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Genentech takes the health and safety of our patients, customers, employees, and
local communities very seriously, and we are actively responding to the global
COVID-19 pandemic. For more, please visit our COVID-19 response page or call
1-877-436-3683.

For AIS
Stay Informed Stay Informed Contact a Representative Contact a Representative
Prescribing Information Prescribing Information Safety Safety

For AIS For AMI For AMPE

For AIS
* For AIS
* For AMI
* For AMPE

* Diagnosing and Treating AIS
* Evaluating AIS
* A Standard of Care for AIS
* Patient Identification
* Clinical Overview
* Real-World sICH data

* Dosing and 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 Safety
Prescribing Information

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

IMPORTANT SAFETY INFORMATION & INDICATION

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 full Prescribing Information for additional Important Safety
Information.

References

* * National Institute of Neurological Disorders and Stroke. Know stroke. Know
the signs. Act in time. National Institute of Neurological Disorders and
Stroke website.
http://www.ninds.nih.gov/disorders/stroke/knowstroke.htm. Last modified
March 29, 2016. Accessed August 12, 2016.

National Institute of Neurological Disorders and Stroke. Know stroke. Know
the signs. Act in time. National Institute of Neurological Disorders and
Stroke website.
http://www.ninds.nih.gov/disorders/stroke/knowstroke.htm. Last modified
March 29, 2016. Accessed August 12, 2016.

* Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the early
management of patients with acute ischemic stroke: 2019 update to the 2018
guidelines for the early management of acute ischemic stroke: a guideline
for healthcare professionals from the American Heart Association/American
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Powers WJ, Rabinstein AA, Ackerson T, et al. Guidelines for the early
management of patients with acute ischemic stroke: 2019 update to the 2018
guidelines for the early management of acute ischemic stroke: a guideline
for healthcare professionals from the American Heart Association/American
Stroke Association. Stroke. 2019;50:e344-e418.

* Demaerschalk BM, Kleindorfer DO, Adeoye OM, et al. Scientific rationale for
the inclusion and exclusion criteria for intravenous alteplase in acute
ischemic stroke: a statement for healthcare professionals from the American
Heart Association/American Stroke Association. Stroke. 2016;47(2):581-641.

Demaerschalk BM, Kleindorfer DO, Adeoye OM, et al. Scientific rationale for
the inclusion and exclusion criteria for intravenous alteplase in acute
ischemic stroke: a statement for healthcare professionals from the American
Heart Association/American Stroke Association. Stroke. 2016;47(2):581-641.

* Ferbert A, Brückmann H, Drummen R. Clinical features of proven basilar
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doi:10.1161/01.str.21.8.1135

Ferbert A, Brückmann H, Drummen R. Clinical features of proven basilar
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doi:10.1161/01.str.21.8.1135

* Kattah JC, Talkad AV, Wang DZ, et al. HINTS to diagnose stroke in the acute
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Kattah JC, Talkad AV, Wang DZ, et al. HINTS to diagnose stroke in the acute
vestibular syndrome: three-step bedside oculomotor examination more
sensitive than early MRI diffusion-weighted imaging. Stroke.
2009;40(11):3504-10.

* Activase [prescribing information]. South San Francisco, CA: Genentech,
Inc; 2018.

Activase [prescribing information]. South San Francisco, CA: Genentech,
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* Arch AE, Weisman DC, Coca S, et al. Missed ischemic stroke diagnosis in the
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Arch AE, Weisman DC, Coca S, et al. Missed ischemic stroke diagnosis in the
emergency department by emergency medicine and neurology services. Stroke.
2016;47(3):668-73.

* Madsen TE, Khoury J, Cadena R, et al. Potentially missed diagnosis of
ischemic stroke in the emergency department in the Greater
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Madsen TE, Khoury J, Cadena R, et al. Potentially missed diagnosis of
ischemic stroke in the emergency department in the Greater
Cincinnati/Northern Kentucky stroke study. Academic Emergency Medicine.
2016;23(10):1128-35.

* English JD, Yavagal DR, Gupta R, et al. Mechanical thrombectomy-ready
comprehensive stroke center requirements and endovascular stroke systems of
care: recommendations from the Endovascular Stroke Standards Committee of
the Society of Vascular and Interventional Neurology (SVIN). Intervent
Neurol. 2015;4:138-150.

English JD, Yavagal DR, Gupta R, et al. Mechanical thrombectomy-ready
comprehensive stroke center requirements and endovascular stroke systems of
care: recommendations from the Endovascular Stroke Standards Committee of
the Society of Vascular and Interventional Neurology (SVIN). Intervent
Neurol. 2015;4:138-150.

