NURSING DEPARTMENT CRITICAL CARE POLICY MANUAL CRITICAL CARE S EPTIFIBATIDE (INTEGRILIN) I. PURPOSE: A. Integrilin (Eptifibatide) is a specific and potent inhibitor of the platelet receptor glycoprotein IIb-IIIa, preventing binding of fibrinogen to GP IIb-IIIa, thus helping to prevent platelet aggregation. B. Integrilin (Eptifibatide) is indicated for the treatment of patients with acute coronary syndrome (unstable angina, non Q MI), including patients who are to be managed medically and those undergoing percutaneous coronary intervention (PCI). II. PATIENT SELECTION: The patient must meet some or all of the following criteria: A. Chest pain at rest (> 10 minutes duration) within the previous 24 hours. B. ECG abnormalities within 12 hours, defined as: ST segment depression > 0.5 mm, or T wave inversion > 1 mm, or ST segment elevation between 0.6 mm and 1 mm, or Positive CK-MB assay, or Positive Troponin T or I C. Percutaneous coronary intervention is planned within 48-72 hours (angioplasty, atherectomy, stent placement). Date of Original: 4/99 Reviewed Revised 12/01 3/08 3/08 3/09 3/09 9/11 9/11 9/13 7-9-14 7-9-14 10/14 10/15 10/16 6/17 7
PAGE 2 III. CONTRAINDICATIONS: Because Integrilin (Eptifibatide) increases the risk of bleeding, it is contraindicated in the following situations: A. A history of bleeding diathesis, or evidence of active abnormal bleeding within the previous 30 days. B. Severe hypertension (systolic blood pressure > 200mmHg or diastolic blood pressure > 110mmHg) not adequately controlled on antihypertensive therapy. C. Major surgery within preceding 6 weeks. D. History of stroke within 30 days, or any history of hemorrhagic stroke. E. Current or planned administration of another parenteral GP IIb-IIIa inhibitor. F. Platelet count < 100,000/mm3. G. Serum creatinine > 2 mg/dl (for the 180 mcg/kg bolus and the 2 mcg/kg/min infusion) or > 4mg/dL (for the 135 mcg/kg bolus and the 0.5 mcg/kg/min infusion). H. Dependency on renal dialysis. I. Known hypersensitivity to any component of the product. 7a EPTIFIBATICLE (INTEGRILLIN)
PAGE 3 IV. SPECIAL CONSIDERATIONS: A. At least two primary, preferably three, I.V. infusion lines, or per M.D. order, will be established prior to dosing with Integrilin (Eptifibatide) minimize venipunctures. B. Bleeding is the most common complication encountered during Integrilin (Eptifibatide) therapy. If bleeding cannot be controlled with pressure, infusion of etifibatide and concomitant heparin should be discontinued.. C. Arterial and venous punctures, IM injections, and the use of urinary catheters, nasotracheal intubation, and nasogastric tubes should be minimized. When obtaining I.V. access, noncompressible sites (e.g., subclavian or jugular veins) should be avoided. D. Before infusion of Integrilin eptifibatide, the following lab tests should be performed to identify pre-existing hemostatic abnormalities: hemoglobin and hematocrit, platelet count, serum creatinine, and PT/PTT. Lab testing to be order by physician. E. The PTT should be maintained between 50 and 70 seconds unless PCI is to be performed. During PCI, the ACT should be maintained between 300-350 seconds. F. The PTT should be checked prior to arterial sheath removal. The sheath should not be removed unless the PTT is < 45 seconds. 7b
