Edoxaban
Dosing in kidney impairment
Renal Impairment Renal clearance accounts for approximately 50% of the total clearance of edoxaban. Consequently, edoxaban blood levels are increased in patients with poor renal function compared to those with higher renal function. Reduce SAVAYSA dose to 30 mg once daily in patients with CrCL 15-50 mL/min. There are limited clinical data with SAVAYSA in patients with CrCL < 15 mL/min; SAVAYSA is therefore not recommended in these patients.
Hemodialysis does not significantly contribute to SAVAYSA clearance [see Dosage and Administration (2.1 , 2.2) and Clinical Pharmacology ] . As renal function improves and edoxaban blood levels decrease, the risk for ischemic stroke increases in patients with NVAF [see Indications and Usage , Dosage and Administration , and Clinical Studies ] .
Dosing in liver impairment
Hepatic Impairment The use of SAVAYSA in patients with moderate or severe hepatic impairment (Child-Pugh B and C) is not recommended as these patients may have intrinsic coagulation abnormalities. No dose reduction is required in patients with mild hepatic impairment (Child-Pugh A) [see Clinical Pharmacology ] .
Preparation and administration
Administration Information 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 ] .
Administration Options For patients who are unable to swallow whole tablets, SAVAYSA tablets may be crushed and mixed with 2 to 3 ounces of water and immediately administered by mouth or through a gastric tube. The crushed tablets may also be mixed into applesauce and immediately administered orally [see Clinical Pharmacology ] .
| From | To | Recommendation |
|---|---|---|
| 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 |