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What were the results WITH TZIELD?

TZIELD has been proven to delay the onset of Stage 3 T1D for people 8 years and older with Stage 2 T1D.

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CLINICAL TRIAL RESULTS

Explore the results of clinical trials that looked at the effectiveness and safety of TZIELD.

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A CLINICAL TRIAL FOR TZIELD SHOWED:

With TZIELD, people had 2 more years before the onset of Stage 3 T1D, compared with placebo.

TZIELD 4 YEARS
PLACEBO 2 YEARS
TZIELD 4 YEARS
PLACEBO 2 YEARS

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:

55% of people who were given TZIELD
28% of people who were given placebo

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* follow-up time 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.

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MOST COMMON
SIDE EFFECTS

In the clinical trial, the most common side effects for people who were given TZIELD included:

Hand with rash icon

Rash

(36% of people)

White blood cells icon with down arrow

decrease in white blood cell counts (LEUKOPENIA)

(21% of people)

Headache icon

headache

(11% of people)

These are not all of the possible side effects of TZIELD.
Talk to your doctor or pharmacist for more information or for medical advice about side effects.

serious side effects

TZIELD may cause serious side effects, including:

Cytokine Release Syndrome icon

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 and symptoms of CRS during treatment with TZIELD.

Decrease in white blood cells icon

Decrease in white blood cells (LYMPHOPENIA)

(73% of people)
TZIELD may cause a drop in a type of white blood cell called lymphocytes. This can affect your body’s ability to fight infections. A decrease in white blood cell counts can happen after your first dose and will start to go back to normal after your fifth dose of TZIELD.

The clinical trial that studied the safety 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‡ follow-up time 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.

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 T1D.

Considering TZIELD?

Here are some resources to help you learn more and discuss treatment with your doctor.

Download the conversation guide Download the treatment brochure

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IMPORTANT SAFETY INFORMATION AND APPROVED USE

What is the most important information I should know about TZIELD?

TZIELD may cause serious side effects, including:

  • Cytokine Release Syndrome (CRS). Signs and symptoms of CRS problems may include:
    • fever
    • feeling tired (fatigue)
    • muscle and joint pain
    • nausea
    • headache
    • increased liver enzymes in your blood

      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.
  • 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.

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 that keeps coming back.
  • have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with 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 breast feed. 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. If you are breastfeeding, you may consider pumping and throwing away your breast milk during treatment with TZIELD and for 20 days after receiving TZIELD treatment.

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

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 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

What is the most important information I should know about TZIELD?

TZIELD may cause serious side effects, including:

  • Cytokine Release Syndrome (CRS). Signs and symptoms of CRS problems may include:
    • fever
    • feeling tired (fatigue)
    • muscle and joint pain
    • nausea
    • headache
    • increased liver enzymes in your blood

      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.

  • 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.

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.

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 that keeps coming back.
  • have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with 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 breast feed. 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. If you are breastfeeding, you may consider pumping and throwing away your breast milk during treatment with TZIELD and for 20 days after receiving TZIELD treatment.

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. 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.

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 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

What is the most important information I should know about TZIELD?

TZIELD may cause serious side effects, including:

  • Cytokine Release Syndrome (CRS). Signs and symptoms of CRS problems may include:
    • fever
    • feeling tired (fatigue)
    • muscle and joint pain
    • nausea
    • headache
    • increased liver enzymes in your blood

      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.

  • 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.

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.

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 that keeps coming back.
  • have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your healthcare provider that you are receiving treatment with 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 breast feed. 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. If you are breastfeeding, you may consider pumping and throwing away your breast milk during treatment with TZIELD and for 20 days after receiving TZIELD treatment.

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. 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.

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 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.