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Acute Ischemic Stroke Indication

Activase is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS in the full prescribing information).

Acute Massive Pulmonary Embolism Indication

Activase is indicated in the management of acute massive pulmonary embolism (AMPE) in adults: (1) for the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lungs; (2) for the lysis of pulmonary emboli accompanied by unstable hemodynamics, eg, failure to maintain blood pressure without supportive measures. The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning.

Important Safety Information

CONTRAINDICATIONS

Acute Ischemic Stroke (AIS):

• Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage [See CONTRAINDICATIONS in the full prescribing information].
• Activase therapy in patients with AIS is contraindicated in certain situations (eg, suspicion of subarachnoid hemorrhage on pretreatment evaluation), recent (within 3 months) intracranial or intraspinal surgery, history of intracranial hemorrhage, uncontrolled hypertension at time of treatment, active internal bleeding, known bleeding diathesis (eg, current use of oral anticoagulants, administration of heparin within 48 hours of onset of stroke, platelet count <100,000/mm³) [See CONTRAINDICATIONS in the full prescribing information].

Pulmonary Embolism (PE):

• Activase therapy in patients with PE is contraindicated in certain situations (eg, active internal bleeding, history of cerebrovascular accident, recent intracranial or intraspinal surgery or trauma, severe uncontrolled hypertension) [See CONTRAINDICATIONS in the full prescribing information].

WARNINGS

The risks of Activase therapy for all approved indications may be increased and should be weighed against the anticipated benefits in certain conditions [See WARNINGS in the full prescribing information].

Acute Ischemic Stroke (AIS):

• Patients with severe neurological deficit (eg, NIHSS >22) at presentation. There is an increased risk of intracranial hemorrhage in these patients.
• Patients with major early infarct signs on a computerized cranial tomography (CT) scan (eg, substantial edema, mass effect, or midline shift).
• Treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended [See WARNINGS in the full prescribing information].

Pulmonary Embolism (PE):

• Treatment of PE with Activase has not been shown to constitute adequate clinical treatment of underlying deep vein thrombosis. The possible risk of reembolization due to the lysis of underlying deep venous thrombi should be considered.

PRECAUTIONS (AIS)

Orolingual angioedema has been observed in postmarketing experience in patients treated with Activase for AIS. Patients should be monitored during and for several hours after infusion for signs of orolingual angioedema.

ADVERSE REACTIONS

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately, along with any concomitant therapy with heparin. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.

Please see full Prescribing Information for additional Important Safety Information.

