Recomlyse

Thrombolytic treatment of suspected MI w/ persistent ST elevation or recent left bundle branch block w/in 6 hr after onset of acute MI (AMI) symptoms in adults; acute ischaemic stroke (AIS) w/in 4.5 hr after onset of symptoms, provided that intracranial hemorrhage has been ruled out in advance by appropriate imaging exam (eg, head CT scan or other imaging diagnostic methods sensitive to bleeding).

IV AMI 16 mg single dose as early as possible after onset of symptoms. AIS 0.25 mg/kg as single IV bolus over approx 5-10 sec as soon as possible w/in 4.5 hr of onset. Max dose: 25 mg.

Hypersensitivity. Significant bleeding disorder currently or in the past 6 mth; known bleeding constitution; active internal bleeding; significant or recent severe or dangerous bleeding; aneurysmal or suspected subarachnoid haemorrhage. History of haemorrhagic stroke or unexplained stroke; ischemic stroke or transient ischemic attack w/in the past 6 mth, except ischemic stroke occurring w/in 4.5 hr; stroke w/in the past 3 mth; CNS lesions or trauma (eg, intracranial tumors, arteriovenous malformations or aneurysms, intracranial & intraspinal surgeries); stroke combined w/ diabetes. Severe uncontrolled high BP; stroke assessed clinically (NIHSS >25) &/or imaging exam. Serious trauma or major surgery w/in the past 3 mth; recent (w/in 2 wk) prolonged CPR (>2 min), obstetrical delivery or non-stress or -compressible vascular puncture (eg, subclavian or jugular vein puncture); arterial puncture in a location that is not easy to compress & stop bleeding in the past wk. Acute pancreatitis, active peptic ulcer, aneurysm or arterial/venous malformation; neoplasm w/ a tendency to bleed; bacterial endocarditis or pericarditis; confirmed, highly suspected or unresolved aortic dissection; aortic arch dissection; mild neurological deficit or rapid improvement of symptoms before treatment; stroke attacks are accompanied by epileptic seizures. >4.5 hr since ischemic stroke symptoms onset & IV drip treatment has not been started or time of symptom onset cannot be determined. Head CT or MRI shows large-scale infarction (infarct area >¹/₃ of the middle cerebral artery blood supply area); blood sugar <2.8 mmol/L or >22.22 mmol/L; acute bleeding tendency, including platelet count <100 x 10⁹/L or other conditions. Oral anticoagulant therapy & INR >1.3; LMWH treatment w/in 24 hr; use of thrombin or factor Xa inhibitors w/in 48 hr w/ thromboplastin time above the upper limit of lab normal values. Severe liver disease, including hepatic failure, cirrhosis, portal HTN (esophageal varices) & active hepatitis.

Immune-mediated hypersensitivity or anaphylactoid reactions caused by rhTNK-tPA, excipients, gentamicin (trace residues), or natural rubber (latex derivatives) stoppers; promptly initiate appropriate treatment if severe hypersensitivity occurs; exercise caution when re-administering Recomlyse. Avoid use of rigid catheters, IM inj & non-essential handling of the patient. Carefully weigh benefit/risk ratio in patients w/ prior stroke or uncontrolled diabetes, extensive infarction or atrial fibrillation. Treat patient w/ AIS under a physician experienced in thrombolysis w/ monitoring facilities & standard resuscitation equipment. Transfer patients receiving Recomlyse for primary coronary recanalization to a coronary intervention-capable facility for angiography & adjunctive percutaneous coronary intervention (PCI) w/o delay (w/in 6-24 hr or earlier if indicated). Do not use for thrombolytic therapy before primary PCI in patients w/ AMI who are scheduled to undergo primary PCI as reperfusion therapy. Carefully evaluate & weigh anticipated benefits against potential risks of therapy, especially in patients w/ recent GI or genitourinary bleeding w/in 10 days; recent minor trauma; any recent IM inj; HTN (systolic BP ≥180 mmHg &/or diastolic BP ≥110 mmHg); haemostatic defects not listed in Contraindications, including severe renal disease; diabetic haemorrhagic retinopathy or other haemorrhagic ophth conditions; septic thrombophlebitis or occluded AV cannula at seriously infected sites; current use of oral anticoagulants (eg, warfarin Na); recent GP IIb/IIIa inhibitor administration; or any other condition that may cause bleeding besides those mentioned in Contraindications. Reperfusion of the ischaemic area may induce cerebral oedema in the infarcted zone. Reperfusion arrhythmias may lead to cardiac arrest, can be life-threatening & may require the use of conventional antiarrhythmic therapies. Monitor BP up to 24 hr after treatment; IV antihypertensive therapy is recommended if systolic BP >180 mmHg or diastolic BP >105 mmHg. Avoid arterial & venous puncture after treatment; non-compressible arterial punctures, including puncturing of the internal jugular & subclavian veins. Immediately discontinue anticoagulants & antiplatelet aggregation drugs when severe bleeding occurs. Do not use platelet aggregation inhibitors w/in 24 hr after thrombolysis. Pregnancy & lactation. Not recommended in childn <18 yr. Higher bleeding risk in elderly ≥75 yr w/ AMI; ≥80 yr w/ AIS. AMI: High likelihood of left heart thrombus eg, mitral stenosis w/ atrial fibrillation; recent major surgery eg, CABG, obstetrical delivery, organ biopsy, previous puncture of non-compressible vessels & resuscitative cardiac compressions; cerebrovascular disease; advanced age (>75 yr); low body wt <50 kg. AIS: Patient should not be treated w/ Recomlyse if symptoms have occurred for >4.5 hr. Decreased/increased mortality in patients, especially those pretreated w/ aspirin; increased risk of symptomatic bleeding. Minor non-disabling stroke; stroke w/ rapid improvement in symptoms; neurologic impairment following a convulsive attack (related to the stroke); extracranial cervical artery dissection; severe trauma w/in the past 2 wk (no head injury); history of MI w/in the past 3 mth.

Intracranial hemorrhage, urinary tract bleeding. AMI: Other minor bleeding adverse events (eg, bleeding gums, sub dermal ecchymosis, alimentary tract hemorrhage, decrease of Hb & other red indices, hematoma at the puncture site, tip of tongue bleeding). AIS: Bleeding gums. Urinary occult blood.

May increase bleeding risk w/ anticoagulants (eg, vit K antagonists) & anti-platelet aggregation drugs (eg, GPIIb/IIIa antagonists).

Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)

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

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