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accredited [150:<100,000/mm 3 ). 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 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/mm 3 ) 19 46 66 reported more frequently than with tirofiban. 1 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/mm 3 . 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 19 45 46 77 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 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 Common Adverse Effects Bleeding, back pain, hypotension, nausea, chest pain, vomiting, headache, bradycardia, puncture site pain, abdominal pain, peripheral edema. 1 Interactions for Abciximab No formal drug interaction studies to date. 1 Specific Drugs Drug Interaction Comments Anticoagulants, oral Potential increased risk of bleeding 1 Use with caution 1 Dextran Increased risk of bleeding 1 Concomitant use contraindicated 1 Dipyridamole Potential increased risk of bleeding 1 Use with caution 1 Heparin Increased risk of bleeding 1 Monitor aPTT or ACT during therapy 1 NSAIAs Potential increased risk of bleeding 1 Use with caution 1 Thrombolytics (e.g., reteplase) Increased risk of major bleeding 1 Weigh risk against anticipated benefit of concomitant therapy 1 Ticlopidine Potential increased risk of bleeding 1 Use with caution 1 Abciximab 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 Compatibility 1 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 CompatibilityHID Compatible Adenosine 111 Atropine sulfate 111 Bivalirudin Diphenhydramine HCl 111 Fentanyl citrate 111 Metoprolol tartrate 111 Midazolam HCl 111 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. Please refer to the ASHP Drug Shortages Resource Center for information on shortages of one or more of these preparations. Abciximab Routes Dosage Forms Strengths Brand Names Manufacturer Parenteral Injection, for IV use 2 mg/mL (10 mg) ReoPro Lilly AHFS DI Essentials. Copyright 2017, Selected Revisions September 18, 2017. American Society of Health-System Pharmacists, Inc., 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814. Use is not currently included in the labeling approved by the US Food and Drug Administration. References 1. Eli Lilly and Company. ReoPro (abciximab) injection for intravenous administration prescribing information. Indianapolis, IN; 2005 Jun. 3. 2. Topol EJ, Califf RM, Weisman HF et al. Randomized trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: results at six months. Lancet . 1994; 343:881-5. [PubMed 7908357] 3. Simoons ML, de Boer MJ, van den Brand MJ et al. Randomized trial of GpIIb/IIIa platelet receptor blocker in refractory unstable angina. Circulation . 1994; 89:596-603. [PubMed 7508826] 4. 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: 956-61. 5. Anon. Centocor will begin shipping Reopro to Lilly in early January: Reopro is the first GpIIbIIIa antagonist for PTCA patients at high risk for ischemic complications. F-D-C Rep . 1995 Jan:16-7. 6. Tcheng JE, Ellis SG, George BS et al. Pharmacodynamics of chimeric glycoprotein IIb/IIIa integrin antiplatelet antibody Fab 7E3 in high-risk coronary angioplasty. Circulation . 1994; 90:1757-64. [PubMed 7923659] 7. Eli Lilly and Company, Indianapolis, IN: Personal communication. 8. Ellis SG, Tcheng JE, Navetta FI et al. Safety and antiplatelet effect of murine monoclonal antibody 7E3Fab directed against platelet glycoprotein IIb/IIIa in patients undergoing elective coronary angioplasty. Cor Art Dis . 1993; 4:167-75. 9. Eli Lilly and Company, Indianapolis, IN: Personal communication. 10. The EPILOG Investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low-dose heparin during percutaneous coronary revascularization. N Engl J Med . 1997; 336:1689-96. [PubMed 9182212] 11. The CAPTURE Investigators. Randomised placebo-controlled trial of abciximab before and during coronary intervention in refractory unstable angina: the CAPTURE study. Lancet . 1997; 349:1429-35. [PubMed 9164316] 12. Kleiman NS. A risk-benefit assessment of abciximab in angioplasty. Drug Saf . 1999; 20:43-57. [PubMed 9935276] 13. Detre KM, Holmes DR Jr, Holubkov R et al. 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Effects of platelet glycoprotein IIb/IIIa blockade with tirofiban on adverse cardiac events in patients with unstable angina or acute myocardial infarction undergoing coronary angioplasty. Circulation . 1997; 96:1445-53. [PubMed 9315530] 49. Adgey AAJ. An overview of the results of clinical trials with glycoprotein IIb/IIIa inhibitors. Am Heart J . 1998; 135:S43-55. 50. Dobesh PP, Latham KA. Advancing the battle against ischemic syndromes: a focus on the GP-IIb/IIIa inhibitors. Pharmacotherapy . 1998; 18:663-85. [PubMed 9692642] 51. Kong DF, Califf Rm, Miller DP et al. Clinical outcomes of therapeutic agents that block the platelet glycoprotein IIb/IIIa integrin in ishemic heart disease. Circulation . 