PETITE-T1D: Safety data
NOW APPROVED EXPANDED PEDIATRIC INDICATION in children as young as 1 year of age with Stage 2 T1D
The PETITE-T1D study
evaluated the safety of TZIELD in pediatric patients 1 year of age to <8 years of age.1
PETITE-T1D STUDY DESIGN:
The safety of TZIELD was evaluated in a non-randomized, single-arm, open-label, multicenter study in 23 pediatric patients age 1 year to less than 8 years with Stage 2 T1D. The median age was 4.9 years (1 patient was less than 2 years old; 52% were age 2 years to less than 5 years old)1
PETITE-T1D: consistent safety profile with TN-10 Trial1,2
Overall, the safety profile of TZIELD observed in pediatric patients <8 years of age with Stage 2 T1D was consistent with the safety profile observed in patients ≥8 years of age with Stage 2 T1D.
Adverse reactions observed in pediatric patients 1 year of age and older who received TZIELD were consistent with those observed in patients aged 8 years and older with Stage 2 T1D.
Use of TZIELD for this indication is supported by evidence from an adequate and well-controlled study (Study TN-10) in adult and pediatric patients 8 years of age and older (including 29 pediatric patients) with Stage 2 T1D and from additional pharmacokinetic and safety data in 23 pediatric patients aged 1 to less than 8 years of age with Stage 2 T1D. The safety and effectiveness of TZIELD have not been established in pediatric patients younger than 1 year of age.1
PETITE-T1D safety profile
Consistent safety profile with TN-10 Trial
Overall, the safety profile of TZIELD observed in pediatric patients <8 years of age with Stage 2 T1D was consistent.
Review TN-10 safety profile hereMost common adverse reactions
The most common adverse reactions that occurred in patients <8 years of age were vomiting (52%) and diarrhea (30%).
Procedure-related venous thrombosis
Venous thrombus and thrombophlebitis have been reported in patients receiving TZIELD intravenously administered via peripherally inserted central catheter (PICC). In the pool of 5 clinical trials of patients, deep vein thrombus was reported in 0.4% of TZIELD-treated patients compared to 0 placebo-treated patients. One TZIELD-treated patient (4.3%) in the PETITE-T1D study experienced a deep vein thrombosis.
ADA=American Diabetes Association; T1D=type 1 diabetes.
The safety profile of TZIELD has been established in pediatric patients 1 year of age and older with Stage 2 T1D.1
See how TZIELD can help your patients with Stage 2 T1D as young as 1 year of age and older1
Download the PETITE-T1D BrochureEarly screening and monitoring can help you identify at-risk children before symptoms arise3,4
Important Safety Information Anchor
IMPORTANT SAFETY INFORMATION
WARNING: Viral Reactivation
- Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia.
- Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD.
WARNINGS AND PRECAUTIONS
Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV have been reported with TZIELD. During and within 2 months of TZIELD treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV-associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk. The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia. Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., PCR testing). TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. During treatment with TZIELD, regularly monitor lymphocyte counts and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD and obtain viral load (e.g., PCR) promptly. If viral reactivation is confirmed, permanently discontinue TZIELD.
Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. CRS manifestations in TZIELD-treated patients included fever, nausea (with or without vomiting), fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment. 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. Obtain a CBC prior to starting TZIELD and monitor white blood cell counts during TZIELD treatment. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), permanently 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 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.
- Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
ADVERSE REACTIONS
Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea and headache.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm. To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy. Report pregnancies to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi
- 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 Boxed WARNING and patient selection criteria.
INDICATION
TZIELD (teplizumab-mzwv) is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 1 year of age and older with Stage 2 T1D.
REFERENCES
- TZIELD Prescribing Information. Provention Bio, Inc.
- Gitelman SE, Simmons K, Sherr JL, et al. Safety and pharmacokinetics of teplizumab in children less than 8 years of age with stage 2 type 1 diabetes. Diabetologia. 2025;69(2):330-342.
- 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.
- 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.
- COMPASS Support START Form
- Call 1-844-778-2246 to speak with a TZIELD COMPASS representative
© 2026 Sanofi. All rights reserved. MAT-US-2601780-v1.0-04/2026
IMPORTANT SAFETY INFORMATION
INDICATION
IMPORTANT SAFETY INFORMATION
WARNING: Viral Reactivation
- Serious, life-threatening cases of viral reactivation, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV) reactivation have been reported with TZIELD. Patients who are immunocompromised are at increased risk. The majority of serious cases occurred in patients who continued TZIELD treatment despite persistent, severe lymphopenia.
- Test patients for active EBV and CMV infection prior to starting treatment. TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. Adhere to lymphocyte count monitoring requirements and discontinuation recommendations. Monitor patients for signs and symptoms of viral reactivation following TZIELD treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD.
WARNINGS AND PRECAUTIONS
Viral Reactivation: Serious, life-threatening cases of viral reactivation, including EBV and CMV have been reported with TZIELD. During and within 2 months of TZIELD treatment, if primary infection or reactivation of EBV or CMV occurs, it may present with increased severity, including EBV-associated lymphoproliferative disease and organ failure. Patients who are immunocompromised, including patients with Down syndrome, may be at increased risk. The majority of serious viral reactivation cases occurred in patients who continued TZIELD despite persistent, severe lymphopenia. Prior to initiating treatment with TZIELD, evaluate patients for active EBV and CMV infection and confirm undetectable viral load (e.g., PCR testing). TZIELD is not recommended in patients with laboratory or clinical evidence of active EBV or CMV infection. During treatment with TZIELD, regularly monitor lymphocyte counts and monitor patients for signs and symptoms of viral reactivation during treatment and for at least 2 months following the last infusion. If viral reactivation is suspected, discontinue TZIELD and obtain viral load (e.g., PCR) promptly. If viral reactivation is confirmed, permanently discontinue TZIELD.
Cytokine Release Syndrome (CRS): CRS occurred in TZIELD-treated patients during the treatment period and through 28 days after the last drug administration. CRS manifestations in TZIELD-treated patients included fever, nausea (with or without vomiting), fatigue, headache, myalgia, arthralgia, increased ALT, increased AST, and increased total bilirubin. These manifestations typically occurred during the first 5 days of TZIELD treatment. 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. Obtain a CBC prior to starting TZIELD and monitor white blood cell counts during TZIELD treatment. If prolonged severe lymphopenia develops (<500 cells per mcL lasting 1 week or longer), permanently 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 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.
- Administer live vaccines at least 8 weeks prior to treatment. Live vaccines are not recommended during treatment, or up to 52 weeks after treatment.
ADVERSE REACTIONS
Most common adverse reactions were lymphopenia, vomiting, rash, leukopenia, diarrhea and headache.
USE IN SPECIFIC POPULATIONS
- Pregnancy: May cause fetal harm. To minimize exposure to a fetus, avoid use of TZIELD during pregnancy and at least 30 days prior to planned pregnancy. Report pregnancies to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi
- 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 Boxed WARNING and patient selection criteria.
INDICATION
TZIELD (teplizumab-mzwv) is indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients 1 year of age and older with Stage 2 T1D.