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Prescribing Information

Intervene during Stage 2 T1D with TZIELD (teplizumab)

Patients 8 years and older who meet the criteria of Stage 2 T1D below may be eligible for the first and only treatment approved to delay the onset of Stage 3 T1D.1,2

Stage 2 T1D criteria

Positive for ≥2 of the following four pancreatic islet autoantibodies (AAbs):3,4

  • Glutamic acid decarboxylase 65 autoantibodies (GADA)
  • Insulin autoantibody (IAA)
  • Insulinoma-associated antigen 2 autoantibody (IA-2A)
  • Zinc transporter 8 autoantibody (ZnT8A)

Dysglycaemia without overt hyperglycaemia confirmed with:3

  • Fasting plasma glucose (FPG) 5.6–6.9 mmol/L
  • 120-min oral glucose tolerance test (OGTT) 7.8–11.0 mmol/L
  • Glycated haemoglobin (HbA1c) 39–47 mmol/mol (5.7–6.4%)
  • Continuous glucose monitor (CGM) values >7.8 mmol/L for 10% of the time over 10 days' continuous wear and confirmed by at least one other non-CGM glucose measurement test

Ensure that the clinical history of the patient does not suggest Type 2 diabetes (T2D).

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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

AAb, autoantibody; FPG, fasting plasma glucose; GADA, glutamic acid decarboxylase 65 autoantibodies; HbA1c, glycated haemoglobin; IAA, insulin autoantibody; IA-2A, insulinoma-associated antigen 2 autoantibody; OGTT, oral glucose tolerance test; T1D, Type 1 diabetes; T2D, Type 2 diabetes; ZnT8A, zinc transporter 8 autoantibody.

  1. TZIELD® (teplizumab) UK Summary of Product Characteristics. 2025.
  2. Herold KC, et al. Diabetes Care. 2023; 46(10): 1848–1856.
  3. Phillip M, et al. Diabetes Care. 2024; 47(8): 1276–1298.
  4. Sims EK, et al. Diabetes. 2022; 71: 610–623.

MAT-XU-2500767 (v1.0) | November 2025