DARZALEX®
(daratumumab)
Medical inquiries
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DARZALEX® (daratumumab)
Medical Information
DARZALEX - Density, Specific Gravity, and Overfill Volume
Last Updated: 10/22/2024
SUMMARY
- The content of DARZALEX (100 mg/5 mL and 400 mg/20 mL) without sorbitol:
Density, Specific Gravity, and Overfill Volume of DARZALEX without Sorbitol1
| Formulation | Density (g/mL) | Specific Gravity | Approximate Overfill Volume (mL) |
|---|---|---|---|
| DARZALEX (100 mg/5 mL) | 1.016 at 20°C | 1.0113 in normal saline | 0.2-0.4 |
| DARZALEX (400 mg/20 mL) | 0.4-1.2 |
- The content of DARZALEX Generation 2 (100 mg/5 mL and 400 mg/20 mL) containing sorbitol:
Density, Specific Gravity, and Overfill Volume of DARZALEX Generation 2 Containing Sorbitol1
| Formulation | Density (g/mL) | Specific Gravity | Approximate Overfill Volume (mL) |
|---|---|---|---|
| DARZALEX (100 mg/5 mL) | 1.022 at 20°C | 1.0173 in normal saline | 0.2-0.4 |
| DARZALEX (400 mg/20 mL) | 0.4-1.2 |
Literature Search
A literature search of MEDLINE®
References
| 1 | Data on File. Daratumumab density, specific gravity, and overfill volume. Janssen Research & Development LLC. US-SRSM-3401; 2024. |