Merck

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)
Selected Warnings and Precautions
  • 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.
Before prescribing INTEGRILIN® (eptifibatide) Injection, please read the Prescribing Information.

ESPRIT=Enhanced Suppression of the Platelet IIb-IIIa Receptor with INTEGRILIN Therapy; GP IIb-IIIa=glycoprotein IIb-IIIa complex; LMWH=low-molecular-weight heparin; MI=myocardial infarction; NSAIDs=nonsteroidal anti-inflammatory drugs; PCI=percutaneous coronary intervention; RRR=relative risk reduction; UA/NSTEMI=unstable angina/non–ST-segment elevation myocardial infarction; UFH=unfractionated heparin; UTVR=urgent target vessel revascularization.

aESPRIT was a randomized, double-blind, placebo-controlled, multicenter study in 2064 patients scheduled to undergo PCI. Patients were randomly allocated to receive eptifibatide, given as two 180-mcg/kg boluses 10 minutes apart and as a continuous infusion of 2.0 mcg/kg/min for 18 to 24 hours, or placebo, in addition to aspirin, heparin, and a thienopyridine. The primary end point was the composite of death, MI, UTVR, and thrombotic bailout to GP IIb-IIIa inhibitor therapy within 48 hours after randomization.

   
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