Teplizumab: clinical use

Prescribing considerations

• Confirm Stage 2 type 1 diabetes with at least two pancreatic islet autoantibodies and dysglycaemia without overt hyperglycaemia; ensure the history does not suggest type 2 diabetes.
• Review full blood count, liver biochemistry, infection status, vaccination history, pregnancy or breastfeeding, and concomitant immunosuppression before initiation.
• Complete age-appropriate vaccination in accordance with product-specific timing requirements.
• Plan premedication and facilities for recognising and managing cytokine release syndrome and hypersensitivity.

Contraindications and cautions

• Hypersensitivity to teplizumab or any excipient.
• Use is not recommended with specified baseline cytopenias or liver-test abnormalities, acute Epstein–Barr virus or cytomegalovirus infection, active serious infection, or chronic active infection other than a localised skin infection.

Monitoring

• Full blood count before and during treatment, with particular attention to lymphocytes and other cytopenias.
• Liver enzymes and bilirubin before and during treatment.
• Clinical monitoring for cytokine release syndrome, hypersensitivity, and infection during and after treatment.
• Suspend or discontinue treatment when product-specific severity criteria are met.

Clinical pharmacology

Teplizumab is a humanised IgG1 kappa monoclonal antibody directed against CD3. It produces partial agonistic signalling and may deactivate beta-cell-autoreactive T lymphocytes, with increases in regulatory T cells and exhausted CD8-positive T cells. It is expected to undergo catabolic breakdown to small peptides and has saturable binding and elimination.

Formulation and product differences

• The UK product is a clear, colourless concentrate for intravenous infusion supplied in single-use vials.
• It requires dilution with sodium chloride solution and contains polysorbate 80.
• The product is essentially sodium-free per vial, although it is administered in sodium chloride infusion solution.

Solution for infusion

Route: Intravenous

Strengths: 2 mg/2 mL