Metalyse

Metalyse

tenecteplase

Manufacturer:

Boehringer Ingelheim

Distributor:

DKSH
Concise Prescribing Info
Contents
Tenecteplase
Indications/Uses
Thrombolytic treatment of acute MI initiated as soon as possible after symptom onset.
Dosage/Direction for Use
Patient ≥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). All doses given as single IV bolus over 5-10 sec.
Contraindications
Hypersensitivity to tenecteplase, gentamicin. Significant bleeding disorder (present or w/in past 6 mth), known haemorrhagic diathesis; 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 past 2 mth, recent head or cranial trauma; prolonged or traumatic CPR (>2 min) w/in past 2 wk; active peptic ulceration; arterial aneurysm, arterial/venous malformation; neoplasm w/ increased bleeding risk; acute pericarditis &/or subacute bacterial endocarditis; acute pancreatitis; haemorrhagic stroke or stroke of unknown origin; ischaemic stroke or transient ischaemic attack in the preceding 6 mth. Severe hepatic dysfunction including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis.
Special Precautions
Discontinue use if anaphylactoid reaction occurs. Not to be given in primary percutaneous coronary intervention. Avoid use of rigid catheters, IM inj. Increased risk of bleeding; thromboembolic events in patients w/ left heart thrombus eg, mitral stenosis or atrial fibrillation. Arrhythmias; systolic BP >160 mmHg; recent GI or genitourinary bleeding (w/in past 10 days); recent IM inj (w/in past 2 days); low body wt <60 kg; cerebrovascular disease. As primary coronary recanalization treatment, immediately transfer patient to coronary intervention-capable facility for angiography & timely coronary intervention w/in 6-24 hr. Concomitant use w/ oral anticoagulants; glycoprotein IIb/IIIa antagonists. Pregnancy & lactation. Childn. Elderly >75 yr.
Adverse Reactions
Anaphylactoid reaction; intracranial haemorrhage; eye haemorrhage; reperfusion arrhythmias, pericardial haemorrhage; haemorrhage, embolism; epistaxis, pulmonary haemorrhage; GI & retroperitoneal haemorrhage, nausea, vomiting; ecchymosis; urogenital haemorrhage; inj & puncture site haemorrhage; decreased BP, increased body temp; fat embolism.
Drug Interactions
Increased risk of bleeding w/ medicinal products affecting coagulation or altering 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 (vial) 50 mg (10,000 U)
Packing/Price
(+ WFI (pre-filled syringe) 10 mL x 1's) 1's
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