Teplizumab
Pronunciation: tep-li-ZOO-mab.
- Generic name
- teplizumab
- Drug class
- CD3-directed monoclonal antibody (immunomodulator)
- Form
- IV infusion (2 mg/2 mL vial)
- Route
- Intravenous infusion
- Legal status
- Prescription-only, specialist-initiated (endocrinology/diabetes, given at an infusion centre)
Availability and supply rules vary by country
Trade names by country: United States · United Kingdom · Canada · Australia
Australia: Tzield (2) · Full directory
Boxed warning: Risk of serious viral reactivation
Teplizumab can cause serious, life-threatening reactivation of viruses the body was previously exposed to, including Epstein-Barr virus (EBV) and cytomegalovirus (CMV). This risk is higher in people with a weakened immune system or with severe, prolonged low lymphocyte counts. Blood tests for these viruses and for lymphocyte counts are required before and during treatment. (1)
What teplizumab is and how it works
Teplizumab is a prescription-only medicine that changes the course of type 1 diabetes. It is the first treatment approved to delay the onset of type 1 diabetes in people at high risk, and can also help preserve some of the body's own insulin production shortly after diagnosis. (1)
Teplizumab is given as a course of daily infusions into a vein at a specialist centre, with close blood test monitoring throughout. It is not an everyday diabetes medicine and does not replace insulin or blood sugar monitoring -- it is a specialist decision made after detailed testing to confirm eligibility and safety.
Mechanism of action: how teplizumab works
Teplizumab binds CD3 on T cells, modulating the autoimmune process that destroys insulin-producing pancreatic beta cells in type 1 diabetes, thereby delaying disease progression or slowing beta-cell loss. (1)
What teplizumab is used for
Delaying onset of type 1 diabetes (Stage 2)
Used in people aged 1 year and older who have Stage 2 type 1 diabetes -- meaning blood tests show the immune markers of type 1 diabetes and some blood sugar changes, but no symptoms yet -- to delay progression to full, symptomatic (Stage 3) type 1 diabetes. (1)
Preserving insulin production after recent diagnosis (Stage 3)
Used in children and teenagers aged 8-17 who have been recently diagnosed with Stage 3 (symptomatic) type 1 diabetes, to help slow the decline in the body's own natural insulin production. (1)
Before taking teplizumab
Do not take / not appropriate for
- Do not use teplizumab if you have a weakened immune system (are immunocompromised). (all countries) (1)
- Do not use teplizumab if you have an active Epstein-Barr virus (EBV) or cytomegalovirus (CMV) infection. (all countries) (1)
Tell your clinician about
- Any history of a weakened immune system, or any current infection.
- Whether you have had chickenpox, mono/glandular fever (EBV), or CMV infection before.
- All vaccines you have had recently, and any vaccines that are due -- your specialist needs to plan vaccine timing carefully around treatment.
- Pregnancy, plans for pregnancy, or breastfeeding.
- Any allergic reactions to antibody medicines in the past.
How to take teplizumab
- Teplizumab is given as a daily IV infusion for a set course, at a specialist infusion centre -- never self-administered at home.
- Before starting, blood tests must show adequate blood counts and liver function, and rule out active EBV/CMV infection.
- Vaccines should be updated well before starting: at least 2 weeks before for inactivated or mRNA vaccines, or at least 8 weeks before for live vaccines. Live vaccines should be avoided for up to a year after finishing a treatment course.
- During the first days of each course, you will usually take medicines like paracetamol/acetaminophen and an antihistamine beforehand to reduce the chance of an infusion-related reaction.
Procedures and treatment changes
Tell the treating team before surgery, procedures, or any medicine change. Do not alter treatment without the responsible clinician. (1) (2)
Missed dose
If a dose within a treatment course is missed, your care team will give it as soon as possible and continue the remaining daily doses of that course. Two doses are never given on the same day. This is managed entirely by your specialist team.
