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Prescribing Information
Medical Information

TZIELD is the first and only disease-modifying treatment indicated to delay the onset of Stage 3 T1D

IN PATIENTS AGED 8 AND OLDER WITH STAGE 2 T1D
YOU CAN’T CONTROL IF, BUT YOU CAN IMPACT
When
Choose to modify T1D with TZIELD and help delay WHEN your patients progress
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An innovation in T1D
TZIELD is the first innovative biologic therapy in T1D since the discovery of insulin 100 years ago.1-6
Clinical trial results
Discover the possibilities of the first and only treatment indicated to delay the onset of Stage 3 T1D in appropriate patients.3,6
A well-established safety profile
Explore the safety profile of TZIELD, from pooled analysis of 5 clinical trials.6
Discover the clinical data of TZIELD
The first and only immunomodulator indicated to delay the onset of Stage 3 T1D in appropriate patients with Stage 2 T1D.1-3
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The importance of screening
Screening your patients early and follow-up monitoring can help you assess optimal T1D management and know when intervention with TZIELD is possible.7
Resources and support
TZIELD COMPASS is a patient support program that helps eligible patients to gain access to TZIELD and provides them with education and resources related to TZIELD.
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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.

T1D=type 1 diabetes.

References: 1. Prescribing Information. Provention Bio, Inc; 2023. 2. diaTribe Learn. FDA approves Tzield (teplizumab) to delay type 1 diabetes. Published November 17, 2022. Updated November 21, 2022. https://diatribe.org/diabetes-medications/fda-approves-tzield-teplizumab-delay-type-1-diabetes 3. Thakkar S, Chopra A, Nagendra L, et al. Teplizumab in type 1 diabetes mellitus: an updated review. touchREV Endocrinol. 2023;19(2):22-30. 4. Pham-Huy A, Top KA, Constantinescu C, et al. The use and impact of monoclonal antibody biologics during pregnancy. CMAJ. 2021;193(29):1129-1136. 5. American Diabetes Association Diabetes Dialogues. Insulin is now a biologic—what does that mean? Accessed April 15, 2024. https://diabetes.org/blog/insulin-now-biologic-what-does-mean 6. Sims EK, Carr ALJ, Oram RA, et al. 100 years of insulin: celebrating the past, present and future of diabetes therapy. Nat Med. 2021;27(7):1154-1164. 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.