S:9.5”
8.6 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
(12.3) in the full prescribing information].
• to report any unusual bleeding immediately to their healthcare provider
As renal function improves and edoxaban blood levels decrease, the risk for
ischemic stroke increases in patients with NVAF [see Indications and Usage
(1.1), Dosage and Administration (2.1), and Clinical Studies (14.1) in the
full prescribing information].
• to inform their healthcare provider immediately if they become pregnant
or intend to become pregnant or are breastfeeding or intend to breastfeed
during treatment with SAVAYSA
8.7 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 (12.3) in the full prescribing information].
8.8 Low Body Weight Consideration for Patients treated for DVT and/or PE
Based on the clinical experience fro