In the event of acute profound thrombocytopenia or a confirmed platelet decrease to <100,000/mm3, discontinue INTEGRILIN and heparin (unfractionated or low-molecular-weight). Monitor serial platelet counts, assess the presence of drug-dependent antibodies, and treat as appropriate (see ADVERSE REACTIONS, Immunogenicity).
There has been no clinical experience with eptifibatide initiated in patients with a baseline platelet count <100,000/mm3. If a patient with low platelet counts is receiving INTEGRILIN, their platelet count should be monitored closely.
PRECAUTIONS
Bleeding Precautions
Care of the Femoral Artery Access Site in Patients Undergoing Percutaneous Coronary Intervention (PCI)
In patients undergoing PCI, treatment with eptifibatide is associated with an increase in major and minor bleeding at the site of arterial sheath placement. After PCI, eptifibatide infusion should be continued until hospital discharge or up to 18 to 24 hours, whichever comes first. Heparin use is discouraged after the PCI procedure. Early sheath removal is encouraged while eptifibatide is being infused. Prior to removing the sheath, it is recommended that heparin be discontinued for 3 to 4 hours and an aPTT of <45 seconds or ACT <150 seconds be achieved. In any case, both heparin and eptifibatide should be discontinued and sheath hemostasis should be achieved at least 2 to 4 hours before hospital discharge.
Use of Thrombolytics, Anticoagulants, and Other Antiplatelet Agents
In the IMPACT II, PURSUIT, and ESPRIT studies, eptifibatide was used concomitantly with unfractionated heparin and aspirin (see CLINICAL STUDIES). In the ESPRIT study, clopidogrel or ticlopidine were used routinely starting the day of PCI. Because eptifibatide inhibits platelet aggregation, caution should be employed when it is used with other drugs that affect hemostasis, including thrombolytics, oral anticoagulants, nonsteroidal anti-inflammatory drugs, and dipyridamole. To avoid potentially additive pharmacologic effects, concomitant treatment with other inhibitors of platelet receptor GP IIb/IIIa should be avoided.
There is only a small experience with concomitant use of eptifibatide and thrombolytics. In a study of 180 patients with acute myocardial infarction (AMI), eptifibatide (in regimens up to a bolus of 180 mcg/kg followed by a continuous infusion of 0.75 mcg/kg/min for 24 hours) was administered concomitantly with the approved "accelerated" regimen of alteplase, a thrombolytic agent. The studied regimens of eptifibatide did not increase the incidence of major bleeding or transfusion compared to the incidence seen when alteplase was given alone.
In the IMPACT II study, 15 patients received a thrombolytic agent in conjunction with the 135/0.5 dosing regimen, 2 of whom experienced a major bleed. In the PURSUIT study, 40 patients who received eptifibatide at the 180/2.0 dosing regimen received a thrombolytic agent, 10 of whom experienced a major bleed.
In another AMI study involving 181 patients, eptifibatide (in regimens up to a bolus of 180 mcg/kg followed by a continuous infusion of up to 2.0 mcg/kg/min for up to 72 hours) was administered concomitantly with streptokinase (1.5 million U over 60 minutes), another thrombolytic agent. At the highest studied infusion rates (1.3 mcg/kg/min and 2.0 mcg/kg/min), eptifibatide was associated with an increase in the incidence of bleeding and transfusions compared to the incidence seen wh |
