Integril 2 Injection: Each ml of sterile solution contains Eptifibatide INN 2 mg.
Integril 0.75 Injection: Each ml of sterile solution contains Eptifibatide INN 0.75 mg.
• Patients with acute coronary syndrome (unstable angina/non-ST- segment elevation myocardial infarction), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI).
• Patients undergoing PCI, including those undergoing intracoronary stenting.
•Normal renal function: 180 μg/kg IV bolus of as soon as possible following diagnosis followed by a continuous infusion of 2 μg/kg/min.
•Creatinine clearance <50 mL/min: 180 μg/kg IV bolus of as soon as possible following diagnosis followed by a continuous infusion of 1 μg/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.
2. Patients with PCI ( Percutaneous Coronary Intervention)
•Normal renal function: 180 μg/kg IV bolus immediately before PCI followed by a continuous infusion of 2 μg/kg/min & a second bolus of 180 μg/kg (given 10 minutes after the first bolus)
•Creatinine clearance <50 mL/min: 180 μg/kg IV bolus immediately before PCI followed by a continuous infusion of 1 μg/kg/min & a second bolus of 180 μg/kg (given 10 minutes after the first bolus)
- Infusion should be continued until hospital discharge, or for up to 18 to 24 hours, whichever comes first. A minimum of 12 hours of infusion is recommended.
- In patients who undergo CABG surgery, INTEGRILIN infusion should be discontinued prior to surgery.
Instructions for Administration
1. Integril solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
2. Integril may be administered in the same IV line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Integril should not be administered through the same IV line as furosemide.
3. Integril may be administered in the same IV line with 0.9% NaCl or 0.9% NaCl/5% dextrose. With either vehicle, the infusion may also contain up to 60 mEq/L of KCl.
4. The bolus dose(s) of Integril should be withdrawn from the 10-mL vial into a syringe. The bolus dose(s) should be administered by IV push.
5. Immediately following the bolus dose administration, a continuous infusion of Integril should be initiated. When using an intravenous infusion pump, Integril should be administered undiluted directly from the 100 mL vial. The 100-mL vial should be spiked with a vented infusion set. Care should be taken to center the spike within the circle on the stopper top.
• If bleeding cannot be controlled with pressure, infusion of Integril and concomitant heparin should be stopped immediately
• Because Integril 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
• Integril is cleared in part by the kidney and its plasma concentrations are doubled in patients with renal disease (creatinine clearance
<50 mL/min). Therefore, the infusion dose of Integril needs to be reduced to 1 mcg/kg/min in these patients. Integril is contraindicated in patients who are dependent upon renal dialysis
• Caution should be exercised when administering eptifibatide to patients with a platelet count <100,000/mm3
• Bleeding is the most common complication encountered during Integril therapy. 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 eptifibatide compared with placebo
• Arterial and venous punctures, intramuscular injections, and the use of urinary catheters, nasotracheal intubation, and nasogastric tubes should be minimized. When obtaining intravenous access, noncompressible sites (e.g., subclavian or jugular veins) should be avoided
• Before infusion of Integril, the following laboratory tests should be performed to identify preexisting 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.
Lactating Mothers: It is not known whether Integril is excreted in human milk. Because many drugs are excreted in human milk, caution should be exercised when Integril is administered to a nursing mother.
Use in Children:
Safety and effectiveness of Integril in pediatric patients have not been studied.
• Enoxaparin did not alter the pharmacokinetics of Integril
• From in vitro studies, eptifibatide is not extensively bound to plasma proteins and thus may be cleared from plasma by dialysis.
• Vials may be transferred to room temperature storage for up to 2 months.
• Unused portion left in the vial should be discarded.
• Vials should be protected from light until administration.
Integril 0.75 Injection: Each vial contains 100 ml of sterile solution.
Integril should be given concomitantly with aspirin and heparin. The recommended aspirin and heparin doses to be used are as follows:
Acute Coronary Syndrome: 160 to 325 mg orally daily thereafter
Percutaneous Coronary Intervention: 160 to 325 mg orally 1 to 24 hours prior to PCI and daily thereafter
Acute Coronary Syndrome:
During medical management: Target aPTT 50 to 70 seconds
• If weight ≥70 kg, 5000 U bolus followed by infusion of 1000 U/hr.
• If weight <70 kg, 60 U/kg bolus followed by infusion of 12 U/kg/hr.
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.
Percutaneous Coronary Intervention:
Target ACT 200 to 300 seconds
• 60 U/kg bolus initially in patients not treated with heparin within 6 hours prior to PCI.
• Additional boluses during PCI to maintain ACT within target. Heparin infusion after the PCI is strongly discouraged.
Patients requiring thrombolytic therapy should have Integril infusions stopped.
* Please see enclosed leaflet for Integril Dosing Charts by Weight.