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TZIELD resources to help support treatment
TZIELD resources to help support treatment
Supporting you and your staff–from screening and staging to the clinical data and administration of TZIELD
Screening and clinical data resources
T.I.M.E. Brochure
Steps to screen patients for autoimmune T1D and seek disease management before the onset of Stage 3 T1D.
TZIELD Clinical Information
Download the clinical information of TZIELD.
TZIELD Safety Summary
Downloadable summary of TZIELD's safety data.
Dosing resources
Step-by-Step TZIELD Dosing Instructions Video
A video detailing dosing, preparation, and administration information for TZIELD.
What to Expect Infusion Guide
Overview of safety and precautions to take before and during infusions with TZIELD.
Dosing and Administration Guide
Guide to dosing, preparation, and administration of TZIELD.
Helpful links
ADA Standards of Care in Diabetes 2024 Guidelines from the ADA to help capture the rapidly changing landscape of diabetes research, technology, and care, updated annually since 1989
Barbara Davis Center for Diabetes Research center dedicated to finding effective methods of prevention and treatment for diabetes
Labcorp Laboratory diagnostic option available for T1D-associated AAb screening
Quest Diagnostics Laboratory diagnostic option available for T1D-associated AAb screening
Stop T1D Program An educational program for HCPs interested in T1D screening and monitoring programs
TrialNet Research network offering free T1D risk screening to relatives of T1D patients
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.
