Wentworth Area Health Service

TENECTEPLASE (Metalyse) Protocol

TENECTEPLASE (Metalyse) Protocol

Indication: Thrombolytic treatment of acute myocardial infarction (within 12 hours of symptom onset) Dosage: Based on body weight. One dose only. Maximum = 10,000 IU (50mg) Body weight (kg) <60kg 60 - 69 kg 70 - 79 kg 80 89 kg 90 kg
Note: 1000 IU = 5mg

Tenecteplase (IU) 6000 7000 8000 9000 10 000

Dose (mg) 30 35 40 45 50

Volume of reconstituted solution (mL) 6 7 8 9 10

Route: IV bolus injection Dilution: Reconstitute with complete volume of pre-filled WFI using vial OR needle. Using vial: Screw pre-filled syringe to the vial adapter. Use the spike on the vial adapter to penetrate the vial stopper. Push syringe down SLOWLY. (See pictogram inside box) Using needle: Push the syringe plunger down SLOWLY to avoid foaming. SWIRL GENTLY. DO NOT SHAKE. Invert vial with syringe attached, transfer appropriate volume of reconstituted solution (5mg/mL) into syringe. Colourless/pale yellow CLEAR solution must be obtained. Compatibility: 0.9% sodium chloride. Incompatibility: Glucose (dextrose) solution. Do not mix with other drugs. Administration: IV bolus over 5 - 10 seconds Presentation: Vials (powder for reconstitution) 40 mg (8,000 IU) (plus 8 mL WFI prefilled syringe, vial adapter and needle for reconstitution) 50 mg (10,000 IU) (plus 10 mL WFI prefilled syringe, vial adapter and needle for reconstitution) Reconstituted solution contains tenecteplase 5mg/mL (1000 U/mL).

Wentworth Area Health Service

TENECTEPLASE (Metalyse) Protocol

Stability: Any unused solution must be discarded. o Reconstituted solution can be kept at 2-8 C for 24 hours OR 8 hours at room temperature. Storage: Store at room temperature. Protect from light. Contraindication: 1. 2. 3. 4. 5. 6. Precaution: 1. 2. 3. 4. 5. 6. Above 70 years old Bleeding Arrhythmias Cholesterol embolization Arterial and venous punctures should be minimized Readministration with tenecteplase has not been evaluated, hence should be done with caution. Active internal bleeding or known bleeding predisposition History of cerebrovascular accident Intracranial and intraspinal surgery or trauma within 2 months Intracranial neoplasm Arteriovenous malformation or aneurysm Severe uncontrolled hypertension (systolic180mmHg diastolic >110mmHg)

Adverse Effects: Minor bleeding (22%), major bleeding (4.7%), stroke (1.8%), intracranial haemorrhage (0.9%), reperfusion arrhythmias, allergic reactions (< 1%), anaphylaxis (<0.1%), cholesterol embolizations (rare) Monitoring Parameters: ECG (reperfusion arrhythmias) Neurological examinations (for intracranial bleed) Vital signs (HR, BP) Evidence of bleeding (e.g. haematuria) Coagulation parameters (APTT, platelets) - do not predict bleeding episodes (coagulation tests may be unreliable) Hematocrit/haemoglobin (bleeding)

Cost:

$1722.00 (40mg vial with solvent) $1818.00 (50mg vial with solvent)

Comments: Tenecteplase (rTNKtpa) and alteplase (rTPA) have similar clinical efficacy for thrombolysis after myocardial infarction, (similar mortality and intracranial haemorrhage rates). However, advantages of TNK include ease and rapidity of administration, longer half-life, greater fibrin specificity, and lower non-cerebral bleeding rates.

Wentworth Area Health Service

TENECTEPLASE (Metalyse) Protocol

References:

Metalyse Product Information, MIMS Online 2004. MICROMEDEX(R) Healthcare Series Vol. 121 expires 9/2004 Llevadot J., Giugliano R., Antman E. Bolus Fibrinolytic Therapy in Acute Myocardial Infarction. JAMA 2001: 286(4) p442-449

COMPILED BY COMMITTEE RESPONSIBLE DATE REVISED DATE EFFECTIVE REVIEW DATE

Ms R Dey, Intensive Care Pharmacist ICU management committee July 2004 August 2004 July 2007