IMPORTANT SAFETY INFORMATION

Indication

ReoPro® (abciximab) is indicated as an adjunct to PCI for the prevention of cardiac ischemic complications:

• In patients undergoing PCI
• In patients with UA not responding to conventional medical therapy when PCI is planned within 24 hours

Safety and efficacy of ReoPro use in patients not undergoing PCI have not been established. ReoPro is intended for use with aspirin and heparin and has been studied only in that setting, as described in clinical studies.

Bleeding Risk
ReoPro has the potential to increase the risk of bleeding, particularly in the presence of anti-coagulation agents, e.g., from heparin or other anticoagulants. The risk of a major bleed due to ReoPro therapy is increased in patients receiving thrombolytics and should be weighed against the anticipated benefits.

Guidelines for reduction in bleeding
Use of a low-dose, weight-adjusted heparin regimen, discontinuation of heparin on completion of the procedure with removal of the arterial sheath within 6 hours, careful vascular access site management and careful patient management, including attention to other potential bleeding sites, use of a weight-adjusted bolus and continuous-infusion dose of ReoPro.

Thrombocytopenia
In clinical trials, patients treated with ReoPro were more likely than patients who received placebo to experience decreases in platelet counts, including severe thrombocytopenia (also see Readministration below).

Readministration of ReoPro
Administration of ReoPro may result in the formation of human anti-chimeric antibodies (HACA) that could potentially cause allergic or hypersensitivity reactions (including anaphylaxis), thrombocytopenia, or diminished benefit upon readministration. In a registry study of ReoPro readministration (1342 treatments in 1286 patients), there were no reports of serious allergic reactions or anaphylaxis. Thrombocytopenia was observed at higher rates in the readministration study than in the phase 3 studies of first-time administration, suggesting that readministration may be associated with an increased incidence and severity of thrombocytopenia. This increased risk was associated with a history of thrombocytopenia on prior ReoPro exposure, a positive HACA assay at baseline, and readministration within 30 days.

Allergic Reactions (including anaphylaxis)
Allergic reactions, some of which were anaphylaxis (sometimes fatal), have been reported rarely in patients treated with ReoPro. Patients with allergic reactions should receive appropriate treatment. Treatment of anaphylaxis should include immediate discontinuation of ReoPro administration and initiation of resuscitative measures.

Contraindications
Because ReoPro may increase the risk of bleeding, use is contraindicated in the following clinical situations: active internal bleeding, recent (within 6 weeks) gastrointestinal (GI) or genitourinary (GU) bleeding of clinical significance, history of cerebrovascular accident (CVA) within 2 years, or CVA with a significant residual neurological deficit, bleeding diathesis, administration of oral anticoagulants within 7 days unless prothrombin time is less than or equal to 1.2 times control, thrombocytopenia (<100,000 cells/μL), recent (within 6 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 percutaneous coronary intervention, or intent to use it during intervention, known hypersensitivity to any component of this product or to murine proteins.

For additional safety information, please consult the Prescribing Information for ReoPro.