TEVIMBRA (Tislelizumab-jsgr)
1. Brand and Generic or Biosimilar Names:
Brand Name: TEVIMBRA
Generic Name: Tislelizumab
2. Available Dosage Forms and Strengths:
Dosage Form: Injection, solution, concentrate
Strength: 100 mg/10 mL (10 mg/mL) in single-dose vial
3. Storage Conditions of the Vial:
Store: Refrigerated at 2°C to 8°C (36°F to 46°F) in the original carton.
Protection: Protect from light.
Do Not: Freeze or shake the vial.
4. Detailed Preparation, Reconstitution, and Dilution Instructions:
Preparation steps:
Inspect vials visually for particulate matter or discoloration. The solution should appear clear to slightly opalescent, colorless to slightly yellow. Discard any vial with cloudy, discolored, or particulate solution.
Dosage Instruction: Withdraw 20 mL of TEVIMBRA from two vials (total of 200 mg in 20 mL).
Transfer the solution into an IV infusion bag containing 0.9% Sodium Chloride Injection, USP to achieve a final concentration of 2 mg/mL to 5 mg/mL.
Mix diluted solution by gentle inversion to avoid foaming or excessive shearing of the solution. Do not shake.
5. Special Considerations in the Compounding Process:
Handling Instructions: Do not shake the vials; mix diluted solution by gentle inversion.
Reconstitution Method: TEVIMBRA is ready-to-use and does not need reconstitution.
6. Appropriate Diluent for Reconstitution:
Not applicable (TEVIMBRA is a concentrate and does not require reconstitution). The appropriate diluent for dilution is 0.9% Sodium Chloride Injection, USP.
7. Amount of Diluent Required for Reconstitution:
Not applicable; TEVIMBRA does not require reconstitution.
8. Resultant Concentration:
After dilution, TEVIMBRA should achieve a final concentration of 2 mg/mL to 5 mg/mL.
9. Compatible Solutions for Dilution:
Diluent: 0.9% Sodium Chloride Injection, USP.
10. Size of IV Infusion Bag:
The package insert does not explicitly specify an infusion bag size; select an appropriately sized bag based on the required final volume to achieve the desired concentration.
11. Final Concentration Range for Infusion Bag Dilution:
Final dilution concentration range: 2 mg/mL to 5 mg/mL.
12. Special Syringes, Tubing, or Infusion Bags Needed:
Use IV equipment with a sterile, non-pyrogenic, low protein-binding 0.2 micron or 0.22 micron in-line filter.
13. Filter Requirements:
Administer through a 0.2 micron or 0.22 micron in-line or add-on filter.
14. Final Appearance:
The diluted solution should appear clear to slightly opalescent, colorless to slightly yellow.
15. Stability Information for Opened Vials or Reconstituted Solution:
Discard: Any unused portion of the product, as TEVIMBRA is for single-use only.
16. Stability or Storage Conditions for Infusion Bag:
If not administered immediately:
Room Temperature: Store at 20°C to 25°C (68°F to 77°F) for up to 4 hours (including preparation and infusion duration).
Refrigerated: Store at 2°C to 8°C (36°F to 46°F) for up to 20 hours (including preparation and infusion duration). Allow the solution to come to room temperature before administration.
Do Not: Freeze the diluted solution.
17. Protection from Light During Administration or Storage:
Protection from Light: Required during storage of vials, not explicitly mentioned for administration.
18. Hazardous, Cytotoxic, or Risk of Birth Defects:
The package insert does not mention TEVIMBRA being classified as hazardous or cytotoxic. However, it is advisable to take precautions based on facility guidelines for sterile handling of parenteral drug products.
19. Oncology Use:
Intended Use: Yes, for oncology.
Package Insert Revision Date:
Reference: FDA package insert available at
https://www.beigene.com/PDF/TEVIMBRAUSPI.pdf
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