pharmacopeia
GET
/api/v1/drug/eptifibatide

Mechanism of action

Sourced from openFDA

Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor, and other adhesive ligands to GP IIb/IIIa. When administered intravenously, eptifibatide inhibits ex vivo platelet aggregation in a dose- and concentration-dependent manner.

Platelet Glycoprotein IIb/IIIA

Indications

Sourced from openFDA
  • Eptifibatide injection is a platelet aggregation inhibitor indicated for: Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) (1.1) Treatment of patients undergoing PCI (including intracoronary stenting) (1.2) 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) ] .ICD-10: I20.9, I21.9

Contraindications

Sourced from openFDA
  • Treatment with eptifibatide injection 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 injection or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria) Bleeding diathesis or bleeding within the previous 30 days (4) Severe uncontrolled hypertension (4) Major surgery within the preceding 6 weeks (4) Stroke within 30 days or any history of hemorrhagic stroke (4) Coadministration of another parenteral GP IIb/IIIa inhibitor (4) Dependency on renal dialysis (4) Known hypersensitivity to any component of the product (4)contraindicated

Dosage & administration

Sourced from openFDA

Before infusion of eptifibatide, 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. ACS or PCI: 180 mcg/kg I.V. bolus as soon as possible after diagnosis followed by infusion at 2 mcg/kg/min. (2.1 , 2.2) PCI: Add a second 180 mcg/kg bolus at 10 minutes. (2.2) In patients with creatinine clearance less than 50 mL/min, reduce the infusion to 1 mcg/kg/min. ( 2.1 , 2.2 , 2.3 ) 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 (I.V.) bolus as soon as possible after diagnosis, followed by continuous infusion of 2 mcg/kg/min 180 mcg/kg I.V.

Warnings & precautions

Sourced from openFDA

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) Thrombocytopenia: Discontinue eptifibatide and heparin. Monitor and treat condition appropriately. (5.2) 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 P2Y 12 inhibitors). Concomitant treatment with other inhibitors of platelet receptor glycoprotein (GP) IIb/IIIa should be avoided.

Adverse reactions

Sourced from openFDA

The following serious adverse reaction is also discussed elsewhere in the labeling: Bleeding [see Contraindications (4) and Warnings and Precautions (5.1) ] Bleeding and hypotension are the most commonly reported adverse reactions. (6.1) To report SUSPECTED ADVERSE REACTIONS, contact Eugia US LLC at 1-866-850-2876 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch . 6.1 Clinical Trials Experience Because clinical studies are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in clinical practice. A total of 16,782 patients were treated in the Phase III clinical trials (PURSUIT, ESPRIT, and IMPACT II) [see Clinical Studies (14) ] . These 16,782 patients had a mean age of 62 years (range: 20 to 94 years). Eighty-nine percent of the patients were Caucasian, with the remainder being predominantly Black (5%) and Hispanic (5%). Sixty-eight percent were men. Because of the different regimens used in PURSUIT, IMPACT II, and ESPRIT, data from the 3 studies were not pooled. Bleeding and hypotension were the most commonly reported adverse reactions (incidence ≥5% and greater than placebo) in the eptifibatide controlled clinical trial database. Bleeding The incidence of bleeding and transfusions in the PURSUIT and ESPRIT studies are shown in Table 2. Bleeding was classified as major or minor by the criteria of the TIMI study group.

Use in specific populations

Sourced from openFDA

Geriatric Use: Risk of bleeding increases with age. (8.5) 8.1 Pregnancy Risk Summary Available data on eptifibatide use in pregnant women from published literature and the pharmacovigilance database are insufficient to establish a drug-associated risk of major birth defects, miscarriage or adverse maternal or fetal outcomes. Untreated myocardial infarction can be fatal to the pregnant woman and fetus (see Clinical Considerations) . In animal reproduction studies, there was no evidence of adverse developmental effects when eptifibatide was administered intravenously to pregnant rats and rabbits at approximately 4 times the recommended maximum daily human dose. The estimated background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2 to 4% and 15 to 20%, respectively. Clinical Considerations Disease-associated maternal and/or embryo/fetal risk Myocardial infarction is a medical emergency in pregnancy which can be fatal to the pregnant woman and fetus if left untreated.

Pharmacokinetics

Sourced from openFDA
Metabolism
The pharmacokinetics of eptifibatide are linear and dose-proportional for bolus doses ranging from 90 to 250 mcg/kg and infusion rates from 0.5 to 3 mcg/kg/min. Plasma elimination half-life is approximately 2.5 hours.

