TZIELD IS THEFIRST AND ONLY TREATMENT OF ITS KIND
An innovative treatment proven to delay the onset of Stage 3* autoimmune type 1 diabetes
*TZIELD is for people 8 years and older with Stage 2 type 1 diabetes. Find out about stages below.
Aubri and Molly,TZIELD patient and caregiver
TZIELD is changing the possibilities
of type 1 diabetes treatment
Finally, type 1 diabetes management is no longer about just waiting for what comes.
It's possible for you to take control of what's next. TZIELD could mean more time without the need for insulin injections, more time to learn about eventual symptoms and risks, and more time to get ready for daily management.
THE EFFECTIVENESS OF TZIELD
Time to Onset of Stage 3 Type 1 Diabetes
With TZIELD, people had a median† of about 4 years before the onset of Stage 3 Type 1 Diabetes compared to aboutcompared to about 2 years for placebo.
Over the course of a clinical study, the risk of the onset of Stage 3 autoimmune type 1 diabetes was significantly lower for people who were given TZIELD, compared with people who did not take TZIELD.
At the 4-year mark of the study, Stage 3 autoimmune type 1 diabetes was diagnosed in 45% of people who were given TZIELD, compared with 72% of people who were given placebo. Your results may vary.
The clinical trial that studied the effectiveness of TZIELD for delaying the onset of Stage 3 T1D included 76 people. The participants had Stage 2 T1D. 44 people in this trial were given TZIELD. 32 people in the trial were given placebo. People in the trial were followed until they were diagnosed with Stage 3 T1D. The median† amount of time that people were followed in the trial was 51 months (just over 4 years). People not diagnosed with Stage 3 T1D were followed for different periods of time.
Your results may vary.
†Median is the middle number in a group of numbers arranged from lowest to highest.
TZIELD was also studied for safety. See the TZIELD safety profile and Important Safety Information below and talk to your doctor and wider healthcare team for more information or medical advice about side effects.
Understanding Stages in TZIELD Results
Stage 2 type 1 diabetes means someone has tested positive for 2 or more type 1 diabetes-related autoantibodies and has abnormal blood sugar levels (called dysglycemia) but no noticeable symptoms. In this stage, type 1 diabetes is progressing, but insulin injections aren’t needed yet.
Stage 3 type 1 diabetes is when the body can no longer make enough insulin and blood sugar levels are too high. In this stage, there are noticeable symptoms, serious complications are a risk, and insulin injections are (or will be) needed.
Want a deeper dive into autoimmune type 1 diabetes stages?
LEARN MOREWant to explore why delaying the onset of Stage 3 autoimmune type 1 diabetes can be so important?
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THE SAFETY PROFILE OF TZIELD
Most Common Side Effects
In the clinical trial, the most common side effects for people who were given TZIELD included:
Rash
(36% of people)
Decrease in white blood cell counts (leukopenia)
(21% of people)
Headache
(11% of people)
These are not all the possible side effects of TZIELD. Talk to your doctor and healthcare team for more information or medical advice about side effects.
The clinical trial that explored the safety of TZIELD included 76 people who had Stage 2 T1D. 44 people in this trial were given TZIELD. 32 people in the trial were given placebo. The median† amount of time that people were followed in the trial was 51 months (just over 4 years). Results may vary.
†Median is the middle number in a group of numbers arranged from lowest to highest.
Serious Side Effects
TZIELD may cause serious side effects, including:
Cytokine Release Syndrome
(2% of people)
TZIELD can cause a side effect called cytokine release syndrome, or CRS. Signs and symptoms of CRS include:
- fever
- muscle and joint pain
- headache
- feeling tired (fatigue)
- nausea
- increased liver enzymes in your blood
These signs and symptoms may start during the first 5 days of TZIELD treatment. Tell your doctor right away if you develop any signs or symptoms of CRS during treatment with TZIELD.
Decrease in White Blood Cells (Lymphopenia)
(73% of people)
TZIELD may cause a drop in a type of white blood cell called a lymphocyte. This can affect your body’s ability to fight infections. A decrease in white blood cell counts can happen after your first dose of TZIELD, but will start to go back to normal after your fifth dose. Some people may develop longer and more severe decreases in lymphocytes.
The safety of TZIELD was studied in 5 clinical trials. Side effects were monitored in 773 patients who were given TZIELD and 245 patients who were given placebo. Not all of the patients in these studies had Stage 2‡ type 1 diabetes.
‡Stage 2 type 1 diabetes means someone has tested positive for 2 or more
type 1 diabetes-related autoantibodies and has abnormal blood sugar levels (called dysglycemia) but does not have noticeable symptoms. In this stage, type 1 diabetes is progressing, but insulin injections aren’t needed yet.
The window of opportunity can be short!
TZIELD is only approved for use during a specific time frame.‡ Talk to a doctor about TZIELD today.
‡During Stage 2 autoimmune type 1 diabetes.
HAVEN’T BEEN SCREENED FOR
AUTOIMMUNE TYPE 1 DIABETES YET?