* Trevo EDFU. Fremont, CA: Stryker International; 2016.

Trevo EDFU. Fremont, CA: Stryker International; 2016.

* Solitaire Revascularization Device. Medtronic website.
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Updated February 2018. Accessed May 9, 2018.

Solitaire Revascularization Device. Medtronic website.
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Updated February 2018. Accessed May 9, 2018.

* FDA Information on Medication Errors Involving Activase and TNKase.
http://www.fda.gov/downloads/ForHealthProfessionals/LearningActivities/UCM464193.pdf.
Accessed August 9, 2016.

FDA Information on Medication Errors Involving Activase and TNKase.
http://www.fda.gov/downloads/ForHealthProfessionals/LearningActivities/UCM464193.pdf.
Accessed August 9, 2016.

* Data on file. Genentech USA. No Title.

Data on file. Genentech USA. No Title.

* National Institute of Neurological Disorders and Stroke rt-PA Stroke Study
Group. N Engl J Med. 1995;333:1581-1587.

National Institute of Neurological Disorders and Stroke rt-PA Stroke Study
Group. N Engl J Med. 1995;333:1581-1587.

* FDA Access Summary basis of approval.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/altegen061896s.pdf. Accessed
August 14, 2017.

FDA Access Summary basis of approval.
https://www.accessdata.fda.gov/drugsatfda_docs/nda/96/altegen061896s.pdf. Accessed
August 14, 2017.

* Summers D, Leonard A, Wentworth D, et al. Comprehensive overview of nursing
and interdisciplinary care of the acute ischemic stroke patient: a
scientific statement from the American Heart Association. Stroke.
2009;40:2911-2944.

Summers D, Leonard A, Wentworth D, et al. Comprehensive overview of nursing
and interdisciplinary care of the acute ischemic stroke patient: a
scientific statement from the American Heart Association. Stroke.
2009;40:2911-2944.

* American Association of Neurosicence Nurses (AANN) Reference Series for
Clinical Practice. Guide to the Care of the Patient with Ischemic Stroke.
2004.
http://www.pennstatehershey.org/c/document_library/get_file?folderId=115233&name=DLFE-2409.pdf. Accessed
August 9, 2016.

American Association of Neurosicence Nurses (AANN) Reference Series for
Clinical Practice. Guide to the Care of the Patient with Ischemic Stroke.
2004.
http://www.pennstatehershey.org/c/document_library/get_file?folderId=115233&name=DLFE-2409.pdf. Accessed
August 9, 2016.

* Tamm A, Siddiqui M, Shuaib A, et al. Impact of stroke care unit on patient
outcomes in a community hospital. Stroke. 2014;45(1):211-216.

Tamm A, Siddiqui M, Shuaib A, et al. Impact of stroke care unit on patient
outcomes in a community hospital. Stroke. 2014;45(1):211-216.

* CMS Quality Measurement Programs Characteristics. Centers for Medicare and
Medicaid Services website.
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/CMSQualityMeasurementProgramsCharacteristics.PDF. Published
June 28, 2012. Accessed August 13, 2016.

CMS Quality Measurement Programs Characteristics. Centers for Medicare and
Medicaid Services website.
https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/QualityMeasures/Downloads/CMSQualityMeasurementProgramsCharacteristics.PDF. Published
June 28, 2012. Accessed August 13, 2016.

* The Joint Commission, Stroke. Last updated June 17, 2016. Accessed August
1, 2016. https://www.jointcommission.org/stroke/.

The Joint Commission, Stroke. Last updated June 17, 2016. Accessed August
1, 2016. https://www.jointcommission.org/stroke/.

* Skolarus LE, Meurer WJ, Shanmugasundaram K, et al. Marked regional
variation in acute stroke treatment among Medicare beneficiaries. Stroke.
2015;46:1890-1896.

Skolarus LE, Meurer WJ, Shanmugasundaram K, et al. Marked regional
variation in acute stroke treatment among Medicare beneficiaries. Stroke.
2015;46:1890-1896.

* ICD-10. https://www.cms.gov/Medicare/Coding/ICD10/. Accessed August 14,
2017.

ICD-10. https://www.cms.gov/Medicare/Coding/ICD10/. Accessed August 14,
2017.