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1. Jauch EC, Saver JL, Adams HP Jr, et al. Guidelines for the early management of patients with acute ischemic stroke: a guideline for healthcare professionals from the American Heart Association/American Stroke Association. Stroke. 2013;44(3):870-947.
2. Saver JL. Time is brain–quantified. Stroke. 2006;37:263-266.
3. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics–2011 update: a report from the American Heart Association. Circulation. 2011;123(4):e18-e209.
4. Kochanek KD, Xu J, Murphy SL, et al. Deaths: Preliminary Data for 2009. Natl Vital Stat Rep. 2011;59:1-51.
5. National Stroke Association website. Stroke 101. http://www.stroke.org/site/DocServer/STROKE_101_Fact_Sheet.pdf?docID=4541. Accessed March 22, 2013.
6. Solomon NA, Glick HA, Russo CJ, et al. Patient preferences for stroke outcomes. Stroke. 1994;25(9):1721-1725.
7. Edlow JA, Smith EE, Stead LG, et al. Clinical policy: Use of intravenous tPA for the management of acute ischemic stroke in the emergency department. American College of Emergency Physicians and American Academy of Neurology. Ann Emerg Med. 2013;61:225-243.
8. American Academy of Neurology. Practice Advisory: thrombolytic therapy for acute ischemic stroke summary statement. Report of the Quality Standards Subcommittee of the American Academy of Neurology. Neurology. 1996; 47(3):835-839.
9. National Institute of Neurological Disorders and Stroke rt-PA Stroke Study Group. Tissue plasminogen activator for acute ischemic stroke. N Engl J Med. 1995;333(24):1581-1587.
10. Albers GW, Bates VE, Clark WM, Bell R, Verro P, Hamilton SA. Intravenous tissue-type plasminogen activator for treatment of acute stroke: the Standard Treatment with Alteplase to Reverse Stroke (STARS) study. JAMA. 2000;283(9):1145-1150.
11. Hill MD, Buchan AM; the Canadian Alteplase for Stroke Effectiveness Study (CASES) Investigators. Thrombolysis for acute ischemic stroke: results of the Canadian Alteplase for Stroke Effectiveness Study. CMAJ. 2005;172(10):1307-1312.
12. Wahlgren N, Ahmed N, Dávalos A, et al; the SITS-MOST Investigators. Thrombolysis with alteplase for acute ischaemic stroke in the Safe Implementation of Thrombolysis in Stroke-Monitoring Study (SITS-MOST): an observational study. Lancet. 2007;369(9558):275-282.
13. Activase Prescribing Information. Genentech USA, Inc. April 2011.
14. Heart.org website. TARGET: STROKE Best Practice Strategies. http://www.strokeassociation.org/idc/groups/heart-public/@wcm/@private/@hcm/@gwtg/documents/downloadable/ucm_310253.pdf. Accessed March 22, 2013.
15. Roger VL, Go AS, Lloyd-Jones DM, et al. Heart disease and stroke statistics—2012 update: a report from the American Heart Association.Circulation. 2012;125(1):e2-e220.
16. Fonarow GC, Smith EE, Saver JL, et al. Timeliness of tissue-type plasminogen activator therapy in acute ischemic stroke: patient characteristics, hospital factors, and outcomes associated with door-to-needle times within 60 minutes. Circulation. 2011;123(7):750-758.
17. Jauch EC. The "golden hour" of acute ischemic stroke: treatment guidelines & recommendations. The Internet Stroke Center website. http://www.strokecenter.org/education/jauch/02.htm. Accessed March 22, 2013.
18. Jauch EC, Cucchiara B, Adeoye O, et al. Part 11: adult stroke. 2010 American Heart Association guidelines for cardiopulmonary resuscitation and emergency cardiovascular care. Circulation. 2010;122(18)(suppl 3):S818-S828.
19. Data on file. Genentech USA, Inc.
20. Brott TG, Haley EC Jr, Levy DE, et al. Urgent therapy for stroke. Part I. Pilot study of tissue plasminogen activator administered within 90 minutes. Stroke. 1992;23(5):632-640.
21. Alberts MJ, Hademenos G, Latchaw RE, et al; for the Brain Attack Coalition. Recommendations for the establishment of primary stroke centers. JAMA. 2000;283(23):3102-3109.
22. Alberts MJ, Latchaw RE, Selman WR, et al; for the Brain Attack Coalition. Recommendations for the establishment of comprehensive stroke centers: a consensus statement from the Brain Attack Coalition. Stroke. 2005;36:1597-1618.
23. Schwamm LH, Audebert HJ, Amarenco P, et al. Recommendations for the implementation of telemedicine within stroke systems of care: a policy statement from the American Heart Association. Stroke. 2009;40(7):2635-2660.
24. Joint Commission. Facts about primary stroke center certification. Joint Commission website. http://www.jointcommission.org/assets/1/18/Primary_Stroke_Center_Certification.pdf. Accessed March 22, 2013.
