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Savaysa Generic Name & Formulations
Legal Class
Rx
General Description
Edoxaban 15mg, 30mg, 60mg; tabs.
Pharmacological Class
Factor Xa inhibitor.
How Supplied
Tabs 15mg—30; 30mg, 60mg—30, 90, 500
Manufacturer
Generic Availability
NO
Mechanism of Action
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.
Savaysa Indications
Indications
To reduce the risk of stroke and systemic embolism (SE) in patients with nonvalvular atrial fibrillation (NVAF). Treatment of deep vein thrombosis (DVT) and pulmonary embolism (PE) following 5–10 days of initial therapy with parenteral anticoagulant.
Limitations of Use
Not for use in NVAF patients with CrCl >95mL/min.
Savaysa Dosage and Administration
Adult
Assess CrCl prior to initiation. NVAF: CrCl >50mL/min: 60mg once daily; CrCl 15–50mL/min: 30mg once daily. DVT/PE: CrCl >50mL/min: 60mg once daily following initial parenteral anticoagulant; CrCl 15–50mL/min, body wt. ≤60kg, or concomitant P-gp inhibitors: 30mg once daily. Transition to or from Savaysa: see full labeling.
Children
<18yrs: not established.
Savaysa Contraindications
Contraindications
Active pathological bleeding.
Savaysa Boxed Warnings
Boxed Warning
Reduced efficacy in nonvalvular atrial fibrillation (NVAF) patients with CrCl >95mL/min. Premature discontinuation increases the risk of ischemic events. Spinal/epidural hematoma.
Savaysa Warnings/Precautions
Warnings/Precautions
Reduced efficacy in NVAF patients with CrCl >95mL/min; use another anticoagulant. Premature discontinuation increases risk of ischemic events; if discontinued for reason other than bleeding or therapy completion, consider coverage with another anticoagulant. Increased risk of spinal/epidural hematoma in anticoagulated patients receiving neuraxial anesthesia or undergoing spinal puncture (eg, use of indwelling epidural catheters); monitor for neurological impairment. Increased risk of bleeding; monitor for signs/symptoms of blood loss; discontinue if active pathological hemorrhage occurs. Patients with mechanical heart valves, moderate to severe mitral stenosis, triple(+) antiphospholipid syndrome (increased risk of thrombosis): not recommended. Discontinue at least 24hrs before surgery. Renal impairment (CrCl <15mL/min), moderate or severe hepatic impairment (Child-Pugh B and C): not recommended. Labor & delivery. Pregnancy. Females of reproductive potential. Abnormal uterine bleeding. Nursing mothers: not recommended.
Savaysa Pharmacokinetics
Absorption
Peak plasma concentrations: within 1–2 hours. Absolute bioavailability: 62%.
Distribution
Volume of distribution (at steady state): 107 L. Plasma protein bound: ~55%.
Elimination
Renal. Half-life: 10–14 hours.
Savaysa Interactions
Interactions
Increased risk of bleeding with concomitant aspirin, other antiplatelets or antithrombotic agents, fibrinolytic therapy, chronic NSAIDs, SSRIs, and SNRIs; monitor. Concomitant other anticoagulants in long term therapy: not recommended. Monitor for bleeding in chronic treatment with low dose aspirin and/or NSAIDs. Avoid concomitant P-gp inducers (eg, rifampin).
Savaysa Adverse Reactions
Adverse Reactions
Bleeding (may be serious or fatal), anemia, rash, abnormal LFTs.
Savaysa Clinical Trials
See Literature
Savaysa Note
Not Applicable
Savaysa Patient Counseling
See Literature
