Things to know
about TZIELD

A young son sitting on the kitchen counter next to his mother and both are holding their own cup and smiling

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Just by being here, you're now someone who knows that type 1 diabetes (T1D) can be spotted before symptoms appear. You're also learning that eligible people living with Stage 2 T1D may have an option for treatment with TZIELD, the first and only drug of its kind used to delay the onset of insulin-dependent (Stage 3) T1D.

In addition to exploring the site and learning all you can, there's no better time than now to talk to your doctor about proactive screening, blood sugar monitoring, and T1D management.

About type 1 diabetes

About TZIELD

Important Safety Information and Indication

What is the most important information I should know about TZIELD? TZIELD may cause serious side effects. These including:
  • Viral Reactivation. Epstein-Barr virus (EBV) and cytomegalovirus (CMV) are common viruses that may stay inactive in your body after an initial infection. TZIELD may cause these viruses to become active again which, especially in patients with a weakened immune system, can become serious and potentially life-threatening. These viral reactivations can happen during treatment with TZIELD and up to 2 months after your last dose. Your healthcare provider will test you for active EBV and CMV infections before treatment with TZIELD. Contact your healthcare provider right away if you develop symptoms of an infection during or after treatment with TZIELD (such as fever, swollen glands, or fatigue).
  • Cytokine release syndrome (CRS). Signs and symptoms may start during the first 5 days of TZIELD treatment and could include fever, nausea (with or without vomiting), 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 for active infections, verify your liver function 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 viral reactivation, 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 any of the conditions or symptoms listed in the section “What is the most important information I should know about TZIELD?”
  • have a weakened immune system, including if you have Down syndrome.
  • have a serious infection or an infection that does not go away or keeps coming back (chronic). 
  • 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.  

If you become pregnant while taking TZIELD, you are encouraged to report your pregnancy to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi.

  • 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:
  • decrease in white blood cell counts
  • vomiting
  • rash
  • diarrhea
  • headache

These are not all of the possible side effects of TZIELD. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to us at 1-800-633-1610 or www.fda.gov/medwatch or 1-800-FDA-1088.

Please see full Prescribing Information, including Risk of SERIOUS SIDE EFFECTS and Medication Guide.

What is TZIELD?

TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body cannot make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 1 year 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 or other forms of diabetes.

It is not known if TZIELD is safe and effective in children under 1 years of age.

Important Safety Information and Indication

What is the most important information I should know about TZIELD? TZIELD may cause serious side effects. These including:
  • Viral Reactivation. Epstein-Barr virus (EBV) and cytomegalovirus (CMV) are common viruses that may stay inactive in your body after an initial infection. TZIELD may cause these viruses to become active again which, especially in patients with a weakened immune system, can become serious and potentially life-threatening. These viral reactivations can happen during treatment with TZIELD and up to 2 months after your last dose. Your healthcare provider will test you for active EBV and CMV infections before treatment with TZIELD. Contact your healthcare provider right away if you develop symptoms of an infection during or after treatment with TZIELD (such as fever, swollen glands, or fatigue).
  • Cytokine release syndrome (CRS). Signs and symptoms may start during the first 5 days of TZIELD treatment and could include fever, nausea (with or without vomiting), 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 for active infections, verify your liver function 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 viral reactivation, 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 any of the conditions or symptoms listed in the section “What is the most important information I should know about TZIELD?”
  • have a weakened immune system, including if you have Down syndrome.
  • have a serious infection or an infection that does not go away or keeps coming back (chronic). 
  • 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.  

If you become pregnant while taking TZIELD, you are encouraged to report your pregnancy to us at our Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi.

  • 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:
  • decrease in white blood cell counts
  • vomiting
  • rash
  • diarrhea
  • headache

These are not all of the possible side effects of TZIELD. For more information, ask your healthcare provider or pharmacist. Call your doctor for medical advice about side effects. You may report side effects to the FDA at 1-800-FDA-1088. You may also report side effects to us at 1-800-633-1610 or www.fda.gov/medwatch or 1-800-FDA-1088.

Please see full Prescribing Information, including Risk of SERIOUS SIDE EFFECTS and Medication Guide.

What is TZIELD?

TZIELD is a prescription medicine used to delay the onset of Stage 3 type 1 diabetes, which is when your body cannot make enough insulin on its own and may require insulin injections. TZIELD is for adults and children 1 year 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 or other forms of diabetes.

It is not known if TZIELD is safe and effective in children under 1 years of age.