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Integrilin

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Integrilin

Indications
Dosage
How Supplied

INDICATIONS

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).

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].

DOSAGE AND ADMINISTRATION

Before infusion of INTEGRILIN, 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.

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.

Dosage in Acute Coronary Syndrome (ACS)

Indication Normal Renal Function Creatinine Clearance < 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.
Dosage in Percutaneous Coronary Intervention (PCI)

Indication Normal Renal Function Creatinine Clearance <50 mL/min
Patients with PCI 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 2 mcg/kg/min and a second bolus of 180 mcg/kg (given 10 minutes after the first bolus) 180 mcg/kg IV bolus immediately before PCI followed by continuous infusion of 1 mcg/kg/min and a second bolus of 180 mcg/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.
  • Aspirin, 160 to 325 mg, should be given 1 to 24 hours prior to PCI and daily thereafter

  • INTEGRILIN should be given concomitantly with heparin to achieve a target ACT of 200 to 300 seconds. Administer 60-units/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 discontinue INTEGRILIN.

Important Administration Instructions

  1. Inspect INTEGRILIN for particulate matter and discoloration prior to administration, whenever solution and container permit.
  2. May administer INTEGRILIN in the same intravenous line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Do not administer INTEGRILIN through the same intravenous line as furosemide.
  3. May administer INTEGRILIN 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.
  4. Withdraw the bolus dose(s) of INTEGRILIN from the 10-mL vial into a syringe. Administer the bolus dose(s) by IV push.
  5. Immediately following the bolus dose administration, initiate a continuous infusion of INTEGRILIN. When using an intravenous infusion pump, administer INTEGRILIN undiluted directly from the 100-mL vial. Spike the 100-mL vial with a vented infusion set. Center the spike within the circle on the stopper top.
  6. Discard any unused portion left in the vial.

Administer INTEGRILIN by volume according to patient weight (see Table 1).

Table 1: INTEGRILIN Dosing Charts by Weight

Patient Weight 180-mcg/kg Bolus Volume 2-mcg/kg/min Infusion Volume (CrCl ≥ 50 mL/min) 1-mcg/kg/min Infusion Volume (CrCl < 50 mL/min)
(kg) (lb) (from 2-mg/mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial) (from 2-mg/mL 100-mL vial) (from 0.75-mg/mL 100-mL vial)
37-41 81-91 3.4 mL 2 mL/h 6 mL/h 1 mL/h 3 mL/h
42-46 92-102 4 mL 2.5 mL/h 7 mL/h 1.3 mL/h 3.5 mL/h
47-53 103-117 4.5 mL 3 mL/h 8 mL/h 1.5 mL/h 4 mL/h
54-59 118-130 5 mL 3.5 mL/h 9 mL/h 1.8 mL/h 4.5 mL/h
60-65 131-143 5.6 mL 3.8 mL/h 10 mL/h 1.9 mL/h 5 mL/h
66-71 144-157 6.2 mL 4 mL/h 11 mL/h 2 mL/h 5.5 mL/h
72-78 158-172 6.8 mL 4.5 mL/h 12 mL/h 2.3 mL/h 6 mL/h
79-84 173-185 7.3 mL 5 mL/h 13 mL/h 2.5 mL/h 6.5 mL/h
85-90 186-198 7.9 mL 5.3 mL/h 14 mL/h 2.7 mL/h 7 mL/h
91-96 199-212 8.5 mL 5.6 mL/h 15 mL/h 2.8 mL/h 7.5 mL/h
97-103 213-227 9 mL 6 mL/h 16 mL/h 3.0 mL/h 8 mL/h
104-109 228-240 9.5 mL 6.4 mL/h 17 mL/h 3.2 mL/h 8.5 mL/h
110-115 241-253 10.2 mL 6.8 mL/h 18 mL/h 3.4 mL/h 9 mL/h
116-121 254-267 10.7 mL 7 mL/h 19 mL/h 3.5 mL/h 9.5 mL/h
> 121 > 267 11.3 mL 7.5 mL/h 20 mL/h 3.7 mL/h 10 mL/h

HOW SUPPLIED

Dosage Forms And Strengths

  • Injection: 20 mg of INTEGRILIN in 10 mL (2 mg/mL), for intravenous bolus
  • Injection: 75 mg of INTEGRILIN in 100 mL (0.75 mg/mL), for intravenous infusion.
  • Injection: 200 mg of INTEGRILIN in 100 mL (2 mg/mL), for intravenous infusion.

Storage And Handling

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

Storage

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).

* Store at 25°C (77°F); excursions permitted to 15-30°C (59-86°F) [see USP Controlled Room Temperature].

Manufactured by: Patheon Italia S.p.A, Ferentino, 03013, Italy. Revised: March 2013

Last reviewed on RxList: 4/4/2013
This monograph has been modified to include the generic and brand name in many instances.

Indications
Dosage
How Supplied
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