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Subsections
Rivaroxaban Hazardous Material

Anticoagulants

RIVAROXABAN

BLACK BOX WARNING: Thrombotic events, spinal or epidural hematomas

Adult Dosing

  • Non-Valvular Atrial Fibrillation
    • 20 mg PO qPM with meal
    • Switching from warfarin:
      • Start when INR < 3
    • Switching from other anticoagulant (ex: LMWH, non-warfarin PO anticoag):
      • Start 0-2 hrs prior to next scheduled PM dose and omit other anticoagulants
  • Prophylaxis of DVT, post hip/knee S/S
    • Hip: 10 mg PO qD x 35 days
    • Knee: 10 mg PO qD x 12 days (Canada = 14 days)
    • Take initial dose 6-10 hours after surgery
  • Tx of DVT, PE
    • Initial dose: 15 mg PO BID x 21 days, THEN
    • 20 mg PO qD for remainder of Tx
  • Risk reduction of recurrence of DVT, PE
    • After ≥6 mths standard anti-coag Tx:
      • 10 mg PO qD
    • (Canada only)
      • Initial dose: 15 mg PO BID x 21 days, THEN
      • 20 mg PO thereafter
  • Risk reduction in CAD/PAD
    • 2.5 mg PO BID, plus ASA 75-100 mg PO qD
  • Prophylaxis of VTE, acute illness
    • 10 mg PO qD x 31-39 days (in hospital + post-discharge)
  • Heparin-induced thrombocytopenia (off-label)
    • 15 mg PO BID x 21 days or until plt recovery, THEN
    • 20 mg PO qD
  • Prosthetic heart valves: not recommended
  • Missed dose:
    • 2.5 mg BID: admin 2.5 mg at next scheduled time
    • 15 mg BID: admin ASAP to maintain 30 mg/day dosing
      • Okay to admin two 15 mg tablets at same time
      • Resume normal dosing schedule next day
    • 10, 15, or 20 mg qD: admin ASAP (Do not double dose within same day)
  • Administration
    • 10 mg: with/without food
    • 15 mg or 20 mg: with food

Pediatric Dosing

  • VTE Tx/prophylaxis (birth-17 yo)
    • Initiate Tx following ≥5 days of initial parenteral anticoag Tx
    • Tx duration: ≥3 mths; unless <2 yo with catheter-related thrombosis then ≥1 mth
      • 2.6-2.9 kg: 0.8 mg PO TID
      • 3-3.9 kg: 0.9 mg PO TID
      • 4-4.9 kg: 1.4 mg PO TID
      • 5-6.9 kg: 1.6 mg PO TID
      • 7-7.9 kg: 1.8 mg PO TID
      • 8-8.9 kg: 2.4 mg PO TID
      • 9-9.9 kg: 2.8 mg PO TID
      • 10-11.9 kg: 3 mg PO TID
      • 12-29.9 kg: 5 mg PO BID
      • 30-49.9 kg: 15 mg PO qD
      • ≥50 kg: 20 mg PO qD
    • Use not recommended if <6 mo and:
      • <37 wks gestation at birth, OR
      • <10 days oral feeding, OR
      • Bodyweight <2.6 kg
  • Thromboprophylaxis post-Fontan procedure (≥2 yo)
    • 7-7.9 kg: 1.1 mg PO BID
    • 8-9.9 kg: 1.6 mg PO BID
    • 10-11.9 kg: 1.7 mg PO BID
    • 12-19.9 kg: 2 mg PO BID
    • 20-29.9 kg: 2.5 mg PO BID
    • 30-49.9 kg: 7.5 mg PO qD
    • ≥50 kg: 10 mg PO qD
  • Administration
    • Take with food/feeding
    • If <30 kg use susp only
    • Do not split tab in attempt to provide fraction of tab dose

