INTEGRILIN- eptifibatide injection, solution
Merck Sharp & Dohme Corp.
1 INDICATIONS AND USAGE
1.1 Acute Coronary Syndrome (ACS)
INTEGRILIN � is indicated to decrease the rate of a combined endpoint of death or new myocardial infarction (MI) in patients with ACS (unstable angina [UA]/non-ST-elevation myocardial infarction [NSTEMI]), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).
1.2 Percutaneous Coronary Intervention (PCI)
INTEGRILIN is indicated 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 [see Clinical Studies (14.1, 14.2)].
2 DOSAGE AND ADMINISTRATION
Before infusion of INTEGRILIN, the following laboratory tests should be performed to identify pre-existing hemostatic abnormalities: hematocrit or hemoglobin, platelet count, serum creatinine, and PT/aPTT. In patients undergoing PCI, the activated clotting time (ACT) should also be measured.
The activated partial thromboplastin time (aPTT) should be maintained between 50 and 70 seconds unless PCI is to be performed. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT.
2.1 Dosage in Acute Coronary Syndrome (ACS)
Indication Normal Renal Function Creatinine Clearance less than 50 mL/min
Patients with ACS 180 mcg/kg intravenous (IV) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min 180 mcg/kg IV bolus as soon as possible after diagnosis, followed by continuous infusion of 1 mcg/kg/min
Infusion should continue until hospital discharge or initiation of coronary artery bypass graft surgery (CABG), up to 72 hours
If a patient is to undergo PCI, the infusion should be continued until hospital discharge or for up to 18 to 24 hours after the procedure, whichever comes first, allowing for up to 96 hours of therapy
Aspirin, 160 to 325 mg, should be given daily
INTEGRILIN should be given concomitantly with heparin dosed to achieve the following parameters:
During Medical Management: Target aPTT 50 to 70 seconds
If weight greater than or equal to 70 kg, 5000-unit bolus followed by infusion of 1000 units/h.
If weight less than 70 kg, 60-units/kg bolus followed by infusion of 12 units/kg/h.
During PCI: Target ACT 200 to 300 seconds
If heparin is initiated prior to PCI, additional boluses during PCI to maintain an ACT target of 200 to 300 seconds.
Heparin infusion after the PCI is discouraged.