Eptifibatide

Eptifibatide injection is a platelet aggregation inhibitor indicated for:

• •Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) (
  1 INDICATIONS AND USAGE

  Eptifibatide injection is a platelet aggregation inhibitor indicated for:

  • •Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI)
  • •Treatment of patients undergoing PCI (including intracoronary stenting)

  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)]

  .
  )
• •Treatment of patients undergoing PCI (including intracoronary stenting) (
  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)]

  .
  )

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.

• •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.
• •Injection: 200 mg of eptifibatide in 100 mL (2 mg/mL), for intravenous infusion.

• •
  Geriatric Use:
  Risk of bleeding increases with age. (
  8.5 Geriatric Use

  The PURSUET and EMPACT II clinical studies enrolled patients up to the age of 94 years (45% were age 65 and over; 12% were age 75 and older). There was no apparent difference in efficacy between older and younger patients treated with eptifibatide. The incidence of bleeding complications was higher in the elderly in both placebo and eptifibatide groups, and the incremental risk of eptifibatide-associated bleeding was greater in the older patients. No dose adjustment was made for elderly patients, but patients over 75 years of age had to weigh at least 50 kg to be enrolled in the PURSUET study; no such limitation was stipulated in the ESPRET study

  [see Adverse Reactions (6.1)].
  )

• •Eptifibatide can cause serious bleeding. If bleeding cannot be controlled, discontinue eptifibatide immediately. Minimize vascular and other traumas. If heparin is given concomitantly, monitor aPTT or ACT. (
  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 P2Y₁₂inhibitors). Concomitant treatment with other inhibitors of platelet receptor glycoprotein (GP) IIb/IIIa should be avoided. In patient 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.
  )
• •Thrombocytopenia: Discontinue eptifibatide and heparin. Monitor and treat condition appropriately. (
  5.2 Thrombocytopenia

  There have been reports of acute, profound thrombocytopenia (immune-mediated and non-immune mediated) with eptifibatide. In the event of acute profound thrombocytopenia or a confirmed platelet decrease to <100,000/mm³, discontinue eptifibatide and heparin (unfractionated or low-molecular weight). Monitor serial platelet counts, assess the presence of drug-dependent antibodies, and treat as appropriate

  [see Adverse Reactions (6.1)]

  .

  There has been no clinical experience with eptifibatide initiated in patients with a baseline platelet count <100,000/mm³. If a patient with low platelet counts is receiving eptifibatide, their platelet count should be monitored closely.
  )