Calculated apixaban and rivaroxaban exposure parameters
| Parameter . | Rivaroxaban 20 mg once per day (± SD) (n = 2) . | Apixaban 5 mg twice per day (n = 1) . |
|---|---|---|
| AUC0-24 hours, milk, ng × h/mL | 693.77 (23.84) | 2725.33 |
| Cavg0-24 hours, milk, ng/mL | 28.91 (0.99) | 113.56 |
| AUC0-24 hours, maternal plasma, ng × h/mL | 2569.55 (312.73) | 1045.82 |
| Cavg0-24 hours, maternal plasma, ng/mL | 107.06 (13.03) | 43.58 |
| M:P ratio (Cavg milk/Cavg plasma) | 0.27 (0.02) | 2.61 |
| Absolute infant dose, mg/kg per day* | 0.0043 | 0.017 |
| RID (%)† | 1.63 (0.01) | 12.78 |
| Parameter . | Rivaroxaban 20 mg once per day (± SD) (n = 2) . | Apixaban 5 mg twice per day (n = 1) . |
|---|---|---|
| AUC0-24 hours, milk, ng × h/mL | 693.77 (23.84) | 2725.33 |
| Cavg0-24 hours, milk, ng/mL | 28.91 (0.99) | 113.56 |
| AUC0-24 hours, maternal plasma, ng × h/mL | 2569.55 (312.73) | 1045.82 |
| Cavg0-24 hours, maternal plasma, ng/mL | 107.06 (13.03) | 43.58 |
| M:P ratio (Cavg milk/Cavg plasma) | 0.27 (0.02) | 2.61 |
| Absolute infant dose, mg/kg per day* | 0.0043 | 0.017 |
| RID (%)† | 1.63 (0.01) | 12.78 |
AUC, area under concentration-time curve; Cavg, average concentration (AUC0-24 hours/24 hours); RID, relevant infant dose; SD, standard deviation.
Absolute infant dose was calculated as the product from Cavg in milk and an assumed milk intake of 0.15 L/kg per day.
Relative infant dose is the absolute infant dose expressed as a percentage of the weight-adjusted maternal dose, based on an average maternal weight of 75 kg (mg/kg per day).