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Anticoagulation in Perspective: A Patient Case Discussion

Dr. Martin Berk presents the risks and benefits of an anticoagulant treatment supported by the results of a large trial in NVAF patients.
  • Overview

    Host Dr. Shira Johnson welcomes Dr. Martin Berk to discuss the key issues and challenges with anticoagulation in reduction of risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation (NVAF). Dr. Berk will also review the clinical safety and efficacy of SAVAYSA® (edoxaban) as a treatment that reduces the risk of stroke and systemic embolism in patients with nonvalvular atrial fibrillation and for the treatment of deep vein thrombosis and pulmonary embolism following 5 to 10 days of initial parenteral anticoagulation therapy. SAVAYSA should not be used in patients with nonvalvular atrial fibrillation with creatinine clearance >95 mL/min due to the increased risk of ischemic stroke compared to warfarin.

    Dr. Martin Berk and Dr. Shira Johnson are presenting on behalf of and receiving compensation from Daiichi Sankyo. Inc. The information presented is consistent with FDA guidelines and the program is not CME accredited and may not be used for CME accreditation.

    This program is intended for healthcare professionals only.

  • Important Safety Information (ISI)

    BOXED WARNINGS

    • REDUCED EFFICACY IN NVAF PATIENTS WITH CRCL >95 ML/MIN
      SAVAYSA® should not be used in patients with CrCl >95 mL/min. In the ENGAGE AF-TIMI 48 study, NVAF patients with CrCl >95mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. In thesepatients another anticoagulant should be used.
    • PREMATUREDISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS
      Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk ofischemic events. If SAVAYSA is discontinued for a reason other than pathological bleeding or completion of a course of therapy,consider coverage with another anticoagulant as described in the transition guidance in the Prescribing Information.
    • SPINAL/EPIDURAL HEMATOMA
      • Epidural or spinal hematomas may occur in patients treated with SAVAYSA who are receiving neuraxial anesthesia or undergoingspinal puncture. These hematomas may result in long-term or permanent paralysis. Consider these risks when scheduling patientsfor spinal procedures
      • Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epiduralcatheters; concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), plateletinhibitors, other anticoagulants; a history of traumatic or repeated epidural or spinal punctures; a history of spinal deformity orspinal surgery
      • Optimal timing between the administration of SAVAYSA and neuraxial procedures is not known

        Monitor patients frequently for signs and symptoms of neurological impairment. If        neurological compromise is noted, urgent treatment
        is necessary. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated.

    CONTRAINDICATIONS
    SAVAYSA is contraindicated in patients with active pathological bleeding.

    WARNINGS AND PRECAUTIONS
    Bleeding Risk
    SAVAYSA increases the risk of bleeding and can cause serious and potentially fatal bleeding. Promptly evaluate any signs or symptoms of blood loss. Discontinue SAVAYSA in patients with active pathological bleeding. Concomitant use of drugs affecting hemostasis may increase the risk of bleeding. These include aspirin and other antiplatelet agents, other antithrombotic agents, fibrinolytic therapy, chronic use of nonsteroidal anti- inflammatory drugs (NSAIDs), selective serotonin reuptake inhibitors (SSRIs), and serotonin norepinephrine reuptake inhibitors (SNRIs). There is no established way to reverse the anticoagulant effects of SAVAYSA, which can be expected to persist for approximately 24 hours after the last dose. The anticoagulant effect of SAVAYSA cannot be reliably monitored with standard laboratory testing. A specific reversal agent for edoxaban is not available. Hemodialysis does not significantly contribute to edoxaban clearance. Protamine sulfate, vitamin K, and tranexamic acid are not expected to reverse its anticoagulant activity.

    Mechanical Heart Valves or Moderate to Severe Mitral Stenosis
    The safety and efficacy of SAVAYSA has not been studied in patients with mechanical heart valves or moderate to severe mitral stenosis. SAVAYSA is not recommended in these patients.

    ADVERSE REACTIONS

    • NVAF: The most common adverse reactions (≥5%) are bleeding and anemia
    • DVT/PE: The most common adverse reactions (≥1%) are bleeding, rash, abnormal liver function tests and anemia

    DISCONTINUATION FOR SURGERY AND OTHER INTERVENTIONS
    Discontinue SAVAYSA at least 24 hours before invasive or surgical procedures because of the risk of bleeding. SAVAYSA can be restarted after the surgical or other procedure as soon as adequate hemostasis has been established.

    DRUG INTERACTIONS

    • Anticoagulants, Antiplatelets, and Thrombolytics: Coadministration of anticoagulants, antiplatelet drugs, and thrombolytics may increase the risk of bleeding
    • P-gp Inducers: Avoid concomitant use of SAVAYSA with rifampin
    • P-gp Inhibitors (DVT/PE only): Coadministration of certain P-gp inhibitor medications requires a dose reduction of SAVAYSA to 30 mg once daily

    SPECIAL POPULATIONS

    • Nursing mothers: Discontinue drug or discontinue nursing
    • Impaired renal function (CrCl 15 to 50 mL/min): Reduce SAVAYSA dose to 30 mg once daily
    • Moderate or severe hepatic impairment: Not recommended
    • Pregnancy Category C

    INDICATIONS
    SAVAYSA® (edoxaban) is indicated to reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). SAVAYSA should not be used in patients with creatinine clearance (CrCl) >95 mL/min because of an increased risk of ischemic stroke compared to warfarin.

    SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5 to 10 days of initial therapy with a parenteral anticoagulant.

    Please see full Prescribing Information, including Boxed WARNINGS and Medication Guide.

    Sponsored by

    DSSV16001850 12/16

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