FOR US HEALTHCARE PROFESSIONALS ONLY
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INDICATION & MOA
About TZIELD
TZIELD is a CD3-directed monoclonal antibody indicated to delay the onset of Stage 3 T1D in adults and pediatric patients aged 8 years and older with Stage 2 T1D.1
TZIELD is a CD3-directed monoclonal antibody that binds to CD3 antigens presented on the surface of T cells.1
The mechanism of action may involve the partial agonistic signaling and deactivation of pancreatic beta cell autoreactive T cells.1
TZIELD can potentially delay the onset of Stage 3 T1D in your patients with Stage 2 T1D.1
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PATIENT CRITERIA
TZIELD patient selection
Appropriate patients for TZIELD are 8 years or older and have a diagnosis of Stage 2 T1D.1 Confirm Stage 2 T1D with the following criteria:
STAGE 2
Positive for ≥2 of the following 5 pancreatic islet autoantibodies (AAbs)1:
- Glutamic acid decarboxylase 65 autoantibody (GADA)
- Insulinoma-associated antigen 2 autoantibody (IA-2A)
- Insulin autoantibody (IAA)
- Islet cell autoantibody (ICA)
- Zinc transporter 8 autoantibody (ZnT8A)
If fewer than 2 AAbs are detected, additional screening may be appropriate for high-risk patients.2
Dysglycemia (fluctuating glucose levels, outside normal range) without overt hyperglycemia, confirmed with3,4:
- 2-H plasma glucose (2-H PG) 140-199 mg/dL during oral glucose tolerance test (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.1
Other methods that may be appropriate are available in the ADA and ISPAD guidelines.
Ensure the clinical history of patient does not suggest type 2 diabetes. Before initiating TZIELD, review section 2.1 of the Prescribing Information.1
Learn how to identify your eligible patients in 4 steps
Identify Patients
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. TZIELD Prescribing Information. Provention Bio, Inc.2. 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):20-27.3. ElSayed NA, Aleppo G, Aroda VR, et al. Standards of care in diabetes—2023. Diabetes Care. 2023;46(suppl 1):S19-S40.4. Type 1 Diabetes TrialNet. Protocol TN-10. Version June 2014. Accessed May 5, 2023. https://clinicaltrials.gov/ProvidedDocs/61/NCT01030861/Prot_000.pdf
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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