Delay of the Stage 3 onset of type 1 diabetes

Active Ingredient: Teplizumab

Indication for Teplizumab

Population group: only children (1 year - 12 years old) , adolescents (12 years - 18 years old) , adults (18 years old or older)
Therapeutic intent: Preventive action

Teizeild is indicated to delay the onset of stage 3 type 1 diabetes (T1D) in adult and paediatric patients 8 years of age and older with stage 2 T1D.

For this indication, competent medicine agencies globally authorize below treatments:

65 ug/m² on Day 1, 125 ug/m² on Day 2, 250 ug/m² on Day 3, 500 ug/m² on Day 4 and 1,030 ug/m² on Days 5-14

For:

Dosage regimens

In the case that patient age in years is ≥ 8 :

Intravenous, 65 micrograms teplizumab per square meter of body surface, one dose, over the duration of 1 day. Afterwards, intravenous, 125 micrograms teplizumab per square meter of body surface, one dose, over the duration of 1 day. Afterwards, intravenous, 250 micrograms teplizumab per square meter of body surface, one dose, over the duration of 1 day. Afterwards, intravenous, 500 micrograms teplizumab per square meter of body surface, one dose, over the duration of 1 day. Afterwards, intravenous, 1,030 micrograms teplizumab per square meter of body surface, one dose, over the duration of 10 days.

Detailed description

Teplizumab should be administered by a healthcare professional with access to appropriate medical support to manage potential severe adverse reactions.

Laboratory evaluation and vaccination prior to initiation

  • Prior to initiating teplizumab, a complete blood count and liver enzyme tests should be obtained.
  • Use of teplizumab is not recommended in patients with:
    • Lymphocyte count less than 1.0 x 109 lymphocytes/L
    • Haemoglobin less than 100 g/L
    • Platelet count less than 100 x 109 platelets/L
    • Absolute neutrophil count less than 1.5 x 109 neutrophils/L
    • Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (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 localised skin infections
  • All age-appropriate vaccinations should be administered prior to initiating teplizumab.

Premedication

Premedication should be used prior to teplizumab infusion for the first 5 days of dosing with: (1) a nonsteroidal anti-inflammatory drug (NSAID) or paracetamol, (2) an antihistamine, and (3) use of an antiemetic could be considered. Additional doses of premedication should be administered if needed.

Posology

Teplizumab should be administered by intravenous infusion (over a minimum of 30 minutes), using a body surface area (BSA)-based dosing, once daily for 14 consecutive days as follows:

  • Day 1: 65 micrograms/m²
  • Day 2: 125 micrograms/m²
  • Day 3: 250 micrograms/m²
  • Day 4: 500 micrograms/m²
  • Days 5 through 14: 1 030 micrograms/m²

Missed dose(s)

If a planned teplizumab infusion is missed, dosing should be resumed by administering all remaining doses on consecutive days to complete the 14-day treatment course.

Treatment discontinuation

Temporary treatment discontinuation may be required according to the severity of laboratory abnormalities. Based on clinical judgment, treatment should be paused if platelet count, neutrophil count, or haemoglobin level decreases significantly.

Dose interruption should not exceed 3 days. Dosing may be resumed by administering all remaining doses on consecutive days to complete the 14-day treatment course (e.g. if dosing is missed on Days 4 and 5, dosing may restart at Day 6 with the dosing level specified for Day 4).

Treatment should be permanently discontinued if:

  • Elevated liver enzymes (ALT or AST greater than 5 times ULN) or bilirubin greater than 3 times ULN
  • Prolonged severe lymphopenia (<0.5 x 109 lymphocytes/L lasting 1 week or longer)
  • Clinically relevant (physician´s decision based on the individual patient´s data) decrease of platelet count, neutrophil count, or haemoglobin level for 3 consecutive days
  • A serious infection develops

Active ingredient

Teplizumab

Teplizumab binds to CD3 (a cell surface antigen present on T lymphocytes) and delays disease progression in patients with stage 2 T1D. The mechanism may involve partial agonistic signalling leading to deactivation of autoreactive CD8+ T lymphocytes and reduced immune-mediated beta-cell destruction. Teplizumab leads to an increase in the proportion of CD8+ T cells with signs of exhaustion in peripheral blood.

Read more about Teplizumab

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