion) for 12 hours.1

Special Populations

No special population dosage recommendations at this time.1

Cautions

Contraindications

• Bleeding diathesis, active internal bleeding, or recent (within 6 weeks) clinically important GI or
genitourinary bleeding.1
• Severe uncontrolled hypertension.1
• Recent (within 6 weeks) major surgery or trauma.1
• History of cerebrovascular accident (CVA) in preceding 2 years or CVA with serious substantial
residual neurologic deficit.1
• Recent (within previous 7 days) oral anticoagulant therapy unless prothrombin time (PT) is ≤1.2 times
control value.1
• Thrombocytopenia (platelet count <100,000/mm3).1
• Intracranial neoplasm.1
• Arteriovenous malformation or aneurysm.1
• Use of IV dextran prior to or during PCI.1
• Presumed or documented history of vasculitis.1
• Known hypersensitivity to any ingredient in the formulation or to murine proteins.1, 9

Warnings/Precautions

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Warnings
Hematologic Effects
Risk of major bleeding (e.g., intracranial hemorrhage, genitourinary or GI bleeding, bleeding at arterial
access site) and minor bleeding (e.g., spontaneous gross hematuria, spontaneous hematemesis); may
require blood or platelet transfusions.1, 2, 4, 5 (See Bleeding Precautions and see Laboratory Monitoring
under Cautions.)

Pulmonary alveolar hemorrhage reported rarely.1

Increased risk of major bleeding observed in patients weighing ≤75 kg;1, 4, 5 during concomitant
thrombolytic therapy;1 when PCI is performed within 12 hours of onset of symptoms of MI;1 following
prolonged (>70 minutes) PCI;1 or following failed PCI.1, 9

If bleeding cannot be controlled by pressure, discontinue abciximab and concomitant heparin

immediately.1

Sensitivity Reactions
Hypersensitivity Reactions
Possible anaphylaxis.1 If anaphylaxis occurs, discontinue abciximab immediately and initiate
appropriate treatment; drugs for treatment of hypersensitivity reactions (e.g., epinephrine, dopamine,
theophylline, antihistamines, corticosteroids) should be immediately available.1

Formation of human antichimeric antibody (HACA) reported.1, 3, 8, 16, 22, 23, 54, 63, 65 Possible
hypersensitivity reactions (including anaphylaxis), thrombocytopenia, or diminished antithrombotic
effect if abciximab is readministered or if monoclonal antibodies are administered in patients with
HACA titers.1

General Precautions
Bleeding Precautions
To reduce risk of bleeding, adhere to strict anticoagulation guidelines; use a short course of low-dose,
weight-adjusted heparin; avoid vascular and other trauma; carefully manage vascular (e.g., femoral
artery) access site; and monitor all potential bleeding sites during and following treatment.1, 18, 44, 60

Use caution in the placement, maintenance, and removal of vascular access sheath; avoid femoral vein
sheath placement.1 When inserting sheath, puncture only anterior wall of femoral artery; avoid Seldinger
(through and through) technique.1 Observe appropriate precautions while sheath is in place (e.g.,
complete bed rest, elevation of head ≤30°, restrain limb in which sheath is inserted, frequent monitoring
of vascular access site and distal pulse in the involved limb).1 Following PCI, discontinue heparin
immediately; remove arterial sheath within 6 hours following PCI (at least 2 hours after discontinuation
of heparin) if aPTT ≤50 seconds or ACT ≤175 seconds.1 Following sheath removal, apply pressure to
femoral artery for at least 30 minutes to achieve hemostasis.1 Measure and monitor hematomas for
enlargement.1

To avoid vascular and other trauma, minimize arterial or venous punctures, IM injections, cutdown sites,
and use of nasotracheal intubation, nasogastric tubes, urinary catheters, and automatic BP cuffs; avoid
establishment of IV access at noncompressible sites (e.g., subclavian or jugular veins); consider using an
indwelling venipuncture device (e.g., heparin lock) for drawing blood; document and monitor vascular

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puncture sites; and remove dressings gently and carefully.1

If emergency surgery is needed, discontinue abciximab.1

Thrombocytopenia
Risk of thrombocytopenia.1 Severe thrombocytopenia (platelet count <20,000/mm3)19, 46, 66 reported
more frequently than with tirofiban.1, 18, 32, 54, 67, 68

Determine platelet count prior to treatment, at 2-4 hours following initial IV injection, and at 24 hours
following initiation of therapy or prior to discharge, whichever occurs first.1, 9 Consider possibility of
pseudothrombocytopenia or heparin-induced thrombocytopenia (in patients receiving concomitant
heparin therapy).1, 14, 47, 54, 59, 70 Exclude pseudothrombocytopenia caused by an in vitro anticoagulant
interaction by sampling blood in tubes containing edetate disodium (EDTA), citrate, or heparin.1 A low
platelet count in the presence of EDTA but not in the presence of heparin and/or citrate supports of a
diagnosis of pseudothrombocytopenia.1

If true thrombocytopenia is verified, discontinue abciximab and initiate appropriate treatment and
monitoring.1 Platelet transfusions may partially restore platelet function.1

Possible increased incidence and severity of thrombocytopenia following readministration.1

Contraindicated in patients with platelet counts <100,000/mm3.1

Laboratory Monitoring
Prior to administration, obtain platelet count, PT, ACT, and aPTT.1

Monitor platelet count during and after treatment.1 (See Thrombocytopenia under Cautions.)

