Etranacogene dezaparvovec-drlb (Hemgenix)
Dilution requiredFull monograph review pending
U.S. label preparation
Hemgenix · Dilution required
- Preparation
- Specialist gene-therapy preparation. Use 500 mL PVC-free PE/PP copolymer bags of 0.9% sodium chloride. Below 120 kg use one bag. At 120 kg or more use two, dividing the volume of saline removed and the dose equally between them.
- Administration and handling
- Use the label-specified equipment, IV filter and monitoring. Sections 2.2 to 2.4 describe priming, dilution, infusion and the final flush.
Product and source details
CSL Behring · BLA125772
Product NDC: 0053-0100, 0053-0110, 0053-0120, 0053-0130, 0053-0140, 0053-0150, 0053-0160, 0053-0170, 0053-0180, 0053-0190, 0053-0200, 0053-0210, 0053-0220, 0053-0230, 0053-0240, 0053-0250, 0053-0260, 0053-0270, 0053-0280, 0053-0290, 0053-0300, 0053-0310, 0053-0320, 0053-0330, 0053-0340, 0053-0350, 0053-0360, 0053-0370, 0053-0380, 0053-0390, 0053-0400, 0053-0410, 0053-0420, 0053-0430, 0053-0440, 0053-0450, 0053-0460, 0053-0470, 0053-0480
SPL effective 2026-05-01 | SPL version 8. Checked 2026-11-13.
Source for this summary: U.S. prescribing information. Use the full label for dose selection, contraindications, preparation tables and monitoring.
Product identifiers and clinical review status
U.S. label preparation available. Full monograph review pending.
Exact formulation, concentration, container, manufacturer, regulatory identifiers, and a reproducible label snapshot have not all been reconciled.
What remains to be completed
- Obtain independent corroboration of the label preparation where available.
- Complete indication- and age-specific dosing, incompatibility, monitoring and stability review.
- Assess any proposed compounding BUD for the exact formulation, concentration, container and conditions.