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Who to screen

Screening can identify at-risk patients and, along with staging and monitoring, can help you determine if you can intervene with TZIELD.1,2

A man hiking outdoors and looking to the distance
A man hiking outdoors and looking to the distance

Proactive screening and monitoring can help identify appropriate patients for TZIELD intervention1,2

A man hiking outdoors and smiling A man hiking outdoors and smiling

Meet Jack

~60% of new T1D cases were in those over 20 years of age.4

  • 25 years old
  • Routine annual physicals
  • His 54-year-old mother has T1D
  • Current HbA1c: 5.9%

DID YOU KNOW? Not only does Jack have abnormal glucose levels, but he is 15x more likely to have T1D since his mother has it.6

A young girl with long brown hair smiling and looking to the side A young girl with long brown hair smiling and looking to the side

Meet Jessie

Patients living with celiac disease have a 2-3x increased risk of developing T1D.6

  • 6 years old
  • Mother has Graves’ disease
  • During course workup, celiac disease was discovered

DID YOU KNOW? T1D incidence in children like Jessie is rising globally by ~4% each year, especially in young children.7,8

A woman laughing and looking to the side A woman laughing and looking to the side

Meet Theresa

Patients with thyroid disorders often develop T1D <2 years from initial diagnosis.6,9

  • 32 years old
  • Diagnosed with Hashimoto's disease ~1 year ago
  • Recently started hormone therapy
  • Current HbA1c: 6.3%

DID YOU KNOW? Theresa is at an increased risk of T1D given her abnormal glucose levels and recent Hashimoto's diagnosis.6

A man smiling outdoors A man smiling outdoors

Meet Rob

Proactive screening identifies when abnormal glucose could be due to T1D rather than T2D.2,10

  • 34 years old
  • BMI: 27 kg/m2
  • Current HbA1c: 6.0%
  • FPG: 120 mg/dL

DID YOU KNOW? >40% of adults >30 years old with T1D are initially diagnosed with T2D.2,11

Abnormal glucose levels could be related to an autoimmune attack (type 1) rather than insulin resistance (type 2)2,10

Age and BMI alone may be unreliable diagnostic criteria for diabetes classification.2,10

Among patients with T1D:

  • ~60% are diagnosed with T1D at ≥20 years of age4*†
  • 62% have a BMI ≥25 kg/m2 12

These findings challenge misconceptions of T1D as a juvenile disease, and a higher BMI solely being T2D-related.13,14

*Median age of 24 years.4

†Data from 2016-2022.4

BMI=body mass index; FPG=fasting plasma glucose; HbA1c=hemoglobin A1c; T1D=type 1 diabetes; T2D=type 2 diabetes.

Why screen?

Help identify T1D at early, presymptomatic stages by screening at-risk individuals for 2 or more autoantibodies, as recommended by the American Diabetes Association.2

Take the next step in T1D management with your patients. Learn more about the importance of screening.

See how TZIELD could help your appropriate patients living with Stage 2 T1D

For Patients 1 to <8 Years OldFor Patients ≥8 Years Old

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. Serious cases have also been reported in adults with higher body surface area or comorbid conditions, such as adrenal insufficiency or cardiovascular disease. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia. Severe lymphopenia may be prolonged in adults.
  • Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as 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.

CONTRAINDICATIONS

TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection).

WARNINGS AND PRECAUTIONS

Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV infections 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. The duration of severe lymphopenia following TZIELD treatment may be prolonged in adults. Serious cases have also been reported in adults with higher body surface area or comorbid conditions, such as adrenal insufficiency or cardiovascular disease.

Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm absence of active infection on assessment of viral load (e.g., PCR testing). 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. Manifestation of CRS 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 if symptoms have resolved or significantly improved, subsequently administering the remaining doses on consecutive days to complete the full 14-day treatment course in patients with Stage 2 T1D or each of the two 12-day courses in patients with Stage 3 T1D; 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: Bacterial and viral infections have occurred in TZIELD-treated patients. Adults may have a longer duration of severe lymphopenia following TZIELD treatment, which may increase the risk of 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. Severe lymphopenia (<500 cells per mcL) lasting 1 week or longer has been reported in TZIELD-treated patients.

Severe lymphopenia following TZIELD treatment may be more prolonged in adults. Obtain a CBC prior to starting TZIELD and monitor lymphocyte 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.

  • Inactivated or mRNA vaccinations are not recommended within the 2 weeks prior to any TZIELD treatment course, during treatment, or up to 6 weeks after completion of any treatment course.
  • Live-attenuated vaccinations are not recommended within the 8 weeks prior to starting TZIELD treatment, during treatment, between treatment courses, or up to 52 weeks after completion of final treatment course.

ADVERSE REACTIONS

Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase 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. 

INDICATIONS

TZIELD (teplizumab-mzwv) is indicated to:

  • Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D.
  • Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Limitations of Use:

  • There is limited evidence of safety and effectiveness in patients aged 45 years and older with Stage 2 T1D.
  • TZIELD is not effective as a disease modifying therapy in non-autoimmune dysglycemic conditions.

