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:
- 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:
- leukopenia (decrease in white blood cell counts)
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.