eptifibatide
Pharmaranks rates Eptifibatide 3.3/5 for recall safety — an independent score from its FDA recall history and its manufacturer's record. Eptifibatide is a platelet aggregation inhibitor used to treat Unstable Angina, Coronary Disease, Myocardial Infarction.
Platelet Aggregation Inhibitor · by Mylan
Generic of Integrilin
Based on 1 source · Recall-safety score from FDA recall history — this product's own recalls and its manufacturer's record. Not an efficacy or quality rating. methodology →
Key facts
- Active ingredient
- Eptifibatide
- Drug class
- Platelet Aggregation Inhibitor
- Form
- Injectable, Solution
- Strength
- Eptifibatide 2MG/ML · Eptifibatide 75MG/100ML
- Type
- Prescription (Rx)
- Brand or generic
- Generic
- May treat
- unstable angina, coronary disease, myocardial infarction
- Manufacturer
- Mylan
- FDA application
- ANDA203258
What is Eptifibatide?
From the FDA label:Eptifibatide is a cyclic heptapeptide containing 6 amino acids and 1 mercaptopropionyl (des-amino cysteinyl) residue. An interchain disulfide bridge is formed between the cysteine amide and the mercaptopropionyl moieties. Chemically it is N 6 -(aminoiminomethyl)-N 2 -(3-mercapto-1-oxopropyl)-L‑lysylglycyl-L-α-aspartyl-L-tryptophyl-L-prolyl-L-cysteinamide, cyclic (1→6)-disulfide. Eptifibatide binds to the platelet receptor glycoprotein (GP) IIb/IIIa of human platelets and inhibits platelet aggregation. The eptifibatide peptide is produced by solution-phase peptide synthesis, and is purified by preparative reverse-phase liquid chromatography and lyophilized. The structural formula is: Eptifibatide Injection is a clear, colorless, sterile, non-pyrogenic solution for intravenous (IV) use with an empirical formula of C 35 H 49 N 11 O 9 S 2 a molecular weight of 832. Each 10 mL vial contains 2 mg/mL of eptifibatide injection and each 100 mL vial contains either 0.75 mg/mL of eptifibatide injection or 2 mg/mL of eptifibatide injection. Each vial of either size also contains 5.25 mg/mL citric acid and sodium hydroxide to adjust the pH to 5.35. Figure 1
How to use
Eptifibatide is sold in more than one form (Injectable and Solution), and each is dosed differently. The instructions below come from the FDA label for application ANDA203258 — follow the label that came with the product you were actually prescribed.
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. ACS or PCI: 180 mcg/kg IV 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 (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…
Side effects
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 Mylan at 1-877-446-3679 (1-877-4-INFO-RX) 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 (Platelet Glycoprotein IIb/IIIa in Unstable Angina: Receptor Suppression Using Eptifibatide Therapy (PURSUET), Enhanced Suppression of the Platelet IIb/IIIa Receptor with Eptifibatide Therapy (ESPRET), and Eptifibatide to Minimize Platelet Aggregation and Prevent Coronary Thrombosis II (EMPACT 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 PURSUET, EMPACT II, and ESPRET, data from…
Warnings
Important safety information
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. 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. 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/mm 3 , 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/mm 3 . If a patient with low platelet counts is receiving eptifibatide, their platelet count should be monitored closely.
Who should not take Eptifibatide
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) • 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 )
Overdose — what happens if you take too much
There has been only limited experience with overdosage of eptifibatide. There were 8 patients in the EMPACT II study, 9 patients in the PURSUET study, and no patients in the ESPRET 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.
U.S. Poison Control: call or text 1-800-222-1222 (free, 24/7). In an emergency call 911. From the FDA label; not medical advice.
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.
Drug class
May treat (source: NIH RxClass)
See how Eptifibatide ranks — best-rated platelet aggregation inhibitor for:
Dosage forms
Injectable and Solution
The forms currently marketed in the U.S., per the FDA National Drug Code Directory.
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Frequently asked questions
- What does Eptifibatide treat?
- Eptifibatide (Eptifibatide) may be used to treat unstable angina, coronary disease, myocardial infarction, based on NIH RxClass drug-classification data (conditions a drug may treat — not a verbatim copy of the FDA-approved label). This is general reference, not medical advice.
- How is Eptifibatide rated?
- pharmaranks gives Eptifibatide a composite score of 3.3 out of 5, currently based on 1 weighted source (FDA regulatory recall-safety data weighted highest). See our methodology at /how-we-rate.
- Is there a coupon or discount for Eptifibatide?
- pharmaranks is an independent ratings site, not a pharmacy — we don't issue coupons or sell Eptifibatide. To pay less, Eptifibatide is already a generic — usually the lowest-cost version — so the main levers are comparing cash prices between pharmacies and using a pharmacy discount-card service. Prices vary by pharmacy, insurance, and location, so always confirm at the counter. This is general reference, not medical or financial advice.
- Who makes Eptifibatide?
- Eptifibatide is marketed by Mylan. You can see Mylan's full profile, rating, and other products on pharmaranks.
- Is Eptifibatide a brand-name or generic drug?
- Eptifibatide is a generic medication; its active ingredient is Eptifibatide. Generics contain the same active ingredient as the brand-name original and are usually lower cost.
- Is Eptifibatide available over the counter?
- No. Eptifibatide is a prescription (Rx) medication in the US — you need a prescription from a licensed clinician (in person or via telehealth); it isn't sold over the counter. For some conditions there are OTC alternatives — ask your pharmacist.
- What forms does Eptifibatide come in?
- Eptifibatide is currently marketed as injectable and solution, per the FDA's National Drug Code Directory.
- What class of drug is Eptifibatide?
- Eptifibatide is classified as platelet aggregation inhibitor, per the FDA's Established Pharmacologic Class.
- Is Eptifibatide FDA-registered?
- Eptifibatide is on record with the U.S. FDA under application number ANDA203258. You can verify this on its official FDA label.
- Has Eptifibatide been recalled by the FDA?
- Eptifibatide has no FDA recalls recorded under its own application in the openFDA enforcement database. Its recall-safety score reflects its manufacturer's overall recall record. This is general reference, not medical advice — check the FDA recall database for the latest alerts.
- Is Eptifibatide safe?
- There's no single safe-or-not verdict. pharmaranks gives Eptifibatide a recall-safety score of 66/100, based on its FDA recall history (no recalls under its own FDA application) — not an efficacy or side-effect rating. Review its FDA-label side effects and warnings before use, and always consult a licensed professional.
- What are the side effects of Eptifibatide?
- Eptifibatide's side effects are taken directly from its FDA label. From the label: 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,… Both common and serious reactions are documented in full on this page. This is general reference from the FDA, not medical advice — always consult a professional.
Clinical content sourced from the FDA label via openFDA (U.S. FDA). View the FDA label on DailyMed → Provided for general reference only — not medical advice. Always consult a licensed professional and the current prescribing information.
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eptifibatide
66/100