How TZIELD is given

00:14 - Introduction

00:49 - How did you balance daily life during your 2-week infusion journey?

01:48 - What was your experience with side effects like during treatment?

03:17 - How did your healthcare team support you during your infusion journey?

04:18 - What resources would you recommend to patients just getting started?

05:23 - What would you tell someone who is nervous about starting TZIELD?

07:06 - What is TZIELD?

07:44 - Important Safety Information

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.

Director:
We are rolling. TZIELD, Take One.

[DISCLAIMER] Please see Important Safety Information at the conclusion of this video and full Prescribing Information/Medication Guide on this webpage.

Molly:
One thing I love about sharing our TZIELD experience is how it connects families like ours together. We can share the same experience and help those who may be in the same situation.

[DISCLAIMER] Patient stories reflect the real-life experiences of persons 8 years and older diagnosed with autoimmune type 1 diabetes (T1D) during the stage prior to insulin-dependence, also known as Stage 2 T1D, and who have been prescribed TZIELD. Individual experiences may vary. Patient stories are not necessarily representative of what another person receiving TZIELD may experience.

Katie:
We are all TZIELD Ambassadors sponsored by Sanofi and we're here to share our infusion stories.

[DISCLAIMER] The people in this video are TZIELD Patient Ambassadors.

Katie:
Having my infusions done in home was a wonderful choice for me because I was still able to take my kids to the bus in the morning, be there when they got off the bus. I didn't have to put my life on hold for two weeks and I was even able to do some of the things I really love doing, like baking and working out, and so that worked the best for me.

William:
Yeah, life pretty much went on like normal for me too. I had my infusions offsite and so I spent two weeks in clinic and did schoolwork remotely and after I finished my infusions, I went back to school and went back to running like normal.

Zivile:
So my son Rimvydas also got his infusions when he was also in school and we took the hybrid approach, and we set that up with our care team. So we did one week in the hospital and then the second week we had two nurses come to our house and we did the infusions there. So we kind of got the best of both worlds that way.

Molly:
It’s just new, it's scary. And then being able to go over the possible side effects and see that it's, it's things that can possibly be controlled upfront or um, be given something throughout to help manage and get through. I actually ended up wanting to wait a few days before we started to infuse because all of the what-ifs for the possible side effects, um, really started to hit home for me and knowing that her care team would be monitoring throughout each infusion to take care of those, those types symptoms made me feel a lot better.

[DISCLAIMER] These answers are based on individual patient experiences. Results may vary from patient to patient.

[DISCLAIMER] For the first 5 days of treatment, your healthcare provider will give you medication by mouth before starting your TZIELD infusion. These medicines include ibuprofen, naproxen, or other pain relievers such as acetaminophen, an antihistamine, and an anti-nausea medicine.

William:
My only side effect from TZIELD was tiredness, and it was either because Mom and I were staying up late watching Friends or partially due to the antihistamine.

[DISCLAIMER] These medicines may help reduce symptoms of cytokine release syndrome (CRS) such as fever, headache, muscle and joint pain, or nausea.

Molly:
That's Aubri, too. She was just tired the whole time. She slept during her first infusion.

[DISCLAIMER] The most common side effects of TZIELD include rash, decrease in white blood cell counts, and headache. TZIELD may cause cytokine release syndrome and a decrease in your white blood cell counts, which can be serious. TZIELD may cause tiredness.

Katie:
Yeah, that was definitely the worst part for me too, was just feeling tired, you know, from the antihistamine. Other than the tiredness, I mostly just experienced nausea day four and five, which was more annoying than anything and my nurse, you know, took care of that with the, uh, anti-nausea medication.

[DISCLAIMER] Tell your doctor right away if you develop fever, nausea, tiredness, headache, rash, or muscle and joint pain, or are planning any vaccines as TZIELD may affect how well they work.

Zivile:
Yeah, so for my son, um, he had a rash and a headache and he also had, um, low blood cell counts, but our healthcare team reassured us that these were common side effects of treatment and that they would resolve over time, and they did.

[DISCLAIMER] For those who experience a decrease in white blood cell counts, these levels typically begin to recover after the 5th day of treatment and returned to pre-treatment levels within 2 weeks of completing infusions.

Amanda:
For our family, the healthcare team was a great source of support. They were constantly checking on us, you know, looking out for rashes and any of those other potential side effects. I felt like they really knew their stuff and they were very caring and attentive to his needs.

