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Reopro (Abciximab) - Drug Interactions, Contraindications, Overdosage, etc

 
 



DRUG INTERACTIONS

Drug Interactions- Formal drug interaction studies with Abciximab have not been conducted. Abciximab has been administered to patients with ischemic heart disease treated concomitantly with a broad range of medications used in the treatment of angina, myocardial infarction and hypertension. These medications have included heparin, warfarin, beta-adrenergic receptor blockers, calcium channel antagonists, angiotensin converting enzyme inhibitors, intravenous and oral nitrates, ticlopidine, and aspirin. Heparin, other anticoagulants, thrombolytics, and antiplatelet agents are associated with an increase in bleeding. Patients with HACA titers may have allergic or hypersensitivity reactions when treated with other diagnostic or therapeutic monoclonal antibodies.

OVERDOSAGE:

There has been no experience of overdosage in human clinical trials.

CONTRAINDICATIONS:

Because Abciximab may increase the risk of bleeding, Abciximab is contraindicated in the following clinical situations:

  • Active internal bleeding
  • Recent (within six weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance.
  • History of cerebrovascular accident (CVA) within two years, or CVA with a significant residual neurological deficit
  • Bleeding diathesis
  • Administration of oral anticoagulants within seven days unless prothrombin time is ≤ 1.2 times control
  • Thrombocytopenia (< 100,000 cells/μL)
  • Recent (within six weeks) major surgery or trauma
  • Intracranial neoplasm, arteriovenous malformation, or aneurysm
  • Severe uncontrolled hypertension
  • Presumed or documented history of vasculitis
  • Use of intravenous dextran before PCI, or intent to use it during an intervention

Abciximab is also contraindicated in patients with known hypersensitivity to any component of this product or to murine proteins.

REFERENCES:

  1. 1. Reverter JC, Beguin S, Kessels H, Kumar R, Hemmer HC, Coller BS. Inhibition of platelet-mediated, tissue-factor-induced thrombin generation by the mouse/human chimeric 7E3 antibody; potential implications for the effect of c7E3 Fab treatment on acute thrombosis and "clinical restenosis". J Clin Invest. 1996;98:863-874.
  2. 2 Alteri D, Edgington T, A monoclonal antibody reacting with distinct adhesion molecules defines a transition in the functional state of the receptor CD11b/CD18 (Mac-1). The Journal of Immunology. 1988;141:2656-2660.
  3. 3. Simon DI, Xu H, Ortlepp S, Rogers C, Rao NK. 7E3 monoclonal antibody directed against the platelet glycoprotein IIb/IIIa cross-reacts with the leukocyte integrin Mac-1 and blocks adhesion to fibrinogen and ICAM-1. Arterioscler Thromb Vasc Biol. 1997;17:528-535.
  4. 4. Mickelson JK, Ali MN, Kleiman NS, Lakkis NM, Chow TW, Hughes BJ. Chimeric 7E3 Fab (ReoPro) decreases detectable CD11b on neutrophils from patients undergoing coronary angioplasty. J Am Coll Cardiol. 1999;33:97-106.
  5. 5. Tcheng J, Ellis SG, George BS. Pharmacodynamics of chimeric glycoprotein IIb/IIIa integrin antiplatelet antibody Fab 7E3 in high risk coronary angioplasty. Circulation. 1994;90:1757- 1764.
  6. 6. Simoons ML, de Boer MJ, van der Brand MJBM, et al. Randomized trial of a GPIIb/IIIa platelet receptor blocker in refractory unstable angina. Circulation. 1994;89:596-603.
  7. 7. 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;330:956-961.
  8. 8. Topol EJ, Califf RM, Weisman HF, et al. Randomised trial of coronary intervention with antibody against platelet IIb/IIIa integrin for reduction of clinical restenosis: results at six months. Lancet. 1994;343:881-886.
  9. 9. Topol EJ, Ferguson JJ, Weisman HF, et al. for the EPIC Investigators. Long-term protection from myocardial ischemic events in a randomized trial of brief integrin blockade with percutaneous coronary intervention. JAMA. 1997;278:479-484.
  10. 10. EPILOG Investigators. Platelet glycoprotein IIb/IIIa receptor blockade and low dose heparin during percutaneous coronary revascularization. N Eng J Med. 1997;336:1689-1696.
  11. 11. Lincoff AM, Tcheng JE, Califf RM, et al. for the EPILOG Investigators. Sustained suppression of ischemic complications of coronary intervention by platelet GP IIb/IIIa blockade with abciximab. Circ. 1999; 99:1951-1958.
  12. 12. 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.
  13. 13. Lincoff AM, Califf RM, Moliterno DJ, et al. for the EPISTENT Investigator. Complementary clinical benefits of coronary stenting and blockade of platelet glycoprotein IIb/IIIa receptors. N Engl J Med 1999; 341:319-327.
  14. 14. CAPTURE Investigators. Randomised placebo-controlled trial of abciximab before, during and after coronary intervention in refractory unstable angina: the CAPTURE study. Lancet. 1997; 349:1429-1435.
  15. 15. Data on file.
  16. 16. Rao, AK, Pratt C, Berke A, et al. Thrombolysis in Myocardial Infarction (TIMI) Trial - Phase I: Hemorrhagic manifestations and changes in plasma fibrinogen and the fibrinolytic system in patients treated with recombinant tissue plasminogen activator and streptokinase. J Am Coll Cardiol. 1988;11:1-11.
  17. 17. Landefeld, CS, Cook EF, Flatley M, et al. Identification and preliminary validation of predictors of major bleeding in hospitalized patients starting anticoagulant therapy. Am J Med. 1987;82:703-713.

Product of The Netherlands

Manufactured by:
Janssen Biologics B.V.
Leiden, The Netherlands
U.S. License Number: 1865

Distributed by:
Eli Lilly and Company
Indianapolis, IN 46285
Revision Date: November 2013

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