Why screen

Screening can help identify at-risk patients before symptoms arise

Once patients are in Stage 1 T1D,
progression to Stage 3 becomes inevitable

Screening has been found to reduce DKA at Stage 3 onset by at least 50%.^2,3

Identifying autoimmune T1D early can give you more time to⁴:

Assemble a care team

Refer your patients to specialists in a number of areas, including mental health and other support areas.

Be vigilant

Advise patients and caregivers to be vigilant for symptoms of hyperglycemia and DKA.

Seek presymptomatic intervention

Talk to your patients and their care teams to know when and how to seek presymptomatic intervention.

Screen and stage for the opportunity to intervene before Stage 3 T1D

Discover factors that can increase your patient's risk of T1D

You can identify at-risk patients before severe symptoms appear

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. 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. 2. 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. 3. 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. 4. Scheiner G, Weiner S, Kruger D, Pettus J. Screening for type 1 diabetes: Role of the diabetes care and education specialist. ADCES Pract. 2022;10(5):20-25.

Why to screen