* Schwamm LH, Pancioli A, Acker JE, et al. Recommendations for the
establishment of stroke systems of care: recommendations from the American
Stroke Association’s Task Force on the Development of Stroke
Systems. Stroke. 2005;36(3):690-703.

Schwamm LH, Pancioli A, Acker JE, et al. Recommendations for the
establishment of stroke systems of care: recommendations from the American
Stroke Association’s Task Force on the Development of Stroke
Systems. Stroke. 2005;36(3):690-703.

* Fonarow GC, Smith EE, Saver JL, et al. Improving door-to-needle times in
acute ischemic stroke: the design and rationale for the American Heart
Association/American Stroke Association's Target: Stroke
initiative. Stroke. 2011;42(10):2983-2989.

Fonarow GC, Smith EE, Saver JL, et al. Improving door-to-needle times in
acute ischemic stroke: the design and rationale for the American Heart
Association/American Stroke Association's Target: Stroke
initiative. Stroke. 2011;42(10):2983-2989.

* Goyal M, Menon BK, Hill MD, Demchuk A. Consistently achieving computed
tomography to endovascular recanalization <90 minutes: solutions and
innovations. Stroke. 2014;45(12):e252-e256.

Goyal M, Menon BK, Hill MD, Demchuk A. Consistently achieving computed
tomography to endovascular recanalization <90 minutes: solutions and
innovations. Stroke. 2014;45(12):e252-e256.

* Kalanithi L, Tai W, Conley J, Platchek T, Zulman D, Milstein A. Better
health, less spending: delivery innovation for ischemic cerebrovascular
disease. Stroke. 2014;45(10):3105-3111.

Kalanithi L, Tai W, Conley J, Platchek T, Zulman D, Milstein A. Better
health, less spending: delivery innovation for ischemic cerebrovascular
disease. Stroke. 2014;45(10):3105-3111.

* Meretoja A, Weir L, Ugalde M, et al. Helsinki model cut stroke thrombolysis
delays to 25 minutes in Melbourne in only 4
months. Neurology. 2013;81(12):1071-1076.

Meretoja A, Weir L, Ugalde M, et al. Helsinki model cut stroke thrombolysis
delays to 25 minutes in Melbourne in only 4
months. Neurology. 2013;81(12):1071-1076.

* Nguyen-Huynh MN. KPNC stroke EXPRESS: expediting the process of evaluating
and stopping stroke. Presentation; 2016.

Nguyen-Huynh MN. KPNC stroke EXPRESS: expediting the process of evaluating
and stopping stroke. Presentation; 2016.

* American Heart Association/American Stroke Association. Target: Stroke
Phase II Campaign Manual. Published October 2014.

American Heart Association/American Stroke Association. Target: Stroke
Phase II Campaign Manual. Published October 2014.

* Wechsler LR, Demaerschalk BM, Schwamm LH, et al. Telemedicine quality and
outcomes in stroke: a scientific statement for healthcare professionals
from the American Heart Association/American Stroke Association. Stroke.
2017 Jan 1;48(1):e3-25.

Wechsler LR, Demaerschalk BM, Schwamm LH, et al. Telemedicine quality and
outcomes in stroke: a scientific statement for healthcare professionals
from the American Heart Association/American Stroke Association. Stroke.
2017 Jan 1;48(1):e3-25.

* American Hospital Association.
http://www.aha.org/research/reports/tw/12oct-tw-quality.pdf. October 2012.
Accessed October 11, 2016.

American Hospital Association.
http://www.aha.org/research/reports/tw/12oct-tw-quality.pdf. October 2012.
Accessed October 11, 2016.

* Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease:
CHEST guideline and expert panel report. Chest. 2016;149(2):315-352.

Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease:
CHEST guideline and expert panel report. Chest. 2016;149(2):315-352.

* Fesmire FM, Brown MD, Espinosa JA, et al. Critical issues in the evaluation
and management of adult patients presenting to the emergency department
with suspected pulmonary embolism. Ann Emerg Med. 2011
Jun;57(6):628-652.e75.

Fesmire FM, Brown MD, Espinosa JA, et al. Critical issues in the evaluation
and management of adult patients presenting to the emergency department
with suspected pulmonary embolism. Ann Emerg Med. 2011
Jun;57(6):628-652.e75.

* Wood KE. Major pulmonary embolism: review of a pathophysiologic approach to
the golden hour of hemodynamically significant pulmonary embolism. Chest.
2002;121:877-905.

Wood KE. Major pulmonary embolism: review of a pathophysiologic approach to
the golden hour of hemodynamically significant pulmonary embolism. Chest.
2002;121:877-905.

