Introducing TZIELD :
The first and only FDA-approved treatment proven to delay the onset of type 1 diabetes (Stage 3 T1D)
TZIELD is for people age 8 and older with Stage 2 T1D.

Learn more about TZIELD
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Provention Bio COMPASSᵀᴹ

If you're starting treatment, get support along your path.

Provention Bio COMPASS is a patient support program that provides helpful tools and resources, information on financial assistance options, and one-on-one support every step of the way.

To enroll in Provention Bio COMPASS, you and your doctor will each fill out a section of the START form. Once completed, your doctor will submit it to enroll you in the program. Download the form below and bring it to your doctor's office to start your enrollment after you've been prescribed TZIELD.

See the START form

Provention Bio COMPASS is a patient support program that helps patients to gain access to TZIELD and provides patients with education and resources related to TZIELD. Provention Bio COMPASS is not a healthcare service or an insurance provider and does not provide care coordination. Be sure to always contact your physician if you have any questions about your health or treatment with TZIELD. Provention Bio COMPASS and your COMPASS Navigator will not provide medical or treatment advice. Provention Bio COMPASS services are available only to those who have been prescribed TZIELD and are intended for US residents only.

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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.

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.