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Important Safety Information and Indication

• 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).
• 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.
• 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: fever or chills; redness, warmth, or swelling of the skin; feeling tired; cough or shortness of breath; severe stomach pain or diarrhea.
• 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.

• 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. 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 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.

• See “What is the most important information I should know about TZIELD?”
• 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:
  • fever, joint pain, swollen lymph nodes (serum sickness)
  • swelling of the face, lips, tongue, or throat (angioedema)
  • urticaria
  • rash
  • vomiting
  • trouble breathing

• 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 us at 1-800-633-1610 or visit https://ae.reporting.sanofi.

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