Tenecteplase


Generic Medicine Info
Indications and Dosage
Intravenous
Acute myocardial infarction
Adult: In patients with persistent ST elevation or recent left Bundle Branch Block (initiate treatment immediately after onset of symptoms): As 5 mg (1,000 units)/mL reconstituted solution: <60 kg: 30 mg (6,000 units); ≥60-<70 kg: 35 mg (7,000 units); ≥70-<80 kg: 40 mg (8,000 units); ≥80-<90 kg: 45 mg (9,000 units); ≥90 kg: 50 mg (10,000 units). Max: 50 mg (10,000 units). All doses to be given as a single bolus inj over approx 5-10 seconds.
Hepatic Impairment
Severe: Contraindicated.
Reconstitution
Add the complete volume of water for inj (WFI) from the provided pre-filled syringe into the vial containing the powder for inj. Do not shake while reconstituting.
Incompatibility
Incompatible with dextrose solutions.
Contraindications
Hypersensitivity, bleeding disorder (at present or within 6 months), history of CNS damage (e.g. neoplasm, aneurysm, intracranial or spinal surgery), haemorrhagic diathesis, active internal bleeding, history of CVA, severe uncontrolled hypertension; major surgery, parenchymal organ biopsy or significant trauma (within 2 months); recent trauma to the head or cranium; prolonged cardiopulmonary resuscitation (>2 minutes) within 2 weeks; acute pericarditis and/or subacute bacterial endocarditis, acute pancreatitis, active peptic ulceration, arterial aneurysm, arterial or venous malformation, neoplasm with bleeding risk, active bleeding (except menstruation), suspected aortic dissection; history of haemorrhagic stroke or stroke of unknown origin; history of ischaemic stroke or TIA within 3 months; dementia. Severe hepatic impairment (e.g. hepatic failure, cirrhosis, portal hypertension [oesophageal varices], active hepatitis).
Special Precautions
Patient with significant hypertension on presentation (systolic blood pressure >160 mmHg or diastolic blood pressure >110 mmHg); history of chronic, severe, poorly controlled hypertension; cerebrovascular disease, recent gastrointestinal or genitourinary bleeding (within 10 days), increased risk of left heart thrombus (e.g. mitral stenosis or atrial fibrillation), recent IM inj (within 2 days), major surgery (<3 weeks), noncompressible vascular punctures, lumbar puncture (within 10 days), low body weight (<60 kg). Patient taking oral anticoagulants. Readministration of therapy. Patients should be transferred without delay to a coronary intervention capable facility for angiography and timely coronary intervention within 6-24 hours or earlier if needed (if used as a primary coronary recanalization treatment). Should not be given if primary PCI is scheduled according to the current relevant treatment guidelines. Avoid using rigid catheters, IM inj and nonessential handling of the patient. Elderly. Pregnancy and lactation.
Adverse Reactions
Significant: Hypersensitivity reaction (e.g. angioedema, anaphylaxis, laryngeal oedema, urticaria, rash), cholesterol embolization, increased risk of thromboembolic events.
Gastrointestinal disorders: Gastrointestinal haemorrhage (e.g. gastric, gastric ulcer, mouth or rectal haemorrhage, haematemesis, melaena).
General disorders and administration site conditions: Inj or puncture site haemorrhage.
Renal and urinary disorders: Urogenital haemorrhage (e.g. haemorrhage urinary tract, haematuria).
Respiratory, thoracic and mediastinal disorders: Epistaxis.
Skin and subcutaneous tissue disorders: Ecchymosis.
Potentially Fatal: Coronary thrombolysis resulting in reperfusion arrhythmia; haemorrhage.
Monitoring Parameters
Monitor CBC, aPTT, ECG; signs and symptoms of bleeding especially on potential bleeding sites (e.g. infusion or puncture site); neurological status (e.g. intracranial haemorrhage), vital signs, hypersensitivity reaction.
Drug Interactions
Increased risk of bleeding with GPIIb/IIIa antagonists, drugs affecting coagulation or alters platelet function (e.g. clopidogrel, ticlopidine, LMWH).
Lab Interference
Alters coagulation and fibrinolytic activity test results.
Action
Description: Tenecteplase is a recombinant fibrin-specific plasminogen activator that is derived from native tissue plasminogen activator (t-PA) by modifications at 3 sites of the protein structure. It binds to fibrin and converts plasminogen to plasmin.
Pharmacokinetics:
Metabolism: Metabolised primarily in the liver.
Excretion: Elimination half-life: Biphasic: 20-24 minutes (initial); 90-130 minutes (terminal).
Storage
Store between 2-8°C or below 30°C. Protect from light.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AD11 - tenecteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
References
Anon. Tenecteplase. Lexicomp Online. Hudson, Ohio. Wolters Kluwer Clinical Drug Information, Inc. https://online.lexi.com. Accessed 21/07/2021.

Boehringer Ingelheim (N.Z.) Limited. Metalyse 40 mg, 50 mg Powder and Solvent For Infusion For Solution For Injection data sheet 03 December 2018. Medsafe. http://www.medsafe.govt.nz. Accessed 22/06/2021.

Buckingham R (ed). Tenecteplase. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/06/2021.

Joint Formulary Committee. Tenecteplase. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 22/06/2021.

Metalyse 8,000 units, 10,000 units Powder and Solvent for Solution For Injection (Boehringer Ingelheim International GmbH). European Medicines Agency [online]. Accessed 22/06/2021.

Metalyse Powder and Solvent For Solution For Injection (Boehringer Ingelheim Pharma GmbH & Co.). MIMS Singapore. http://www.mims.com/singapore. Accessed 22/06/2021.

Metalyse Powder and Solvent For Solution For Injection (Boehringer Ingelheim Pharma GmbH & Co.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 22/06/2021.

Tnkase (Genetech, Inc.). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 22/06/2021.

Disclaimer: This information is independently developed by MIMS based on Tenecteplase from various references and is provided for your reference only. Therapeutic uses, prescribing information and product availability may vary between countries. Please refer to MIMS Product Monographs for specific and locally approved prescribing information. Although great effort has been made to ensure content accuracy, MIMS shall not be held responsible or liable for any claims or damages arising from the use or misuse of the information contained herein, its contents or omissions, or otherwise. Copyright © 2022 MIMS. All rights reserved. Powered by MIMS.com
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