NOW APPROVED EXPANDED PEDIATRIC INDICATION
In children as young as 1 year of age with Stage 2 T1D
In appropriate patients as young as 1 year of age with Stage 2 T1D
ACT WITHIN THE WINDOW OF
WHEN
TZIELD is the first innovative biologic therapy in T1D since the discovery of insulin 100 years ago.1-6
Explore the clinical data of TZIELD1,7
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
A well-established safety profile1
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.
Supporting the infusion journey for you and your patients
Treatment experience
See how TZIELD COMPASS and Sanofi can support the patient treatment path.
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.
Important Safety Information Anchor
IMPORTANT SAFETY INFORMATION
WARNING: Viral Reactivation
- Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia.
- Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD.
WARNINGS AND PRECAUTIONS
Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV have been reported with TZIELD. During and within 2 months of TZIELD treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV-associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk. The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia. Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., PCR testing). TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. During treatment with TZIELD, regularly monitor lymphocyte counts and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD and obtain viral load (e.g., PCR) promptly. If viral reactivation is confirmed, permanently discontinue TZIELD.
Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. CRS manifestations in TZIELD-treated patients included fever, nausea (with or without vomiting), fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment. 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. Obtain a CBC prior to starting TZIELD and monitor white blood cell counts during TZIELD treatment. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), permanently 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 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.
- Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
ADVERSE REACTIONS
Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea and headache.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm. To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy. Report pregnancies to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi
- 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 Boxed WARNING and patient selection criteria.
INDICATION
TZIELD (teplizumab-mzwv) is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 1 year of age and older with Stage 2 T1D.
REFERENCES
- TZIELD Prescribing Information. Provention Bio, Inc.
- 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.
- 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
- 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
- Thakkar S, Chopra A, Nagendra L, et al. Teplizumab in type 1 diabetes mellitus: an updated review. touchREV Endocrinol. 2023;19(2):22-30.
- 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
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- COMPASS Support START Form
- Call 1-844-778-2246 to speak with a TZIELD COMPASS representative
© 2026 Sanofi. All rights reserved. MAT-US-2306541-v6.0-04/2026
IMPORTANT SAFETY INFORMATION
INDICATION
IMPORTANT SAFETY INFORMATION
WARNING: Viral Reactivation
- Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia.
- Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD.
WARNINGS AND PRECAUTIONS
Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV have been reported with TZIELD. During and within 2 months of TZIELD treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV-associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk. The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia. Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., PCR testing). TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. During treatment with TZIELD, regularly monitor lymphocyte counts and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD and obtain viral load (e.g., PCR) promptly. If viral reactivation is confirmed, permanently discontinue TZIELD.
Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. CRS manifestations in TZIELD-treated patients included fever, nausea (with or without vomiting), fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment. 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. Obtain a CBC prior to starting TZIELD and monitor white blood cell counts during TZIELD treatment. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), permanently 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 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.
- Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
ADVERSE REACTIONS
Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea and headache.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm. To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy. Report pregnancies to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi
- 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 Boxed WARNING and patient selection criteria.
INDICATION
TZIELD (teplizumab-mzwv) is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 1 year of age and older with Stage 2 T1D.