Formulary
Teplizumab: Indications, Dosing, Side Effects and Interactions
Teplizumab is a humanised monoclonal antibody that binds to CD3 antigens on T-lymphocytes, thereby limiting the autoimmune destruction and preserving the...
MedNext Academy | 3 min read
Teplizumab: Indications, Dosing, Side Effects and Interactions
Teplizumab is a humanised monoclonal antibody that binds to CD3 antigens on T-lymphocytes, thereby limiting the autoimmune destruction and preserving the...
Drug action
Teplizumab is a humanised monoclonal antibody that binds to CD3 antigens on T-lymphocytes, thereby limiting the autoimmune destruction and preserving the function of pancreatic islet insulin-producing beta cells.
Indications and dose
**Type 1 diabetes mellitus [to delay onset of stage 3 in those with stage 2 disease]**
- **Adult** (By Intravenous Infusion): 65 micrograms/m 2 once daily on day 1, then 125 micrograms/m 2 once daily on day 2, then 250 micrograms/m 2 once daily on day 3, then 500 micrograms/m 2 once daily on day 4, then 1030 micrograms/m 2 once daily on days 5-14.
**Type 1 diabetes mellitus [to delay onset of stage 3 in those with stage 2 disease] for teplizumab**
- **Child 8-17 years** (By intravenous infusion): 65 micrograms/m2 once daily on day 1, then 125 micrograms/m2 once daily on day 2, then 250 micrograms/m2 once daily on day 3, then 500 micrograms/m2 once daily on day 4, then 1030 micrograms/m2 once daily on days 5-14.
Cautions
Elderly (65 years and older-no information available); risk of cytokine release syndrome Cautions, further information Cytokine release syndrome (CRS) To mitigate CRS, patients should be premedicated with an NSAID or paracetamol, an antihistamine, and, if needed, an antiemetic for the first 5 days of treatment; additional doses of premedication may be given as required. If severe CRS develops, consider temporarily interrupting treatment for 1-2 days or discontinuing treatment-consult product literature. M
Contraindications
Absolute neutrophil count less than 1 x 10 9 cells/litre in patients of African descent or less than 1.5 x 10 9 cells/litre in all other groups (do not initiate); active serious infection except localised skin infections (do not initiate); chronic active infection except localised skin infections (do not initiate); elevated alanine aminotransferase (ALT) exceeding 2 times the upper limit of normal (do not initiate); elevated aspartate aminotransferase (AST) exceeding 2 times the upper limit of normal (do not initiate); elevated bilirubin exceeding 1.5 times the upper limit of normal (do not initiate); evidence of acute cytomegalovirus infection (do not initiate); evidence of acute Epstein-Barr virus infection (do not initiate); haemoglobin less than 10 g/dL (do not initiate); lymphocyte count less than 1 x 10 9 cells/litre (do not initiate); platelet count less than 150 x 10 9 cells/litre (do not initiate) Contra-indications, further information Vaccination against infection To reduce the risk of infection, patients should receive all recommended vaccinations prior to initiation; teplizumab treatment may also interfere with the immune response and decrease vaccine efficacy. Live attenuated vaccines are not recommended within the 8 weeks before starting, during, or up to 52 weeks after, treatment (safety of immunisation during treatment unknown). Inactivated or mRNA vaccines are not recommended within the 2 weeks before starting, during, or 6 weeks after, treatment. M
Side effects
Common or very common Chills; cytokine release syndrome; diarrhoea; fever; headache; increased risk of infection; leucopenia; lymphopenia (discontinue if severe and prolonged); nausea; neutropenia; skin reactions; thrombocytopenia Frequency not known Abscess; fatigue; hypersensitivity; illness; pain; sepsis; vomiting Side-effects, further information Manufacturer advises discontinue treatment if transaminase levels more than 5 times the upper limit of normal or blood bilirubin more than 3 times the upper limit of normal-consult product literature.
Pregnancy
Avoid use during, and for at least 30 days before planned, pregnancy (limited information available). M
Breast feeding
Specialist sources indicate use with caution (no information available). Large molecular weight suggests limited excretion into milk and drug molecule likely to be partially destroyed in the infant's gastro-intestinal tract; waiting for at least 2 weeks postpartum to resume treatment may minimise transfer to infant.
Medicinal forms
Clinical governance
**Author:** MedNext Clinical Team. **Clinical reviewer:** Dr Shameer Deen, MBBS, MS, MRCS. **Sources:** BNF, Indian Pharmacopoeia, CIMS India. **Correction:** Report errors at support@mednext.academy.
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