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Acute Ischemic Stroke (AIS)
Stay Informed Stay Informed Contact a Representative Contact a Representative
Prescribing Information Prescribing Information Safety Safety

Acute Ischemic Stroke (AIS) Acute Myocardial Infarction (AMI) Acute Massive
Pulmonary Embolism (AMPE)
Acute Ischemic Stroke (AIS)
* Acute Ischemic Stroke (AIS)
* Acute Myocardial Infarction (AMI)
* Acute Massive Pulmonary Embolism (AMPE)

* Home
* Diagnosing and Treating AIS
* Evaluating AIS
* A Standard of Care for AIS
* Patient Identification
* Clinical Overview
* Pivotal Trial and Real-World sICH Data

* Dosing & Administration
* Reconstituting Activase
* Dosing and Administering Activase
* Patient Monitoring
* Product Return and Replacement

* Stroke Reporting
* Stroke Coordinators, Stewards of Change
* Tracking All-AIS Treatment Rate
* Analyze: Process and Outcomes
* Take Action to Help Enhance Success

* Resource Center
* Download & Order Resources
* Video Library
* Additional Resources

* Interactive Learning

Stay Informed Contact a Representative Prescribing Information Safety

CONSIDER WHETHER YOUR PATIENTS' SYMPTOMS COULD RESULT IN LONG-TERM DISABILITY

When evaluating treatment options in patients with acute ischemic stroke (AIS)

KEY QUESTIONS FOR YOUR EVALUATION

CONSIDER WHETHER YOUR PATIENTS' SYMPTOMS COULD RESULT IN LONG-TERM DISABILITY

When evaluating treatment options in patients with acute ischemic stroke (AIS)

KEY QUESTIONS FOR YOUR EVALUATION

DOSING AND ADMINISTRATION

View videos and instructions for the recommended dosing and administration of
Activase for AIS

PIVOTAL TRIAL AND REAL-WORLD SICH DATA

What are your institution's symptomatic Intracranial Hemorrhage (sICH) rates?

SEE REGISTRY DATA

CONTACT A REPRESENTATIVE

Connect with a Genentech representative to learn more about Activase

LEARN MORE
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IMPORTANT SAFETY INFORMATION & INDICATIONS

INDICATIONS

Activase® (alteplase) is indicated for the treatment of acute ischemic stroke.
Exclude intracranial hemorrhage as the primary cause of stroke signs and
symptoms prior to initiation of treatment. Initiate treatment as soon as
possible but within 3 hours after symptom onset.

Activase is indicated for use in acute myocardial infarction (AMI) for the
reduction of mortality and reduction of the incidence of heart failure.

Limitation of Use: The risk of stroke may outweigh the benefit produced by
thrombolytic therapy in patients whose AMI puts them at low risk for death or
heart failure.

Activase is indicated for the lysis of acute massive pulmonary embolism (PE),
defined as:

* Acute pulmonary emboli obstructing blood flow to a lobe or multiple lung
segments.
* Acute pulmonary emboli accompanied by unstable hemodynamics, e.g., failure to
maintain blood pressure without supportive measures.

IMPORTANT SAFETY INFORMATION

CONTRAINDICATIONS

Do not administer Activase to treat acute ischemic stroke in the following
situations in which the risk of bleeding is greater than the potential benefit:
current intracranial hemorrhage (ICH); subarachnoid hemorrhage; active internal
bleeding; recent (within 3 months) intracranial or intraspinal surgery or
serious head trauma; 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.

Do not administer Activase to treat acute myocardial infarction or pulmonary
embolism in the following situations in which the risk of bleeding is greater
than the potential benefit: active internal bleeding; history of recent stroke;
recent (within 3 months) intracranial or intraspinal surgery or serious head
trauma; presence of intracranial conditions that may increase the risk of
bleeding; bleeding diathesis; and current severe uncontrolled hypertension.