* Tan KT, Oudkerk M, van Beek EJR. Deep Vein Thrombosis and Pulmonary
Embolism. In: Hallet JW Jr, Mills JL, Earnshaw JJ, Reekers JA,
eds. Comprehensive Vascular and Endovascular Surgery. Philadelphia, PA:
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Tan KT, Oudkerk M, van Beek EJR. Deep Vein Thrombosis and Pulmonary
Embolism. In: Hallet JW Jr, Mills JL, Earnshaw JJ, Reekers JA,
eds. Comprehensive Vascular and Endovascular Surgery. Philadelphia, PA:
Elsevier Limited; 2003.

* Martin-Schild S, Albright KC, Tanksley J, et al. Zero on the NIHSS does not
equal the absence of stroke. Ann Emerg Med. 2011;57:42-45.

Martin-Schild S, Albright KC, Tanksley J, et al. Zero on the NIHSS does not
equal the absence of stroke. Ann Emerg Med. 2011;57:42-45.

* NIH Stroke Scale International. Approach to Human Subject Protection and
Patient Safety. Available at: http://www.nihstrokescale.org. Accessed March
18, 2020.

NIH Stroke Scale International. Approach to Human Subject Protection and
Patient Safety. Available at: http://www.nihstrokescale.org. Accessed March
18, 2020.

* Centers for Disease Control and Prevention. MMWR. 2009 May 1;58:421-426.

Centers for Disease Control and Prevention. MMWR. 2009 May 1;58:421-426.

* Menon BK, Saver JL, Prabhakaran S, et al. Risk score for intracranial
hemorrhage in patients with acute ischemic stroke treated with intravenous
tissue-type plasminogen activator. Stroke. 2012;43:2293-2299.

Menon BK, Saver JL, Prabhakaran S, et al. Risk score for intracranial
hemorrhage in patients with acute ischemic stroke treated with intravenous
tissue-type plasminogen activator. Stroke. 2012;43:2293-2299.

* Searls DE, Pazdera L, Korbel E, Vysata O, Caplan LR. Symptoms and signs of
posterior circulation ischemia in the New England Medical Center
posterior circulation registry. Arch Neurol. 2012;69(3):346-351.
doi:10.1001/archneurol.2011.2083

Searls DE, Pazdera L, Korbel E, Vysata O, Caplan LR. Symptoms and signs of
posterior circulation ischemia in the New England Medical Center
posterior circulation registry. Arch Neurol. 2012;69(3):346-351.
doi:10.1001/archneurol.2011.2083

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

FOLLOW THESE STEPS FOR RECONSTITUTING 50-MG VIALS.6

* Reconstitute Activase immediately before administration, using only
preservative free Sterile Water for Injection (SWFI), U.S. Pharmacopeia
(USP).
* A single 50-mg vial of Activase may be used to treat patients weighing up to
122 lbs (55.5 kg). Reconstitute Activase immediately before administration,
using aseptic technique at all times.
* Begin by assembling the 50-mg vial of Activase, the vial of SWFI USP,
(included with the Activase package), a 50-mL syringe, a large-bore needle
(eg, 18-gauge), and alcohol wipes. Also, prepare a polyvinyl chloride bag or
glass vial along with an infusion set.
* Reconstitution should be carried out by adding SWFI to the 50-mg vial of
Activase powder.

Step 1: Remove the protective cap from the top of the Activase vial and the vial
of SWFI. Swab the top of each vial with an alcohol wipe to reduce the risk of
contamination.

Step 2: Using the large-bore needle and syringe, withdraw 50 mL of SWFI. Do not
use Bacteriostatic Water for Injection, USP. Do not prime the syringe with air.
Safely discard the diluent vial according to institutional procedures.

Step 3: Insert the syringe into the stopper on the 50-mg vial of Activase and
inject the contents, directing the stream into the lyophilized cake. DO NOT USE
IF VACUUM IS NOT PRESENT. Safely discard the needle and syringe according to
institutional procedures.

Step 4: Mix the solution with a gentle swirl. DO NOT SHAKE. Slight foaming of
the solution is normal. Let the solution stand undisturbed for several minutes
to allow any large bubbles to dissipate. Visually inspect the Activase solution
for particulate matter and discoloration before administration.

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www.activase.com Open in urlscan Pro 104.18.3.62 Public Scan

Form analysis 2 forms found in the DOM

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www.activase.com Open in urlscan Pro
104.18.3.62 Public Scan

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