Home » Drug Information » FDA Approved Drugs » 1997
Medical Areas: Cardiology/Vascular Diseases
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The following drug information is obtained from various newswires, published
medical journal articles, and medical conference presentations.
Company: Centocor Ortho Biotech
Approval Status: Approved November 1997
Treatment Area: cardiac ischemia
ReoPro (abciximab) has been approved as an adjunctive therapy to
prevent cardiac ischemic complications (PCI), as well as in
unstable angina patients not responding to conventional medical
therapy when PCI is planned within 24 hours.
Previously, ReoPro was indicated solely for use in angioplasty
patients at high risk for complications and was administered as a
bolus 10-60 minutes before the procedure followed by a 12-hour
continuous infusion. The expanded labeling allows physicians to use
ReoPro in a broader population of patients undergoing PCI (balloon
angioplasty, atherectomy, stent placement). In addition, in
patients with refractory unstable angina, ReoPro can now be
administered 18 to 24 hours before PCI, concluding one hour after
Results from a large multisite clinical trial show that
bleeding, the most common side effect associated with ReoPro
therapy can be reduced by the use of modified dosing regimens and
specific patient management techniques.