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1.1. Adults

Direct oral anticoagulants (DOACs) are FDA-approved to treat and prevent deep venous thrombosis (DVT) and pulmonary embolism (PE), reduce the risk of stroke and systemic embolism from non-valvular atrial fibrillation, and to be used as prophylaxis against DVT and PE after knee and hip surgery. DOACs work by interfering with pathways in the coagulation cascade: directly inhibiting thrombin (e.g., dabigatran); or selectively, reversibly inhibiting factor Xa (e.g., apixaban, edoxaban, rivaroxaban)1-6.

Maximum recommended adult dosages for DOACs are summarized in Tables 1 and 2. Medication profiles identifying patients prescribed dosages exceeding these recommendations will be reviewed.

Table 1. Maximum Daily Adult Dosages for DOACs: Direct Thrombin Inhibitors1-3
Drug NameDosage Form/StrengthTreatment IndicationMaximum Recommended Dosage 
dabigatran (Pradaxa®)75 mg, 110 mg, 150 mg capsulesReduction in risk of stroke and systemic embolism in non-valvular AF
  • CrCl greater than 30 mL/min:
    • 50 mg twice daily
  • CrCl 15-30 mL/min:
    • 75 mg twice daily
  • CrCl less than 15 mL/ min:
    • dosing recommendations cannot be provided
  • CrCl 30-50 mL/min with concomitant use of P-gp inhibitors:
    • 75 mg twice daily
  • CrCl less than 30 mL/min with concomitant use of P-gp inhibitors:
    • Avoid coadministration
dabigatran Treatment of DVT and PE/reduction in the risk of recurrence of DVT and PE
  • CrCl greater than 30 mL/ min:
    • 150 mg twice daily*
  • CrCl less than or equal to 30 mL/ min:
    • dosing recommendations cannot be provided
  • CrCl less than 50 mL/ min with concomitant use of P-gp inhibitors:
    • Avoid coadministration
dabigatran Prophylaxis of DVT and PE following hip replacement surgery
  • CrCl greater than 30 mL/min:
    • 110 mg for first day, then 220 mg once daily
  • CrCl less than or equal to 30 mL/ min:
    • dosing recommendations cannot be provided
  • CrCl less than 50 mL/ min with concomitant use of P-gp inhibitors:
    • Avoid coadministration

Legend:

  • AF = atrial fibrillation
  • DVT = deep venous thrombosis
  • PE = pulmonary embolism
  • * = Requires 5 to 10 days parenteral therapy before initiation of therapy
Table 2. Maximum Daily Adult Dosages for DOACs: Factor Xa Inhibitors1,2,5-7
Drug NameDosage Form/StrengthTreatment IndicationMaximum Recommended Dosage 
apixaban (Eliquis®)2.5 mg, 5 mg tabletsReduction of risk of stroke and systemic embolism in patients with non-valvular AF5 mg twice daily#
apixaban Prophylaxis of DVT following hip or knee replacement surgery2.5 mg twice daily
apixaban Treatment of DVT and PE10 mg twice daily for 7 days, then 5 mg twice daily
apixaban Reduction in risk of recurrence of DVT and PE2.5 mg twice daily^
edoxaban (Savaysa®)15 mg, 30 mg, 60 mg tablets

Non-valvular AF: 

CrCl greater than 50 mL/min and less than or equal to 95 mL/min

60 mg once daily+
  

Non-valvular AF:

CrCl 15-50 mL/min

30 mg once daily
  non-valvular AF: CrCl less than 15 mL/minnot recommended
  

Treatment of DVT and PE:

greater than or equal to 60 kg

60 mg once daily*
  

Treatment of DVT and PE:

less than 60 kg, CrCl 15-50 mL/min, adjunctive therapy with certain P-gp inhibitors

30 mg once daily*
  treatment of DVT and PE: CrCl less than 15 mL/minnot recommended
rivaroxaban (Xarelto®)2.5 mg, 10 mg, 15 mg, 20 mg tablets, 1 mg/ 1 mL granules for suspensionReduction in the risk of stroke in non-valvular AF, CrCl greater than 50 mL/min20 mg once daily with evening meal
  Reduction in the risk of stroke in non-valvular AF, CrCl less than or equal to 50 mL/min15 mg once daily with evening meal
  Treatment of DVT and PE, CrCl greater than or equal to 15 mL/min15 mg twice daily for 21 days, then 20 mg once daily
  treatment of DVT and PE, CrCl less than 15 mL/minavoid use
  Reduction in risk of recurrence of DVT and PE (following initial treatment), CrCl greater than or equal to 15 mL/min10 mg once daily^
  reduction in risk of recurrence of DVT and PE (following initial treatment), CrCl less than 15 mL/minavoid use
  Prophylaxis of DVT following hip or knee replacement surgery, CrCl greater than or equal to 15 mL/min10 mg once daily
  prophylaxis of DVT following hip or knee replacement surgery, CrCl less than 15 mL/minavoid use
  VTE prophylaxis in hospitalized adults with acute illness and limited mobility and other risk factors for VTE, CrCl greater than or equal to 15 mL/min10 mg once daily
  VTE prophylaxis in hospitalized adults with CrCl less than 15 mL/minAvoid use
  Reduction of major cardiovascular event risk in patients with chronic coronary heart disease, peripheral artery disease2.5 mg twice daily, plus aspirin 75-100 mg once daily

Legend

  • AF = atrial fibrillation
  • DVT = deep venous thrombosis
  • PE = pulmonary embolism
  • P-gp = P-glycoprotein
  • VTE = venous thromboembolism
  • + Avoid in patients with CrCl greater than 95 ml/min due to increased risk of ischemic stroke compared to warfarin
  • * Requires 5 to 10 days parenteral therapy before initiation of therapy
  • # Dose should be decreased to 2.5 mg twice daily in patients receiving strong inhibitors of both CYP3A4 and P-glycoprotein concurrently, or those with at least two of the following: age greater than or equal to 80 years, body weight less than or equal to 60 kg, or serum creatinine greater than or equal to 1.5 mg/dL
  • ^ Following at least 6 months of DVT or PE treatment