Generic Name and Formulations:
Abciximab 2mg/mL; soln for IV inj; preservative-free.
Janssen Biotech, Inc.
Indications for REOPRO:
Adjunct to percutaneous coronary intervention (PCI) for prevention of cardiac ischemic complications: in patients undergoing PCI and; in patients with unstable angina not responding to conventional medical therapy when PCI is planned within 24hrs. For use with heparin and aspirin.
0.25mg/kg IV bolus administered 10–60 minutes before start of PCI, followed by a continuous IV infusion of 0.125micrograms/kg/min (max 10micrograms/min) for 12 hrs. Unstable angina not responding to conventional therapy: 0.25mg/kg IV bolus followed by an 18–24hr IV infusion of 10micrograms/min, concluding 1hr after PCI.
Active internal bleeding. GI or GU bleeding within 6 wks. Cerebrovascular accident within 2yrs or with residual neurologic deficit. Bleeding diathesis. Oral anticoagulants within 7 days, unless prothrombin time ≤1.2 times control. Thrombocytopenia. Major surgery or trauma within 6 wks. Intracranial neoplasm, arteriovenous malformation, or aneurysm. Severe uncontrolled hypertension. Vasculitis. IV dextran before or during PCI.
See literature. Increased risk of bleeding when PCI within 12hrs of MI symptom onset, PCI lasting >70min, failed PCI. Discontinue infusion if uncontrolled bleeding occurs. Properly care for femoral artery access site to minimize bleeding. Minimize other arterial and venous punctures, IM inj, catheter use, intubation, NG tube, automatic BP cuffs, to lower bleeding risk; avoid use of non-compressible IV access sites. Discontinue heparin 2hrs prior to arterial sheath removal. Monitor prothrombin time, ACT, APTT, and platelet count before and during treatment. Discontinue if confirmed thrombocytopenia occurs. Pregnancy (Cat.C). Nursing mothers.
Risk of bleeding increased with concomitant heparin, thrombolytics, anticoagulants, NSAIDs, dipyridamole, and ticlopidine.
Bleeding, intracranial hemorrhage, stroke, thrombocytopenia, hypersensitivity reactions, hypotension, bradycardia, GI upset, abdominal-, back-, chest-, and puncture site pain, peripheral edema, arrhythmias.