REFERENCES

  1. TZIELD Prescribing Information. Provention Bio, Inc.
  2. American Diabetes Association Professional Practice Committee for Diabetes. Standards of care in diabetes—2026. Diabetes Care. 2026;49(suppl 1):S1-S371.
  3. Beliard K, Ebekozien O, Demeterco-Berggren C, et al. Increased DKA at presentation among newly diagnosed type 1 diabetes patients with or without COVID-19: data from a multi-site surveillance registry. J Diabetes. 2021;13(3):270-272.
  4. Fang M, Wang D, Echouffo-Tcheugui JB, Selvin E. Age at diagnosis in US adults with type 1 diabetes. Ann Intern Med. 2023;176(11):1567-1568.
  5. 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.
  6. Edelman SV, Agardh D, Cui N, et al. Risk of new-onset type 1 diabetes in individuals with celiac disease and thyroid disease—an observational study. Diabetes Obes Metab. 2025;27(8):4229-4238.
  7. Kandemir N, Vuralli D, Ozon A, et al. Epidemiology of type 1 diabetes mellitus in children and adolescents: a 50-year, single-center experience. J Diabetes. 2024;16(5):e13562.
  8. Buchmann M, Tuncer O, Auzanneau M, et al. Incidence, prevalence, and care of type 1 diabetes in children and adolescents in Germany: time trends and regional socioeconomic situation. J Health Monit. 2023;8(2):57-78.
  9. Edelman SV, Agardh D, Cui N, et al. Risk of new-onset type 1 diabetes in individuals with celiac disease and thyroid disease—an observational study. Diabetes Obes Metab. 2025;27(8)(suppl 1):1-17.
  10. Understanding A1C diagnosis. American Diabetes Association. Accessed April 17, 2025. https://diabetes.org/about-diabetes/a1c
  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, Jeon Y, Echouffo-Tcheugui JB, et al. Prevalence and management of obesity in US adults with type 1 diabetes. Ann Intern Med. 2023;176(3):427-429.
  13. Diaz-Valencia PA, Bougnères P, Valleron AJ. Global epidemiology of type 1 diabetes in young adults and adults: a systematic review. BMC Public Health. 2015;15:255.
  14. Van der Schueren B, Ellis D, Faradji RN, et al. Obesity in people living with type 1 diabetes. Lancet Diabetes Endocrinol. 2021;9(11):776-785.

© 2026 Sanofi. All rights reserved. MAT-US-2503241-v3.0-04/2026

IMPORTANT SAFETY INFORMATION

INDICATIONS

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. Serious cases have also been reported in adults with higher body surface area or comorbid conditions, such as adrenal insufficiency or cardiovascular disease. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia. Severe lymphopenia may be prolonged in adults.
  • Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as 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.

CONTRAINDICATIONS

TZIELD is contraindicated in patients who are immunocompromised or have active viral infection (such as EBV or CMV infection).

WARNINGS AND PRECAUTIONS

Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV infections 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. The duration of severe lymphopenia following TZIELD treatment may be prolonged in adults. Serious cases have also been reported in adults with higher body surface area or comorbid conditions, such as adrenal insufficiency or cardiovascular disease.

Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm absence of active infection on assessment of viral load (e.g., PCR testing). 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. Manifestation of CRS 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 if symptoms have resolved or significantly improved, subsequently administering the remaining doses on consecutive days to complete the full 14-day treatment course in patients with Stage 2 T1D or each of the two 12-day courses in patients with Stage 3 T1D; 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: Bacterial and viral infections have occurred in TZIELD-treated patients. Adults may have a longer duration of severe lymphopenia following TZIELD treatment, which may increase the risk of 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. Severe lymphopenia (<500 cells per mcL) lasting 1 week or longer has been reported in TZIELD-treated patients.

Severe lymphopenia following TZIELD treatment may be more prolonged in adults. Obtain a CBC prior to starting TZIELD and monitor lymphocyte 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.

  • Inactivated or mRNA vaccinations are not recommended within the 2 weeks prior to any TZIELD treatment course, during treatment, or up to 6 weeks after completion of any treatment course.
  • Live-attenuated vaccinations are not recommended within the 8 weeks prior to starting TZIELD treatment, during treatment, between treatment courses, or up to 52 weeks after completion of final treatment course.

ADVERSE REACTIONS

Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea, neutropenia, increased liver transaminase 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. 

INDICATIONS

TZIELD (teplizumab-mzwv) is indicated to:

  • Delay the onset of Stage 3 type 1 diabetes (T1D) in adult and pediatric patients 1 year of age and older with Stage 2 T1D.
  • Delay the decline in endogenous insulin production in pediatric patients aged 8 to 17 years recently diagnosed with Stage 3 T1D. This indication is approved under accelerated approval based on evidence of reduced C-peptide decline. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trial(s).

Limitations of Use:

  • There is limited evidence of safety and effectiveness in patients aged 45 years and older with Stage 2 T1D.
  • TZIELD is not effective as a disease modifying therapy in non-autoimmune dysglycemic conditions.