INTEGRILIN is indicated:

• For the treatment of patients with acute coronary syndrome (UA/NQMI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death or new myocardial infarction.
• For the treatment of patients undergoing PCI. In this setting, INTEGRILIN has been shown to decrease the rate of a combined endpoint of death, new myocardial infarction, or need for urgent intervention.

In the IMPACT II, PURSUIT and ESPRIT studies of eptifibatide, most patients received heparin and aspirin, as described in CLINICAL STUDIES.

The safety and efficacy of eptifibatide has been established in clinical studies that employed concomitant use of heparin and aspirin. Different dose regimens of eptifibatide were used in the major clinical studies. (See CLINICAL STUDIES)

Acute Coronary Syndrome.

The recommended adult dosage of eptifibatide in patients with acute coronary syndrome and normal renal function is an intravenous bolus of 180 µg/kg as soon as possible following diagnosis, followed by a continuous infusion of 2.0 µg/kg/min until hospital discharge or initiation of CABG surgery, up to 72 hours. If a patient is to undergo a percutaneous coronary intervention (PCI) while receiving eptifibatide, the infusion should be continued up to hospital discharge, or for up to 18-24 hours after the procedure, whichever comes first, allowing for up to 96 hours of therapy.

The recommended adult dosage of eptifibatide in patients with acute coronary syndrome with an estimated creatinine clearance (using the Cockroft-Gault equation) * < 50 mL/min or, if creatinine clearance is not available, a serum creatinine > 2.0 mg/dL, is an intravenous bolus of 180 µg/kg as soon as possible following diagnosis, immediately followed by a continuous infusion of 1.0 µg/kg-min.

Percutaneous Coronary Intervention (PCI)

The recommended adult dosage of eptifibatide in patients with normal renal function is an intravenous bolus of 180 µg/kg administered immediately before the initiation of PCI followed by a continuous infusion of 2.0 µg/kg/min and a second 180 µg/kg bolus 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.

The recommended adult dose of eptifibatide in patients with an estimated clearance (using the Cockroft-Gault equation) * <50 mL/min or, if creatinine clearance is not available, a serum creatinine >2.0 mg/dL, is an intravenous bolus of 180 µg/kg administered immediately before the initiation of the procedure, immediately followed by a continuous infusion of 1.0 µg/kg-min and a second 180 µg/kg bolus administered 10 minutes after the first.

In patients who undergo coronary artery bypass graft surgery, eptifibatide infusion should be discontinued prior to surgery.

Aspirin and Heparin Dosing Recommendations

In the clinical trials that showed eptifibatide to be effective, most patients received concomitant aspirin and heparin. The recommended aspirin and heparin doses to be used are as follows:

Acute Coronary Syndrome

Aspirin:
160-325 mg po initially and daily thereafter

Heparin:
Target aPTT 50-70 seconds during medical management

• 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

Target ACT 200-300 seconds during PCI

• If heparin is initiated prior to PCI, additional boluses during PCI to maintain an ACT target of 200-300 seconds.
• Heparin infusion after the PCI is discouraged.

PCI

Aspirin:
160-325 mg po 1-24 hours prior to PCI and daily thereafter

Heparin:
Target ACT 200-300 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 eptifibatide infusions stopped.

Instructions for Administration

1. Like other parenteral drug products, INTEGRILIN solutions should be inspected visually for particulate matter and discoloration prior to administration, whenever solution and container permit.
2. INTEGRILIN may be administered in the same intravenous line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. INTEGRILIN should not be administered through the same intravenous line as furosemide.
3. INTEGRILIN 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 potassium chloride. No incompatibilities have been observed with intravenous administration sets. No compatibility studies have been performed with PVC bags.
4. The bolus dose of INTEGRILIN should be withdrawn from the 10-mL vial into a syringe. The bolus dose should be administered by IV push over 1-2 minutes.
5. Immediately following the bolus dose administration, a continuous infusion of INTEGRILIN should be initiated. When using an intravenous infusion pump, INTEGRILIN 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.

INTEGRILIN is to be administered by volume according to patient weight. Patients should receive study drug according to the following table:

INTEGRILIN (eptifibatide) Injection is supplied as a sterile solution in 10-mL vials containing 20 mg of eptifibatide (NDC 0085-1177-01) and 100-mL vials containing either 75 mg of eptifibatide (NDC 0085-1136-01) or 200 mg of eptifibatide (NDC 0085-1177-02).

Vials should be stored refrigerated at 2-8^°C (36-46^°F). Vials may be transferred to room temperature storage * for a period not to exceed 2 months. Upon transfer, vial cartons must be marked by the dispensing pharmacist with a "DISCARD BY" date (2 months from the transfer date or the labeled expiration date, whichever comes first).

Do not use beyond the labeled expiration date. Protect from light until administration. Discard any unused portion left in the vial.

Do not use beyond the labeled expiration date. Protect from light until administration. Discard any unused portion left in the vial.

* USP controlled Room Temperature: 25^°C (77^°F) with excursions permitted between 15-30^°C (59-86^°F).

Rx only.

INTEGRILIN is a registered trademark of Millennium Pharmaceuticals, Inc.

Marketed By:
Millennium Pharmaceuticals, Inc.
Cambridge, MA 02139
and
Schering Corporation
Kenilworth, NJ 07033
Distributed By:
Schering Corporation
Kenilworth, NJ 07033

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