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ACTIVASE
Thromboembolic disorders
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Drug Name:

ACTIVASE Rx

Generic Name and Formulations:
Alteplase 50mg, 100mg; per vial; lyophilized pwd for IV infusion after reconstitution and dilution.

Company:
Genentech, Inc.

Therapeutic Use:

Indications for ACTIVASE:

Treatment of acute myocardial infarction (AMI) to reduce mortality and incidence of heart failure. Treatment of acute ischemic stroke. Treatment of acute massive pulmonary embolism (PE) for lysis.

Adult:

AMI: Max total dose: 100mg. Accelerated infusion: ≤67kg: 15mg IV bolus followed by 0.75mg/kg (max 50mg) infused over 30min, then 0.5mg/kg (max 35mg) over 60min. >67kg: 15mg IV bolus followed by 50mg infused over 30min, then 35mg infused over 60min. 3-hour infusion: (≥65kg): 60mg infused in the first hour (of which 6–10mg is given as bolus), then 20mg/hr for 2hrs; (<65kg): 1.25mg/kg over 3hrs (of which 0.075mg/kg as bolus, 0.675mg/kg for the rest of the first hour, then 0.25mg/kg/hr for 2hrs). Stroke: start treatment within 3hrs of symptom onset. 0.9mg/kg (max 90mg total dose) infused over 60min with 10% of the total dose given as an initial IV bolus over 1 minute. PE: 100mg infused over 2hrs. Heparin may be used concomitantly in MI or after infusion in PE.

Children:

Not established.

Contraindications:

AMI and PE: History of recent stroke. Stroke: Intracranial or subarachnoid hemorrhage. All: Active internal bleeding. Intracranial or intraspinal surgery or serious head trauma within 3 months. Intracranial neoplasm, arteriovenous malformation or aneurysm. Bleeding diathesis. Severe uncontrolled hypertension.

Warnings/Precautions:

Stroke: treatment >3hrs after symptom onset not recommended. Avoid IM inj and trauma to the patient while on therapy. Increased bleeding risk at puncture sites (eg, arterial, internal jugular, subclavian venous); avoid. Discontinue if serious bleeding occurs, if INR >1.7, or activated partial thromboplastin time is elevated. Increased risk of complications with recent major surgery, intracranial hemorrhage, GI or GU bleeding, or trauma, cerebrovascular disease, hypertension (systolic BP >175mm Hg and/or diastolic BP >110mm Hg), left heart thrombus, acute pericarditis, endocarditis, hemostatic defects, hepatic dysfunction, pregnancy, hemorrhagic ophthalmic conditions, septic thrombophlebitis, elderly. PE: consider possible risk of reembolization due to lysis of underlying deep venous thrombi. Avoid extravasation. Pregnancy (Cat.C). Nursing mothers.

Interactions:

Increased risk of bleeding with anticoagulants, antiplatelets. Angioedema risk with ACEI; monitor; discontinue if occurs. May interfere with coagulation tests.

Pharmacological Class:

Tissue plasminogen activator (tPA).

Adverse Reactions:

Bleeding (may be fatal), allergic reactions (eg, anaphylactoid, laryngeal edema, orolingual angioedema, rash, urticaria); rare: cholesterol embolism.

How Supplied:

Vials—1 (w. diluent)

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