Edoxaban

SAVAYSA is a factor Xa inhibitor indicated: To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Limitation of Use for NVAF SAVAYSA should not be used in patients with creatinine clearance (CrCL) > 95 mL/min because of increased risk of ischemic stroke compared to warfarin at the highest dose studied (60 mg). 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

Edoxaban is a selective inhibitor of FXa. It does not require antithrombin III for antithrombotic activity. Edoxaban inhibits free FXa, and prothrombinase activity and inhibits thrombin-induced platelet aggregation. Inhibition of FXa in the coagulation cascade reduces thrombin generation and reduces thrombus formation.

Treatment of NVAF: Assess CrCL before initiating therapy. The recommended dose is 60 mg once daily in patients with CrCL >50 to ≤ 95 mL/min. Do not use SAVAYSA in patients with CrCL > 95 mL/min. Reduce dose to 30 mg once daily in patients with creatinine clearance 15 to 50 mL/min. Treatment of DVT and PE: The recommended dose is 60 mg once daily. Reduce dose to 30 mg once daily for patients with CrCL 15 to 50 mL/min or body weight less than or equal to 60 kg or who use certain P-gp inhibitors

SAVAYSA is contraindicated in patients with: Active pathological bleeding. Active pathological bleeding

Boxed warning: should not be used in patients with CrCL > 95 mL/min. In the ENGAGE AF-TIMI 48 study, nonvalvular atrial fibrillation 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. In these patients another anticoagulant should be used. Bleeding: Serious and potentially fatal bleeding. Promptly evaluate signs and symptoms of blood loss. Mechanical Heart Valves or Moderate to Severe Mitral Stenosis: Use is not recommended. Increased Risk of Thrombosis in Patients with Triple Positive Antiphospholipid Syndrome: SAVAYSA use not recommended.

The following clinically significant adverse reactions are discussed in greater detail in other sections of the prescribing information. Increased Risk of Stroke with Discontinuation of SAVAYSA in Patients with Nonvalvular Atrial Fibrillation Risk of Bleeding Spinal/Epidural Anesthesia or Puncture Treatment of NVAF: The most common adverse reactions (≥ 5%) are bleeding and anemia. Treatment of DVT and PE: The most common adverse reactions (≥ 1%) are bleeding, rash, abnormal liver function tests and anemia

Anticoagulants, Antiplatelets, Thrombolytics, and Selective Serotonin Reuptake Inhibitors (SSRIs)/Serotonin Norepinephrine Reuptake Inhibitors (SNRIs): Avoid concomitant use due to increased risk of bleeding. Rifampin: Avoid concomitant use

Store at 20-25°C (68-77°F), excursions permitted to 15°-30°C (59°-86°F).