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Recommended dosing schedule1

TZIELD is administered by intravenous infusion over 14 consecutive days.

             

Day 1

65 mcg/m2

.             

Day 2

125 mcg/m2

.             

Day 3

250 mcg/m2

.             

Day 4

500 mcg/m2

             

Day 5-14

1030 mcg/m2

If an infusion is missed

Resume by administering all remaining doses on consecutive days to complete the 14-day course.

 

Determine the dose2

TZIELD is administered by intravenous infusion over a minimum of 30 minutes using BSA-based dosing.

 

Calculate BSA dosing with the Mosteller formula

BSA Equation

BSA (m²) = √([height (cm) × weight (kg)] / 3600)

Example

Male, 8 years old, 120 cm, 26 kg

BSA (m²) = √(120) × (26) / 3600)  =  0.931 m2

When calculating BSA, round to the 100th using standard rounding rules (example, 0.93 m2).

Based on BSA dosing requirements, 2 vials may be needed for some individuals (BSA > 1.94 m2) for Days 5-14.

 

BSA=body surface area

 

Prior to initiation1

Prior to initiating TZIELD, obtain a complete blood count and liver enzyme tests. Use of TZIELD is not recommended in patients with certain laboratory abnormalities.

  • 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

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 ageappropriate 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.
     

TZIELD API

  1. TZIELD Prescribing Information. Provention Bio, Inc; 2023.

  2. Mosteller RD. Simplified calculation of body-surface area. N Engl J Med. 1987;317(17):1098.

MAT-KW-2500536/V1/March 2026