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ReoPro® (abciximab) is indicated as an adjunct to percutaneous coronary intervention (PCI) for the prevention of cardiac ischemic complications:
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.
ReoPro has the potential to increase the risk of bleeding, particularly in the presence of anticoagulation agents, for example, 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.
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.
In clinical trials, patients treated with ReoPro were more likely than patients who received placebo to experience decreases in platelet counts (also see Readministration).
Modestly lower rates were observed among patients treated with placebo plus standard-dose heparin.
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.
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.
ReoPro® (abciximab) intravenous bolus plus infusion
Onset The onset of ReoPro following a 0.25 mg/kg bolus dose (plus 0.125 mcg/kg/minute 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.
For additional safety information, please consult the Important Safety Information or the Prescribing Information for ReoPro.