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Integrilin (Eptifibatide Injection)
Manufactured by: Glaxo Smith Kline  This product requires a valid prescription
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Integrilin vials should be stored refrigerated at 2-8 degreees celsius (36-46 degrees). Vials may be transferred to room temperature storage for a period not to exceed two months.
INTEGRILIN (eptifibatide) Injection, a potent GP IIb-IIIa inhibitor, helps prevent occlusion of the arteries supplying the heart muscle with oxygen to reduce the incidence of heart attack. INTEGRILIN prevents the aggregation of blood platelets that, when allowed to form clots, can obstruct the flow of blood through the coronary arteries.
INTEGRILIN can be administered upon diagnosis, including the emergency room setting, regardless of whether the patient ultimately undergoes PCI or drug therapy alone.
Treatment with INTEGRILIN has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS and the composite of death, MI, or urgent target vessel revascularization in patients undergoing PCI.
Indications:
For the treatment of patients with acute coronary syndrome (UA/NSTEMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI)
For the treatment of patients undergoing percutaneous coronary intervention (PCI), including those undergoing intracoronary stenting
Contraindications:
A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days.
Severe hypertension (systolic blood pressure greater than 200 mm Hg or diastolic blood pressure greater than 110 mm Hg) 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.
Known hypersensitivity to any component of the product.
Precautions and Warnings:
In patients undergoing PCI, INTEGRILIN® (eptifibatide) Injection is associated with an increase in major and minor bleeding at the site of arterial sheath placement. Special care should be employed to minimize the risk of bleeding among these patients.
If bleeding cannot be controlled with pressure, infusion of INTEGRILIN and concomitant heparin should be stopped immediately.
Because INTEGRILIN inhibits platelet aggregation, caution should be employed when it is used with drugs that affect hemostasis, including thrombolytics, oral anticoagulants, NSAIDs, and dipyridamole.
Use with other GP IIb-IIIa inhibitors should be avoided.
INTEGRILIN is cleared in part by the kidney and its plasma concentrations are doubled in patients with renal disease (creatinine clearance less than 50 mL/min). Therefore, the infusion dose of INTEGRILIN needs to be reduced to 1 mcg/kg/min in these patients. INTEGRILIN is contraindicated in patients who are dependent upon renal dialysis. If creatinine clearance is not available and serum creatinine is greater than 2 mg/dL, the infusion dose should be reduced to 1 mcg/kg/min.
Caution should be exercised when administering eptifibatide to patients with a platelet count less than 100,000/mm3.
Bleeding is the most common complication encountered during INTEGRILIN therapy. In the registration studies, the majority of excess major bleeding events were localized at the femoral artery access site. Oropharyngeal, genitourinary, gastrointestinal, and retroperitoneal bleeding were seen more commonly with INTEGRILIN compared with placebo.
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