Unlike a blood sugar level test, an autoantibody test can spot markers of type 1 diabetes and can help detect the condition early and is the first step to determine whether TZIELD may be appropriate for you. Ask a doctor about screening options.
START TODAY Remember,
type 1 diabetes doesn’t wait.
Neither should you.
There is a limited window for a doctor to consider TZIELD. Now is the time to take action and discuss with your doctor if TZIELD is right for you. Here are some additional resources to help you learn more.
- Cytokine release syndrome (CRS). Signs and symptoms may start during the first 5 days of TZIELD treatment and could include fever, nausea, feeling tired (fatigue), headache, muscle and joint pain, or increased liver enzymes in your blood. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD
- Decrease in white blood cells. TZIELD may cause a decrease in a type of white blood cell called lymphocytes. A decrease in white blood cells is a serious, but common side effect that can affect your body’s ability to fight infections. A decrease in white blood cell counts can happen after your first dose. Your white blood cell counts will start to go back to normal after your fifth dose of TZIELD. Some people may develop longer and more severe decreases in lymphocytes
Your healthcare provider will do blood tests to check your liver and your complete blood counts before you start treatment and during treatment with TZIELD. During and after your treatment with TZIELD, your healthcare provider will check for serious side effects, as well as other side effects, and treat you as needed. Your healthcare provider may temporarily or completely stop your treatment with TZIELD, if you develop liver problems, have a serious infection, or if your blood counts stay too low.
What should I tell my healthcare provider before receiving TZIELD? Before or after receiving TZIELD, tell your healthcare provider about all your medical conditions, including if you:- have a serious infection or an infection that does not go away or keeps coming back
- have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your doctor that you are receiving TZIELD before receiving a vaccine
- are pregnant or plan to become pregnant. TZIELD may harm your unborn baby. Do not receive TZIELD during pregnancy and at least 30 days before a planned pregnancy
- are breastfeeding or plan to breastfeed. It is not known if TZIELD passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive TZIELD
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of TZIELD? The most common side effects of TZIELD include:- rash
- leukopenia (decrease in white blood cell counts)
- headache
These are not all of the possible side effects of TZIELD. Talk to your healthcare provider for more information, and tell them about any side effects you notice. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
Please see Medication Guide and Prescribing Information.
What is TZIELD?
TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body can’t make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 8 years of age and older who have Stage 2 type 1 diabetes. This means that they have tested positive for 2 or more type 1 diabetes-related autoantibodies, have abnormal blood sugar levels, and do not have type 2 diabetes.
It is not known if TZIELD is safe and effective in children under 8 years of age.
IMPORTANT SAFETY INFORMATION AND APPROVED USE
- Cytokine release syndrome (CRS). Signs and symptoms may start during the first 5 days of TZIELD treatment and could include fever, nausea, feeling tired (fatigue), headache, muscle and joint pain, or increased liver enzymes in your blood. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD
- Decrease in white blood cells. TZIELD may cause a decrease in a type of white blood cell called lymphocytes. A decrease in white blood cells is a serious, but common side effect that can affect your body’s ability to fight infections. A decrease in white blood cell counts can happen after your first dose. Your white blood cell counts will start to go back to normal after your fifth dose of TZIELD. Some people may develop longer and more severe decreases in lymphocytes
Your healthcare provider will do blood tests to check your liver and your complete blood counts before you start treatment and during treatment with TZIELD. During and after your treatment with TZIELD, your healthcare provider will check for serious side effects, as well as other side effects, and treat you as needed. Your healthcare provider may temporarily or completely stop your treatment with TZIELD, if you develop liver problems, have a serious infection, or if your blood counts stay too low.
What should I tell my healthcare provider before receiving TZIELD? Before or after receiving TZIELD, tell your healthcare provider about all your medical conditions, including if you:- have a serious infection or an infection that does not go away or keeps coming back
- have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your doctor that you are receiving TZIELD before receiving a vaccine
- are pregnant or plan to become pregnant. TZIELD may harm your unborn baby. Do not receive TZIELD during pregnancy and at least 30 days before a planned pregnancy
- are breastfeeding or plan to breastfeed. It is not known if TZIELD passes into your breast milk and if it can harm your baby. Talk to your healthcare provider about the best way to feed your baby if you receive TZIELD
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
What are the possible side effects of TZIELD? The most common side effects of TZIELD include:- rash
- leukopenia (decrease in white blood cell counts)
- headache
These are not all of the possible side effects of TZIELD. Talk to your healthcare provider for more information, and tell them about any side effects you notice. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.
Please see Medication Guide and Prescribing Information.
What is TZIELD?
TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body can’t make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 8 years of age and older who have Stage 2 type 1 diabetes. This means that they have tested positive for 2 or more type 1 diabetes-related autoantibodies, have abnormal blood sugar levels, and do not have type 2 diabetes.
It is not known if TZIELD is safe and effective in children under 8 years of age.