Eptifibatide: Package Insert and Label Information

EPTIFIBATIDE- eptifibatide injection
Amneal 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 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

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 less than 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 injection 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 greater than or equal to 50 mL/min) 1-mcg/kg/min Infusion Volume (CrCl less than 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 to 41 81 to 91 3.4 mL 2 mL/h 6 mL/h 1 mL/h 3 mL/h
42 to 46 92 to 102 4 mL 2.5 mL/h 7 mL/h 1.3 mL/h 3.5 mL/h
47 to 53 103 to 117 4.5 mL 3 mL/h 8 mL/h 1.5 mL/h 4 mL/h
54 to 59 118 to 130 5 mL 3.5 mL/h 9 mL/h 1.8 mL/h 4.5 mL/h
60 to 65 131 to 143 5.6 mL 3.8 mL/h 10 mL/h 1.9 mL/h 5 mL/h
66 to 71 144 to 157 6.2 mL 4 mL/h 11 mL/h 2 mL/h 5.5 mL/h
72 to 78 158 to 172 6.8 mL 4.5 mL/h 12 mL/h 2.3 mL/h 6 mL/h
79 to 84 173 to 185 7.3 mL 5 mL/h 13 mL/h 2.5 mL/h 6.5 mL/h
85 to 90 186 to 198 7.9 mL 5.3 mL/h 14 mL/h 2.7 mL/h 7 mL/h
91 to 96 199 to 212 8.5 mL 5.6 mL/h 15 mL/h 2.8 mL/h 7.5 mL/h
97 to 103 213 to 227 9 mL 6 mL/h 16 mL/h 3 mL/h 8 mL/h
104 to 109 228 to 240 9.5 mL 6.4 mL/h 17 mL/h 3.2 mL/h 8.5 mL/h
110 to 115 241 to 253 10.2 mL 6.8 mL/h 18 mL/h 3.4 mL/h 9 mL/h
116 to 121 254 to 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

3 DOSAGE FORMS AND STRENGTHS

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

4 CONTRAINDICATIONS

Treatment with eptifibatide is contraindicated in patients with:

  • A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days
  • Severe hypertension (systolic blood pressure > 200 mm Hg or diastolic blood pressure > 110 mm Hg) not adequately controlled on antihypertensive therapy
  • Major surgery within the preceding 6 weeks
  • History of stroke within 30 days or any history of hemorrhagic stroke
  • Current or planned administration of another parenteral GP IIb/IIIa inhibitor
  • Dependency on renal dialysis
  • Hypersensitivity to eptifibatide or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria)

5 WARNINGS AND PRECAUTIONS

5.1 Bleeding

Bleeding is the most common complication encountered during eptifibatide therapy. Administration of eptifibatide is associated with an increase in major and minor bleeding, as classified by the criteria of the Thrombolysis in Myocardial Infarction Study group (TIMI) [see Adverse Reactions (6.1)]. Most major bleeding associated with eptifibatide has been at the arterial access site for cardiac catheterization or from the gastrointestinal or genitourinary tract. Minimize the use of arterial and venous punctures, intramuscular injections and the use of urinary catheters, nasotracheal intubation and nasogastric tubes. When obtaining intravenous access, avoid non-compressible sites (e.g., subclavian or jugular veins).

Use of Thrombolytics, Anticoagulants and Other Antiplatelet Agents

Risk factors for bleeding include older age, a history of bleeding disorders and concomitant use of drugs that increase the risk of bleeding (thrombolytics, oral anticoagulants, nonsteroidal anti-inflammatory drugs and P2Y12 inhibitors). Concomitant treatment with other inhibitors of platelet receptor glycoprotein (GP) IIb/IIIa should be avoided. In patients treated with heparin, bleeding can be minimized by close monitoring of the aPTT and ACT [see Dosage and Administration (2)].

Care of the Femoral Artery Access Site in Patients Undergoing Percutaneous Coronary Intervention (PCI)

In patients undergoing PCI, treatment with eptifibatide is associated with an increase in major and minor bleeding at the site of arterial sheath placement. After PCI, eptifibatide infusion should be continued until hospital discharge or up to 18 to 24 hours, whichever comes first. Heparin use is discouraged after the PCI procedure. Early sheath removal is encouraged while eptifibatide is being infused. Prior to removing the sheath, it is recommended that heparin be discontinued for 3 to 4 hours and an aPTT of < 45 seconds or ACT <150 seconds be achieved. In any case, both heparin and eptifibatide should be discontinued and sheath hemostasis should be achieved at least 2 to 4 hours before hospital discharge. If bleeding at access site cannot be controlled with pressure, infusion of eptifibatide and heparin should be discontinued immediately.

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