Table 4.
Prescribing information for Teplizumab49
| Indication: Teplizumab is a CD3-directed antibody indicated to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and pediatric patients aged 8 years and older with Stage 2 T1D. |
| Investigation before use: It is advisable to obtain a complete blood count and liver enzymes tests, prior to the initiation of teplizumab. |
| Premedicate with: |
| 1) Nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen, |
| 2) An antihistamine, and/or |
| 3) An antiemetic before each teplizumab dose for at least the first 5 days of the 14-day treatment course. |
| Warnings And Precautions: |
| • Use of teplizumab is not recommended in patients with |
| 1) Lymphocyte count less than 1,000 lymphocytes/mcL |
| 2) Hemoglobin less than 10 g/dL |
| 3) Platelet count less than 150,000 platelets/mcL |
| 4) Absolute neutrophil count less than 1,500 neutrophils/mcL |
| 5) Elevated ALT or AST more than 2 times the upper limit of normal (ULN) or bilirubin more than 1.5 times ULN |
| 6) Laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV) |
| 7) Any active serious infection or chronic active infection (other than localized skin infections) |
| • Administer all age-appropriate vaccinations prior to starting teplizumab |
| 1) Administer live-attenuated (live) vaccines at least 8 weeks prior to treatment. |
| 2) Administer inactivated (killed) vaccines or mRNA vaccines at least 2 weeks prior to treatment. |
| Recommended Dosage and Administration Intravenous infusion administration of teplizumab (over a minimum of 30 minutes), using a body surface area-based dosing, once daily for 14 consecutive days as follows: |
| • Day 1: 65 mcg/m2 |
| • Day 2: 125 mcg/m2 |
| • Day 3: 250 mcg/m2 |
| • Day 4: 500 mcg/m2 |
| • Days 5 through 14: 1,030 mcg/m2 |
| Do not administer two doses on the same day. |
| Recommendations Regarding Missed Dose (s): Resume dosing by administering all remaining doses on consecutive days to complete the 14-day treatment course if a planned teplizumab infusion is missed. |
| Adverse Reactions: Most common adverse reactions (>10%) were lymphopenia, rash, leukopenia and headache, cytokine release syndrome and serious infections. |