Active Ingredient: Teplizumab
Teplizumab is indicated to delay the onset of Stage 3 type 1 diabetes in adults and pediatric patients 8 years of age and older with Stage 2 type 1 diabetes.
For this indication, competent medicine agencies globally authorize below treatments:
For:
In 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, in case that patient age in years is ≥ 8, intravenous, 125 micrograms teplizumab per square meter of body surface, one dose, over the duration of 1 day. Afterwards, in case that patient age in years is ≥ 8, intravenous, 250 micrograms teplizumab per square meter of body surface, one dose, over the duration of 1 day. Afterwards, in case that patient age in years is ≥ 8, intravenous, 500 micrograms teplizumab per square meter of body surface, one dose, over the duration of 1 day. Afterwards, in case that patient age in years is ≥ 8, intravenous, 1,030 micrograms teplizumab per square meter of body surface, one dose, over the duration of 10 days.
Select adult patients and pediatric patients 8 years of age and older for teplizumab treatment who have a diagnosis of Stage 2 type 1 diabetes.
Administer teplizumab by intravenous infusion (over a minimum of 30 minutes), using a body surface area-based dosing, once daily for 14 consecutive days as follows:
Do not administer two doses on the same day.
If a planned teplizumab infusion is missed, resume dosing by administering all remaining doses on consecutive days to complete the 14-day treatment course.
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