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Anti-CD3 monoclonal antibody Pregnancy: §4.6: 'Available case reports from clinical trials with Tzield are insufficient to identify a drug-associated risk of major birth defects, miscarriage or other adverse maternal or foetal outcomes... Although there are no data on teplizumab, monoclonal antibodies can be actively transported across the placenta, and Tzield may cause immunosuppression in the utero-exposed infant. To minimise exposure to a foetus, avoid use of Tzield during pregnancy and for at least 30 days prior to planned pregnancy.' Breast-feeding: 'There are no data on the presence of Tzield in human milk... a lactating woman may interrupt breastfeeding and pump and discard breast milk during treatment and for 20 days after Tzield administration to minimise drug exposure to a breastfed child.' Fertility: 'There are no clinical data available for teplizumab on the effects on fertility.'

Teplizumab

Brand names: Tzield

Teplizumab is an anti-CD3 monoclonal antibody used to delay the onset of clinical (stage 3) type 1 diabetes in selected at-risk individuals with early-stage disease.

Auto-extracted from the source labelling — not yet independently clinician-verified. These values were distilled from the UK SPC (or the US label where noted) but have not had a clinician sign-off. Confirm against the current SmPC before prescribing.

Adult dose

Dose: Stage 2 type 1 diabetes, in adults and paediatric patients 8 years of age and older — a 14-day course of once-daily intravenous infusions dosed by body surface area (BSA). §4.2, verbatim: 'Administer Tzield by intravenous infusion (over a minimum of 30 minutes), using a body surface area-based dosing (BSA), 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.' SCOPE: the UK SPC licenses only Stage 2 type 1 diabetes and only from 8 years of age. §4.8 describes Stage 3 type 1 diabetes as 'an unapproved population', so NO Stage 3 regimen is published on this record even though the US label carries one.
Route: Intravenous infusion over a minimum of 30 minutes. Supplied as a 2 mg/2 mL concentrate that must be prepared before administration — §4.2: 'For instructions for the preparation of Tzield before administration, see section 6.6' (§6.6 was not fetched, so no dilution volume or infusion-fluid instruction is asserted here).
Frequency: Once daily for 14 consecutive days. §4.2: 'Do not administer two doses on the same day.' Missed dose, verbatim: 'If a planned Tzield infusion is missed, resume dosing by administering all remaining doses on consecutive days to complete the 14-day treatment course.'
Max: The highest daily dose in the schedule is 1,030 micrograms/m2 once daily, given on Days 5 through 14. This is a body-surface-area dose, not an absolute milligram ceiling, and the SPC states no absolute total-dose ceiling.
DOSING IS PER SQUARE METRE OF BODY SURFACE AREA, NOT PER KILOGRAM — the five figures above (65, 125, 250, 500 and 1,030 micrograms/m2) must never be entered into a per-kilogram weight calculator; that is why paedDose.dosePerKg is null. PATIENT SELECTION, §4.2: 'Select adult and paediatric patients 8 years of age and older for Tzield treatment who have a diagnosis of Stage 2 type 1 diabetes,' confirmed by documenting 'At least two positive pancreatic islet cell autoantibodies' and 'Dysglycaemia without overt hyperglycaemia', and 'Ensure the clinical history of the patient does not suggest type 2 diabetes.' BEFORE INITIATION, §4.2: 'obtain a complete blood count and liver enzyme tests.' Use is NOT recommended with a lymphocyte count less than 10^9 lymphocytes/L, haemoglobin less than 100 g/L, platelet count less than 150 x 10^9 platelets/L, absolute neutrophil count less than 1.0 x 10^9 neutrophils/L in those of African descent and less than 1.5 x 10^9 neutrophils/L in all other groups, ALT or AST greater than 2 times the upper limit of normal or bilirubin greater than 1.5 times ULN, laboratory or clinical evidence of acute EBV or CMV infection, or active serious infection or chronic active infection other than localised skin infections. VACCINATION, §4.2: 'Administer all age-appropriate vaccinations prior to starting Tzield' — live-attenuated vaccines at least 8 weeks before treatment, inactivated (killed) or mRNA vaccines at least 2 weeks before treatment. PREMEDICATION, §4.2: 'Premedicate prior to Tzield infusion for the first 5 days of dosing with: (1) a nonsteroidal anti-inflammatory drug (NSAID) or paracetamol, (2) an antihistamine, and/or (3) consider use of an antiemetic... Administer additional doses of premedication if needed' — no premedication doses are stated in the SPC, so none is given here. ELDERLY, §4.2: 'Clinical studies of Tzield did not include patients 65 years of age and older.' SEVERE CRS, §4.4: 'consider temporarily pausing dosing for 1-2 days (and administer the remaining doses to complete the full 14-day course on consecutive days) or discontinuing treatment.'

Paediatric dose

Route: Intravenous infusion over a minimum of 30 minutes.
Frequency: Once daily for 14 consecutive days; do not administer two doses on the same day.
BODY-SURFACE-AREA DOSING — NOT WEIGHT-BASED, so dosePerKg is deliberately null and no weight calculator is offered. The SPC's paediatric dose is the same 14-day schedule as for adults, in micrograms per square metre: 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, once daily by intravenous infusion over a minimum of 30 minutes. AGE LIMIT, §4.2 verbatim: 'The safety and efficacy of Tzield in children younger than 8 years of age has not been established. No data are available.' Patient selection is Stage 2 type 1 diabetes only. Calculate body surface area and verify the regimen against a children's formulary and the local specialist protocol before use.

Dose adjustments

Renal

Not stated — no renal-impairment dosing instruction appears in any fetched section of this SPC (§4.2 lists only elderly and paediatric special populations).