WARNINGS AND PRECAUTIONS

BLEEDING

Activase can cause significant, sometimes fatal internal or external bleeding,
especially at arterial and venous puncture sites. Avoid intramuscular injections
and trauma to the patient. Perform venipunctures carefully and only as required.
Fatal cases of hemorrhage associated with traumatic intubation in patients
administered Activase have been reported. Aspirin and heparin have been
administered concomitantly with and following infusion with Activase in the
management of acute myocardial infarction and pulmonary embolism. The
concomitant administration of heparin and aspirin with and following infusions
of Activase for the treatment of acute ischemic stroke during the first 24 hours
after symptom onset has not been investigated. Because heparin, aspirin, or
Activase may cause bleeding complications, carefully monitor for bleeding,
especially at arterial puncture sites. Hemorrhage can occur 1 or more days after
administration of Activase, while patients are still receiving anticoagulant
therapy. If serious bleeding occurs, terminate the Activase infusion, and treat
appropriately.

In the following conditions, the risks of bleeding with Activase are increased
and should be weighed against the anticipated benefits: recent major surgery or
procedure; cerebrovascular disease; recent intracranial hemorrhage; recent
gastrointestinal or genitourinary bleeding; recent trauma; hypertension; acute
pericarditis; subacute bacterial endocarditis; hemostatic defects including
those secondary to severe hepatic or renal disease; significant hepatic
dysfunction; pregnancy; diabetic hemorrhagic retinopathy or other hemorrhagic
ophthalmic conditions; septic thrombophlebitis or occluded AV cannula at
seriously infected site; advanced age; and patients currently receiving oral
anticoagulants, or any other condition in which bleeding constitutes a
significant hazard or would be particularly difficult to manage because of its
location.

HYPERSENSITIVITY

Hypersensitivity, including urticarial / anaphylactic reactions, have been
reported after administration of Activase. Rare fatal outcome for
hypersensitivity was reported. Angioedema has been observed during and up to 2
hours after Activase infusion in patients treated for acute ischemic stroke and
acute myocardial infarction. In many cases, patients received concomitant
angiotensin-converting enzyme inhibitors. Monitor patients treated with Activase
during and for several hours after infusion for hypersensitivity. If signs of
hypersensitivity occur, e.g. anaphylactoid reaction or angioedema develops,
discontinue the Activase infusion and promptly institute appropriate therapy
(e.g., antihistamines, intravenous corticosteroids, epinephrine).

THROMBOEMBOLISM

The use of thrombolytics can increase the risk of thrombo-embolic events in
patients with high likelihood of left heart thrombus, such as patients with
mitral stenosis or atrial fibrillation. Activase has not been shown to treat
adequately underlying deep vein thrombosis in patients with PE. Consider the
possible risk of re-embolization due to the lysis of underlying deep venous
thrombi in this setting.

CHOLESTEROL EMBOLIZATION

Cholesterol embolism, sometimes fatal, has been reported rarely in patients
treated with thrombolytic agents; the true incidence is unknown. It is
associated with invasive vascular procedures (e.g., cardiac catheterization,
angiography, vascular surgery) and/or anticoagulant therapy.

COAGULATION TESTS MAY BE UNRELIABLE DURING ACTIVASE THERAPY

Coagulation tests and/or measures of fibrinolytic activity may be unreliable
during Activase therapy unless specific precautions are taken to prevent in
vitro artifacts. When present in blood at pharmacologic concentrations, Activase
remains active under in vitro conditions, which can result in degradation of
fibrinogen in blood samples removed for analysis.

ADVERSE REACTIONS

The most frequent adverse reaction associated with Activase therapy is bleeding.

Please see the full Prescribing Information for additional Important Safety
Information and Instructions for Use.

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OPTIMIZING CARE FOR PATIENTS WITH ACUTE ISCHEMIC STROKE

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This video presents an overview of the steps required to diagnose acute ischemic
stroke, including brain imaging. It also describes patient eligibility for
Activase® treatment and presents some recommendations on how to enhance the
efficacy of a stroke program.

100-MG ACTIVASE RECONSTITUTION, DOSING, AND ADMINISTRATION VIDEO

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activating the close button.

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activating the close button.

This video provides a demonstration of the appropriate reconstitution, dosing,
and administration of Activase for eligible acute ischemic stroke patients.

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www.activase.com Open in urlscan Pro 2606:4700::6812:883 Public Scan

Form analysis 2 forms found in the DOM

GET /search.html

GET /search.html

Text Content

www.activase.com Open in urlscan Pro
2606:4700::6812:883 Public Scan

Form analysis
2 forms found in the DOM