Overdose
Teplizumab is given under direct medical supervision with close monitoring, so any dosing concerns are managed by the treating team at the time. (1)
Side effects
Side effects and their urgency vary; report severe, persistent, or concerning symptoms.
A drop in white blood cell counts (lymphocytes and other types) is very common and expected -- this is why blood counts are checked so often.
What to notice: A drop in white blood cell counts (lymphocytes and other types) is very common and expected -- this is why blood counts are checked so often.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Rash.
What to notice: Rash.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Headache.
What to notice: Headache.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Changes in liver blood tests.
What to notice: Changes in liver blood tests.
What to do: Discuss persistent or troublesome symptoms with the treating clinician or pharmacist. (1)
Serious warnings
Signs of viral reactivation (EBV/CMV) — boxed_warning
Symptoms: Fever, sore throat, swollen glands, extreme tiredness, or feeling generally unwell.
Action: Tell your care team immediately. Regular blood monitoring is used to catch this early; your specialist may need to pause or stop treatment. (1)
Signs of cytokine release syndrome — emergency
Symptoms: High fever, chills, a fast heartbeat, low blood pressure, or difficulty breathing, usually during the first days of a treatment course.
Action: Seek urgent medical attention -- this is monitored closely during infusions, and pre-treatment medicines are given to help reduce the risk. (1)
Signs of a severe drop in white blood cells (severe lymphopenia) — high caution
Symptoms: Frequent or unusual infections, mouth sores, or feeling unusually unwell.
Action: Your specialist checks blood counts every few days during each treatment course and will decide whether treatment should be permanently discontinued if a severe, prolonged drop is found. (1)
Signs of a serious allergic reaction — emergency
Symptoms: Swelling of the face, lips, tongue, or throat; difficulty breathing; widespread rash; joint pain and fever occurring days after an infusion (serum sickness).
Action: Seek urgent medical attention -- your specialist will decide whether treatment can continue. (1)
Interactions
- Live vaccines (such as MMR or varicella) should not be given close to treatment -- at least 8 weeks before starting, and not for up to 52 weeks after finishing a course. Non-live (inactivated or mRNA) vaccines should be given at least 2 weeks before starting. (1)
Pregnancy, breastfeeding, kidney/liver function, age
Pregnancy
Teplizumab should be avoided during treatment and for at least 30 days before trying to conceive, as it may affect the developing baby's immune system. (1) (2)
Breastfeeding
Your specialist may advise pumping and discarding breast milk during treatment and for 20 days afterward. (1) (2)
Children
Approved from age 1 (Stage 2) and age 8 (Stage 3, for slowing insulin decline); limited data in adults 45 years and older with Stage 2 disease. (1) (2)
Elderly
Limited safety and effectiveness data in patients 45 years and older with Stage 2 type 1 diabetes. (1) (2)
Hepatic_impairment
Not established in the source reviewed for this dossier; liver enzyme thresholds are required before starting and are monitored during treatment. (1) (2)
Renal_impairment
Not established in the source reviewed for this dossier. (1) (2)
Source_ids
Monitoring
Before starting
- Full blood count (lymphocytes at least 1,000/microlitre, haemoglobin at least 10 g/dL, platelets at least 150,000/microlitre, neutrophils at least 1,500/microlitre)
- Liver enzymes and bilirubin within specified limits
- EBV and CMV viral testing
- Up-to-date vaccination status
During treatment
- Lymphocyte counts checked every 2-3 days during each treatment course.
- Liver enzymes and bilirubin checked during treatment.
- Ongoing monitoring for viral reactivation for at least 2 months after each treatment course.
Storage
Teplizumab is stored and prepared by the treatment centre; patients do not typically store or handle it themselves.
Professional information
Clinician-facing context only, sourced from the current US FDA prescribing information; verify against the current full label before prescribing.
