Eptifibatide: Package Insert and Label Information

EPTIFIBATIDE- eptifibatide injection
Slate Run Pharmaceuticals, LLC

1 INDICATIONS AND USAGE

1.1 Acute Coronary Syndrome (ACS)

Eptifibatide injection 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)

Eptifibatide injection 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 eptifibatide injection, 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 <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.

Eptifibatide injection 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.

2.2 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, eptifibatide 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
  • Eptifibatide injection 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 eptifibatide injection.

2.3 Important Administration Instructions

  1. Inspect eptifibatide injection for particulate matter and discoloration prior to administration, whenever solution and container permit.
  2. May administer eptifibatide injection in the same intravenous line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Do not administer eptifibatide injection through the same intravenous line as furosemide.
  3. May administer eptifibatide injection 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 eptifibatide injection 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 eptifibatide injection. When using an intravenous infusion pump, administer eptifibatide injection 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 eptifibatide injection by volume according to patient weight (see Table 1).

Table 1. Eptifibatide Injection 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

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