TEST CATALOG ORDERING & RESULTS SPECIMEN HANDLING CUSTOMER SERVICE EDUCATION & INSIGHTS
Test Catalog

Test ID: RIVAR    
Rivaroxaban, Anti-Xa, Plasma

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

Measuring rivaroxaban concentration in selected clinical situations (eg, renal insufficiency, assessment of compliance, periprocedural measurement of drug concentration, suspected overdose, advanced age and extremes of body weight)

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

Rivaroxaban, an oral anticoagulant that directly inhibits factor Xa, has been approved by the FDA for prophylaxis of thrombosis in atrial fibrillation and surgical patients and 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).

 

Plasma Concentrations of Rivaroxaban in Patient Populations Studied(1)

Patient population/clinical setting

Rivaroxaban dose

C-min (ng/mL)*
trough plasma conc (predose)

C-max (ng/mL)**
peak plasma conc (2-4 hours postdose)

VTE prevention after total hip replacement surgery

10 mg once daily

9 (1-38)

125 (91-196)

DVT treatment (continued treatment)

20 mg once daily

26 (6-87)

270 (189-419)

Stroke prevention in patients with non-valvular AF (CR-CL > or =50 mL/min)

20 mg once daily

44 (12-137)

249 (184-343)

Stroke prevention in patients with non-valvular AF (CR-CL 30-49 mL/min)

15 mg once daily

57 (18-136)

229 (178-313)

Secondary prevention in patients with acute coronary syndrome

2.5 mg twice daily

17 (6-37)

46 (28-70)

 

Median (5th-95th percentile)

*Defined as samples collected 20-28 hours after dosing

**Defined as samples collected 2-4 hours after dosing

AF-atrial fibrillation, CR-CL-creatinine clearance, DVT-deep vein thrombosis, VTE-venous thromboembolism

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.

<4 ng/mL

Interpretation Provides information to assist in interpretation of the test results

The lower limit of detection of this assay is 4 ng/mL.

 

Therapeutic reference ranges have not been established. See Clinical Information section for peak and trough drug concentrations observed from clinical trials.

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

Routine monitoring of rivaroxaban is not indicated. Therapeutic reference ranges have not been established, however, peak and trough levels observed in clinical trials at different dosing are available. Rivaroxaban concentration may be affected by drug interactions and liver or renal disease.

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

1. Mueck W, Stampfuss J, Kubitza D, Becka M: Clinical pharmacokinetic and pharmacodynamic profile of rivaroxaban. Clinical Pharmacokinetics. 2014;53(1):1-16 doi: 10.1007/s40262-013-0100-7

2. Bayer Pharma AG. Xarelto (rivaroxaban) Summary of Product Characteristics; 2013. Available at: www.ema.europa.eu/docs/en_GB/document_library/EPAR_-_Product_Information/human/000944/WC500057108.pdf

3. EINSTEIN Investigators, Bauersachs R, Berkowitz SD, et al: Oral rivaroxaban for symptomatic venous thromboembolism. N Engl J Med. 2010;363:2499-510

4. EINSTEIN-PE Investigators, Buller HR, Prins MH, et al: Oral rivaroxaban for the treatment of symptomatic pulmonary embolism. N Engl J Med. 2012;366:1287-1297

5. Patel MR, Mahaffey KW, Garg J, et al: Rivaroxaban versus warfarin in nonvalvular atrial fibrillation. N Engl J Med. 2011;365:883891

6. Siegal DM, Curnutte JT, Connolly SJ, et al: Andexanet alfa for reversal of factor Xa inhibitor activity. N Engl J Med. 2015;373:2413-2424

7. Martin K, Beyer-Westendorf J, Davidson BL, et al: Use of the direct oral anticoagulants in obese patients: guidance from the SSC of the ISTH. J Thromb Haemost. 2016;14:1308-1313

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