| Active substance | Teplizumab |
| Holder | Sanofi Belgium |
| Status | Running |
| Indication | Teplizumab is indicated for the treatment of adult and pediatric patients aged 8 years and older with stage 2 type 1 diabetes to delay the onset of stage 3 type 1 diabetes Teplizumab is administered by intravenous infusion (over a minimum of 30 minutes), using a body surface area-based dosing, once daily for 14 consecutive days as follows: • Day 1: 65 μg/m2 • Day 2: 125 μg/m2 • Day 3: 250 μg/m2 • Day 4: 500 μg/m2 • Days 5 through 14: 1030 μg/m2 Should a scheduled teplizumab infusion be missed, treatment shall be continued on the next scheduled day and any remaining doses be administered on subsequent days to complete the 14-day treatment. Two doses must not be administered on the same day. Teplizumab must be diluted prior to administration. |
| Public documents | Approbation |
| Information for the patient | |
| Informed consent guardian | |
| Informed consent child 8 - 13 years | |
| Informed consent child 14 years & older | |
| Informed consent adult | |
| Last update | 02/04/2025 |