MEDICATION GUIDE
TZIELD® (TEE-zeeld)
(teplizumab-mzwv)
injection, for intravenous use |
What is the most important information I should know about TZIELD?
TZIELD may cause serious side effects, including:
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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 people with a weakened immune system, can become serious and potentially life-threatening. These infections can happen during treatment with TZIELD and for 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).
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Cytokine Release Syndrome (CRS). Signs and symptoms of CRS problems may include:
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- fever
- nausea with or without vomiting
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- feeling tired (fatigue)
- headache
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- muscle and joint pain
- increased liver enzymes in your blood
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| 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. |
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Serious Infections: Treatment with TZIELD may lower your immune system's ability to fight infections, which may increase your risk of getting a serious infection. TZIELD is not recommended if you currently have a serious infection, or an infection that keeps coming back or does not go away (chronic infection), other than a minor skin infection. Contact your healthcare provider right away if you develop symptoms of an infection during or after treatment with TZIELD such as.
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- fever or chills
- redness, warmth, or swelling of the skin
- feeling tired
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- cough or shortness of breath
- severe stomach pain or diarrhea
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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 of any treatment course. 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 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.
See "What are the possible side effects of TZIELD?" for more information about side effects. |
What is TZIELD?
TZIELD is a prescription medicine used to:
- delay the onset of Stage 3 type 1 diabetes (T1D) in adults and children 1 year of age and older who have Stage 2 T1D
- delay the decline in insulin produced by the body (endogenous) in children 8 to 17 years of age who were recently diagnosed with Stage 3 T1D
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- It is not known if TZIELD is safe and effective in children under 1 year of age who have Stage 2 T1D.
- It is not known if TZIELD is safe and effective in children under 8 years of age who have Stage 3 T1D.
- There is limited evidence of TZIELD being safe and effective in people 45 years of age and older with Stage 2 T1D.
- TZIELD is not effective as a disease modifying therapy in non-autoimmune dysglycemic conditions. These are conditions when your blood sugar goes too high and is not caused by your immune system.
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| Do not take TZIELD if you have a weakened immune system (immunocompromised) or have an active viral infection such as EBV or CMV infection. |
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 that 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. Your healthcare provider will tell you when you can safely receive any vaccine before and after the treatment with TZIELD.
- 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 the Provention Bio's Adverse Event reporting line at 1-800-633-1610 or visit https://ae.reporting.sanofi.
- 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 any TZIELD treatment.
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. |
How will I receive TZIELD?
- Your healthcare provider will recommend a 14-day treatment course if you have Stage 2 (T1D) or two 12-day treatment courses if you have Stage 3 type (T1D).
- TZIELD is given by a healthcare provider through a needle placed in a vein (intravenous infusion) in the arm.
- TZIELD is received as an infusion one-time a day, every day.
- Each TZIELD infusion will last at least 30 minutes if you are an adult or your child is 8 years of age or older.
- Each TZIELD infusion will last at least 2 hours if your child is 1 to less than 8 years of age.
- For the first 5 days of treatment, your healthcare provider will give medicines to be taken by mouth before starting the TZIELD infusion. These medicines include pain relievers (such as ibuprofen, naproxen or acetaminophen), an antihistamine, and possibly an anti-nausea medicine. These medicines may help reduce symptoms of CRS such as fever, headache, muscle and joint pain, or nausea, with or without vomiting. Vomiting and diarrhea may occur more frequently in children less than 8 years of age.
- If a scheduled infusion is missed, your healthcare provider will continue the treatment on the next scheduled day. Two infusions are not given on the same day.
Tell your healthcare provider if you think something will stop you from completing treatment with TZIELD. |
What are the possible side effects of TZIELD?
TZIELD may cause serious side effects including:
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See "What is the most important information I should know about TZIELD?"
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Allergic (hypersensitivity) reactions: Serious allergic reactions can happen while receiving TZIELD. Your healthcare provider will watch you closely while you are receiving TZIELD and after your infusion for signs of a reaction. Tell your healthcare provider right away if you have any of the following symptoms of an allergic reaction:
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- fever, joint pain, swollen lymph nodes (serum sickness)
- urticaria
- vomiting
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- swelling of the face, lips, tongue, or throat (angioedema)
- rash
- trouble breathing
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The most common side effects of TZIELD include:
- decrease in white blood cell counts
- vomiting
- rash
- diarrhea
- increase in liver enzyme levels
- 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 Provention Bio at 1-800-633-1610 or visit https://ae.reporting.sanofi. |
General information about the safe and effective use of TZIELD.
Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. You can ask your pharmacist or healthcare provider for information about TZIELD that is written for health professionals. |
What are the ingredients in TZIELD?
Active ingredient: teplizumab-mzwv.
Inactive ingredients: dibasic sodium phosphate, monobasic sodium phosphate, polysorbate 80, sodium chloride, and water for injection.
Manufactured by:
Provention Bio, Inc.
Morristown, NJ 07960
A SANOFI COMPANY
U.S. License Number: 2170
TZIELD is a registered trademark of Provention Bio, Inc.
Copyright © 2026, Provention Bio, Inc. All rights reserved.
For more information, call 1-800-633-1610 or go to www.tzield.com. |