1998; 98:2829-35. [PubMed 9860783] 52. Vorchheimer DA, Badimon JJ, Fuster V. Platelet glycoprotein IIb/IIIa receptor antagonists in cardiovascular disease. JAMA . 1999; 281:1407-14. [PubMed 10217057] 53. Giugliano RP, Hyatt RR. Thrombocytopenia with GP IIb/IIIa inhibitors: a meta-analysis. J Am Coll Cardiol . 1998; 31(Suppl 2A):185A. 54. Ferguson JJ, Kereiakes DJ, Adgey AAJ et al. Safe use of platelet GP IIb/IIIa inhibitors. Am Heart J . 1998; 135:S77-89. 55. Quinn M, Fitzgerald DJ. Long-term administration of glycoprotein IIb/IIIa antagonists. Am Heart J . 1998; 135:S113-8. [PubMed 9588390] 56. Topol EJ, Byzova TV, Plow EF. Platelet GPIIb/IIIa blockers. Lancet . 1999; 353:227-31. [PubMed 9923894] 57. Key Pharmaceuticals. Integrelin (eptifibatide) injection prescribing information. Kenilworth, NJ; 1998 May. 59. Merck & Co. Aggrastat (tirofiban hydrochloride) injection premixed and injection prescribing information. West Point, PA; 1999 Jul. 60. Reviewers comments (personal observations) on tirofiban. 61. Merck & Co., West Point, PA: Personal communication on tirofiban. 62. Peerlinck, De Lepeleire I, Goldberg M et al. MK-383 (L-700,462), a selective nonpeptide platelet glycoprotein IIb/IIIa antagonist, is active in man. Circulation . 1993; 88:1512-7. [PubMed 8403299] 63. Phillips DR, Scarborough RM. Clinical pharmacology of eptifibatide. Am J Cardiol . 1997; 80(Suppl 4A):11b-20b. [PubMed 9291241] 64. Key Pharmaceuticals. Integrilin (eptifibatide) product monograph. Kenilworth, NJ; 1998 Aug. 65. Le Breton H, Plow EF, Topol EJ et al. Role of platelets in restenosis after percutaneous coronary revascularization. J Am Coll Cardiol . 1996; 28:1643-51. [PubMed 8962547] 66. PURSUIT Trial Investigators. Inhibition of platelet glycoprotein IIb/IIIa with eptifibatide in patients with acute coronary syndromes. N Engl J Med . 1998; 339:436-43. [PubMed 9705684] 67. Kereiakes DJ, Kleiman NS, Ambrose J et al. Randomized, double-blind, placebo-controlled dose-ranging study of tirofiban (MK-383) platelet IIb/IIIa blockade in high risk patients undergoing coronary angioplasty. J Am Coll Cardiol . 1996; 27:536-42. [PubMed 8606262] 68. Ferguson JJ, Waly HM, Wilson JM. Fundamentals of coagulation and glycoprotein IIb/IIIa receptor inhibition. Am Heart J . 1998; 135:S35-42. [PubMed 9539494] 69. Harrington RA. Design and methodology of the PURSUIT trial: evaluating eptifibatide for acute coronary syndromes. Am J Cardiol . 1997; 80(Suppl 4A):34b-8b. [PubMed 9291244] 70. Merck & Co. Product information form for American hospital formulary service: Aggrastat (tirofiban hydrochloride). West Point, PA; 1998. 72. Lefkovits J, Plow EF, Topol EJ. Platelet glycoprotein IIb/IIIa receptors in cardiovascular medicine. N Engl J Med . 1995; 332:1553-9. [PubMed 7739710] 73. Topol EJ, Ferguson JJ, Weisman HF et al. Long-term protection from myocardial ischemic events in a randomized trial of brief integrin β 3 blockade with percutaneous coronary intervention. JAMA . 1997; 278:479-84. [PubMed 9256222] 74. Lincoff AM, Tcheng JE, Califf RM et al. Sustained suppression of ischemic complications of coronary intervention by platelet GP IIb/IIIa blockade with abciximab: one year outcome in the EPILOG trial. Circ . 1999; 99:1951-8. 75. Ghaffari S, kereiakes DJ, Lincoff AM et al. Platelet glycoprotein IIb/IIIa receptor blockade with abciximab reduces ischemic complications in patients undergoing directional atherectomy. Am J Cardiol . 1998; 82:7-12. [PubMed 9671000] 76. Keriakes D, Lincoff AM, Miller DP et al. Abciximab therapy and unplanned coronary stent deployment: favorable effects on stent use, clinical outcomes, and bleeding complications. Circ . 1998; 97:857-64. 77. The EPISTENT Investigators. Randomised placebo-controlled and balloon-angioplasty-controlled trial to assess safety of coronary stenting with use of platelet glycoprotein-IIb/IIIa blockade. Lancet . 1998; 352:87-92. [PubMed 9672272] 78. Lincoff AM, Califf RM, Moliterno DJ et al. 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Next Interactions Print this page Add to My Med List More about abciximab Side Effects During Pregnancy Drug Interactions Support Group 0 Reviews Add your own review/rating Drug class: glycoprotein platelet inhibitors Consumer resources Abciximab Abciximab Intravenous (Advanced Reading) Professional resources Abciximab (Wolters Kluwer) Other brands: ReoPro Related treatment guides High Risk Percutaneous Transluminal Angioplasty> ]} FEATURED: CAR-T Cell Therapy Overview Mechanism of Action KTE-C19 Studies KTE-C19 Cancer Targets Adverse Events Manufacturing Drug Status Rx Availability Prescription only C Pregnancy Category Risk cannot be ruled out N/A CSA Schedule Not a controlled drug Approval History Drug history at FDA Drug Class Glycoprotein platelet inhibitors Related Drugs High Risk Percutaneous Transluminal Angioplasty ReoPro , More... Abciximab Rating No Reviews - Be the first! No Reviews - Be the first! Not Rated - Be the first!} } decent


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