25. National Institute of Neurological Disorders and Stroke. Proceedings of a National Symposium on Rapid Identification and Treatment of Acute Stroke. March 22, 2013. Bethesda, MD: National Institutes of Health; 1997. NINDS website. http://www.ninds.nih.gov/news_and_events/proceedings/strokeworkshop.htm. Updated May 5, 2001. Accessed March 22, 2013.
26. Estes D. Preparing for primary stroke center certification: optimizing stroke outcomes with t-PA. Paper presented at: Medical City Dallas Hospital; 2008; Dallas, TX.
27. 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. Updated May 21, 2010. Accessed March 22, 2013.
28. Heiss W-D. Ischemic penumbra: evidence from functional imaging in man. J Cereb Blood Flow Metab. 2000;20(9):1276-1293.
29. Heiss WD. Flow thresholds of functional and morphological damage of brain tissue. Stroke. 1983;14(3):329-331.
30. Rymer MM, Summers D, and Khatri P. The Stroke Center Handbooks: Organizing for Better Outcomes: A Guide to Stroke Center Development and Operations. 2006.
31. Graham GD. Tissue plasminogen activator for acute ischemic stroke in clinical practice: a meta-analysis of safety data. Stroke. 2003;34:2847-2850.
32. American Stroke Association (ASA). ASA website. http://www.heart.org/HEARTORG/HealthcareResearch/GetWithTheGuidelinesHFStroke/Get-With-The-Guidelines-Stroke-Home-Page_UCM_306098_SubHomePage.jsp#. Accessed March 22, 2013.
33. Joint Commission. Advanced certification for primary stroke centers. Joint Commission website. http://www.jointcommission.org/certification/primary_stroke_centers.aspx. Accessed March 22, 2013.
34. Alberts MJ and Baranski J. Building the case for a primary stroke center. National Stroke Association website. http://www.stroke.org/site/DocServer/Resource_Guide.pdf?docID=4681. Accessed March 22, 2013.
35. Demaerschalk BM, Miley ML, Kiernan T-E J, et al; for STARR Coinvestigators. Stroke telemedicine. Mayo Clin Proc. 2009;84(1):53-64.
36. Demaerschalk B, Kiernan T. Stroke telemedicine in Arizona. Paper presented at: Mayo Clinic College of Medicine; 2008; Phoenix, AZ. http://www.azcvd.gov/pdf/Stroke%20Telemedicine%20Presentation.pdf. Accessed March 22, 2013.
37. Shafqat D, Kvedar JC, Guanci MM, Chang Y, Schwamm LH. Role for telemedicine in acute stroke: feasibility and reliability of remote administration of the NIH Stroke Scale. Stroke. 1999;30(10):2141-2145.
38. Hess DC, Wang S, Gross H, Nichols FT, Hall CE, Adams RJ. Telestroke: extending stroke expertise into underserved areas. Lancet Neurol. 2006;5(3):275-278.
39. Centers for Medicare & Medicaid Services. Hospital Inpatient Quality Reporting Program. Available at: https://www.cms.gov/Medicare/Quality-Initiatives-Patient-Assessment-Instruments/ HospitalQualityInits/HospitalRHQDAPU.html. Accessed on March 22, 2013.
40. Centers for Medicare & Medicaid Services. CMS-1518-F; CMS-1430-F. Medicare Program; Hospital Inpatient Prospective Payment Systems for Acute Care Hospitals and the Long-Term Care Hospital Prospective Payment System and FY 2012 Rates; Hospitals' FTE Resident Caps for Graduate Medical Education Payment. August 1, 2011.
41. Centers for Medicare & Medicaid Services. Fact Sheet: CMS makes changes to improve quality of care during hospital inpatient stays. Washington DC: CMS; August 1, 2012.
42. The Joint Commission. Improving America's Hospitals: The Joint Commission's Annual Report on Quality and Safety. Oakbrook Terrace, IL: The Joint Commission. 2012.
43. Acker III JE, Pancioli AM, Crocco TJ, et al. Implementation strategies for emergency medical services within stroke systems of care: a policy statement from the American Heart Association/American Stroke Association Expert Panel on Emergency Medical Services Systems and the Stroke Council. Stroke. 2007;38;3097-3115.
44. Schwamm LH, Pancioli A, Acker III 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;690-703.
45. 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;42:2983-2989.
46. Wood KE. Major pulmonary embolism: review of a pathophysiologic approach to the golden hour of hemodynamically significant pulmonary embolism. Chest. 2002;121:877-905.
47. 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; 2004:625-663.
48. Kucher N, Goldhaber SZ. Management of massive pulmonary embolism. Circulation. 2005;112:e28-e32.
49. American Academy of Neurology Web site. Guideline search. http://www.aan.com/practice/guideline/index.cfm?fuseaction=home.welcome&Topics=20&keywords=&Submit=Search+Guidelines. Accessed March 8, 2013.

