Generic Name: Abciximab
Class: Platelet-Aggregation Inhibitors
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
CAS Number: 143653-53-6
Introduction
Platelet aggregation inhibitor; a platelet glycoprotein (GP IIb/IIIa)-receptor inhibitor.1 2 4 5
Uses for ReoPro
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 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
ReoPro 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 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
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 for ReoPro
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
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 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 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 for ReoPro
No formal drug interaction studies to date.1
Specific Drugs
Drug | Interaction | Comments |
|---|---|---|
Anticoagulants, oral | Potential increased risk of bleeding1 | Use with caution1 |
Dextran | Increased risk of bleeding1 | Concomitant use contraindicated1 |
Dipyridamole | Potential increased risk of bleeding1 | Use with caution1 |
Heparin | Increased risk of bleeding1 | Monitor aPTT or ACT during therapy1 |
NSAIAs | Potential increased risk of bleeding1 | Use with caution1 |
Thrombolytics (e.g., reteplase) | Increased risk of major bleeding1 | Weigh risk against anticipated benefit of concomitant therapy1 |
Ticlopidine | Potential increased risk of bleeding1 | Use with caution1 |
ReoPro 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
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
Compatible |
|---|
Adenosineb |
Atropine sulfateb |
Bivalirudin |
Diphenhydramine HClb |
Fentanyl citrateb |
Metoprolol tartrateb |
Midazolam HClb |
ActionsActions
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.
Routes | Dosage Forms | Strengths | Brand Names | Manufacturer |
|---|---|---|---|---|
Parenteral | Injection, for IV use | 2 mg/mL (10 mg) | ReoPro | Lilly |
Disclaimer
This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.
The American Society of Health-System Pharmacists, Inc. and Drugs.com represent that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. and Drugs.com make no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. and Drugs.com do not endorse or recommend the use of any drug. The information is not a substitute for medical care.
AHFS Drug Information. © Copyright, 1959-2011, Selected Revisions August 2010. American Society of Health-System Pharmacists, Inc., 7272 Wisconsin Avenue, Bethesda, Maryland 20814.
† Use is not currently included in the labeling approved by the US Food and Drug Administration.
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