Tenecteplase Paramedic Program PDF

Paramedic Programs Box 417 Lac La Biche, AB T0A 2C0 Generic Name: tenecteplase Trade Name: TNKase Classification: thrombolytic enzyme Supplied: 50 mg in 20 cc glass vial w/ 10 ml vial of sterile water for injection (SWFI) – **must be reconstituted Actions (Pharmacodynamics):  A modified form of hu...

Paramedic Programs Box 417 Lac La Biche, AB T0A 2C0 Generic Name: tenecteplase Trade Name: TNKase Classification: thrombolytic enzyme Supplied: 50 mg in 20 cc glass vial w/ 10 ml vial of sterile water for injection (SWFI) – **must be reconstituted Actions (Pharmacodynamics):  A modified form of human tissue plasminogen activator (tPA) that binds to fibrin and converts plasminogen to plasmin.  This fibrin specificity produces local fibrinolysis in the area of recent clot formation, with limited systemic proteolysis.  tenectaplase is administered as a single bolus with an initial half-life of 20-24 minutes, cleared through liver metabolism Indications:  ST elevation (threshold values: J-point elevation of 2 mm (men) or 1.5 mm (women) in leads V2 and V3 and 1 mm in all other leads) or new presumably new LBBB; in context of signs and symptoms of AMI and time of onset of signs and symptoms <12 hrs Dosage:    Once diluted with 10 ml NS TNKase™ concentration is 5 mg/ml Single bolus delivered over 5 seconds (not compatible with dextrose solutions) *** ½ amount of dose is administered to age 76 and older. Patient Weight (kg) < 60 > 60 to 69 > 70 to 79 > 80 to 89 > 90 TNKase™ (mg) 75 years or less 30 mg (6 ml) 35 mg (7 ml) 40 mg (8 ml) 45 mg (9 ml) 50 mg (10 ml) TNKase™ (mg) 75 years or older 15 mg (3 ml) 17.5 mg (3.5 ml) 20 mg (4 ml) 22.5 mg (4.5 ml) 25 mg (5 ml) Contraindications:  Any prior intracranial hemorrhage or intraspinal injury  Known structural cerebral vascular lesion or aneurysm (e.g., AVM)  Known malignant intracranial neoplasm (primary or metastatic)  Ischemic stroke within 3 months EXCEPT acute ischemic stroke within 3 hours  Suspected aortic dissection  Active internal/external bleeding or bleeding diathesis (excluding menses)  Significant closed head trauma or facial trauma within 3 months  Suspected aortic dissection or pericarditis Relative Contraindications:  Greater than 75 years of age (increased risk of ICP)  History of chronic, severe, poorly controlled hypertension or Severe uncontrolled hypertension on presentation (SBP > 180 mm Hg or DBP >110 mm Hg)  History of prior ischemic stroke > 3 months, dementia, or known intracranial pathology not covered in contraindications  CPR (greater than 10 mins)  major surgery, trauma, GI or GU bleeding (within 10 days)  Recent (within 2 to 4 weeks) internal bleeding  Non-compressible vascular punctures © Portage College Paramedic Program Page 1 of 3        Transient ischemic attack (TIA) within 6 months Pregnancy Active peptic ulcer Current use of anticoagulants (ex: Warfarin, Apixaban, Rivaroxaban, Dabigatran) (: the higher the INR, the higher the risk of bleeding Advanced liver disease Patients that have received streptokinase should not receive a second time. Prior allergic reaction to these agents Notes:  Standard management of AMI should be implemented concomitantly with and following the single bolus of tenectaplase.  Due to the urgency of administering thrombolytic therapy within a limited time period, rapid EMS response, assessment, recognition and transport are critical elements in the prehospital management of the patient.  Fibrinolytic therapy within 12 hours of symptom onset for ST elevation myocardial infarction (MI). Set UP: 1. 2. 3. 4. 5. 6. Remove the shield assembly from the supplied B-D™ 10ccc Syringe with TwinPak™ Dual Cannula Device (see figure) and aseptically withdraw 10 mL of Sterile Water for Injection (SWFI), USP from the supplied diluent vial using the red hub cannula syringe filling device. Do not use Bacteriostatic Water for Injection, USP. Note: Do not discard the shield assembly. Inject the entire contents of the syringe (10 mL) into the TNKase™ vial directing the diluent stream down the side of the vial. Slight foaming upon reconstitution is not unusual; any large bubbles will dissipate if the product is allowed to stand undisturbed for several minutes. Gently swirl until contents are completely dissolved. DO NOT SHAKE. The reconstituted preparation results in a colorless to pale yellow transparent solution containing TNKase™ at 5mg/mL at a pH of approximately 7.3. The osmolality of this solution is approximately 290 mOsm/kg. Determine the appropriate dose of TNKase™ (see Dose Information Table) and withdraw this volume (in milliliters) from the reconstituted vial with the syringe. Any unused solution should be discarded. Once the appropriate dose of TNKase™ is drawn into the syringe, stand the shield vertically on a flat surface (with green side down) and passively recap the red hub cannula. Remove the entire shield assembly, including the red hub cannula, by twisting counter0-clockwise. Note: The shield assembly also contains the clear-ended blunt plastic cannula; retain for split septum IV access. Administration: 1. The product should be visually inspected prior to administration for particulate matter and discoloration. TNKase™ may be administered as reconstituted at 5 mg/mL. 2. Precipitation may occur when TNKase™ is administered in an IV line containing dextrose. Dextrose-containing lines should be flushed with a saline-containing solution prior to and following single bolus administration of TNKase™. 3. Reconstituted TNKase™ should be administered as a single IV bolus over 5 seconds. 4. Because TNKase™ contains no antibacterial preservatives, it should be reconstituted immediately before use. If the reconstituted TNKase™ is not used immediately, refrigerate the TNKase™ vial at 2 – 8 degrees C and use within 8 hours. 5. Although the supplied syringe is compatible with a conventional needle, this syringe is designed to be used with needleless IV systems. From the information below, follow the instructions applicable to the IV system in use. 6. Dispose of the syringe, cannula and shield per established procedures. Split septum IV system  Remove the green cap  Attach the clear-ended blunt plastic cannula to the syringe.  Remove the shield and use the blunt plastic cannula to access the split septum injection port.  Because the blunt plastic cannula has two side ports, air or fluid expelled through the cannula will exit in two sideways directions; direct away from face or mucous membranes. Luer-Lok® system  Connect syringe directly to IV port. Conventional needle (not supplied in this kit)  Attach a large bore needle, e.g., 18 gauge, to the syringe’s universal Luer-Lok® © Portage College Paramedic Program Page 2 of 3 References: 1 (613, 623) 4 (1224-1226) 5 (457-458) 7 (VHR Guidelines 2022), 8 (150), 9 (342), 10 (41) Revised: May 2023 © Portage College Paramedic Program Page 3 of 3