DARZALEX®
(daratumumab)
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DARZALEX® (daratumumab)
Medical Information
Dosage and Administration of DARZALEX – Use of Lower Infusion Volumes
Last Updated: 11/19/2024
SUMMARY
- Janssen cannot recommend any practices, procedures, or dosing modifications that deviate from product labeling and are not approved by the regulatory agencies.
- There are no systematically collected data to support using lower infusion volumes or higher concentrations of daratumumab in patients.
- There are no systematically collected data on infusion rates of DARZALEX in patients with fluid restriction.
- Clinical judgment should be exercised when considering any infusion volume adjustments outside of those listed in the DARZALEX product labeling.
- No DARZALEX dose modifications (increase or decrease) were permitted per the clinical trial protocols for the GEN501, MMY2002 (SIRIUS), MMY1001 (EQUULEUS), MMY3003 (POLLUX), MMY3004 (CASTOR), MMY3007 (ALCYONE), MMY3006 (CASSIOPEIA), and MMY3008 (MAIA) studies.1
- 8 - Administer DARZALEX infusion intravenously at the appropriate infusion rate. Consider incremental escalation of the infusion rate only in the absence of infusion reactions as defined in Table: Infusion Rates for DARZALEX Administration.9
| | Dilution volume | Initial rate (first hour) | Rate incrementa | Maximum rate |
|---|---|---|---|---|
| Week 1 infusion | ||||
| Option 1 (Single-dose infusion) | ||||
| Week 1 Day 1 (16 mg/kg) | 1000 mL | 50 mL/hour | 50 mL/hour every hour | 200 mL/hour |
| Option 2 (Split-dose infusion) | ||||
| Week 1 Day 1 (8 mg/kg) | 500 mL | 50 mL/hour | 50 mL/hour every hour | 200 mL/hour |
| Week 1 Day 2 (8 mg/kg) | 500 mL | 50 mL/hour | 50 mL/hour every hour | 200 mL/hour |
| Week 2 (16 mg/kg) infusionb | 500 mL | 50 mL/hour | 50 mL/hour every hour | 200 mL/hour |
| Subsequent (Week 3 onwards, 16 mg/kg) infusionsc | 500 mL | 100 mL/hour | 50 mL/hour every hour | 200 mL/hour |
| aConsider incremental escalation of the infusion rate only in the absence of infusion reactions. bUse a dilution volume of 500 mL for the 16 mg/kg dose only if there were no infusion reactions the previous week. Otherwise, use a dilution volume of 1000 mL. cUse a modified initial rate (100 mL/hour) for subsequent infusions (i.e. Week 3 onwards) only if there were no infusion reactions during the previous infusion. Otherwise, continue to use instructions indicated in the table for the Week 2 infusion rate. | ||||
Literature Search
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References
| 1 | Data on File. Clinical Protocol GEN501 (HxCD38-C-501-CSRcomp-1158). Janssen Research & Development, LLC. EDMS-ERI-62601423; 2015. |
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