Metalyse

Metalyse

tenecteplase

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Tenecteplase
Indications/Uses
Thrombolytic treatment of acute MI (AMI) w/ persistent ST elevation or recent left Bundle Branch Block w/in 6 hr after the onset of AMI symptoms.
Dosage/Direction for Use
Administer as single IV bolus over 5-10 sec as early as possible after symptom onset. Max dose: 50 mg (10,000 U). Patient weighing ≥90 kg 50 mg (10,000 U), ≥80 to <90 kg 45 mg (9,000 U), ≥70 to <80 kg 40 mg (8,000 U), ≥60 to <70 kg 35 mg (7,000 U), <60 kg 30 mg (6,000 U).
Contraindications
Hypersensitivity to tenecteplase & gentamicin (trace residue from the manufacturing process). Significant bleeding disorder at present or w/in the past 6 mth, known haemorrhagic diathesis. Concomitant treatment w/ oral anticoagulant (INR >1.3). History of CNS damage (ie, neoplasm, aneurysm, intracranial or spinal surgery). Severe uncontrolled arterial HTN. Major surgery, parenchymal organ biopsy or significant trauma w/in the past 2 mth, recent head or cranium trauma. Prolonged or traumatic CPR (>2 min) w/in the past 2 wk. Active peptic ulceration. Arterial aneurysm & known arterial/venous malformation. Neoplasm w/ increased bleeding risk. Acute pericarditis &/or subacute bacterial endocarditis. Acute pancreatitis. Haemorrhagic stroke or stroke of unknown origin at any time, ischaemic stroke or transient ischaemic attack (TIA) in the preceding 6 mth. Severe hepatic dysfunction including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis.
Special Precautions
Discontinue use & initiate appropriate treatment if anaphylactoid reaction occurs. Immediately terminate concomitant heparin administration if serious bleeding particularly cerebral haemorrhage occurs. Carefully monitor all possible bleeding sites. Consider protamine administration if heparin has been administered w/in 4 hr before onset of bleeding; cryoprecipitate, fresh frozen plasma & platelet transfusion after each administration; antifibrinolytics. Carefully evaluate use in systolic BP >160 mmHg; recent GI or GUT bleeding w/in past 10 days; recent IM inj w/in past 2 days; low body wt <60 kg; cerebrovascular disease; those receiving oral anticoagulants. Patients receiving Metalyse as primary coronary recanalization treatment should be transferred immediately to a coronary intervention capable facility for angiography & timely coronary intervention w/in 6-24 hr or earlier. Not to be given if primary percutaneous coronary intervention (PCI) is scheduled according to current relevant treatment guidelines as administered in the ASSENT-4 PCI study. Coronary thrombolysis may result in arrhythmia associated w/ reperfusion. Increased risk of bleeding w/ GPIIb/IIIa antagonists. May increase risk of thromboembolic events in patients w/ left heart thrombus (eg, mitral stenosis or atrial fibrillation). Incompatible w/ dextrose soln. Pregnancy & lactation. Elderly >75 yr.
Adverse Reactions
Haemorrhage (superficial & internal bleeding). Epistaxis; GI haemorrhage (eg, gastric, gastric ulcer, rectal & mouth haemorrhage), haematemesis, melaena; ecchymosis; urogenital haemorrhage (eg, haematuria, haemorrhage urinary tract); inj & puncture site haemorrhage.
Drug Interactions
May increase risk of bleeding w/ medicinal products that affect coagulation or alter platelet function.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AD11 - tenecteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
Presentation/Packing
Form
Metalyse powd for inj 10,000 U
Packing/Price
(+ WFI (pre-filled syringe)) 1's
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