Actilyse

Actilyse

alteplase

Manufacturer:

Boehringer Ingelheim

Distributor:

Zuellig
/
Agencia Lei Va Hong
Concise Prescribing Info
Contents
Alteplase
Indications/Uses
Thrombolytic treatment in acute MI: 90-min dose regimen for patients in whom treatment can be started w/in 6 hr after symptom onset. 3-hr dose regimen for patients in whom treatment can be started between 6-12 hr after symptom onset. Thrombolytic treatment in acute massive pulmonary embolism w/ haemodynamic instability. Fibrinolytic treatment of acute ischaemic stroke: Treatment must be started w/in 4.5 hr after onset of stroke symptoms & after exclusion of intracranial hemorrhage.
Dosage/Direction for Use
Acute MI & acute massive pulmonary embolism Reconstituted soln should be administered IV & is for immediate use. Acute ischaemic stroke 0.9 mg/kg (max 90 mg) starting w/ 10% of the total dose as an initial IV bolus, immediately followed by the remainder of the total dose infused IV over 60 min.
Contraindications
Known hypersensitivity to alteplase, gentamicin, or to any of the excipients (arginine, diluted phosphoric acid, polysorbate 80). High risk of haemorrhage (significant bleeding disorder at present or w/in the past 6 mth; known haemorrhagic diathesis; patients receiving effective oral anticoagulant treatment eg, warfarin Na (INR >1.3); manifest or recent severe or dangerous bleeding; known history of or suspected intracranial haemorrhage (ICH); suspected subarachnoid haemorrhage or condition after subarachnoid haemorrhage from aneurysm; any history of CNS damage (ie, neoplasm, aneurysm, intracranial or spinal surgery); recent (<10 days) traumatic external heart massage, obstetrical delivery, recent puncture of a non-compressible blood vessel (eg, subclavian or jugular vein puncture); severe uncontrolled arterial HTN; bacterial endocarditis, pericarditis; acute pancreatitis; documented ulcerative GI disease during the last 3 mth, oesophageal varices, arterial aneurysm, arterial/venous malformations; neoplasm w/ increased bleeding risk; severe liver disease, including hepatic failure, cirrhosis, portal HTN (oesophageal varices) & active hepatitis; major surgery or significant trauma in past 3 mth). Any known history of haemorrhagic stroke or stroke of unknown origin. Known history of ischaemic stroke or transient ischaemic attack in the preceding 6 mth except current acute ischaemic stroke w/in 4.5 hr. Symptoms of ischaemic attack beginning more than 4.5 hr prior to infusion start or symptoms for which the onset time is unknown & could potentially be more than 4.5 hr ago. Minor neurological deficit or symptoms rapidly improving before start of infusion. Severe stroke as assessed clinically (eg, NIHSS >25) &/or by appropriate imaging techniques. Seizure at onset of stroke. Evidence of ICH on the CT-scan. Symptoms suggestive of subarachnoid haemorrhage, even if CT-scan is normal. Administration of heparin w/in the previous 48 hr & a thromboplastin time exceeding ULN. Patients w/ any history of prior stroke & concomitant diabetes. Prior stroke w/in the last 3 mth. Platelet count of <100,000/mm3. Systolic BP >185 mmHg or diastolic BP >110 mmHg, or aggressive management (IV pharmacotherapy) necessary to reduce BP to these limits. Blood glucose <50 mg/dL or >400 mg/dL (<2.8 mM or >22.2 mM). Childn <16 yr for the treatment of acute ischaemic stroke.
Special Precautions
Immune-mediated hypersensitivity reactions. If severe hypersensitivity reaction occurs, discontinue infusion & initiate appropriate treatment promptly. Thrombolytic therapy requires careful attention to all possible bleeding sites (including those following catheter insertion, arterial & venous puncture cutdown & needle puncture). Avoid use of rigid catheters, IM inj & non-essential handling of the patient during treatment w/ Actilyse. In case of potentially dangerous haemorrhage, particularly cerebral haemorrhage, discontinue fibrinolytic therapy & immediately terminate concomitant heparin administration. Consider the use of Actilyse in patients receiving oral anticoagulant treatment when appropriate test(s) of anticoagulant activity for the product(s) concerned show no clinically relevant activity. Do not initiate treatment w/ platelet aggregation inhibitors w/in the first 24 hr following thrombolysis w/ alteplase. Monitor patients for angio-oedema during & for up to 24 hr after infusion. Monitor BP during treatment administration & up to 24 hr. Risks outweigh the expected benefit in patients w/ very mild stroke. Do not administer in patients w/ very severe stroke. Paed population. Elderly.
Adverse Reactions
Intracerebral haemorrhage in the treatment of acute ischaemic stroke; all haemorrhages; recurrent ischaemia/angina pectoris, hypotension & heart failure/pulmonary oedema. Intracerebral haemorrhage in the treatment of acute MI & acute massive pulmonary embolism; pharyngeal haemorrhage; GI haemorrhage; ecchymosis; urogenital haemorrhage; inj site haemorrhage; cardiogenic shock, cardiac arrest & reinfarction.
Drug Interactions
Increased risk of haemorrhage w/ coumarine derivatives, oral anticoagulants, platelet aggregation inhibitors, unfractionated heparin or LMWH or active substances which interfere w/ coagulation (administered before, during or w/in the first 24 hr after treatment w/ Actilyse). Enhanced risk of hypersensitivity reaction w/ ACE inhibitors. Increased risk of bleeding w/ GPIIb/IIIa antagonists.
MIMS Class
Anticoagulants, Antiplatelets & Fibrinolytics (Thrombolytics)
ATC Classification
B01AD02 - alteplase ; Belongs to the class of enzymes. Used in the treatment of thrombosis.
Presentation/Packing
Form
Actilyse powd for infusion 50 mg
Packing/Price
1's
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