What is the most important information I should know about TZIELD?
TZIELD may cause serious side effects. These include:
- Cytokine Release Syndrome (CRS). Signs and symptoms may start during the first 5 days of TZIELD treatment and could include fever, nausea, 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
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 a serious infection or an infection that does not go away or keeps coming back
- have recently received or are scheduled to receive an immunization (vaccine). TZIELD may affect how well a vaccine works. Tell your doctor that you are receiving 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 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
What are the possible side effects of TZIELD?
The most common side effects of TZIELD include:
- leukopenia (decrease in white blood cell counts)
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 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. It is not known if TZIELD is safe and effective in children under 8 years of age.