In a clinical study,
INTEGRILIN provided significant risk reduction in PCI patients across a range of risk levels
- Patients included those undergoing urgent or elective PCI.1
- INTEGRILIN reduced the composite incidence of death, MI, UTVR, or thrombotic bailout at 48 hours (the primary end point in ESPRITa) by 37% (RRR) vs placebo (6.6% [n=1040] vs 10.5% [n=1024], respectively; P=0.0015).1
- INTEGRILIN reduced the cumulative incidence of death or MI compared to placebo at 30 days (RRR 38%, P=0.0016),1 6 months (RRR 37%, P=0.002),2 and 1 year (RRR 37%, P=0.001).3
Selected Warnings and Precautions
Indications for INTEGRILIN Injection
- To decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with acute coronary syndrome (unstable angina/non–ST-elevation myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI)
- To decrease the rate of a combined endpoint of death, new MI, or need for urgent intervention in patients undergoing PCI, including those undergoing intracoronary stenting
Selected Safety Information
INTEGRILIN Is Contraindicated in Patients With:
- A history of bleeding diathesis or evidence of active abnormal bleeding within the previous 30 days
- Severe hypertension (systolic blood pressure >200 mmHg or diastolic blood pressure >110 mmHg) not adequately controlled
on antihypertensive therapy
- Major surgery within preceding 6 weeks
- History of stroke within 30 days or any history of hemorrhagic stroke
- Current or planned administration of another parenteral GP IIb/IIIa inhibitor
- Dependency on renal dialysis
- Hypersensitivity to INTEGRILIN® (eptifibatide) Injection or any component of the product
(hypersensitivity reactions that occurred included anaphylaxis and urticaria)
- Bleeding is the most common complication encountered during INTEGRILIN therapy.
Administration of INTEGRILIN is associated with an increase in major and minor bleeding.
Most major bleeding has been at the arterial access site for cardiac catheterization or from
the gastrointestinal or genitourinary tract. Oropharyngeal and retroperitoneal bleeding were
also seen more commonly with INTEGRILIN compared to placebo.
- Risk factors for bleeding include older age, a history of bleeding disorders, and concomitant use of drugs that increase the risk of bleeding (thrombolytics, oral anticoagulants, nonsteroidal anti-inflammatory drugs, P2Y12 inhibitors). Concomitant treatment with other GP IIb/IIIa inhibitors should be avoided. In patients treated with heparin, bleeding can be minimized by close monitoring of the activated partial thromboplastin time (aPTT) and activated clotting time (ACT).
- In patients undergoing PCI, INTEGRILIN is associated with an increase in major and minor bleeding at the site of arterial sheath placement. If bleeding at the access site cannot be controlled with pressure, infusion of INTEGRILIN and heparin should be discontinued immediately.
- In the event of acute profound thrombocytopenia or a confirmed platelet decrease to <100,000/mm3, discontinue INTEGRILIN and heparin (unfractionated heparin [UFH] or low-molecular-weight heparin [LMWH]). Monitor serial platelet counts, assess the presence of drug-dependent antibodies, and treat as appropriate.
- There has been no clinical experience with INTEGRILIN 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.
- INTEGRILIN is cleared in part by the kidney and its plasma concentrations are doubled in patients with an estimated creatinine clearance <50 mL/min. Therefore, the infusion dose of INTEGRILIN needs to be reduced to 1 mcg/kg/min in these patients.
- Bleeding and hypotension are the most commonly reported adverse reactions with INTEGRILIN.