T1D PROGRESSION
T1D is present long before insulin is needed
T1D is a lifelong autoimmune disease with 3 distinct stages, allowing for identification of disease before exogenous insulin is needed.1
FOR US HEALTHCARE PROFESSIONALS ONLY
The burden of T1D is the greatest in Stage 3
Once Stage 3 develops, type 1 diabetes (T1D) can become a life-altering and time-consuming disease for the entire family.1-4
Each stage of T1D has distinct and detectable characteristics1
TAP THE ARROWS TO VIEW STAGES
STAGE 11
T1D IMPACT
From disease onset, Stage 3 T1D can be an everyday burden
T1D is recognized as a disease wherein much of the daily management is owned not only by people living with diabetes, but by their loved ones as well.6
T1D IMPACT
Focus often shifts to around-the-clock efforts to manage blood glucose within a healthy range. People living with T1D face:
- Stress related to the ongoing management of the disease2
- Daily oversight/management of carbohydrates, medications, and physical activity3
- Higher rates of absenteeism from work than those not living with T1D7
There are no data to suggest that TZIELD will have any effect on these outcomes.
WHY SCREEN
Limited time to screen if you want to intervene
Identifying patients with Stage 2 T1D can create a window of opportunity before they develop Stage 3 T1D.5
OF STAGE 2 PATIENTS PROGRESSED TO STAGE 3 T1D WITHIN 4 YEARS
IN AN ANALYSIS OF >1000 PATIENTS FROM THE TRAILNET NATURAL HISTORY STUDY.8
Detecting Stage 2 T1D could allow time for5:
- Disease preparation and education for patients and their families
- Early-stage intervention and management
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.
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.
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. Fisher L, Hessler D, Polonsky WH, et al. T1-REDEEM: a randomized controlled trial to reduce diabetes distress among adults with type 1 diabetes. Diabetes Care. 2018;41(9):1862-1869.3. Kiriella DA, Islam S, Oridota O, et al. Unraveling the concepts of distress, burnout, and depression in type 1 diabetes: a scoping review. EClinincalMedicine. 2021;40:101118.4. McQueen RB, Rasmussen CG, Waugh K, et al. Cost and cost-effectiveness of large-scale screening for type 1 diabetes in Colorado. Diabetes Care. 2020;43(7):1496-1503.5. Scheiner G, Weiner S, Kruger DF, Pettus J. Screening for type 1 diabetes: role of the diabetes care and education specialist. ADCES Pract. September 2022:20-25.6. Solowiejczyk J. The family approach to diabetes management: theory into practice toward the development of a new paradigm. Diabetes Spectr. 2004;17(1):31-36.7. American Diabetes Association. Economic costs of diabetes in the U.S. in 2017. Diabetes Care. 2018;41(5):917-928.8. Krischer JP; Type 1 Diabetes TrialNet Study Group. The use of intermediate endpoints in the design of type 1 diabetes prevention trials. Diabetologia. 2013;56(9):1919-1924.
Provention Bio, TZIELD, and the TZIELD logo are the registered trademarks of Provention Bio, a Sanofi Company.
The Provention Bio logo is the trademark of Provention Bio, a Sanofi Company.
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