PAGE 4 G. In patients treated with heparin, bleeding can be minimized by close monitoring of the PTT. H. If the patient experiences a confirmed platelet decrease to < 100,000mm3, eptifibatide and heparin should be discontinued and the condition appropriately monitored and treated. I. In clinical studies, patients were enrolled up to 94 years of age, with no apparent difference in efficacy between the older and younger patients treated with eptifibatide. The incidence of bleeding complications was higher in the elderly patients, with the incremental risk of eptifibatideassociated bleeding greater in the older patients. J. Use toothettes for oral care. V. PROCEDURE: A. The patient and/or patient s family should be well informed by the physician of the risk of potential bleeding complications with the administration of Integrilin (Eptifibatide). B. After orders have been received from the cardiologist for the administration of Integrilin (Eptifibatide), all labs, per physician orders, should be drawn and lines placed prior to dosing the patient. C. Continue therapy with Heparin and aspirin as ordered by the physician during administration of Integrilin (Eptifibatide). Follow the IV Heparin protocol for PTT parameters/times to maintain target PTT between 50 and 70 seconds. 7c
PAGE 5 VI. DOSAGE AND ADMINISTRATION: A. The recommended adult dosage of eptifibatide in patients with acute coronary syndrome is an IV bolus of 180 mcg/kg as soon as possible following diagnosis, followed by a continuous infusion of 2 mcg/kg/min until hospital discharge or initiation of CABG surgery, up to 72 hours. B. If a patient is to undergo PCI while receiving eptifibatide, consideration can be given to decreasing the infusion rate to 0.5 mcg/kg/min at the time of the procedure. C. In patients not presenting with acute coronary syndrome, and undergoing PCI, the recommended adult dosage of eptifibatide is an IV bolus of 135 mcg/kg, administered immediately before the initiation of PCI, followed by a continuous infusion of 0.5 mcg/kg/min for 20-24 hours. D. Instructions for administration: 1. Integrilin (eptifibatide) solution should be inspected visually for particulate matter and discoloration prior to administration. 2. Integrilin may be administered in the same IV line as alteplase, atropine, dobutamine, heparin, lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. It should not be administered through the same IV line as furosemide. 3. Integrilin (eptifibatide) may be administered in the same IV line with 0.9% NaCl or 0.9% NaCl 5% dextrose. The infusion may also contain up to 40mEq/L of potassium chloride. 4. The bolus dose of Integrilin (eptifibatide) should be withdrawn from the 10-ml vial into a syringe, and administered IV push over 1-2 minutes. Each 10-ml vial contains 20mg eptifibatide in sterile solution. 7d
PAGE 6 5. Immediately following the bolus dose administration, a continuous infusion of Integrilin (eptifibatide) should be initiated. When using an IV infusion pump, Integrilin (eptifibatide) should be administered undiluted directly from the 100-ml vial. This vial should be spiked with a vented infusion set, with care taken to center the spike within the circle on the stopper top. Each 100-ml vial contains 75 mg eptifibatide in sterile solution. 6. Integrilin (eptifibatide) is to be administered by volume according to patient weight. 7. Integrilin (eptifibatide) vials should be refrigerated at 36-46 degrees F. 8. The physician will determine and order the bolus and infusion rate of his/her choice. 7e
INTEGRILIN (EPTIFIBATIDE) DOSING CHART FOR PATIENTS WITH ACUTE CORONARY SYNDROME (180 mcg/kg Bolus and 2 mcg/kg/min Infusion) Patient Bolus Infusion Weight Volume Rate (kg) (2 mg/ml) (0.75 mg/ml) 37-41 3.4ml 6ml/hr 42-46 4 7 47-53 4.5 8 54-59 5 9 60-65 5.6 10 66-71 6.2 11 72-78 6.8 12 79-84 7.3 13 85-90 7.9 14 91-96 8.5 15 97-103 9 16 104-109 9.5 17 109-115 10.2 18 116-121 10.7 19 >121 11.3 20 INTEGRILIN (EPTIFIBATIDE) DOSING CHART BY WEIGHT FOR PATIENTS WITHOUT ACUTE CORONARY SYNDROMES UNDERGOING PCI (135 mcg/kg Bolus and 0.5 mcg/kg/min Infusion) Patient Bolus Infusion Weight Volume Rate (kg) (2 mg/ml) (0.75 mg/ml) 40-55 3.4ml 2 ml/hr 56-68 4.2 2.5 69-80 5.1 3 81-93 5.9 3.5 94-105 6.8 4 106-118 7.6 4.5 119-131 8.4 5 132-143 9.2 5.5 7g