Activase® (alteplase) | Treatment for Acute Ischemic Stroke (AIS)

Time 2021-01-03 12:03:42

Web Name: Activase® (alteplase) | Treatment for Acute Ischemic Stroke (AIS)

WebSite: http://www.activase.com

ID:155225

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View videos and instructions for the recommended dosing and administration of Activase for AIS IndicationsActivase® (alteplase) is indicated for the treatment of acute ischemic stroke (AIS). 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.ContraindicationsDo 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 3months) 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 3months) 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.BleedingActivase 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.HypersensitivityHypersensitivity, 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).ThromboembolismThe 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 EmbolizationCholesterol 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 TherapyCoagulation tests and/or measures of fibrinolytic activity may be unreliable during Activase therapy unless specific precautions are taken to prevent invitro 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 ReactionsThe most frequent adverse reaction associated with Activase therapy is bleeding. 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 [published online ahead of print October 30, 2019]. Stroke. doi:10.1161/STR.0000000000000211. 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. Lewandowski C, Santhakumar S. Posterior circulation stroke. Presented at: ACEP; October, 2000; Chicago, IL. 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. 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 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. Solitaire Revascularization Device. Medtronic website. http://www.medtronic.com/us-en/healthcare-professionals/products/neurological/revascularization-stroke/solitaire.html. 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. 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. Rost N. Stroke Reperfusion Therapy: IV t-PA Administration. Massachusetts General Hospital: Stroke Services Website. Last updated: January 01, 2016. Accessed January 16, 2019. doi:10.1161/STR.0b013e318284056a. 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.  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. 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. 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. 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. 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. 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. 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. Kearon C, Akl EA, Ornelas J, et al. Antithrombotic therapy for VTE disease: CHEST guideline and expert panel report. Chest. 2016 Feb;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. 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: 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. NIH Stroke Scale International. Approach to Human Subject Protection and Patient Safety. Available at: http://www.nihstrokescale.org. Accessed March 18, 2020. 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. The information contained in this section of the site is intended for U.S. healthcare professionals only. Click OK if you are a healthcare professional. The link you have selected will take you away from this site to one that is not owned or controlled by Genentech, Inc. Genentech, Inc. makes no representation as to the accuracy of the information contained on sites we do not own or control. Genentech does not recommend and does not endorse the content on any third-party websites. Your use of third-party websites is at your own risk and subject to the terms and conditions of use for such sites. 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. Complete blood count, including platelet counta Markers of cardiac ischemiaa Prothrombin time (PT)/international normalized ratio (INR)a Activated partial thromboplastin time (aPTT)a Electrocardiograma a Although it is desirable to know the results of these tests before administering Activase, fibrinolytic therapy should not be delayed while awaiting results unless: 1) there is clinical suspicion of a bleeding abnormality or thrombocytopenia, 2) the patient has received heparin or warfarin, or 3) the patient has received other anticoagulants (direct thrombin inhibitors or direct factor Xa inhibitors). Submit the form below to share this with a friend or colleague. Genentech will not contact the individuals you share content with. All fields are required. 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By completing and submitting this form, you agree to allow Genentech and its agents to collect the information provided and to be contacted by Genentech and its agents in the future regarding our products, other Genentech products, and related disease education. Genentech will not sell, rent or otherwise distribute your name and any personally identifiable information outside of Genentech and its agents. Genentech will only use your information in accordance with its Privacy Policy. Thank you for registering to receive information and updates about Activase®. Be sure to add email@activase.com to your address book and allowed senders list to ensure you receive the information you requested. To view this video please enable JavaScript, and consider upgrading to a web browser that supports HTML5 video

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