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. In the EPILOG and EPISTENT trials, the incidence of major bleeding in patients receiving ReoPro and low-dose heparin was similar to placebo levels.
Non-CABG bleeding in trials of percutaneous
coronary intervention (EPILOG and EPISTENT)
| Placebob (n=1748) | ReoPro+ Low Dose Heparinc (n=2525) |
ReoPro+ Standard-dose Heparind (n=918) |
|
| Majora | 1.0% (18) | 0.8% (21) | 1.9% (17) |
| Minor | 2.6% (46) | 3.2% (82) | 7.6% (70) |
a Patients who had bleeding in more than one classification are counted only once according to the most severe classification. Patients with multiple bleeding events of the same classification are also counted once within that classification.
b Standard-dose heparin with or without stent (EPILOG and EPISTENT)
c Low-dose heparin with or without stent (EPILOG and EPISTENT)
d Standard-dose heparin (EPILOG)
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 (also see Readministration below).
| EPILOG and EPISTENT patients treated with ReoPro plus low-dose heparin |
Patients (%) |
| Any thrombocytopenia (platelets less than 100,000 cells/µL) | 2.5-3.0% |
Severe thrombocytopenia (platelets less than 50,000 cells/µL) |
0.4-1.0% |
| Platelet transfusions | 0.9-1.1% |
Modestly lower rates were observed among patients treated with placebo plus standard-dose heparin.
Dosage and Administration
The safety and efficacy of ReoPro have only been investigated with concomitant administration of heparin and aspirin as described in CLINICAL STUDIES. Please see the full prescribing information for detailed information.
Onset and Reversibility
Onset The onset of ReoPro following a 0.25 mg/kg bolus dose (plus 0.125 µg/kg/min infusion) is rapid with the inhibitory effects evident within 10 minutes. Low levels of GP IIb/IIIa receptor blockade are present for more than 10 days following cessation of the infusion.
Reversibility Upon discontinuation of therapy with ReoPro, bleeding time returns to less than or equal to 12 minutes within 12 hours. Inhibitory effects of ReoPro can be rapidly reversed, at least in part, with platelet transfusions.
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
- 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
