Disclaimer during Indication and ISI:
Please see Important Safety Information in this video and see accompanying 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 (T1D) in adults and children 1 year of age and older who have Stage 2 T1D.
It is not known if TZIELD is safe and effective in children under 1 year of age who have Stage 2 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.
Do not take TZIELD if you have a weakened immune system (immunocompromised) or have an active viral infection such as EBV or CMV infection.
IMPORTANT SAFETY INFORMATION
What is the most important information I should know about TZIELD?
TZIELD may cause serious side effects, 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 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).
Graphic:
Kristi is a mental health professional living in Texas with her husband and three children, Jacob, Josh, and Josie. Josh was diagnosed with Stage 2 type 1 diabetes in 2022.
Disclaimer:
Kristi and Josh are being compensated for sharing their story in this video.
KRISTI:
I am being compensated by Sanofi to share our story.
Disclaimer (appears on screen until ISI scroll):
Please see additional Important Safety Information in this video and see accompanying full Prescribing Information, including Risk of SERIOUS SIDE EFFECTS and Medication Guide.
Disclaimer:
Josh is a TZIELD patient. Individual results may vary.
JOSH:
I'm 18 years old. I like to hang out with my friends. I like to cook. I love making meals for myself and I love hanging out with my family. They're really fun to be with.
Disclaimer:
Patient stories reflect the real-life experiences of persons diagnosed with Stage 2 T1D who have been prescribed TZIELD. However, individual experiences may vary. Patient stories are not necessarily representative of what another person using TZIELD may experience.
KRISTI:
Josh was 17 and a junior in high school when he was diagnosed with stage two type one diabetes.
He had been feeling fatigued and sleeping much more than what we thought was normal, so his doctor ran a comprehensive battery of tests and the results were an abnormal blood glucose level. We thought that he was going to be diagnosed with type two diabetes because we have a family history of that. We don't have a family history of type one.
We were shocked when it was found that Josh had multiple type one diabetes related autoantibodies. Along with abnormal blood glucose levels, this led to a diagnosis of stage two type one diabetes.
We were relieved that we had found Josh's diabetes in stage two, but there was a lot of anxiety that we felt for what would lie ahead and how it would change his life.
JOSH:
At first I didn't really know what to think. I didn't know much about it, but I pretty quickly started doing some research on my own as well as with my family and figured out how serious it really is and how much it really could change my life.
KRISTI:
I also see an endocrinologist for management of my thyroid disease. So at a doctor's visit, I mentioned to him that Josh had been diagnosed with stage two type one diabetes, and he told us about a treatment called TZIELD.
Disclaimer:
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.
It is not known if TZIELD is safe and effective in children under 1 year of age who have Stage 2 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.
Do not take TZIELD if you have a weakened immune system (immunocompromised) or have an active viral infection such as EBV or CMV infection.
KRISTI:
He said TZIELD is an infusion that takes place over 14 consecutive days and would have the potential to delay Josh's diabetes from the progression of stage two to stage three insulin dependence.
Disclaimer – on screen and verbalized by Kristi:
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.
It is not known if TZIELD is safe and effective in children under 1 year of age who have Stage 2 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.
Do not take TZIELD if you have a weakened immune system (immunocompromised) or have an active viral infection such as EBV or CMV infection.
TZIELD may cause serious side effects including viral reactivation of Epstein-Barr virus (EBV) and cytomegalovirus (CMV) which are common and may stay inactive in your body after an initial infection. Viral reactivation can occur during treatment and for up to 2 months after your last dose and can be potentially life-threatening, especially in people with a weakened immune system, including if you have Down syndrome. TZIELD may also cause other serious side effects including cytokine release syndrome, serious infections, a decrease in your white blood cell counts which can affect your body's ability to fight infections, and allergic reactions. Tell your doctor right away if you develop fever swollen glands or lymph nodes, tiredness, muscle and joint pain, severe stomach pain, diarrhea, nausea, with or without vomiting, redness, warmth or swelling of the skin, swelling of the face, lips, tongue or throat, headache, cough, shortness of breath or trouble breathing, a serious infection or one that does not go away or have recently received or are planning any vaccines, as TZIELD may affect how well they work. The most common side effects of TZIELD include decrease in white blood cell counts, vomiting, rash, diarrhea, increase in liver enzyme levels and headache. These are not all the possible side effects with TZIELD.
KRISTI:
Once Josh made the decision, our first step was to get insurance approval. That came through rather quickly. So the next step was to find an infusion center to provide the treatment, and that was more of a challenge. Our COMPASS Navigator was really helpful at answering our questions and helping us find the closest infusion center.
Disclaimer:
What is the most important information I should know about TZIELD? TZIELD may cause serious side effects. These include: 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). Please see additional Important Safety Information throughout this video.
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.
Graphic: Josh began his infusions in June of 2023
JOSH:
So the way I prepared for the infusion is I would go in and they would draw some blood and do a blood test just to make sure everything was going smoothly before it started.
Disclaimer:
TZIELD is given by a healthcare provider through a needle placed in a vein (intravenous infusion) in your arm.
JOSH:
I passed the time by talking with my mom or the nurses who were really fun to hang out with.
Disclaimer:
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.
JOSH:
There was some aches when I would get home, and then the most notable side effect that I did end up getting was rashes along my hands, which just having itchy hands is not fun, but that was about the worst it got.
Graphic: Josh also developed a rash on his abdomen and his ankle which was mostly resolved by the 2-week mark.
Disclaimer:
Individual results may vary.
JOSH:
Having more time before I progress to stage three is important to me.
My next step in life is attend a university for engineering.
Disclaimer:
There is no evidence to suggest that TZIELD will have any effect on burden of disease, outcomes, or life expectancy.
JOSH:
And it's a relief to be able to fully focus on my studies and social life, which is very important to me.
INDICATION AND ISI
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