![]() The anticoagulant effect of SAVAYSA cannot be reliably monitored with standard laboratory testing. 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. 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). Concomitant use of drugs affecting hemostasis may increase the risk of bleeding. ![]() Discontinue SAVAYSA in patients with active pathological bleeding. Promptly evaluate any signs or symptoms of blood loss. SAVAYSA increases the risk of bleeding and can cause serious and potentially fatal bleeding. Consider the benefits and risks before neuraxial intervention in patients anticoagulated or to be anticoagulated. ![]() If neurological compromise is noted, urgent treatment is necessary. Monitor patients frequently for signs and symptoms of neurological impairment. Optimal timing between the administration of SAVAYSA and neuraxial procedures is not known.Factors that can increase the risk of developing epidural or spinal hematomas in these patients include: use of indwelling epidural catheters concomitant use of other drugs that affect hemostasis, such as nonsteroidal anti-inflammatory drugs (NSAIDs), platelet inhibitors, other anticoagulants a history of traumatic or repeated epidural or spinal punctures a history of spinal deformity or spinal surgery.Consider these risks when scheduling patients for spinal procedures These hematomas may result in long-term or permanent paralysis. Epidural or spinal hematomas may occur in patients treated with SAVAYSA who are receiving neuraxial anesthesia or undergoing spinal puncture. ![]() 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. Premature discontinuation of any oral anticoagulant in the absence of adequate alternative anticoagulation increases the risk of ischemic events. PREMATURE DISCONTINUATION OF SAVAYSA INCREASES THE RISK OF ISCHEMIC EVENTS.In these patients another anticoagulant should be used. In the ENGAGE AF-TIMI 48 study, NVAF patients with CrCl >95 mL/min had an increased rate of ischemic stroke with SAVAYSA 60 mg once daily compared to patients treated with warfarin. SAVAYSA should not be used in patients with CrCl >95 mL/min. REDUCED EFFICACY IN NVAF PATIENTS WITH CRCL >95 ML/MIN.According to the approved label for SAVAYSA, no dose reduction is recommended for concomitant P-gp inhibitor use or for low body weight (≤60 kg/132 lb) in patients with NVAF. Patients on antiretroviral therapy (ritonavir, nelfinavir, indinavir, saquinavir) as well as cyclosporine were excluded from the study. Patients in the edoxaban treatment arms had their dose halved if 1 or more of the following clinical factors were present: creatinine clearance (CrCl) ≤50 mL/min, low body weight (≤60 kg/132 lb), or concomitant use of specific P-glycoprotein (P-gp) inhibitors (verapamil, quinidine, dronedarone). A total of 21,026 patients received at least 1 dose of study drug (modified intention-to-treat population). A total of 21,105 patients were randomized and followed for a median of 2.8 years and treated for a median of 2.5 years. The low-dose edoxaban arm was evaluated but not approved. The ENGAGE AF-TIMI 48 study was a multinational, double-blind, noninferiority study comparing the efficacy and safety of SAVAYSA 60 mg, a low-dose edoxaban arm, and warfarin in reducing the risk of stroke and SE in patients with NVAF.
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