William:
Yeah, definitely. By the end of the treatment process, I, my endocrinologist and the healthcare team were basically family and knew them on a level that was not expecting to know them on.

Molly:
Aubri loved her healthcare team as well. It definitely made us feel like we weren't just a number. By the end of it, she was so comfortable with everyone. She was most excited to see her lab lady every day.

William:
Not Mom? What do you mean?

Molly:
No, not me. <laugh> Not mom at all.

Aubri:
I really liked her. She helped me get through my fear of needles and she made me feel like I wasn't alone and she was here and that I was okay.

Katie:
Yeah, they make you feel really comfortable.

Molly:
It was like family by the end.

Amanda:
Our family felt very supported by the TZIELD COMPASS Patient Support Program. Our TZIELD COMPASS Navigator was in frequent communication with us from the very beginning. We discussed insurance questions, educational questions. It was a great opportunity to just have that TZIELD COMPASS Navigator helping us along the way.

William:
Since the infusion center wasn't in our hometown, the TZIELD COMPASS Navigator helped us with the travel logistics and figure out a hotel and all the information about the infusions.

Amanda:
I really appreciated how they helped our family even after the process. With reimbursement, insurance questions. It was a great asset to have in our corner.

Katie:
Yeah, I would agree with that. I mean, I wasn't nervous because there was so much support around this. I mean, they said, you know, we'll get the process started and you can change your mind at any time and, um, and answer any questions I might have, so it was a really great resource.

Molly:
I would tell someone that it's okay to be nervous. It's okay to have questions. It's okay to be afraid. Those are all real feelings that I think all of us have experienced.

[DISCLAIMER] Individual results may vary. There is no evidence to suggest that TZIELD will have any effect on burden of disease, outcomes, quality of life, or life expectancy.

Aubri:
I would tell them that I was scared too and I didn't know what was gonna happen. I would say it's like worth it and I'm just glad I've been able to take it because I'm able to live life and be a teenager.

Zivile:
I'm not gonna lie, I was pretty worried before treatment began, but what really helped was that I thought, gee, other people have gotten this before him and really helped to reassure me that things were gonna be okay.

[DISCLAIMER] In a clinical study, TZIELD delayed the onset of insulin-dependent type 1 diabetes by a median* of 4 years, compared to 2 years with placebo. Individual results may vary.
*Median is the middle number in a group of numbers arranged from lowest to highest.

Katie:
I would tell them if they were nervous about starting TZIELD, that I was diagnosed in early 2023 with presymptomatic Stage 2 type 1 diabetes, and was told that I would need insulin within a year. But here it is, 2025, and I still don't need insulin.

[DISCLAIMER] The clinical trial included 76 people in the stage right before they become insulin-dependent (Stage 2 T1D). 44 received TZIELD and 32 received placebo.

William:
Once I saw the data of people that had not progressed from non-symptomatic to symptomatic needing insulin, it was enough of a reason for me to do it. There's a chance to get more time before type 1 diabetes progresses. That really made me optimistic about my future.

[DISCLAIMER] People were followed until they were diagnosed with insulin-dependent T1D (Stage 3). The median* amount of time that people were followed was 51 months (just over 4 years). People not diagnosed with insulin-dependent T1D were followed for different periods of time.

*Median is the middle number in a group of numbers arranged from lowest to highest.

Amanda:
I think sometimes health care feels very overwhelming, but it was nice to have, in addition to our healthcare team, our endocrinologist, to also have a, essentially a third party between our healthcare team, our family, and the TZIELD COMPASS Navigator, that we really felt supported and we knew what was coming.

[DISCLAIMER] There is no evidence to suggest that TZIELD will have any effect on burden of disease, outcomes, or life expectancy.

William:
Couldn't have said it any better.

Amanda:
Oh, thanks. <laugh>

AVO:
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.

IMPORTANT SAFETY INFORMATION

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

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.

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

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:

• rash
• leukopenia (decrease in white blood cell counts)
• headache

These are not all of the possible side effects of TZIELD. Talk to your healthcare provider for more information, and tell them about any side effects you notice. You may report side effects to the FDA at www.fda.gov/medwatch or 1-800-FDA-1088.

Please see accompanying Medication Guide and Prescribing Information.

To learn more, visit www.TZIELD.com

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