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IN PATIENTS AGED 8 AND OLDER WITH STAGE 2 TYPE 1 DIABETES (T1D)

You can’t control if, but you can impact

WHEN

Choose to modify T1D with TZIELD and help delay WHEN your patients progress to Stage 3 T1D.1

TZIELD is the first innovative biologic therapy in T1D since the discovery of insulin 100 years ago.1-6
TZIELD innovation

Explore the clinical data of TZIELD1,7

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Clinical trial results

Discover the possibilities of the first and only treatment indicated to delay the onset of Stage 3 T1D in appropriate patients.1,4,5

Efficacy data
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A well-established safety profile

Explore the safety profile of TZIELD, from pooled analysis of 5 clinical trials.1

Safety data

Islet autoantibody (AAb)
screening can help identify T1D patients8-13

Consensus guidance recommends identifying patients at risk for autoimmune T1D with islet AAb screening. Proactive screening can help identify patients at risk, including:

  • Those with select autoimmune diseases (Hashimoto's disease, Graves' disease, Celiac Disease)
  • Those with a relative who has T1D (adults and children)
  • Those with abnormal glucose levels

Incidence of clinical T1D differs for patients, highlighting the need for early detection of individuals at risk.

Screening along with staging and monitoring, can help you determine when you can intervene with TZIELD.

T1D StagesWho to screen
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A young girl riding her bike and smiling

Supporting the infusion journey for you and your patients

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Treatment experience

See how TZIELD COMPASS and Sanofi can support the patient treatment path.

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Dosing & administration1

TZIELD is administered by intravenous infusion over a single-
course treatment completed over 14 consecutive days.

SUPPORTING PHYSICIANS

Access helpful resources

From screening and staging information to clinical data and administration guides for TZIELD, support is available for you and your staff.

HCP resource library

Important Safety Information Anchor

INDICATION

TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
  • Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
  • Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
  • Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
  • Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.
    • Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
    • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.

ADVERSE REACTIONS

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm.
  • Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Please see full Prescribing Information, including patient selection criteria, and Medication Guide. View Important Safety Information page.

REFERENCES

  1. TZIELD Prescribing Information. Provention Bio, Inc; 2023.
  2. Pham-Huy A, Top AK, Constantinescu C, Seo CH, El-Chaar D. The use and impact of monoclonal antibody biologics during pregnancy. CMAJ. 2021;193(29):E1129-E1136.
  3. Sims EK, Carr ALJ, Oram RA, DiMeglio LA, Evans-Molina C. 100 years of insulin: celebrating the past, present and future of diabetes therapy. Nat Med. 2021;27(7):1154-1164. doi:10.1038/s41591-021-01418-2.
  4. diaTribe Learn. FDA approves Tzield (teplizumab) to delay type 1 diabetes. Published November 17, 2022. Updated November 21, 2022. https://diatribe.org/fda-approves-tzield-teplizumab-delay-type-1-diabetes
  5. Thakkar S, Chopra A, Nagendra L, et al. Teplizumab in type 1 diabetes mellitus: an updated review. touchREV Endocrinol. 2023;19(2):22-30.
  6. American Diabetes Association. Insulin is now a biologic—what does that mean? Updated March 23, 2020. Accessed April 2, 2025. https://diabetes.org/blog/insulin-now-biologic-what-does-mean
  7. Herold KC, Bundy BN, Long SA, et al; Type 1 Diabetes TrialNet Study Group. An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. N Engl J Med. 2019;381(7):603-613.
  8. Phillip M, Achenbach P, Addala A, et al. Consensus guidance for monitoring individuals with islet autoantibody‑positive pre‑stage 3 type 1 diabetes. Diabetes Care. 2024;47(8):1276-1298.
  9. Couper JJ, Haller MJ, Greenbaum CJ, et al. ISPAD Clinical Practice Consensus Guidelines 2018: Stages of type 1 diabetes in children and adolescents. Pediatr Diabetes. 2018;19(suppl 27):20-27.
  10. Popoviciu MS, Kaka N, Sethi Y, et al. Type 1 diabetes mellitus and autoimmune diseases: A critical review of the association and the application of personalized medicine. J Pers Med. 2023;13(3):422.
  11. Holt RIG, DeVries JH, Hess-Fischl A, et al. The management of type 1 diabetes in adults. A consensus report by the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD). Diabetologia. 2021;64(12):2609-2652.
  12. Fang M, Wang D, Echouffo-Tcheugui JB, Selvin E. Age at diagnosis in U.S. adults with type 1 diabetes. Ann Intern Med. 2023;176(11):1567-1568.
  13. Hormazábal-Aguayo I, Ezzatvar Y, Huerta-Uribe N, Ramirez-Velez R, Izquierdo M, Garcia-Hermoso A. Incidence of type 1 diabetes mellitus in children and adolescents under 20 years of age across 55 countries from 2000 to 2022: A systematic review with meta-analysis. Diabetes Metab Res Rev. 2024;40(3):e3749.
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INDICATION

IMPORTANT SAFETY INFORMATION

INDICATION

TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D.

IMPORTANT SAFETY INFORMATION

WARNINGS AND PRECAUTIONS

  • Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. Prior to TZIELD treatment, premedicate with antipyretics, antihistamines and/or antiemetics, and treat similarly if symptoms occur during treatment. If severe CRS develops, consider pausing dosing for 1 day to 2 days and administering the remaining doses to complete the full 14-day course on consecutive days; or discontinue treatment. Monitor liver enzymes during treatment. Discontinue TZIELD treatment in patients who develop elevated alanine aminotransferase or aspartate aminotransferase more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.
  • Serious Infections: Use of TZIELD is not recommended in patients with active serious infection or chronic infection other than localized skin infections. Monitor patients for signs and symptoms of infection during and after TZIELD administration. If serious infection develops, treat appropriately, and discontinue TZIELD.
  • Lymphopenia: Lymphopenia occurred in most TZIELD-treated patients. For most patients, lymphocyte levels began to recover after the fifth day of treatment and returned to pretreatment values within two weeks after treatment completion and without dose interruption. Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), discontinue TZIELD.
  • Hypersensitivity Reactions: Acute hypersensitivity reactions including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm occurred in TZIELD-treated patients. If severe hypersensitivity reactions occur, discontinue TZIELD and treat promptly.
  • Vaccinations: The safety of immunization with live-attenuated (live) vaccines with TZIELD-treated patients has not been studied. TZIELD may interfere with immune response to vaccination and decrease vaccine efficacy. Administer all age-appropriate vaccinations prior to starting TZIELD.
    • Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
    • Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. Inactivated vaccines are not recommended during treatment or 6 weeks after completion of treatment.

ADVERSE REACTIONS

Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia, and headache.

USE IN SPECIFIC POPULATIONS

  • Pregnancy: May cause fetal harm.
  • Lactation: A lactating woman may consider pumping and discarding breast milk during and for 20 days after TZIELD administration.

Please see full Prescribing Information, including patient selection criteria, and Medication Guide. View Important Safety Information page.