You can use the additional time that you have in Stage 2 to:
Actor portrayal
TZIELD is the first and only treatment of its kind. It delays Stage 3 T1D for people 8 years and older with early-stage T1D and abnormal blood sugar levels. Talk to your doctor to see if TZIELD may be right for you or your loved one.
Explore how to detect Stage 2 T1D
A clinical trial showed that:
With TZIELD, people had 2 more years before the onset of Stage 3 T1D, compared with placebo.
The median* time to diagnosis was 50 months for those who were given TZIELD, compared with 25 months for those who were given placebo.
More people who were given TZIELD had not been diagnosed with Stage 3 T1D by the end of the study, compared with people who were given placebo.
People who had not been diagnosed with Stage 3 T1D:
The clinical trial that explored the safety and effectiveness of TZIELD for delaying the onset of Stage 3 T1D included 76 people. The participants had early-stage T1D with abnormal blood sugar levels. 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* follow-up time was 51 months (just over 4 years). Your results may vary. People not diagnosed with Stage 3 T1D were followed for different periods of time.
*Median is the middle number in a group of numbers arranged from lowest to highest.
Rash
Decrease in white blood cell counts
Headache
†Common side effects affected more than 10% of people who were given TZIELD in the clinical trial.
TZIELD may also cause serious side effects. Please see Important Safety Information and talk to your doctor right away if you notice any side effects after starting TZIELD.
TZIELD is an intravenous (IV) infusion. This means it's given through a needle into a vein in your arm. Infusions are once a day, every day for 14 days. Treatment is completed after 14 days.
1 infusion, once a day
Every day for 14 days
At least 30 minutes long
Keep in mind: you will also need some extra time before and after each infusion. This is so a nurse can prepare the infusion and monitor you or your child for a short period afterwards.
Your doctor may check in about any side effects or medical conditions after treatment. They can also help you work out the right schedule for checking your blood sugar levels and for follow-up appointments.
Some infusion locations could include:
A doctor’s office
An infusion center
Your home with a nurse
You can talk to your doctor about finding a 2-week period for infusions that works for your schedule. If you are enrolled in Provention Bio COMPASS™, your COMPASS Navigator may also be able to help.
T1D is an autoimmune disease. It occurs when the immune system attacks the cells in the pancreas that make insulin, called beta cells. But T1D happens in stages. The attack on the beta cells starts before you need insulin injections. This is called early-stage T1D.
Stage 1
The immune system has started to attack beta cells
Blood sugar levels are within a normal range
No insulin is needed
Stage 2
Beta cells continue to be attacked
Blood sugar levels may be too high or low at times. This is called dysglycemia
No insulin is needed
Beta cells are damaged and can’t make enough insulin
Blood sugar levels are higher than a healthy range. This is called hyperglycemia
The body can't make enough insulin, so taking insulin injections will be needed
When the immune system starts its attack on beta cells, proteins called autoantibodies show up in the blood. Screening for these diabetes-related autoantibodies can help to detect early-stage T1D.
Stage 2 T1D means you have early-stage T1D and abnormal blood sugar levels.
People with a family history of T1D can have up to a 15 times greater risk of developing it. If someone in your family has T1D, talk to your doctor about getting screened.
TZIELD may cause serious side effects, including:
These signs and symptoms may start during the first 5 days of TZIELD treatment. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD.
The most common side effects of TZIELD include:
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 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.
TZIELD may cause serious side effects, including:
These signs and symptoms may start during the first 5 days of TZIELD treatment. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD.
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.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of TZIELD include:
These are not all of the possible side effects of TZIELD. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088, or to Provention Bio at 1-844-778-2246.
Please see Medication Guide and Prescribing Information. Talk to your doctor about 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 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.
TZIELD may cause serious side effects, including:
These signs and symptoms may start during the first 5 days of TZIELD treatment. Tell your healthcare provider right away if you develop any signs and symptoms of CRS during treatment with TZIELD.
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.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
The most common side effects of TZIELD include:
These are not all of the possible side effects of TZIELD. For more information, ask your healthcare provider or pharmacist. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088, or to Provention Bio at 1-844-778-2246.
Please see Medication Guide and Prescribing Information. Talk to your doctor about 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 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.
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