Generic name: EDOXABAN TOSYLATE 15mg
Dosage form: tablet, film coated
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Nonvalvular Atrial Fibrillation
The recommended dose of SAVAYSA is 60 mg taken orally once daily [see Warnings and Precautions (5.1), Clinical Studies (14.1)]. Assess creatinine clearance, as calculated using the Cockcroft-Gault equation*, before initiating therapy with SAVAYSA. Do not use SAVAYSA in patients with CrCL > 95 mL/min.
*Cockcroft-Gault CrCL = (140-age) x (weight in kg) x (0.85 if female) / (72 x creatinine in mg/dL).
Treatment of Deep Vein Thrombosis and Pulmonary Embolism
The recommended dose of SAVAYSA is 60 mg taken orally once daily following 5 to 10 days of initial therapy with a parenteral anticoagulant [see Clinical Studies (14.2)].
The recommended dose of SAVAYSA is 30 mg once daily in patients with CrCL 15 to 50 mL/min, patients who weigh less than or equal to 60 kg, or patients who are taking certain concomitant P-gp inhibitor medications based on clinical study data in this indication [see Clinical Studies (14.2)].
If a dose of SAVAYSA is missed, the dose should be taken as soon as possible on the same day. Dosing should resume the next day according to the normal dosing schedule. The dose should not be doubled to make up for a missed dose.
SAVAYSA can be taken without regard to food [see Clinical Pharmacology (12.3)].
Transition to or from SAVAYSA
|Warfarin or other Vitamin K Antagonists||SAVAYSA||Discontinue warfarin and start SAVAYSA when the INR is ≤ 2.5|
|Oral anticoagulants other than warfarin or other Vitamin K Antagonists||SAVAYSA||Discontinue current oral anticoagulant and start SAVAYSA at the time of the next scheduled dose of the other oral anticoagulant|
|Low Molecular Weight Heparin (LMWH)||SAVAYSA||Discontinue LMWH and start SAVAYSA at the time of the next scheduled administration of LMWH|
|Unfractionated heparin||SAVAYSA||Discontinue the infusion and start SAVAYSA 4 hours later|
|Abbreviations: INR=International Normalized Ratio|
|SAVAYSA||Warfarin||Oral option: For patients taking 60 mg of SAVAYSA, reduce the dose to 30 mg and begin warfarin concomitantly. For patients receiving 30 mg of SAVAYSA, reduce the dose to 15 mg and begin warfarin concomitantly. INR must be measured at least weekly and just prior to the daily dose of SAVAYSA to minimize the influence of SAVAYSA on INR measurements. Once a stable INR ≥ 2.0 is achieved, SAVAYSA should be discontinued and the warfarin continued|
|SAVAYSA||Warfarin||Parenteral option: Discontinue SAVAYSA and administer a parenteral anticoagulant and warfarin at the time of the next scheduled SAVAYSA dose. Once a stable INR ≥ 2.0 is achieved the parenteral anticoagulant should be discontinued and the warfarin continued|
|SAVAYSA||Non-Vitamin-K Dependent Oral anticoagulants||Discontinue SAVAYSA and start the other oral anticoagulant at the time of the next dose of SAVAYSA|
|SAVAYSA||Parenteral anticoagulants||Discontinue SAVAYSA and start the parenteral anticoagulant at the time of the next dose of SAVAYSA|
Discontinuation for Surgery and Other Interventions
Discontinue SAVAYSA at least 24 hours before invasive or surgical procedures because of the risk of bleeding [see Warnings and Precautions (5.3)].
If surgery cannot be delayed, there is an increased risk of bleeding. This risk of bleeding should be weighed against the urgency of intervention [see Warnings and Precautions (5.3)].
SAVAYSA can be restarted after the surgical or other procedure as soon as adequate hemostasis has been established noting that the time to onset of pharmacodynamic effect is 1-2 hours [see Warnings and Precautions (5.2)]. Administer a parenteral anticoagulant and then switch to oral SAVAYSA, if oral medication cannot be taken during or after surgical intervention.
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