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Values are valid only on day of printing. |
Measuring edoxaban concentration in plasma
This test is not useful for monitoring low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) concentrations.
Edoxaban, an oral anticoagulant that directly inhibits factor Xa, has been approved by the FDA for prevention of stroke and systemic embolism in patients with non-valvular atrial fibrillation (NVAF) and for the treatment of venous thromboembolism (VTE). Unlike warfarin, it does not require routine therapeutic monitoring. However, in selected clinical situations, measurement of drug level would be useful (eg, renal insufficiency, assessment of compliance, periprocedural measurement of drug concentration, suspected overdose, advanced age and extremes of body weight).
Predicted Edoxaban Steady-State Exposure Concentrations
Nonvalvular atrial fibrillation (1) | Median trough levels* | Median peak levels |
30 mg once daily | 38 ng/mL (7-147) | 169 ng/mL (10-400) |
60 mg once daily | 39 ng/mL (13-110) | 300 ng/mL (60-569) |
| ||
Nonvalvular atrial fibrillation (2) | Median trough levels* (median collection time 20 hours (IQR 15.4-24.3) post dose) |
|
30 mg once daily | 18.4 ng/mL (10.1-32.3) |
|
60 mg once daily | 36 ng/mL (19-62) |
|
| ||
Deep vein thromboembolism and pulmonary embolism continued treatment (3) | Median trough levels | Peak levels |
30 mg once daily | 16 ng/mL (IQR 8.3-32) | 164 ng/mL (IQR 99-225) |
60 mg once daily | 19 ng/mL (10-39) | 234 ng/mL (IQR 149-317) |
<10 ng/mL
The lower limit of detection of this assay is 10 ng/mL.
Therapeutic reference ranges have not been established. For peak and trough drug concentrations observed from clinical trials see Clinical Information.
Routine monitoring of edoxaban is not indicated. Therapeutic reference ranges have not been established, however, peak and trough levels observed in clinical trials at different dosing are available. Edoxaban concentration may be affected by drug interactions as well as liver and renal disease.
1. Testa S, Dellanoce C, Paoletti O, et al: Edoxaban plasma levels in patients with non-valvular atrial fibrillation: Inter and intra-individual variability, correlation with coagulation screening test and renal function. Thromb Res 2019 Mar;175:61-67
2. Ruff CT, Giugliano RP, Braunwald E, et al: Association between edoxaban dose, concentration, anti-Factor Xa activity, and outcomes: an analysis of data from the randomized, double-blind ENGAGE AF-TIMI 48 trial. Lancet 2015 Jun 6; 385(9984):2288-2295
3. Verhamme P, Wells PS, Segers A, et al: Dose reduction of edoxaban preserves efficacy and safety for the treatment of venous thromboembolism. An analysis of the rendomised, double-blind HOKUSAI VTE trial. Thromb Haemost 2016 Sep27;116(4):747-753
4. Package insert: SAVAYSA (edoxaban): Daiichi Sankyo Co., LTD. Tokyo 103-8426, Japan
5. Gosselin RC, Adcock DM, Bates SM, et al: International Council for Standardization in Haematology (ICSH) Recommendations for Laboratory Measurement of Direct Oral Anticoagulants. Thrmb Haemost 2018;118:437-450
6. Douxfils J, Ageno W, Samama CM, et al: Laboratory testing in patients treated with direct oral anticoagulants: a practical guide for clinicians. J Thromb Haemost 2018;16:209-219
7. Adcock DM, Gosselin RC: The danger of relying on the APTT and PT in patients on DOAC therapy, a potential patient safety issue. Int J Lab Hematol 2017;39(Suppl. 1):37-40
8. He L, Kochan J, Lin M, et al: Determination of edoxaban equivalent concentrations in human plasma by an automated anti-factor Xa chromogenic assay. Thromb Res 2017;155:121-127
9. Cuker A, Husseinzadeh H: Laboratory measurement of the anticoagulant activity of edoxaban: a systematic review. J Thromb Thrombolysis 2015;39:288-294