Posology : מינונים

2     DOSAGE AND ADMINISTRATION
Before infusion of INTEGRILIN, 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.

2.1   Dosage in Acute Coronary Syndrome (ACS)

Indication      Normal Renal Function                    Creatinine Clearance less than 50 mL/min Patients with   180 mcg/kg intravenous (IV) bolus        180 mcg/kg IV bolus as soon as possible after ACS             as soon as possible after diagnosis, diagnosis, followed by continuous infusion of followed by continuous infusion of       1 mcg/kg/min
2 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

INTEGRILIN 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, 5000-unit bolus followed by infusion of 1000 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.


2.2   Dosage in Percutaneous Coronary Intervention (PCI)
Indication      Normal Renal Function                     Creatinine Clearance less than 50 mL/min 
Patients with    180 mcg/kg IV bolus immediately          180 mcg/kg IV bolus immediately before PCI PCI              before PCI followed by continuous        followed by continuous infusion of infusion of 2 mcg/kg/min and a           1 mcg/kg/min and a second bolus of second bolus of 180 mcg/kg (given        180 mcg/kg (given 10 minutes after the first 10 minutes after the first bolus)        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, INTEGRILIN 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

•   INTEGRILIN 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 INTEGRILIN.
2.3   Important Administration Instructions
1. Inspect INTEGRILIN for particulate matter and discoloration prior to administration, whenever solution and container permit.
2. May administer INTEGRILIN in the same intravenous line as alteplase, atropine, dobutamine, heparin,
lidocaine, meperidine, metoprolol, midazolam, morphine, nitroglycerin, or verapamil. Do not administer INTEGRILIN through the same intravenous line as furosemide.
3. May administer INTEGRILIN in the same IV line with 0.9% NaCl or 0.9% NaCl/5% dextrose. With either vehicle, the infusion may also contain up to 60 mEq/L of potassium chloride.
4. Withdraw the bolus dose(s) of INTEGRILIN from the 10-mL vial into a syringe. Administer the bolus dose(s) by IV push.
5. Immediately following the bolus dose administration, initiate a continuous infusion of INTEGRILIN. When using an intravenous infusion pump, administer INTEGRILIN 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.
6. Discard any unused portion left in the vial.

Administer INTEGRILIN by volume according to patient weight (see Table 1).

Table 1: INTEGRILIN Dosing Charts by Weight
Patient Weight           180-mcg/kg                     2-mcg/kg/min                   1-mcg/kg/min Bolus Volume                  Infusion Volume                Infusion Volume (CrCl greater than or equal to   (CrCl less than 50 mL/min)
50 mL/min)
(kg)       (lb)            (from                     (from 0.75-mg/mL               (from 0.75-mg/mL 2-mg/mL vial)                   100-mL vial)                   100-mL vial) 37-41     81-91             3.4 mL                        6 mL/h                          3 mL/h           42-46     92-102            4 mL                          7 mL/h                         3.5 mL/h
47-53    103-117            4.5 mL                        8 mL/h                          4 mL/h
54-59    118-130            5 mL                          9 mL/h                         4.5 mL/h 60-65    131-143            5.6 mL                        10 mL/h                         5 mL/h 66-71    144-157            6.2 mL                        11 mL/h                        5.5 mL/h 72-78    158-172            6.8 mL                        12 mL/h                         6 mL/h 79-84    173-185            7.3 mL                        13 mL/h                        6.5 mL/h 85-90    186-198            7.9 mL                        14 mL/h                         7 mL/h 91-96    199-212            8.5 mL                        15 mL/h                        7.5 mL/h 

97-103    213-227           9 mL                        16 mL/h                        8 mL/h 104-109   228-240          9.5 mL                       17 mL/h                        8.5 mL/h 110-115   241-253          10.2 mL                      18 mL/h                        9 mL/h 116-121   254-267          10.7 mL                      19 mL/h                        9.5 mL/h >121      >267            11.3 mL                      20 mL/h                        10 mL/h