Tividenofusp alfa-eknm (Avlayah)
Reconstitution and dilutionFull monograph review pending
U.S. label preparation
Avlayah · Reconstitution and dilution
- Preparation
- Reconstitute each vial with 5.2 mL sterile water for injection. Use 0.9% sodium chloride to reach 0.6-15 mg/mL. Select the final volume by dose and weight in Table 2.
- Administration and handling
- Use the specified dedicated 0.2-micron filter. Table 3 gives the escalating rates for each infusion volume.
- Manufacturer's storage limits
- Reconstituted vials may stand for up to 4 hours at 20-25 C. Diluted bags may be refrigerated at 2-8 C for up to 24 hours. Complete infusion within 10 hours of removal and do not return the bag to refrigeration. A compounding beyond-use date requires a separate assessment.
Product and source details
Denali Therapeutics Inc. · BLA761485
Product NDC: 84976-001
SPL effective 2026-03-20 | SPL version 2. 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.