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.
Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Dosage |
---|---|---|---|
dabigatran (Pradaxa®) | 75 mg, 110 mg, 150 mg capsules | Reduction in risk of stroke and systemic embolism in non-valvular AF |
|
dabigatran | Treatment of DVT and PE/reduction in the risk of recurrence of DVT and PE |
| |
dabigatran | Prophylaxis of DVT and PE following hip replacement surgery |
|
Legend:
- AF = atrial fibrillation
- DVT = deep venous thrombosis
- PE = pulmonary embolism
- * = Requires 5 to 10 days parenteral therapy before initiation of therapy
Drug Name | Dosage Form/Strength | Treatment Indication | Maximum Recommended Dosage |
---|---|---|---|
apixaban (Eliquis®) | 2.5 mg, 5 mg tablets | Reduction of risk of stroke and systemic embolism in patients with non-valvular AF | 5 mg twice daily# |
apixaban | Prophylaxis of DVT following hip or knee replacement surgery | 2.5 mg twice daily | |
apixaban | Treatment of DVT and PE | 10 mg twice daily for 7 days, then 5 mg twice daily | |
apixaban | Reduction in risk of recurrence of DVT and PE | 2.5 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/min | not 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/min | not recommended | ||
rivaroxaban (Xarelto®) | 2.5 mg, 10 mg, 15 mg, 20 mg tablets, 1 mg/ 1 mL granules for suspension | Reduction in the risk of stroke in non-valvular AF, CrCl greater than 50 mL/min | 20 mg once daily with evening meal |
Reduction in the risk of stroke in non-valvular AF, CrCl less than or equal to 50 mL/min | 15 mg once daily with evening meal | ||
Treatment of DVT and PE, CrCl greater than or equal to 15 mL/min | 15 mg twice daily for 21 days, then 20 mg once daily | ||
treatment of DVT and PE, CrCl less than 15 mL/min | avoid use | ||
Reduction in risk of recurrence of DVT and PE (following initial treatment), CrCl greater than or equal to 15 mL/min | 10 mg once daily^ | ||
reduction in risk of recurrence of DVT and PE (following initial treatment), CrCl less than 15 mL/min | avoid use | ||
Prophylaxis of DVT following hip or knee replacement surgery, CrCl greater than or equal to 15 mL/min | 10 mg once daily | ||
prophylaxis of DVT following hip or knee replacement surgery, CrCl less than 15 mL/min | avoid 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/min | 10 mg once daily | ||
VTE prophylaxis in hospitalized adults with CrCl less than 15 mL/min | Avoid use | ||
Reduction of major cardiovascular event risk in patients with chronic coronary heart disease, peripheral artery disease | 2.5 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