Acute Ischemic Stroke Indication

Activase is indicated for the management of acute ischemic stroke in adults for improving neurological recovery and reducing the incidence of disability. Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage (see CONTRAINDICATIONS in the full prescribing information).

Acute Massive Pulmonary Embolism Indication

Activase is indicated in the management of acute massive pulmonary embolism (AMPE) in adults: (1) for the lysis of acute pulmonary emboli, defined as obstruction of blood flow to a lobe or multiple segments of the lungs; (2) for the lysis of pulmonary emboli accompanied by unstable hemodynamics, eg, failure to maintain blood pressure without supportive measures. The diagnosis should be confirmed by objective means, such as pulmonary angiography or noninvasive procedures such as lung scanning.

Important Safety Information

CONTRAINDICATIONS

Acute Ischemic Stroke (AIS):

• Treatment should only be initiated within 3 hours after the onset of stroke symptoms, and after exclusion of intracranial hemorrhage by a cranial computerized tomography (CT) scan or other diagnostic imaging method sensitive for the presence of hemorrhage [See CONTRAINDICATIONS in the full prescribing information].
• Activase therapy in patients with AIS is contraindicated in certain situations (eg, suspicion of subarachnoid hemorrhage on pretreatment evaluation), recent (within 3 months) intracranial or intraspinal surgery, history of intracranial hemorrhage, uncontrolled hypertension at time of treatment, active internal bleeding, known bleeding diathesis (eg, current use of oral anticoagulants, administration of heparin within 48 hours of onset of stroke, platelet count <100,000/mm³) [See CONTRAINDICATIONS in the full prescribing information].

Pulmonary Embolism (PE):

• Activase therapy in patients with PE is contraindicated in certain situations (eg, active internal bleeding, history of cerebrovascular accident, recent intracranial or intraspinal surgery or trauma, severe uncontrolled hypertension) [See CONTRAINDICATIONS in the full prescribing information].

WARNINGS

The risks of Activase therapy for all approved indications may be increased and should be weighed against the anticipated benefits in certain conditions [See WARNINGS in the full prescribing information].

Acute Ischemic Stroke (AIS):

• Patients with severe neurological deficit (eg, NIHSS >22) at presentation. There is an increased risk of intracranial hemorrhage in these patients.
• Patients with major early infarct signs on a computerized cranial tomography (CT) scan (eg, substantial edema, mass effect, or midline shift).
• Treatment of patients with minor neurological deficit or with rapidly improving symptoms is not recommended [See WARNINGS in the full prescribing information].

Pulmonary Embolism (PE):

• Treatment of PE with Activase has not been shown to constitute adequate clinical treatment of underlying deep vein thrombosis. The possible risk of reembolization due to the lysis of underlying deep venous thrombi should be considered.

PRECAUTIONS (AIS)

Orolingual angioedema has been observed in postmarketing experience in patients treated with Activase for AIS. Patients should be monitored during and for several hours after infusion for signs of orolingual angioedema.

ADVERSE REACTIONS

The most common complication during Activase therapy is bleeding. Should serious bleeding in a critical location (intracranial, gastrointestinal, retroperitoneal, pericardial) occur, Activase therapy should be discontinued immediately, along with any concomitant therapy with heparin. Death and permanent disability are not uncommonly reported in patients who have experienced stroke (including intracranial bleeding) and other serious bleeding episodes.

Please see full Prescribing Information for additional Important Safety Information.