Pariglasgene brecaparvovec-opnr (Genglycos)
Dilution requiredFull monograph review pending
U.S. label preparation
Genglycos · Dilution required
- Preparation
- Specialist gene-therapy preparation. For 15 to 39 kg use a 100 mL saline bag, and for 40 kg or more use 250 mL. Remove saline equal to the calculated dose volume. Add the thawed product through a sterile 0.2 micron PES or equivalent syringe filter. Use 0.9% sodium chloride only.
- Administration and handling
- Use a separate 0.2 micron in-line filter and follow the weight-specific rate escalation in Table 2, with premedication and reaction monitoring. See the full product instructions before preparing the kit.
Product and source details
Ultragenyx Pharmaceutical Inc. · BLA125858
SPL effective 2026-08-28 | SPL version 4. 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.