Tzield (teplizumab)
Tzield is approved to delay the onset of Stage 3 type 1 diabetes mellitus (T1D) in adult and paediatric patients aged 8 years and older with Stage 2 type 1 diabetes mellitus. Tzield contains the active ingredient teplizumab.
Tzield is a diabetes medicine that has been approved for adults and children 8 years of age and older. In people who have stage 2 type 1 diabetes mellitus, Tzield can be used to slow down the development of stage 3 type 1 diabetes.
Type 1 diabetes mellitus (T1D) is a disease that occurs when a person’s immune system (the body’s natural defences) attacks the insulin-producing cells in the pancreas, called beta cells. Insulin is a hormone that regulates glucose (sugar) levels in the blood. Initially, at stage 1, the destruction of these beta cells does not cause any symptoms or changes to blood sugar levels.
Stage 2 T1D is diagnosed when a person’s blood sugar levels rise above normal because their pancreas isn’t making enough insulin.
At stage 3, a person may experience diabetic symptoms, and they may need regular insulin injections to manage blood glucose levels and prevent other health problems. Tzield, an intravenous infusion (solution given into a vein via a drip infusion), can be prescribed to delay a person progressing from stage 2 T1D to stage 3 T1D.
Tzield contains the active ingredient teplizumab. Teplizumab is a monoclonal antibody - a protein that recognises and binds to other specific proteins in the body. It attaches to a molecule called CD3, found on the surface of certain T-cells (immune cells). Teplizumab’s attachment to these specific T-cells changes how the T-cells behave.
Subsequently, it is thought that teplizumab helps protect the beta cells in the pancreas. It calms the immune cells that would attack the beta cells in people with Stage 2 T1D. By protecting the beta cells and their functioning, progression of T1D slows down.
The effectiveness of Tzield was assessed in a Phase 2 Clinical study - TN-10 (the AT-RISK study). A total of 76 participants aged 8 to 49 years, identified as high risk for T1D, were randomly allocated to receive either treatment with teplizumab (44 participants) or the placebo (treatment with no active medicine – 32 participants).
The safety of Tzield was assessed with pooled data analyses from 7 completed clinical studies. Over 1000 participants, at various stages of T1DM, aged 8–45 years across the studies, were monitored for adverse events (side effects or unexpected outcomes).
Key findings from clinical studies
- In Study TN-10, Stage 3 T1D was diagnosed in 20 (45%) of the patients treated with Tzield and in 23 (72%) of the patients treated with placebo.
- Study TN-20 also showed that, following a single course of treatment lasting 14 days, the participant’s average time to progress to Stage 3 T1D was 50 months in the Tzield treatment group and 25 months in the placebo treatment group.
- The clinical study demonstrated that teplizumab-treatment in an early phase of the autoimmune process (Stage 2 T1DM) can delay of the onset of advanced disease.
- The most common side effects with Tzield (potentially more than 1 in 10 people) include:
– lymphopenia (low levels of lymphocytes, a type of white blood cell)
– leukopenia (low levels of white blood cells)
– neutropenia (low levels of neutrophils, a type of white blood cell)
– rash and itchiness (pruritus). - Some side effects can be serious. The most frequent (potentially up to 1 in 100 people) is cytokine release syndrome (CRS). Cytokines are a group of small proteins important for immune responses and inflammation. CRS is an inflammatory response in the body caused by heightened cytokine release. Symptoms may include fever, nausea, fatigue, headache, muscle soreness, achy joints, and raised liver enzyme levels in blood tests.
The TGA decided that the application provided sufficient evidence supporting the safety and effectiveness of Tzield and the medicine can be registered in Australia.
More detailed information on why the TGA approved Tzield will be published in the upcoming Australian Public Assessment Report (AusPAR).
For comprehensive information on potential side effects and risks, refer to the Consumer Medicine Information (CMI) leaflet or Product Information (PI) document.
This decision summary will not be updated to reflect any subsequent changes and may therefore not contain the most current information about the medicine. For the latest information, refer to the medicine’s CMI or PI.
The CMI leaflet offers guidance for consumers to support safe and effective use of the medicine. The CMI includes information on dose, how to use the medicine properly, potential side effects, safety precautions, storage instructions and more.
The Australian CMI for Tzield can be accessed through the searchable TGA eBusiness Services or ARTG databases.
The PI document provides essential prescribing information for health professionals, including details on dosage recommendations, pregnancy category, contraindications, precautions and potential side effects.
The Australian PI for Tzield can be accessed through the searchable TGA eBusiness Services or ARTG databases.
For health advice and information, including a symptom checker and service finder refer to the healthdirect website.
For advice on prescription medicines, over the counter medicines and other medicines (including complementary medicines) call Medicines Line.
For information on medicines subsidised by the Australian Government refer to the Pharmaceutical Benefits Scheme (PBS) website.
For data and reports on health and welfare topics in Australia refer to the Australian Institute of Health and Welfare website.
Before starting treatment with Tzield, your doctor should check your blood count and liver function with a blood test. Regular blood tests are recommended during and for a short time after treatment with Tzield. Some extra tests may be required based on clinical judgement.
To note, premedication should be used prior to Tzield infusion for the first 5 days.
For more comprehensive information on laboratory tests, suggested vaccinations, and ongoing monitoring, refer to the Product Information.