Table 3.
Unlabeled Uses of Target Specific Oral Anticoagulants.
| Dabigatran (n = 13) | Rivaroxaban (n = 97) | Apixaban (n = 30) | P Value | |
|---|---|---|---|---|
| Total unlabeled use | 4 | 16 | 8 | .27 |
| Unlabeled indicationa | 2 | 1 | 0 | .06 |
| Unlabeled dosea | 2 | 15 | 8 | |
| Unlabeled renal doseb | 1 | 11 | 4 | |
| Unlabeled DDI adjustment | 0 | 0 | 3 | |
| Unlabeled dose for indication | 0 | 2 | 0 | |
| Other unlabeled doses | 1 | 2 | 1 | |
| Unable to evaluate | 0 | 1 | 0 | |
| Distribution of unlabeled dose | .002 | |||
| High | 0 | 10 | 0 | |
| Low | 2 | 5 | 8 |
Abbreviations: DDI, drug–drug interaction; CrCl, creatinine clearance.
a
Based on total unlabeled use.
b
Unlabeled renal dose is defined as CrCl 20 to 40 mL/min for dabigatran and 40 to 60 mL/min for rivaroxaban with incorrect renal dose adjustment; for apixaban, defined as adjusting dose with <2 risk factors (age, serum creatinine, and bodyweight), incorrect dose adjustment, or wrong hemodialysis dose.