About TZIELD

About TZIELD
The first innovative biologic therapy in T1D since the discovery of insulin 100 years ago1-6
TZIELD was designed to target the underlying autoimmune process of T1D6
An autoreactive T cell, a T-cell receptor with CD3, and TZIELD (teplizumab-mzwv)An autoreactive T cell, a T-cell receptor with CD3, and TZIELD (teplizumab-mzwv)
A male walking a dog
The first and only approved immunomodulator to delay the onset of Stage 3 T1D in patients 8 years and older with Stage 2 T1D3,6
  • TZIELD is an anti-CD3 monoclonal antibody that binds to CD3 antigens on the surface of T cells
  • The mechanism of action may involve the partial agonistic signaling and deactivation of autoreactive T cells that target pancreatic beta cell
  • TZIELD leads to an increase in the proportion of regulatory T cells and of exhausted CD8+ T cells in peripheral blood
TZIELD may help give eligible patients more time in Stage 2 T1D. In Stage 2, patients can still make enough endogenous insulin to prevent hyperglycemia.6,7
Intervene during Stage 2 T1D with TZIELD
Patients 8 years and older who meet the criteria of Stage 2 T1D below may be eligible for the first and only disease-modifying treatment approved to delay the onset of Stage 3 T1D.3,6
Stage 2 T1D criteria6,8,9:
Positive for ≥2 of the following 5 pancreatic islet AAbs:
  • Glutamic acid decarboxylase 65 AAb (GADA)
  • Insulinoma-associated antigen 2 AAb (IA-2A)
  • Insulin AAb (IAA)
  • Islet cell AAb (ICA)
  • Zinc transporter-8 AAb (ZnT8A)
Dysglycemia without overt hyperglycemia confirmed with:
  • 2-h PG 140-199 mg/dL during OGTT
  • 30-/60-/90-minute PG ≥200 mg/dL during OGTT
If an OGTT is not available, an alternative method for diagnosing dysglycemia without overt hyperglycemia may be appropriate. Other methods that may be appropriate are available in the ADA and ISPAD guidelines.
Ensure that the clinical history of the patient does not suggest type 2 diabetes. Before initiating TZIELD, review Section 2.1 of the Prescribing Information.
Identifying autoimmune T1D early can give
you and your patients more time to10:
Be ready
Prepare for Stage 3 T1D disease management and burden.
Be vigilant
Look out for symptoms of hyperglycemia and DKA.
Be proactive
Consider intervention with TZIELD in those with Stage 2 T1D aged 8 years and older.
Discover resources to support you and your office staff
Explore the safety data of the first and only treatment of its kind
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.
References: 1. 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. 2. Thakkar S, Chopra A, Nagendra L, et al. Teplizumab in type 1 diabetes mellitus: an updated review. touchREV Endocrinol. 2023;19(2):22-30. 3. 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-diabetes4. 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. TZIELD Prescribing Information. Provention Bio, Inc; 2023. 7. Insel RA, Dunne JL, Atkinson MA, et al. Staging presymptomatic type 1 diabetes: a scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care. 2015;38(10):1964-1974. 8. American Diabetes Association Professional Practice Committee. Diagnosis and classification of diabetes: standards of care in diabetes—2024. Diabetes Care. 2024;47(Suppl 1): S20–S42. 9. Type 1 Diabetes TrialNet. Protocol TN-10. Version June 2014. Accessed May 5, 2023. https://classic.clinicaltrials.gov/ProvidedDocs/61/NCT01030861/Prot_000.pdf 10. Edelman S. Early intervention by family physicians to delay type 1 diabetes. J Fam Pract. 2023:72(6 suppl):S19-S24.