What is it prescribed for?
TZIELD is prescribed to delay the onset of Stage 3 type 1 diabetes (T1D) in adults and children aged 8 years and older who already have Stage 2 type 1 diabetes. At this stage, patients have abnormal blood sugar levels and immune markers but may not yet have full symptoms of diabetes. Type 1 diabetes is an autoimmune disease where the body attacks insulin-producing cells in the pancreas. Once Stage 3 begins, patients usually require lifelong insulin treatment. TZIELD is the first medication designed to delay this progression, giving patients more time before needing insulin therapy. The FDA approved TZIELD in November 2022.
What is the name of the drug and what does it do?
The drug is TZIELD™ (teplizumab-mzwv), given as an intravenous (IV) infusion. It is a monoclonal antibody therapy that targets the immune system rather than blood sugar directly. TZIELD is not a cure for diabetes, but it helps slow down the disease process. It is used early in the disease to protect the body’s remaining insulin-producing cells.
How does it work?
TZIELD works by targeting CD3 receptors on T cells, which are part of the immune system. In type 1 diabetes, these immune cells attack the pancreas.
- TZIELD modifies the activity of these T cells
- It reduces their attack on insulin-producing beta cells
- It helps restore a more balanced immune response
This slows the damage to the pancreas and delays the development of full diabetes.
What did the research discover?
Clinical studies showed that TZIELD can delay the onset of Stage 3 type 1 diabetes by about 2 years or more in some patients.
- Patients receiving TZIELD developed diabetes later than those on placebo
- Some patients remained diabetes-free significantly longer
- The treatment was especially effective when given early
These findings made TZIELD the first disease-modifying therapy for type 1 diabetes.
What are some of the side effects?
Common side effects include:
- Low white blood cell counts (lymphopenia)
- Rash
- Headache
- Fever or flu-like symptoms
- Nausea or diarrhea
More serious risks include:
- Cytokine release syndrome (CRS), which can cause fever and inflammation
- Serious infections
- Viral reactivation, including Epstein-Barr virus or cytomegalovirus
Because of these risks, patients are closely monitored during and after treatment.
What are the dosage recommendations and how is it prescribed?
TZIELD is given as an intravenous infusion once daily for 14 days.
Important treatment details:
- Each infusion lasts at least 30 minutes
- Patients are pre-treated with medications such as:
- Acetaminophen or NSAIDs
- Antihistamines
- Sometimes anti-nausea medications
- Blood tests are required before and during treatment
The full treatment is a one-time 14-day course, not a long-term daily medication.
Source:
TZIELD™ (teplizumab-mzwv) injection, for intravenous use [prescribing information]. Silver Spring (MD): U.S. Food and Drug Administration; 2022. Available from: https://www.accessdata.fda.gov/drugsatfda_docs/label/2022/761183s000lbl.pdf. Accessed by: June 6, 2026.
