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Actilyse is indicated for:
Pharmacology
Alteplase is a serine protease. It converts plasminogen to plasmin, and fibrin makes this conversion work much better. Without fibrin, it converts only a limited amount of plasminogen. When alteplase is given into the systemic circulation at a pharmacologic concentration, it binds to fibrin in a thrombus and converts the plasminogen trapped there to plasmin. This starts fibrinolysis locally, with limited proteolysis in the rest of the body.
Pharmacodynamics: After a 100 mg dose of Alteplase, circulating fibrinogen falls by 16% to 36%. In one controlled trial, patients received Alteplase at 1.25 mg/kg body weight over 3 hours. In 8 of 73 of them (11%), fibrinogen dropped below 100 mg/dL.
Pharmacokinetics: In patients with acute myocardial infarction (AMI), alteplase clears quickly from the plasma, with an initial half-life of less than 5 minutes. The dominant initial plasma half-life is the same for the 3-hour regimen and the accelerated regimen in AMI. Plasma clearance of alteplase is 380 to 570 mL/min, and the liver does most of this work. The initial volume of distribution is close to the plasma volume.
Dosage Reference
Reference Information Only
Dosages shown are general references from official sources. Always consult your doctor or pharmacist for personalized dosing.
Adults:
Acute ischemic stroke
Give Alteplase as soon as possible, and within 3 hours after the symptoms begin. The recommended dose is 0.9 mg/kg, and the total dose must not go above 90 mg. 10% of the total dose is given first as an intravenous bolus over 1 minute, and the rest is infused over 60 minutes. Check blood pressure often and keep it under control, both during and after the infusion. If the patient hasn't recently used oral anticoagulants or heparin, treatment can start before the coagulation study results are back. Stop Alteplase if the pretreatment International Normalized Ratio (INR) is greater than 1.7 or the activated partial thromboplastin time (aPTT) is elevated.
Acute myocardial infarction
Give it as soon as possible after the symptoms start. The total dose for acute myocardial infarction (AMI) is based on the patient's weight and must not go above 100 mg, whichever regimen is chosen (accelerated or 3 hour). Alteplase has these two dose regimens for managing AMI, and there are no controlled studies comparing clinical outcomes between them.
Pulmonary embolism (PE)
The recommended dose is 100 mg, given as an IV infusion over 2 hours. Start parenteral anticoagulation near the end of the infusion or straight after it, once the partial thromboplastin time or thrombin time has come back to twice normal or less.
Side Effects
The following adverse reactions can occur with alteplase: bleeding, orolingual angioedema, cholesterol embolization, and reembolization of deep venous thrombi during treatment for acute massive pulmonary embolism.
Cautions & Contraindications
Warnings & Precautions
Alteplase raises the risk of bleeding, so avoid giving intramuscular injections and keep a close watch for any bleeding. If serious bleeding occurs, stop Alteplase. Patients should be monitored during the infusion and for several hours afterwards for orolingual angioedema. If angioedema develops, stop Alteplase. Cholesterol embolism has been reported rarely in patients treated with thrombolytic agents. In patients with pulmonary embolism, think about the risk of reembolization from the lysis of underlying deep venous thrombi.
Contraindications
Do not give Alteplase to treat acute ischemic stroke in the situations below, because the risk of bleeding is greater than the potential benefit [see Warnings and Precautions (5.1)]. These are current intracranial hemorrhage, subarachnoid hemorrhage, active internal bleeding, recent (within 3 months) intracranial or intraspinal surgery or serious head trauma, and the presence of intracranial conditions that may increase the risk of bleeding (e.g., some neoplasms, arteriovenous malformations, or aneurysms). Bleeding diathesis and current severe uncontrolled hypertension are also on the list. For acute myocardial infarction (AMI) or pulmonary embolism (PE), Alteplase must not be given in the following situations, again because the risk of bleeding is greater than the potential benefit: active internal bleeding, a history of recent stroke, recent (within 3 months) intracranial or intraspinal surgery or serious head trauma, and the presence of intracranial conditions that may increase the risk of bleeding (e.g. some neoplasms, arteriovenous malformations, or aneurysms). Bleeding diathesis and current severe uncontrolled hypertension rule it out as well.
Pregnancy & Breastfeeding
Alteplase is Pregnancy Category C. In rabbits given alteplase by intravenous injection, it killed the embryo at doses of about two times (3 mg/kg) the human dose for AMI. At 0.65 times (1 mg/kg) the human dose, pregnant rats and rabbits dosed during the period of organogenesis showed no harm to the mother or the fetus. There are no adequate and well-controlled studies in pregnant women.
It is not known whether alteplase is excreted in human milk. Many drugs are excreted in human milk.
⚠️ Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
Use in Special Populations
Pediatric use: The safety and effectiveness of Alteplase in pediatric patients have not been established.
Geriatric use. In acute ischemic stroke, exploratory multivariate analyses of Studies 1 and 2 found that age greater than 77 years was one of several interrelated baseline characteristics linked with a higher risk of intracranial hemorrhage. The results suggest that elderly patients treated with Alteplase have a reduced but still favorable clinical outcome.
In acute myocardial infarction, a large trial of accelerated-infusion Alteplase enrolled 41,021 patients with AMI and placed them on one of four thrombolytic regimens [see Clinical Studies (14.2)]. Patients over 75 years of age were a predefined subgroup and made up 12% of enrolment. In this group, stroke occurred in 4.0% of those on the Alteplase accelerated infusion, 2.8% on streptokinase IV [SK (IV)] and 3.2% on streptokinase SQ [SK (SQ)]. The combined rate of 30-day mortality or nonfatal stroke was 20.6% for accelerated infusion of Alteplase, 21.5% for SK (IV) and 22.0% for SK (SQ).
Storage
Keep lyophilized Alteplase at controlled room temperature, not above 30°C, or in a refrigerator at 2 to 8°C. If you store it for a long time, protect the lyophilized material from too much light. Once Alteplase has been reconstituted, it can be used within 8 hours if it has been kept between 2 and 30°C. Throw away any solution left over after the administration is finished. Don't use the vial after the expiration date stamped on it.
Common questions about Actilyse 50 mg/50 ml
What is Actilyse 50 mg/50 ml IV Infusion?
Actilyse 50 mg/50 ml IV Infusion is a medicine that contains Alteplase. It is made by Radiant Pharmaceuticals Ltd. It belongs to the Anti-platelet drugs group of medicines.
What is Actilyse used for?
Actilyse is used for: Heart Failure, Myocardial Infarction, Stroke.
What are the side effects of Actilyse?
The following adverse reactions can occur with alteplase: bleeding, orolingual angioedema, cholesterol embolization, and reembolization of deep venous thrombi during treatment for acute massive pulmonary embolism.
Can I take Actilyse during pregnancy or while breastfeeding?
Alteplase is Pregnancy Category C. In rabbits given alteplase by intravenous injection, it killed the embryo at doses of about two times (3 mg/kg) the human dose for AMI. Talk to your doctor before taking any medicine during pregnancy or while breastfeeding.
How should I store Actilyse?
Keep lyophilized Alteplase at controlled room temperature, not above 30°C, or in a refrigerator at 2 to 8°C. If you store it for a long time, protect the lyophilized material from too much light.
Do I need a prescription for Actilyse?
Actilyse is a prescription (Rx) medicine. Take it as your doctor advises.