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teplizumab

Teizeild · ATC code A10XX01

Key facts
Active substance
teplizumab
Drug class
Anti-diabetic medication
ATC code
A10XX01
Authorisation
centrally authorised across the EU (EMA)
Dosage forms
Teizeild 1 mg/mL concentrate for solution for infusion
Marketing authorisation holder
Sanofi Winthrop Industrie
Information as of
2026-10-28

Key facts

Teplizumab is a biological medicine given by intravenous infusion. It is used to delay the onset of stage 3 type 1 diabetes in patients aged 8 years and older with stage 2 type 1 diabetes.

What it is used for

  • To delay the onset of stage 3 type 1 diabetes (T1D) in adults and children 8 years and older with stage 2 T1D (Teizeild).

Dosing

  • Intravenous infusion (at least 30 minutes) once daily for 14 consecutive days, dosed by body surface area: first day 65 micrograms/m2, second day 125 micrograms/m2, third day 250 micrograms/m2, fourth day 500 micrograms/m2, fifth to fourteenth day 1,030 micrograms/m2.
  • For the first 5 days, premedicate with an NSAID or paracetamol and an antihistamine, possibly an antiemetic.
  • Before starting: blood count and liver tests; not recommended, among others, with lymphocytes below 1.0 x 10^9/L, haemoglobin below 100 g/L, platelets below 100 x 10^9/L, elevated liver tests or acute EBV/CMV infection.
  • Missed doses are given on consecutive days to complete the course; interruptions should not exceed 3 days.
  • Discontinue permanently, among others, if ALT or AST exceed 5 times ULN or bilirubin exceeds 3 times ULN.

Contraindications

  • Hypersensitivity to the active substance or any of the excipients.

Important warnings

  • Cytokine release syndrome during treatment and up to 28 days after, usually in the first 5 days; premedication and liver test monitoring.
  • Serious infections: discontinue if a serious infection develops.
  • Lymphopenia in 75% of patients, usually recovering within two weeks.
  • Hypersensitivity reactions including anaphylaxis.
  • Complete vaccinations before starting; inactivated or mRNA vaccines not recommended from 2 weeks before to 6 weeks after treatment, live-attenuated vaccines from 8 weeks before to 52 weeks after.

Side effects

  • Most frequent: lymphopenia (75%), leukopenia (58%), neutropenia (37%) and rash (36%).
  • Most frequent serious reaction: cytokine release syndrome (0.9%).
  • Others: thrombocytopenia, haemoglobin decreased, headache, nausea, vomiting, diarrhoea, abdominal pain, infections, EBV reactivation.

Interactions

  • No interaction studies; caution with medicines associated with liver abnormalities or cytopenias and with other immune modulators.
  • No relevant CYP450 interactions expected; vaccine responses may be impaired.

Pregnancy and breastfeeding

  • Not recommended during pregnancy; effective contraception during treatment and for 30 days after the last dose.
  • Breast-feeding: see the full text.

Summary of the official product information, written with AI on 2026-10-29. Every number was checked automatically against the original text. Not reviewed by a physician – the full official text is authoritative.

Full official text →

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For patients

Package leaflet, verbatim

This product has no separate US patient information.

Authorisation and brand names by country

Medicines with exactly this active-substance composition, as listed in the national registers – alphabetical and without ranking. Whether a product is currently available is not shown here.

EU – centrally authorised (all member states)

  • TeizeildSanofi Winthrop Industrie · EMEA/H/C/005496

Source: European Medicines Agency (EMA), product information

Brand names in 3 more European countries
Iceland
Teizeild
Liechtenstein
Teizeild
Norway
Teizeild

EMA – Article 57 product data (EU/EEA), 2026-10-29

Medelix receives no money from pharmaceutical companies. Brand names are listed alphabetically and without ranking.

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Sources

  1. European Medicines Agency. Teizeild – EPAR, Product Information. 2026-10-28. https://www.ema.europa.eu/en/documents/product-information/teizeild-epar-product-information_en.pdf
  2. Wikidata (CC0): ATC A10XX.

Editorial: Medelix editorial team · last updated 2026-10-28 · How these pages are made · Report an error

Source: European Medicines Agency (EMA), product information. Not advertising, not a treatment recommendation. For questions about your own treatment, ask your doctor or pharmacist.