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The ADA recommends proactively screening at-risk patients for the following 4 islet autoantibodies (AAbs)2,3*

GADA

Glutamic acid  decarboxylase 65  AAb

IAA

Insulin AAb

IA-2A

Insulinomaassociated antigen 2 AAb

ZnT8A

Zinc transporter-8  AAb

  • Rescreen patients with increased risk in 1 year7

‡Adapted from Breakthrough T1D and Barbara Davis Center for Diabetes consensus guidance.

§Please refer to the full Breakthrough T1D and Barbara Davis Center for Diabetes guidance for additional information on screening and monitoring.

  • For high-risk patients, monitor metabolic status annually4

  • For all other patients, repeat screen every 3 years4

‡Adapted from Breakthrough T1D and Barbara Davis Center for Diabetes consensus guidance.

§Please refer to the full Breakthrough T1D and Barbara Davis Center for Diabetes guidance for additional information on screening and monitoring.

  • Collaborate and/or refer to a specialist based on stage4

  • Perform glycemic assessment and metabolic monitoring as needed in collaboration4,7

‡Adapted from Breakthrough T1D and Barbara Davis Center for Diabetes consensus guidance.

§Please refer to the full Breakthrough T1D and Barbara Davis Center for Diabetes guidance for additional information on screening and monitoring.

Pediatric Patients

Screen during recommended well-child visits (1-2 years, 4-6 years and 11-13 years)7§

  • Rescreen patients with increased risk in 1 year7

  • For all other patients, rescreen around 6 years and 9-11 years of age7

Screening for islet AAbs and close monitoring can reduce DKA risk in children by ~88%.9

‡Adapted from Breakthrough T1D and Barbara Davis Center for Diabetes consensus guidance.

§Please refer to the full Breakthrough T1D and Barbara Davis Center for Diabetes guidance for additional information on screening and monitoring.

  • Consider collaborating with a specialist4

  • If <3 years: rescreen every 6 months for 3 years, then annually for 3 more years4

  • If ≥3 years: rescreen annually for 3 years4

Screening for islet AAbs and close monitoring can reduce DKA risk in children by ~88%.9

‡Adapted from Breakthrough T1D and Barbara Davis Center for Diabetes consensus guidance.

§Please refer to the full Breakthrough T1D and Barbara Davis Center for Diabetes guidance for additional information on screening and monitoring.

  • Collaborate and/or refer to a specialist based on stage4

  • Perform glycemic assessment and metabolic monitoring as needed in collaboration4,7

Screening for islet AAbs and close monitoring can reduce DKA risk in children by ~88%.9

‡Adapted from Breakthrough T1D and Barbara Davis Center for Diabetes consensus guidance.

§Please refer to the full Breakthrough T1D and Barbara Davis Center for Diabetes guidance for additional information on screening and monitoring.

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 ageappropriate 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.
     

TZIELD API

  1. Scheiner G, Weiner S, Kruger DF, Pettus J. Screening for type 1 diabetes: Role of the diabetes care and education specialist. ADCES Pract. 2022;10(5):20-25.

  2. American Diabetes Association Professional Practice Committee. Diagnosis and classification of diabetes: standards of care in diabetes—2025. Diabetes Care. 2025;(48)(Suppl 1):S27-S49.

  3. TZIELD Prescribing Information. Provention Bio, Inc; 2023.

  4. 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.

  5. Wenzlau JM, Juhl K, Yu L, et al. The cation efflux transporter ZnT8 (Slc30A8) is a major autoantigen in human type 1 diabetes. Proc Natl Acad Sci U S A. 2007;104(43):17040-17045.

  6. Data on file. IQVIA. Data as of April 2024.

  7. Simmons KMW, Frohnert BI, O’Donnell HK, et al. Historical insights and current perspectives on the diagnosis and management of presymptomatic type 1 diabetes. Diabetes Technol Ther. 2023;25(11):790-799.

  8. American Diabetes Association. Blood glucose & A1C diagnosis. Accessed January 18, 2024. https://diabetes.org/about-diabetes/diagnosis

  9. Winkler C, Schober E, Ziegler A-G, et al. Markedly reduced rate of diabetic ketoacidosis at onset of type 1 diabetes in relatives screened for islet autoantibodies. Pediatr Diabetes. 2012;13(4):308-313.

MAT-KW-2500536/V1/March 2026