United States
Indication: Stage 2 (delay onset) / Stage 3 (preserve insulin production)
Dose summary: Stage 2 (single 14-day course): Day 1: 65 mcg/m2; Day 2: 125 mcg/m2; Day 3: 250 mcg/m2; Day 4: 500 mcg/m2; Days 5-14: 1,030 mcg/m2. Stage 3 (two 12-day courses 6 months apart): Day 1: 106 mcg/m2; Day 2: 425 mcg/m2; Days 3-12: 850 mcg/m2. IV infusion minimum 30 min (age 8+) or 2 hours (age 1-<8).
Renal context: Not established in the source reviewed for this dossier. (1)
Hepatic guidance
Baseline ALT/AST must be no more than 2x the upper limit of normal and bilirubin no more than 1.5x. ALT/AST rising above 5x ULN or bilirubin above 3x ULN during treatment is a threshold at which the prescriber will permanently stop treatment.
Overdose note
Administered under direct medical supervision with lab monitoring at every dose; no self-administered overdose scenario applies. (1)
Frequently asked questions
Is teplizumab (Tzield/Teizeild) available in the US, UK, Europe, Canada, and Australia?
Yes, it is approved in all of these regions (as Tzield in the US/UK/Canada/Australia, and as Teizeild in the EU). New Zealand approval was not found in this research and should be confirmed locally. (1) (2)
Does teplizumab cure type 1 diabetes?
No. It delays the onset of symptomatic type 1 diabetes in people at high risk, or helps preserve some remaining natural insulin production shortly after diagnosis -- it does not cure or reverse type 1 diabetes. (1)
Why does teplizumab treatment involve daily blood tests?
Teplizumab can cause a drop in white blood cells called lymphopenia, and can trigger reactivation of viruses like Epstein-Barr virus or cytomegalovirus, which can be serious. Frequent blood counts during each 12-14 day treatment course let your care team catch these problems early and decide whether to pause or stop treatment. (1)
What is the mechanism of action of teplizumab?
Teplizumab binds CD3 on T cells, modulating the autoimmune process that destroys insulin-producing pancreatic beta cells in type 1 diabetes, thereby delaying disease progression or slowing beta-cell loss. (1)
What is the generic name of Teplizumab?
The generic name is teplizumab. (1)
What class of drug is teplizumab?
Teplizumab is classed as: CD3-directed monoclonal antibody (immunomodulator). (1)
References
- TZIELD (teplizumab-mzwv) -- full prescribing informationU.S. Food and Drug Administration / DailyMed (NIH), full prescribing information, Sanofi (Provention Bio) · United States · accessed 2026-07-29 · source 1
- Global regulatory approval status of teplizumab (Tzield/Teizeild)Breakthrough T1D UK (patient advocacy organisation) and Sanofi corporate press releases · United Kingdom / European Union / Canada / Australia · accessed 2026-07-29 · source 2
- TZIELD (TEPLIZUMAB-MZWV) INJECTION [PROVENTION BIO, INC.] — US prescribing information (DailyMed SPL)U.S. National Library of Medicine (DailyMed) · US · accessed 2026-08-14 · source 3
- Teplizumab-mzwv injection — patient drug information (MedlinePlus)U.S. National Library of Medicine (MedlinePlus) · US · accessed 2026-08-14 · source 4
- TZIELD — FDA approval record (Drugs@FDA BLA761183)U.S. Food and Drug Administration · US · accessed 2026-08-14 · source 5
- teplizumab — RxNorm normalized drug concept (RXCUI 2621880)U.S. National Library of Medicine (RxNorm) · US · accessed 2026-08-14 · source 6
Brand names by country
Single-ingredient teplizumab names are shown separately by country. Product availability, strengths, and supply rules can change; combination products are not included here.
Priority countries
United States
- TZIELD1 mg/mL · provention bio, inc.
United Kingdom
- Tzield (2)reported approved via advocacy and manufacturer summary · not specified in fetched source · Sanofi
Canada
- Tzield (2)reported approved via advocacy and manufacturer summary · not specified in fetched source · Sanofi
Australia
- Tzield (2)reported approved via advocacy and manufacturer summary · not specified in fetched source · Sanofi
View brands in additional countries.
European Union
Teizeild (2)