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Eptifibatide is a brand name for Eptifibatide. The medicine, its uses, side effects and dosage are the same regardless of brand.
Used for: 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…
Verbatim from this product's FDA label. Tap a section to expand.
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.
V. bolus as soon as possible after diagnosis followed by infusion at 2 mcg/kg/min. 2) PCI: Add a second 180 mcg/kg bolus at 10 minutes. 2) In patients with creatinine clearance less than 50 mL/min, reduce the infusion to 1 mcg/kg/min.
V. 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, 5,000 units bolus followed by infusion of 1,000 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. V. V. 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 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.
1) ] Bleeding and hypotension are the most commonly reported adverse reactions. gov/medwatch . 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. Major bleeding consisted of intracranial hemorrhage and other bleeding that led to decreases in hemoglobin greater than 5 g/dL.
Minor bleeding included spontaneous gross hematuria, spontaneous hematemesis, other observed blood loss with a hemoglobin decrease of more than 3 g/dL, and other hemoglobin decreases that were greater than 4 g/dL but less than 5 g/dL.
In patients who received transfusions, the corresponding loss in hemoglobin was estimated through an adaptation of the method of Landefeld et al.
Table 2:
5 WARNINGS AND PRECAUTIONS 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. 1) Thrombocytopenia: Discontinue eptifibatide and heparin.
Monitor and treat condition appropriately. 1 Bleeding Bleeding is the most common complication encountered during eptifibatide therapy. 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. , 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 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.
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)
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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. 3 Important Administration Instructions Inspect eptifibatide injection for particulate matter and discoloration prior to administration, whenever solution and container permit.
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.
V. 9% NaCl/5% dextrose. With either vehicle, the infusion may also contain up to 60 mEq/L of potassium chloride. Withdraw the bolus dose(s) of eptifibatide injection from the 10 mL vial into a syringe. V. push. Immediately following the bolus dose administration, initiate a continuous infusion of eptifibatide.
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. Discard any unused portion left in the vial.
Administer eptifibatide injection by volume according to patient weight (see Table 1). 7 mL/h 10 mL/h
Bleeding and Transfusions in the PURSUIT and ESPRIT Studies Note: Denominator is based on patients for whom data are available. * For major and minor bleeding, patients are counted only once according to the most severe classification.
† Includes transfusions of whole blood, packed red blood cells, fresh frozen plasma, cryoprecipitate, platelets, and autotransfusion during the initial hospitalization. 8% in the placebo and eptifibatide groups, respectively). 4% of patients, respectively.
3%). Oropharyngeal (primarily gingival), genitourinary, gastrointestinal, and retroperitoneal bleeding were also seen more commonly in eptifibatide-treated patients compared to placebo-treated patients. 8%). Table 3 displays the incidence of TIMI major bleeding according to the cardiac procedures carried out in the PURSUIT study.
The most common bleeding complications were related to cardiac revascularization (CABG-related or femoral artery access site bleeding). A corresponding table for ESPRIT is not presented, as every patient underwent PCI in the ESPRIT study and only 11 patients underwent CABG.
Table 3:
Major Bleeding by Procedures in the PURSUIT Study Note: Denominators are based on the total number of patients whose TIMI classification was resolved. 6%) In the PURSUIT and ESPRIT studies, the risk of major bleeding with eptifibatide increased as patient weight decreased.
This relationship was most apparent for patients weighing less than 70 kg. 9% in IMPACT II). Intracranial Hemorrhage and Stroke Intracranial hemorrhage was rare in the PURSUIT, IMPACT II, and ESPRIT clinical studies. 3, and 5 patients in the group treated with eptifibatide 180/2 experienced a hemorrhagic stroke.
8% in placebo patients. 75, and 2 patients in the placebo group. 7% in the placebo group. In the ESPRIT study, there were 3 hemorrhagic strokes, 1 in the placebo group and 2 in the eptifibatide group. In addition there was 1 case of cerebral infarction in the eptifibatide group.
Immunogenicity/Thrombocytopenia The potential for development of antibodies to eptifibatide has been studied in 433 subjects. 75 mcg/kg/min) was administered twice, 28 days apart. In both cases, plasma for antibody detection was collected approximately 30 days after each dose.
The development of antibodies to eptifibatide at higher doses has not been evaluated. In patients with suspected eptifibatide-related immune-mediated thrombocytopenia, IgG antibodies that react with the GP IIb/IIIa complex were identified in the presence of eptifibatide and in eptifibatide-naïve patients.
These findings suggest acute thrombocytopenia after the administration of eptifibatide can develop as a result of naturally occurring drug-dependent antibodies or those induced by prior exposure to eptifibatide. Similar antibodies were identified with other GP IIb/IIIa ligand-mimetic agents.
Immune-mediated thrombocytopenia with eptifibatide may be associated with hypotension and/or other signs of hypersensitivity. In the PURSUIT and IMPACT II studies, the incidence of thrombocytopenia (<100,000/mm 3 or ≥50% reduction from baseline) and the incidence of platelet transfusions were similar between patients treated with eptifibatide and placebo.
2% in the eptifibatide group. Other Adverse Reactions In the PURSUIT and ESPRIT studies, the incidence of serious nonbleeding adverse reactions was similar in patients receiving placebo or eptifibatide (19% and 19%, respectively, in PURSUIT; 6% and 7%, respectively, in ESPRIT).
In PURSUIT, the only serious nonbleeding adverse reaction that occurred at a rate of at least 1% and was more common with eptifibatide than placebo (7% versus 6%) was hypotension. Most of the serious nonbleeding adverse reactions consisted of cardiovascular reactions typical of a UA population.
In the IMPACT II study, serious nonbleeding adverse reactions that occurred in greater than 1% of patients were uncommon and similar in incidence between placebo- and eptifibatide-treated patients. 5% of the study population (except for "other" in the ESPRIT study).
2 Postmarketing Experience The following adverse reactions have been reported in post-approval use of eptifibatide in combination with heparin and aspirin. Because the reactions below are reported voluntarily from a population of uncertain size, it is generally not possible to reliably estimate their frequency or establish a causal relationship to drug exposure: cerebral, GI, and pulmonary hemorrhage.
Fatal bleeding reactions have been reported. 1) ] .
If bleeding at access site cannot be controlled with pressure, infusion of eptifibatide and heparin should be discontinued immediately. 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). 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.