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Test Catalog

Test ID: EDOXA    
Edoxaban, Anti-Xa, Plasma

Useful For Suggests clinical disorders or settings where the test may be helpful

Measuring edoxaban concentration in plasma

 

This test is not useful for monitoring low-molecular-weight heparin (LMWH) or unfractionated heparin (UFH) concentrations.

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

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*
(24 hours after last dose)

Median peak levels
(2 hours after dose)

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
(obtained pre-dose)

Peak levels
(obtained 1-3 hours post dose)

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)

*Trough levels derived from separate references/studies containing different post dose draw times.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

<10 ng/mL

Interpretation Provides information to assist in interpretation of the test results

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.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

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.

Clinical Reference Recommendations for in-depth reading of a clinical nature

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

Special Instructions Library of PDFs including pertinent information and forms related to the test