A single 2-week course can potentially delay Stage 3 T1D onset

For adults and pediatric patients aged 8 years and older with Stage 2 type 1 diabetes (T1D); TZIELD is administered by intravenous infusion.1

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Dosing instructions

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Dosage form and strength1:
TZIELD injection: 2 mg per 2 mL (1 mg/mL) clear and colorless solution in a single-dose vial.
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Recommended dosing schedule1:
TZIELD is administered by intravenous infusion (over a minimum of 30 minutes), using body surface area-based dosing, once daily for 14 consecutive days.
Day 1
65 mcg/m2
Day 2
125 mcg/m2
Day 3
250 mcg/m2
Day 4
500 mcg/m2
Days 5-14
1030 mcg/m2
If a planned infusion is missed, resume course by administering all remaining doses on consecutive days to complete the 14-day course.
Do not administer 2 doses on the same day.1
TZIELD is a 2-week treatment!A smiling boy wearing winter clothes stands in snow looking up with arms raised.
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Labs & premedication

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Labs prior to initiation
Prior to initiating TZIELD, obtain a complete blood count and liver enzyme tests. Use of TZIELD is not recommended in patients with certain laboratory abnormalities1:
  • Lymphocyte count less than 1000 lymphocytes/mcL
  • Hemoglobin less than 10 g/dL
  • Platelet count less than 150,000 platelets/mcL
  • Absolute neutrophil count less than 1500 neutrophils/mcL
  • Elevated ALT or AST greater than 2 times the upper limit of normal (ULN) or bilirubin greater than 1.5 times ULN
  • Laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
  • Active serious infection or chronic active infection other than localized skin infections
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Premedicate prior to TZIELD infusion for the first 5 days of dosing with: (1) a nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, (2) an antihistamine, and/or (3) an antiemetic. Administer additional doses of premedication if needed.1

Practice resources

Please review the full Prescribing Information for more information and before prescribing TZIELD. Download the following for your practice:
What to Expect
Infusion Guide
Dosing and
Administration Guide

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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.



  • 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.