Tenecteplase
Reconstitution onlyFull monograph review pending
U.S. label preparation
TNKase · Reconstitution only
- Preparation
- Use only the supplied sterile water. Match the diluent vial to the drug vial: 5.2 mL for the 25 mg kit or 10 mL for the 50 mg kit. The reconstituted concentration is 5 mg/mL.
- Administration and handling
- Confirm the indication and dose before withdrawal. Dextrose is incompatible. Follow the label's saline-flush instructions when the line contains dextrose.
Product and source details
Genentech, Inc. · BLA103909
Product NDC: 50242-176, 50242-014
SPL effective 2025-12-15 | 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.