When abciximab is initiated 18-24 hours prior to PCI, maintain aPTT between 60-85 seconds.1 During
PCI, maintain ACT ≥200 seconds.1, 10, 12, 16, 18, 19, 45, 46, 77, 96 If anticoagulation is continued
following PCI, maintain aPTT between 55-75 seconds.1

Monitor aPTT or ACT prior to arterial sheath removal; do not remove sheath unless aPTT ≤50 seconds
or ACT is 150-180 seconds (approximately 6 hours after PCI).1, 96

Specific Populations
Pregnancy
Category C.1

Lactation
Not known whether abciximab is distributed into milk.1 Use with caution.1, 9

Pediatric Use
Safety and efficacy not established in children <18 years of age.1, 9

Geriatric Use
No substantial differences in safety and efficacy in patients 65-74 years of age relative to younger

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adults.1 Insufficient experience in patients ≥75 years of age to determine whether these patients respond
differently than younger adults.1

Women
Increased risk of minor bleeding complications with adjunctive heparin in women compared with
men.85, 103

Common Adverse Effects

Bleeding, back pain, hypotension, nausea, chest pain, vomiting, headache, bradycardia, puncture site
pain, abdominal pain, peripheral edema.1

Interactions

No formal drug interaction studies to date.1

Specific Drugs

Drug Interaction Comments

Potential increased risk of
Anticoagulants, oral Use with caution1
bleeding1
Dextran Increased risk of bleeding1 Concomitant use contraindicated1
Potential increased risk of
Dipyridamole Use with caution1
bleeding1
Heparin Increased risk of bleeding1 Monitor aPTT or ACT during therapy1
Potential increased risk of
NSAIAs Use with caution1
bleeding1
Thrombolytics (e.g., Increased risk of major Weigh risk against anticipated benefit of
reteplase) bleeding1 concomitant therapy1
Potential increased risk of
Ticlopidine Use with caution1
bleeding1

Pharmacokinetics

Absorption

Onset
Maximal inhibition of platelet aggregation occurs within 10 minutes following IV administration.1

Duration
Bleeding time returns to ≤12 minutes within 12-24 hours following discontinuance of infusion.1 Platelet
function generally recovers within 48 hours.1

Distribution

Extent

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Not known whether abciximab is distributed into breast milk or is absorbed systemically after
ingestion.1

Elimination

Half-life
Initial half-life is <10 minutes; second phase half-life is about 30 minutes.1 Abciximab remains in
circulation for ≥15 days in a platelet-bound state.1

Stability

Storage

Parenteral
Injection
2-8°C.1 Do not freeze.1

Compatibility

For information on systemic interactions resulting from concomitant use, see Interactions.

Parenteral
No incompatibilities observed with glass bottles, PVC bags, or IV administration sets.1

Solution Compatibility1
No incompatibilities observed with IV fluids.1

Compatible
Dextrose 5%
Sodium chloride 0.9%

Drug Compatibility
No incompatibilities observed with commonly used cardiovascular drugs.1 Nevertheless, administer
abciximab in separate IV line whenever possible; do not mix with other drugs.1

>Y-Site Compatibilityd
Compatible
Adenosineb
Atropine sulfateb
Bivalirudin
Diphenhydramine HClb
Fentanyl citrateb
Metoprolol tartrateb
Midazolam HClb

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Actions

• Fab fragment of chimeric human-murine monoclonal immunoglobulin antibody 7E3.1, 2, 3, 4, 5, 6

• Binds selectively to platelet GP IIb/IIIa receptors and reversibly inhibits platelet aggregation (by
preventing binding of fibrinogen, von Willebrand factor, and other adhesive ligands to GP IIb/IIIa
receptors).1, 2, 4, 5

Advice to Patients

• Risk of serious bleeding or hemorrhage.1, 4, 5, 9

• Importance of close laboratory monitoring.1
• Importance of informing clinicians of existing or contemplated therapy, including prescription and
OTC drugs and dietary or herbal supplements, as well as any concomitant illnesses (e.g.,
cardiovascular disease).1
• Importance of women informing clinicians if they are or plan to become pregnant or plan to breast-
feed.1
• Importance of advising patients of other important precautionary information.1 (See Cautions.)

Preparations

Excipients in commercially available drug preparations may have clinically important effects in some
individuals; consult specific product labeling for details.

Abciximab
Routes Dosage Forms Strengths Brand Names Manufacturer
Parenteral Injection, for IV use 2 mg/mL (10 mg) ReoPro® Lilly

Use is not currently included in the labeling approved by the US Food and Drug Administration.

References

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