Edoxaban tablets (Savaysa, adults) - selected U.S. label sections
- Product / population
- Adult SAVAYSA oral tablets; atrial fibrillation and venous thromboembolism are distinct indications.
- Renal measure
- Cockcroft-Gault creatinine clearance in mL/min
Selected renal sections only, not a complete monograph. Exact product, indication, patient population, renal method and all other contraindications/interactions remain controlling.
Second independent renal reference and clinician adjudication remain pending; no all-indication, dialysis or pediatric dose may be inferred from an omitted field.
Nonvalvular atrial fibrillation - renal regimen
| Cockcroft-Gault CrCl | Oral regimen |
|---|---|
| Above 50 through 95 mL/min | 60 mg once daily |
| 15 through 50 mL/min | 30 mg once daily |
| Above 95 mL/min | Do not use for NVAF; choose another anticoagulant |
The high-clearance restriction reflects reduced efficacy for NVAF and is not a low-renal-function precaution.
DVT or PE - separate dose rule
After 5-10 days of parenteral anticoagulation, the usual labeled dose is 60 mg once daily. Reduce to 30 mg once daily for CrCl 15-50 mL/min, body weight at or below 60 kg, or specified P-gp inhibitors. This summary does not provide an ESRD or dialysis regimen.
Source: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e77d3400-56ad-11e3-949a-0800200c9a66