Eptifibatide 2 mg/mL
eptifibatide · INJECTION, SOLUTION · Mylan Institutional LLC
Eptifibatide is a injection, solution containing eptifibatide at 2 mg/mL, taken intravenous. Manufactured by Mylan Institutional LLC.
Key Facts
- Brand Name
- Eptifibatide
- Generic Name
- eptifibatide
- NDC Code (Product)
72078-025- Manufacturer
- Mylan Institutional LLC
- Strength
- 2 mg/mL
- Dosage Form
- INJECTION, SOLUTION
- Route
- INTRAVENOUS
- Marketing Status
- Application #
- ANDA203258
- Drug Class
- Platelet Aggregation Inhibitor [EPC]
- Marketing Start
- 04/01/2021
Recall History
Slate Run Pharmaceuticals
Labeling: Not Elsewhere Classified. The carton for Eptifibatide Injection 75 mg/100 mL states 75 mg/100 mL vial for weight-adjusted bolus dosing. The approved statement is 75 mg/100 mL vial for weight-adjusted infusion.
Teva North America
CGMP Deviations
Akorn, Inc.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Akorn, Inc.
Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Eugia US LLC
Failed Impurities/Degradation Specifications: failed related substance identified as Eptifibatide dimer.
Akorn, Inc.
Short Fill: fill volume was out of specification at 94 mL (specification: no less than 100 mL) and Failed Impurities/Degradation Specifications: Out of Specification (OOS) for known impurity, D-aspartic acid.
Side Effects Reported to FDA
FDA FAERS database · These are reported events, not confirmed side effects
Full Prescribing Information
Indications & Usage
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) (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) ] .
Dosage & Administration
2 DOSAGE AND ADMINISTRATION 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. bolus as soon as possible after diagnosis, followed by continuous infusion of 1 mcg/…
Contraindications
4 CONTRAINDICATIONS 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)
Drug Interactions
7 DRUG INTERACTIONS Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. Avoid concomitant use with other glycoprotein (GP) IIb/IIIa inhibitors. (7.1) 7.1 Use of Thrombolytics, Anticoagulants, and Other Antiplatelet Agents Coadministration of antiplatelet agents, thrombolytics, heparin, aspirin, and chronic NSAID use increases the risk of bleeding. Concomitant treatment with other inhibitors of platelet receptor GP IIb/IIIa should be avoided.
Adverse Reactions
6 ADVERSE REACTIONS 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 …
Frequently Asked Questions
What is Eptifibatide used for?
Eptifibatide contains eptifibatide. It is a injection, solution taken intravenous. Consult your doctor for specific uses.
Is Eptifibatide a controlled substance?
Eptifibatide is not classified as a controlled substance by the DEA.
What is the generic name for Eptifibatide?
The generic name for Eptifibatide is eptifibatide. There are 1 other brand versions of eptifibatide.
What is the NDC code for Eptifibatide 2 mg/mL?
The NDC (National Drug Code) for Eptifibatide 2 mg/mL is 72078-025, listed by Mylan Institutional LLC.