Overdosage

Sourced from openFDA

There has been only limited experience with overdosage of eptifibatide. There were 8 patients in the IMPACT II study, 9 patients in the PURSUIT study, and no patients in the ESPRIT study who received bolus doses and/or infusion doses more than double those called for in the protocols. None of these patients experienced an intracranial bleed or other major bleeding. Eptifibatide was not lethal to rats, rabbits, or monkeys when administered by continuous intravenous infusion for 90 minutes at a total dose of 45 mg/kg (about 2 to 5 times the recommended maximum daily human dose on a body surface area basis). Symptoms of acute toxicity were loss of righting reflex, dyspnea, ptosis, and decreased muscle tone in rabbits and petechial hemorrhages in the femoral and abdominal areas of monkeys. From in vitro studies, eptifibatide is not extensively bound to plasma proteins and thus may be cleared from plasma by dialysis.

Approval history

Sourced from openFDA
  • Dec 8, 2015ANDAANDA206127Eugia Pharma
  • Mar 7, 2018ANDAANDA204693Sagent Pharms Inc
  • Jul 20, 2018ANDAANDA203258Mylan Labs Ltd
  • Nov 23, 2018ANDAANDA208554Baxter Hlthcare Corp
  • Jan 25, 2019ANDAANDA209864Slate Run Pharma
  • Sep 7, 2021ANDAANDA213081Shuangcheng
  • May 9, 2024ANDAANDA213599Meitheal

FAERS reports

View JSON
Reference statistics only. FAERS reports are voluntarily submitted and are not incidence rates, safety signals, or causal evidence. Counts reflect reporting volume — how often a reaction was reported, not how often it occurs. For decision-grade use, consult openFDA and the FAERS Public Dashboard directly.
752 total reports matchedLatest report Share = reports listing the reaction ÷ total matched reports. Rows can sum to >100% because a single report often lists multiple reactions.
  1. 1Myocardial Infarction20828%
  2. 2Thrombocytopenia648.5%
  3. 3Drug Ineffective496.5%
  4. 4Hypotension415.5%
  5. 5Haemoglobin Decreased374.9%
  6. 6Acute Myocardial Infarction334.4%
  7. 7Haemorrhage304.0%
  8. 8Cardiac Arrest293.9%
  9. 9Vascular Stent Thrombosis283.7%
  10. 10Haematoma263.5%
  11. 11Thrombosis In Device263.5%
  12. 12Drug Interaction233.1%
  13. 13Off Label Use233.1%
  14. 14Chest Pain222.9%
  15. 15Heparin-induced Thrombocytopenia202.7%

Literature

View JSON

Recent PubMed references pinned to Eptifibatide as a MeSH major topic. Citations link to pubmed.ncbi.nlm.nih.gov.

Clinical trials

View JSON

The 10 most recently updated of 35 ClinicalTrials.gov registrations naming Eptifibatide as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

Frequently asked questions

How does Eptifibatide work?
Eptifibatide reversibly inhibits platelet aggregation by preventing the binding of fibrinogen, von Willebrand factor, and other adhesive ligands to GP IIb/IIIa. When administered intravenously, eptifibatide inhibits ex vivo platelet aggregation in a dose- and concentration-dependent manner.
What is Eptifibatide used for?
According to FDA labeling, Eptifibatide carries indications including: Eptifibatide injection is a platelet aggregation inhibitor indicated for: Treatment of acute coronary syndrome (ACS) managed medically or with percutaneous coronary intervention (PCI) (1.1) Treatment of patients undergoing PCI (including intracoronary stenting) (1.2) 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) ] .. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.
What class of drug is Eptifibatide?
Eptifibatide is classified as Platelet aggregation inhibitors excl. heparin, Platelet Aggregation Inhibitor, Platelet Glycoprotein IIb/IIIA Inhibitors, Decreased Platelet Aggregation, Hematologic Activity Alteration, Increased Blood Pressure.
What are the contraindications for Eptifibatide?
Eptifibatide labeling lists contraindications including: Treatment with eptifibatide injection 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 injection or any component of the product (hypersensitivity reactions that occurred included anaphylaxis and urticaria) Bleeding diathesis or bleeding within the previous 30 days (4) Severe uncontrolled hypertension (4) Major surgery within the preceding 6 weeks (4) Stroke within 30 days or any history of hemorrhagic stroke (4) Coadministration of another parenteral GP IIb/IIIa inhibitor (4) Dependency on renal dialysis (4) Known hypersensitivity to any component of the product (4). Always consult the full prescribing information and a clinician.
Note. Data for eptifibatide is illustrative MVP content compiled from public sources. pharmacopeia is for educational and informational use only and is not a substitute for professional medical advice.

Search pharmacopeia

Search drugs, classes, and ingredients