Table 2.
| Pharmacokinetics parameter | Result |
|---|---|
|
| |
| Clearance (Cl) | 0.317 L/day |
| Mean volume of distribution (Vd) | 7.33 L |
| Elimination half-life (t1/2) | 19 days |
| AUC0–∞ | 53,000 mcg × hours/mL |
| Cmax | 185 mcg/mL |
| Dosage and administration | |
| Dose | 10 mg/kg |
| Timing | During active CDI treatment; usually days 0–14 |
| Route | Intravenous |
| Infusion time | 1 hour |
| Special instructions | Use 0.2–5 µm in-line or add- on filter |
| Supplied | |
| 1 Vial (50 mL) | 1,000 mg bezlotoxumab in 40 mL solution |
| Preparation | |
| Compatible solutions | 0.9% sodium chloride of dextrose 5% water |
| Final concentration | 1–10 mg/mL |
| Storage | |
| Undiluted | Refrigerated |
| Diluted, room temperature | 16 hours |
| Diluted, refrigerated (2°C–8°C; 36°F–46°F) | 24 hours |
| Cost (AWP) | |
| 1 Vial (1,000 mg) | $4,500 |
Abbreviations: AUC0–∞, area under the concentration–time curve from time zero to infinity; AWP, average wholesale price; CDI, Clostridium difficile infection; Cmax, maximum drug concentration.