safely and effectively. See full prescribing information for SAVAYSA. SAVAYSA (edoxaban) tablets for oral use Initial U.S. Approval: 2015 WARNING (A) REDUCED EFFICACY IN NONVALVULAR ATRIAL FIBRILLA- TION PATIENTS WITH CREATININE CLEARANCE (CRCL) 95 ML/MIN (B) PREMATURE DISCONTINUATION OF SAVAYSA...
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) (1.1) SAVAYSA is indicated for the treatment of deep vein thrombosis (DVT) ...
Assess CrCL before initiating therapy (2.1) SAVAYSA (edoxaban) tablets for oral use The recommended dose is 60 mg once daily in patients with CrCL >50 to Initial U.S. Approval: 2015 ≤ 95 mL/min. Do not use SAVAYSA in patients with CrCL > 95 mL/min (2.1) Reduce dose to 30 mg ...
The secondary objectives were to assess the safety and tolerability of edoxaban tablets crushed and delivered either via a NG tube as a suspension or mixed with apple puree and ingested, and to assess the PK properties of the most abundant active metabolite of edoxaban, M-4, for all ...
Tablets 15 mg 30 mg 60 mg The safety and efficacy of edoxaban have not been established in pediatric patients. Dosage Considerations – Should be Given as Follows: Stroke Prophylaxis with Atrial Fibrillation Indicated to reduce risk of stroke and systemic embolism associated with nonvalvular atrial ...