Dosing and administration instructions

Recommended dosing schedule for TZIELD

The recommended TZIELD dosage for adults and paediatric patients aged 8 years and older uses BSA-based dosing and is administered according to the following regimen:^*1

Calculating your patients' BSA using the Mosteller formula²

• When calculating BSA, round to the 100th using standard rounding rules (example: 0.89 m²)
• Based on BSA dosing requirements, two vials may be needed for some individuals (BSA >1.94 m²) for days 5–14¹

Use this interactive tool below to calculate individual dosing and support safe and confident infusion delivery in your clinical practice

TZIELD is a concentrate solution for infusion. Each vial contains 2 mg of teplizumab in 2 mL of concentrate. The product must be diluted prior to use.¹
TZIELD should be administered by a healthcare professional with access to appropriate medical support to manage potential severe adverse reactions.

Patient selection¹

Select adult and paediatric patients 8 years of age and older for TZIELD treatment who have a diagnosis of Stage 2 Type 1 diabetes (T1D)

• Confirm Stage 2 T1D by documenting:
  • At least two positive pancreatic islet cell autoantibodies (AAbs)
  • Dysglycaemia without overt hyperglycaemia
• Ensure the clinical history of the patient does not suggest Type 2 diabetes (T2D)

Premedication¹

• Premedicate prior to TZIELD infusion for the first five days of dosing with a non-steroidal anti-inflammatory drug (NSAID) or paracetamol, an antihistamine, and/or an antiemetic
• Administer additional doses of premedication if needed

Laboratory and infection evaluation and vaccinations prior to treatment¹

Prior to initiation of TZIELD, there are a number of laboratory and infection evaluations required to ensure that TZIELD is suitable for patients. All age-appropriate vaccinations must also be administered before treatment

Prior to initiating TZIELD, obtain a complete blood count and liver enzyme tests.

Patients should be evaluated for active Epstein-Barr Virus (EBV) and cytomegalovirus (CMV) infection to confirm undetectable viral load (e.g., polymerase chain reaction [PCR] testing).

Use of TZIELD is not recommended in patients with:

• Lymphocyte count <10⁹ lymphocytes/L
• Haemoglobin <100 g/L
• Platelet count <150 x 10⁹ platelets/L
• Absolute neutrophil count <1.0 x 10⁹ neutrophils/L in those of African descent and <1.5 x 10⁹ neutrophils/L in all other groups
• Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) >2 x upper limit of normal (ULN) or bilirubin greater than 1.5 times ULN
• Laboratory or clinical evidence of acute infection with EBV or CMV
• Active serious infection or chronic active infection other than localised skin infections

Administer all age-appropriate vaccinations prior to starting TZIELD:

• Administer live-attenuated (live) vaccines at least 8 weeks prior to treatment
• Administer inactivated (killed) vaccines or messenger ribonucleic acid (mRNA) vaccines at least 2 weeks prior to treatment

INDICATION: TZIELD is indicated to delay the onset of Stage 3 T1D in adult and paediatric patients 8 years of age and older with Stage 2 T1D.¹

*The dosing schedule in TN-10 was different to the recommended dosing schedule in the Summary of Product Characteristics (SmPC).¹

AAbs, autoantibodies; ALT, alanine aminotransferase; AST, aspartate aminotransferase; BSA, body surface area; CMV, cytomegalovirus; DKA, diabetic ketoacidosis; EBV, Epstein-Barr virus; mRNA, messenger ribonucleic acid; NSAID, non-steroidal anti-inflammatory drug; SmPC, Summary of Product Characteristics; T1D, Type 1 diabetes;  T2D, Type 2 diabetes; UK, United Kingdom; ULN, upper limit of normal.

MAT-XU-2500768 (v3.0) | September 2026