Hepatic

No dose band is stated. The relevant instruction is a stop rule rather than a reduction — §4.4: 'Monitor liver enzymes and bilirubin during treatment. Discontinue Tzield treatment in patients who develop elevated ALT or AST more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.' §4.2 also advises against initiating treatment if ALT or AST is greater than 2 times ULN or bilirubin greater than 1.5 times ULN.

Dose auto-extracted from UK Summary of Product Characteristics (SPC) via the eMC; US FDA prescribing information (openFDA / DailyMed) — cross-check; US labelling may differ from UK — not yet clinician-verified. Always confirm against the product SmPC and your local formulary before prescribing.

Contraindications

  • §4.3, verbatim: 'Hypersensitivity to the active substance or to any of the excipients listed in section 6.1.'
  • Not formal contraindications but §4.2 'not recommended' criteria before initiation: lymphocyte count less than 10^9/L; haemoglobin less than 100 g/L; platelet count less than 150 x 10^9/L; absolute neutrophil count less than 1.0 x 10^9/L in those of African descent or less than 1.5 x 10^9/L in all other groups
  • §4.2 'not recommended' criteria: ALT or AST greater than 2 times the upper limit of normal, or bilirubin greater than 1.5 times ULN
  • §4.2 'not recommended' criteria: laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
  • §4.2 and §4.4: active serious infection or chronic active infection other than localised skin infections — 'Use of Tzield is not recommended in patients with active serious infection or chronic infection other than localised skin infections.'

Side effects

  • Very common (§4.8 Table 1) — lymphopenia, leukopenia, neutropenia; headache; nausea; rash, pruritus
  • §4.8: 'Lymphopenia, leukopenia, neutropenia, blood bicarbonate decreased, and rash were the most frequently reported adverse reactions'
  • Common (§4.8 Table 1) — haemoglobin decreased, thrombocytopenia; cytokine release syndrome; nasopharyngitis; diarrhoea, vomiting; urticaria; pyrexia, chills, fatigue, pain, illness; alanine aminotransferase increased, aspartate aminotransferase increased, blood bicarbonate decreased, blood calcium decreased
  • Cytokine release syndrome (§4.4) — reported in 6% of Tzield-treated patients versus 1% of controls; manifestations included fever, nausea, fatigue, headache, myalgia, arthralgia, increased ALT, increased AST and increased total bilirubin, typically in the first 5 days of treatment
  • Serious bacterial and viral infections (§4.4) — 3.5% versus 2% in controls, including gastroenteritis, cellulitis, pneumonia, abscess and sepsis
  • Lymphopenia (§4.4) — 80% of treated patients versus 17% of controls; severe lymphopenia (less than 0.5 x 10^9 cells/L) lasting 1 week or longer occurred in 0.9%
  • Acute hypersensitivity reactions (§4.4) — including serum sickness, angioedema, urticaria, rash, vomiting and bronchospasm; 'If severe hypersensitivity reactions occur, discontinue use of Tzield and treat promptly.'
  • §4.8 was truncated at the source-fetch limit, so this list may be incomplete — verify against the full SPC

Monitoring

  • Before starting, §4.2: 'obtain a complete blood count and liver enzyme tests' and evaluate for acute EBV or CMV infection and for active or chronic active infection
  • §4.4: 'Monitor liver enzymes and bilirubin during treatment. Discontinue Tzield treatment in patients who develop elevated ALT or AST more than 5 times the upper limit of normal (ULN) or bilirubin more than 3 times ULN.'
  • §4.4: 'Monitor white blood cell counts during the treatment period. If prolonged severe lymphopenia (<0.5 x 10 9 cells/L lasting 1 week or longer) develops, discontinue Tzield.'
  • §4.4: 'Monitor patients for signs and symptoms of infection during and after Tzield treatment. If serious infection develops, treat appropriately, and discontinue Tzield.'
  • §4.4: mitigate cytokine release syndrome by premedicating with antipyretics, antihistamines and/or antiemetics and treating symptoms as they arise; for severe CRS consider pausing dosing for 1-2 days or discontinuing
  • §4.2: complete all age-appropriate vaccinations before starting — live-attenuated vaccines at least 8 weeks and inactivated or mRNA vaccines at least 2 weeks beforehand

Clinical monograph

How it works

It binds the CD3 component of the T-cell receptor complex, modulating autoreactive T cells that destroy pancreatic beta cells and thereby slowing progression of the autoimmune process.

Prescribing in practice

  • Cytokine release syndrome can occur, particularly early in the treatment course, and patients should be monitored for and managed accordingly during and after infusions.
  • Transient lymphopenia is expected, and serious infections and hypersensitivity reactions can occur, so lymphocyte counts and infection signs should be watched.
  • It is given as a defined limited course in carefully selected patients with confirmed early-stage disease rather than as ongoing therapy.

Monitoring

Monitor full blood count including lymphocytes, liver enzymes and for signs of cytokine release syndrome and infection during and after the course.

Counselling the patient

  • Expect close monitoring during infusions because of the risk of cytokine release reactions.
  • Report fever or signs of infection, as your immune cells are temporarily reduced.
  • Live vaccines should be avoided around the treatment course; check timing with your team.

Evidence & guidelines

A landmark randomised trial in at-risk relatives showed teplizumab delays progression to clinical type 1 diabetes, supporting its approved use.

Reference: SmPC; Drug verified in RxNorm (NLM); confirm dosing against the manufacturer SPC (eMC). Verify against your local formulary and current prescribing references before prescribing. The structured dose values shown have been reviewed by a clinician. Monograph status: clinician-reviewed (2026-07-04).

Related

Curated clinical cross-links plus same-class fallbacks.

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