AHFS Class:

68:20.92 Antidiabetic Agents, Miscellaneous

Generic Name

• Teplizumab (CAS Registry Number: 876387-05-2)

Teplizumab-mzwv is available as a 1-mg/mL concentrate for injection in 2-mL preservative-free single-dose vials.³⁹²³ Each mL contains teplizumab-mzwv 1 mg with dibasic sodium phosphate 0.26 mg, monobasic sodium phosphate 0.98 mg, polysorbate 80 0.05 mg, and sodium chloride 8.78 mg in water for injection.³⁹²³ The concentrate for injection must be diluted in sodium chloride 0.9% prior to administration.³⁹²³ To prepare a diluted solution for administration, initially, 2 mL of the concentrate should be added to 18 mL of sodium chloride 0.9% in a sterile glass vial or PVC infusion bag to yield 20 mL of solution containing teplizumab-mzwv 100 mcg/mL.³⁹²³ The solution should be mixed gently by slowly inverting the vial or rocking the infusion bag.³⁹²³ The appropriate dose of teplizumab-mzwv should be withdrawn from the 100-mcg/mL solution using a syringe and added to a 25-mL infusion bag containing sodium chloride 0.9%.³⁹²³ The final diluted solution should be mixed by gently rocking back and forth; do not shake the bag.³⁹²³

pH

The concentrate for injection has a pH of 6.1.³⁹²³

Trade Name(s)

Tzield

Teplizumab-mzwv is administered by intravenous infusion over a minimum of 30 minutes.³⁹²³

Intact vials should be stored at 2 to 8°C in the original carton to protect from light.³⁹²³ Store vials upright and do not freeze or shake.³⁹²³

Teplizumab-mzwv concentrate for injection is a clear and colorless solution; do not use if the solution is discolored or contains particulate matter.³⁹²³

It is recommended to start the infusion within 2 hours of preparation of the final diluted solution.³⁹²³ If not used immediately, the diluted solution may be stored at 15 to 30°C; however, the infusion should be completed within 4 hours of the start of preparation.³⁹²³ Discard the diluted solution if not administered within 4 hours of preparation.³⁹²³

Sorption

Manufacturer states the final diluted solution for infusion should be prepared in PVC infusion bags.³⁹²³

Solution Compatibility

For a list of references cited in the text of this monograph, search the monograph titled References.

ASHP^® Injectable Drug Information^TM. Selected Revisions December 5, 2024. © Copyright, 2025. American Society of Health-System Pharmacists^®, 4500 East-West Highway, Suite 900, Bethesda, Maryland 20814.