Renal and Hepatic Dosing

  • Renal
    • Adults
      • Non-Valvular Atrial Fibrillation:
        • CrCl 15-50 ml/min: 15 mg PO qPM with meal
        • CrCl <15 ml/min: Avoid
        • CrCl 30-49 ml/min: 15 mg PO qPM with meal (CAN only)
      • Prophylaxis of DVT, post hip/knee S/S; Tx of DVT, PE; Risk reduction of recurrence of DVT, PE; Prophylaxis of VTE, acute illness:
        • CrCl <15 mL/min: Avoid
      • CVE risk reduction in chronic CAD/PAD:
        • No indication for CrCl dose adjustment
    • Peds
      • eGFR <50 mL/min/1.73 m2 or <1 yo with SCr >97.5th percentile
        • Avoid use
  • Hepatic
    • Adults
      • Moderate-severe (Child-Pugh B-C) or any hepatic dz associated with coagulopathy: avoid use
    • Peds
      • No data available; no specific recommendations

Contraindications and Cautions

  • Contraindications
    • Hypersensitivity
    • Active pathological bleeding
    • Hepatic disease associated with coagulopathy and bleeding risk (Canada only)
    • Concomitant systemic Tx with strong CYP3A4 and P-gp inhibitor (Canada only)
    • Nursing women (Canada only)
    • Pregnancy (Canada only)
  • Cautions
    • FDA Black Box Warnings:
      • Premature D/C = incr risk of thrombotic events; consider other anticoagulant when D/C
      • Risk of spinal/epidural hematomas during neuraxial anesthesia/spinal puncture
      • Monitor for S/S neurological impairment and Tx as indicated
    • Risk of serious/fatal bleeding; monitor for S/S and Tx as indicated
      • D/C Tx with active pathological hemorrhage
    • Risk of renal toxicity; see dosing section
      • Recommend D/C with acute renal failure
    • Risk of pregnancy-related hemorrhage; assess risks vs benefits
      • Monitor closely for S/S blood loss
    • Avoid with acute PE in hemodynamically unstable Pts
      • Not a good substitute for unfractionated heparin in these Pts
    • Risk of hemorrhage with acute illness; do not use with high bleed risk pts
    • Risk of thrombosis with triple-positive antiphospholipid syndrome; DOAC Tx not recommended
    • Avoid with concomitant strong Pgp and CYP3A inhibitors or inducers
    • Not recommended with transcatheter aortic valve replacement

Indications and Uses

  • Prevention of stroke or systemic embolism with nonvalvular AF (Go to Evidence-Based Inquiry)
  • Prophylaxis of DVT with knee or hip replacement surgery
  • Tx of DVT and PE
  • Reduction in risk of recurrence of DVT, PE
  • CV or thrombotic vascular event risk reduction in CAD/PAD
  • Prophylaxis of VTE with acute illness at risk for thromboembolic complications
  • Thromboprophylaxis in peds with congenital heart dz after Fontan procedure

Mechanism of Action

  • Selective, direct Factor Xa Inhibitor

Adverse Drug Reactions

  • 1-10%
    • bleeding (5%)
    • back pain (2.9%)
    • wound secretion (2.8%)
    • abdominal pain (2.7%)
    • dizziness (2.2%)
    • pruritis (2.2%)
    • extremity pain (1.7%)
    • insomnia (1.6%)
    • anxiety (1.4%)
    • blister (1.4%)
    • fatigue (1.4%)
    • muscle spasm (1.3%)
    • depression (1.2%)
    • syncope (1.2%)
  • Postmarketing
    • Blood/lymphatic system: agranulocytosis, thrombocytopenia
    • Gastrointestinal: retroperitoneal hemorrhage
    • Hepatobiliary: jaundice, cholestasis, hepatitis (including hepatocellular injury)
    • Immune system: anaphylactic reaction, anaphylactic shock, angioedema
    • Nervous system: cerebral hemorrhage, subdural hematoma, epidural hematoma, hemiparesis
    • Skin/subcutaneous tissue: Stevens-Johnson Syndrome (SJS), drug reaction with eosinophilia and systemic symptoms (DRESS)
    • Injury, poisoning and procedural complications: atraumatic splenic rupture

