Metalyse

Thrombolytic treatment of acute MI (AMI) w/ persistent ST elevation or recent left Bundle Branch Block w/in 6 hr after onset of AMI symptoms.

Administer as single IV bolus over 5-10 sec as early as possible after symptom onset based on body wt. 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).

Hypersensitivity to tenecteplase & gentamicin (trace residue from manufacturing process). Significant bleeding disorder at present or w/in the past 6 mth, known haemorrhagic diathesis, any history of CNS damage (ie, neoplasm, aneurysm, intracranial or spinal surgery). Severe uncontrolled arterial HTN. Active ulcerative GI disease. Arterial aneurysm &/or arterial/venous malformation. Neoplasm w/ increased bleeding risk. Bacterial endocarditis, pericarditis. Acute pancreatitis. Haemorrhagic stroke or stroke of unknown origin at any time. Patients receiving effective oral anticoagulants (eg, vit K antagonists w/ INR >1.3). Major surgery, biopsy of parenchymal organ or significant trauma w/in the past 2 mth (including any trauma associated w/ current AMI), recent trauma to head or cranium. Severe hepatic dysfunction including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis.

Discontinue use & initiate appropriate treatment if anaphylactoid reaction occurs. Possible allergic reactions w/ polysorbates. Carefully monitor all possible bleeding sites. Avoid use of rigid catheters, IM inj & non-essential handling of patient during treatment. Immediately terminate concomitant heparin administration if serious bleeding particularly cerebral haemorrhage occurs. 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 to balance potential risks of bleeding w/ expected benefits in patients receiving oral anticoagulants; prolonged (>2 min) or traumatic CPR or cardiac massage; recent IM inj or small recent traumas (eg, biopsies, major vessels puncture); history of stroke or transient ischaemic attack; systolic BP >160 mmHg; recent GI or genitourinary bleeding w/in past 10 days; body wt <50 kg. May increase risk of thromboembolic events in patients w/ existing thrombi eg, left heart thrombus (eg, mitral stenosis or atrial fibrillation). Immediately transfer patients receiving Metalyse as primary coronary recanalization treatment 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/ glyco-protein IIb/IIIa antagonists. Incompatible w/ dextrose soln. Pregnancy & lactation. Elderly ≥75 yr.

Haemorrhage (superficial & internal bleeding). Epistaxis; GI haemorrhage (eg, gastric, gastric ulcer, rectal & mouth haemorrhage), haematemesis, melaena; ecchymosis; urogenital haemorrhage (eg, haematuria, urinary tract haemorrhage); inj & puncture site haemorrhage.

May increase risk of bleeding w/ medicinal products that affect coagulation or alter platelet function.

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

B01AD11 - tenecteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.

POM