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Home , Apixaban, Plasminogen activator

CLINICAL PROTOCOL

Subject: Page Protocol # EMERGENT TREATMENT OF PATIENTS WITH AND 1 of 4 NMH CCP 07.0024 CLOTTING EMERGENCIES WHO ARE TAKING NOVEL ORAL Version: 1.0 Title: Revision of: Effective Date: EMERGENT TREATMENT OF PATIENTS WITH BLEEDING AND NEW 04/29/2013 CLOTTING EMERGENCIES WHO ARE TAKING NOVEL ORAL Removal Date: (ELIQUIS)

I. PURPOSE: To standardize management of patients with bleeding and clotting emergencies who are taking novel oral anticoagulants (NOACs). This protocol covers emergent reversal and ischemic in patients on apixaban (Eliquis) therapy.

II. CLINICAL PROTOCOL: A. The NOAC apixaban (Eliquis) is FDA approved for stroke prevention in patients with . This agent presents clinicians with several challenges because there are no specific , and no readily available quantitative assay to determine the degree of anticoagulation in a patient on this therapy. B. Patients taking this agent are likely to present to the hospital with; 1. life-threatening bleeding (e.g., intracerebral hemorrhage or GI bleeding), or a need for an emergent invasive procedure (surgery, cardiac Catherization) 2. acute ischemic stroke. The administration of tissue (IV tPA) in the setting of NOAC use is potentially dangerous. C. There are no accepted evidence-based guidelines for managing these situations. This protocol is a consensus of clinicians from stroke, neurology, neurosurgery, hematology, neurocritical care, laboratory medicine, cardiology, and pharmacy.

III. REVERSAL PROTOCOL FOR PATIENTS WITH SEVERE/LIFE-THREATENING BLEEDING TAKING APIXABAN (ELIQUIS) A. Inclusion criteria: 1. Patient has taken any dose of apixaban within last 48 hours. a. If time of last dose is unknown, but patient is suspected of having taken apixaban in last 48 hours, and PT is abnormal and 2. Patient has clinically significant acute intracranial or intraspinal hemorrhage, and/or 3. Any life threatening bleeding (including surgical or traumatic) in which emergent reversal of coagulopathy is necessary, and/or

Title: Page Protocol # NMH CCP 07.0024 TREATMENT OF PATIENTS WITH BLEEDING AND CLOTTING EMERGENCIES 2 of 4 Version: 1.0 WHO ARE TAKING NOVEL ORAL ANTICOAGULANTS APIXABAN (ELIQUIS)

4. Any other situation (e.g. need for emergent invasive procedure) in which emergent reversal of coagulopathy is necessary. B. Procedure for Apixaban (Eliquis) Reversal 1. Discontinue all anticoagulants and anti- therapies 2. Support vital functions as per routine protocols 3. Send PT “super stat”. 4. Do not follow INR; it is less reliable than PT. 5. Do not wait for results if time of last dose is known (refer to Inclusion 1). 6. If time of last dose is within 12 hours order 100 IU/kg of FEIBA x 1. a. Consider activated charcoal administration 7. If time of last dose is unknown or greater than 12 hours order 50 IU/kg FEIBA x 1. 8. Call Pharmacy and alert them that FEIBA is being ordered for life threatening apixiban coagulopathy and is needed immediately. 9. Infuse FEIBA 10. After 1 hour, redraw PT level to assess reversal of coagulopathy. 11. Stat consult to Hematology. 12. Consider re-dosing of FEIBA if uncontrolled bleeding continues (in consultation with Hematology). 13. Patient should be moved to an ICU, but do not delay FEIBA infusions for ICU transfer. 14. Apixaban is not dialyzable; do not initiate emergent dialysis for this indication.

IV. INTRAVENOUS FOR ACUTE ISCHEMIC STROKE IN PATIENTS TAKING OR SUSPECTED OF TAKING APIXABAN (ELIQUIS): A. Principle: No IV thrombolysis if clinically meaningful effect of the drug may be present. B. All standard inclusion/exclusion criteria apply (for 0-3 hours, or 3 – 4.5 hours windows, as appropriate). 1. For patients taking or suspected of taking apixaban 2. If last dose has been taken within 48 hours, do not administer IV tPA (regardless of laboratory results). a. If last dose unknown, draw PT “super stat” and wait for results. b. If PT is abnormal, do not administer IV tPA. c. Consider intra-arterial therapies (mechanical, local thrombolysis) as appropriate. d. Do not administer FEIBA and then administer IV tPA; however, consider FEIBA prior to groin puncture if intra-arterial therapies are planned.

Title: Page Protocol # NMH CCP 07.0024 TREATMENT OF PATIENTS WITH BLEEDING AND CLOTTING EMERGENCIES 3 of 4 Version: 1.0 WHO ARE TAKING NOVEL ORAL ANTICOAGULANTS APIXABAN (ELIQUIS)

V. CLINICAL PROTOCOL UPDATE SCHEDULE: Every two years, or more often, as appropriate

VI. REFERENCES: Apixaban Prescribing Information (accessed at eliquis.com, Feb 25, 2013) Konkle, B.A. Monitoring target specific anticoagulants. J. Thrombosis and Thrombolysis. Online publication Feb 5, 2013

VII. APPENDICES: None Title: Page Protocol # NMH CCP 07.0024 TREATMENT OF PATIENTS WITH BLEEDING AND CLOTTING EMERGENCIES 4 of 4 Version: 1.0 WHO ARE TAKING NOVEL ORAL ANTICOAGULANTS APIXABAN (ELIQUIS)

VIII. APPROVAL:

Responsible Party: Robert Fortney, MS, RN, CNRN, NE-BC Director, Musculoskeletal & Neurosciences

Reviewers: Kimberly Levasseur-Franklin, Pharm D. Pharmacy Brandon McMahon, M.D. (Hematology) Dan Fintel, M.D. (Cardiology)

Rod Passman, M.D. (Cardiac Electrophysiology) Paul Lindholm, M.D. (Laboratory Medicine) Deborah Bergman, A.P.N., FNP (Stroke NP) Bernard Bendok, M.D. (Neurosurgery)

Committees: Medical Safety Committee, March 11, 2013 Pharmacy and Therapeutics, March 21, 2013

Approval Party: Richard Bernstein, M.D. Medical Director, NMH Stroke Service Electronic Approval: 04/22/2013

IX. REVIEW HISTORY: Written: 03/11/2013