Pregnancy and Lactation

  • Pregnancy
    • Risk Summary: pregnancy = thromboembolism risk factor
      • Potential for pregnancy-related hemorrhage and/or emergent delivery
    • Human Data: insufficient data, crosses placenta in vitro, pregnancy dosing not established
    • Animal Data: crosses placenta, increase fetal toxicity, fetal body wgt decrease, maternal/fetal death
  • Lactation
    • Risk Summary: dose of 15-30 mg/day produce low levels in milk that are:
      • Below doses (<2%) required for anticoagulation in infants
    • Effect on production: unknown
    • Minimizing exposure: if mother requires Tx, it is not a reason to D/C breastfeeding

Kinetics/Dynamics

  • Bioavailability:
    • 10 mg: 80-100%
    • 20 mg: 66% fasting, 79% w/ food
  • Peak Plasma
    • Time: 2-4 hrs
    • Concentration: 125 mcg/L
  • Half-Life, terminal: 5-9 hrs
  • Protein-Bound: 92-95%
  • Vd: 50 L
  • Clearance: 10 L/hr
  • Metabolism: CYP3A4, CYP2J2 via oxidative degradation and hydrolysis
  • Excretion:
    • Urine (36%)
    • Feces (7%)

Overdose Management

Interactions

Trade Names

    • Dosing Strengths: (tablet) 2.5 mg, 10 mg, 15 mg, 20 mg (granules for suspension) 1 mg/mL
    • United States: Xarelto
    • Canada: Xarelto

      Other Information

      Evidence-Based Practice

      1. What agents should older patients with atrial fibrillation take to prevent stroke?

      References

      1. ASHP Drug Compendium (Rivaroxaban (Systemic); Direct Factor Xa Inhibitors)
      2. FDA Monograph rivaroxaban (Xarelto) https://www.accessdata.fda.gov/drugsatfda_docs/label/2025/022406s044,215859s005lbl.pdf (Accessed June 2025)
      3. Health Canada Monograph rivaroxaban (Xarelto) https://pdf.hres.ca/dpd_pm/00053267.PDF
      4. Daei M, Khalili H, Heidari Z. Direct oral anticoagulant safety during breastfeeding: A narrative review. Eur J Clin Pharmacol 2021;77:1465-71.
      5. Drugs and Lactation Database (LactMed®) [Internet]. Bethesda (MD): National Institute of Child Health and Human Development; 2006-. Rivaroxaban. [Updated 2024 Apr 15]. Available from: https://www.ncbi.nlm.nih.gov/books/NBK500742/
      6. Foody J, Moore KT. American Geriatrics Society Beers Criteria and Anticoagulant Use in Older Adults With Renal Impairment. Kidney Int Rep. 2018 Jan;3(1):222-223
      7. Fordyce CB, Hellkamp AS, Lokhnygina Y, et al. On-Treatment Outcomes in Patients With Worsening Renal Function With Rivaroxaban Compared With Warfarin: Insights From ROCKET AF. Circulation. 2016 Jul 05;134(1):37-47.
      8. Rolf Burghaus et al., Evaluation of the Efficacy and Safety of Rivaroxaban Using a Computer Model for Blood Coagulation. PLoS One. 2011; 6(4): e17626.
      9. Shatzel JJ, Crapster-Pregont M, Deloughery TG. Non-vitamin K antagonist oral anticoagulants for heparin-induced thrombocytopenia. A systematic review of 54 reported cases. Thromb Haemost. 2016;116(2):397-400.
      10. Singh R, Emmady PD. Rivaroxaban. [Updated 2023 Apr 17]. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2024 Jan-. Available from: https://www.ncbi.nlm.nih.gov/books/NBK557502/
      11. Warkentin TE, Pai M, Linkins LA. Direct oral anticoagulants for treatment of HIT: update of Hamilton experience and literature review. Blood. 2017 Aug 31;130(9):1104-1113.

      Contributor(s)

      1. Vaioleti, Alani, PharmD
      2. Reiner, Stefan, PharmD

      Updated/Reviewed: June, 2025