Who to screen
Who to screen
Screening can identify at-risk patients and, along with staging and monitoring, can reduce the risk of DKA and help you determine when you can intervene with TZIELD
Patients may be at risk regardless of age or family history1-3
Age at Autoimmune T1D Diagnosis
Distribution of age at diagnosis in US adults with T1D (n=947), National Health Interview Survey (NHIS), 2016 to 2022. Adapted from Fang M. Ann Intern Med. 2023.
However, those with certain family and personal history of
autoimmunity may be at increased risk4,5
autoimmunity may be at increased risk4,5
It's important to screen:
First-degree relatives of autoimmune T1D patients, who can have a ~15x higher risk of developing autoimmune T1D vs the general population
Those with personal or family history of select autoimmune disease, including celiac disease and thyroid disorders such as Hashimoto’s or Graves’ disease
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.
DKA=diabetic ketoacidosis; T1D=type 1 diabetes.
References: 1. Fang M, Wang D, Echouffo-Tcheugui JB, et al. Age at diagnosis in U.S. adults with type 1 diabetes. Ann Intern Med. 2023;176(11):1567-1568. 2. Hormazábal-Aguayo I, Ezzatvar Y, Huerta-Uribe N, et al. 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. Published online December 1, 2023. doi:10.1002/dmrr.3749 3. Ogle GD, Wang F, Gregory GA, et al. Type 1 diabetes estimates in children and adults. IDF Atlas Reports. Published 2022. Accessed December 15, 2023. https://diabetesatlas.org/atlas/t1d-index-2022/ 4. 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. 5. 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. 6. Elding Larsson H, Vehik K, Bell R, et al. Reduced prevalence of diabetic ketoacidosis at diagnosis of type 1 diabetes in young children participating in longitudinal follow-up. Diabetes Care. 2011;34(11):2347-2352. 7. Barker JM, Goehrig SH, Barriga K, et al. DAISY study. Clinical characteristics of children diagnosed with type 1 diabetes through intensive screening and follow-up. Diabetes Care. 2004;27(6):1399-1404. 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.