Tzield (teplizumab-mzwv) is a biologic (made from live cells) prescription medicine that can slow down the progress of type 1 diabetes when caught at an early stage. The FDA approved Tzield in 2023 for adults and children 8 years and older who have early-stage type 1 diabetes with no noticeable symptoms. Tzield is the first type 1 diabetes medicine to work to delay the need to use insulin. A health care provider puts it into a vein (intravenous infusion, or IV) at a clinic or at home. It is given in just one series of IVs, once a day for 14 days straight.
How Does Tzield Work in Type 1 Diabetes?
Type 1 diabetes is an autoimmune disease in which your immune system mistakenly attacks and damages the beta cells in your pancreas. The beta cells produce insulin, a hormone that helps your body use sugar for energy. Damage to the beta cells happens gradually and in three stages. In stage 3, so many of the beta cells are damaged that your body cannot make enough insulin, and blood sugar levels rise. This is when the symptoms of diabetes usually appear and health care providers diagnose type 1 diabetes.
Tzield can slow down the damage your immune system causes to the beta cells when type 1 diabetes is in stage 2. At this stage, beta cells can still make enough natural insulin, and you don’t have any symptoms. This may delay type 1 diabetes from moving to stage 3 and the need for insulin shots.
Is Tzield Right for Me?
Anyone can develop type 1 diabetes at any age or with any lifestyle.
Tzield may be the right choice for you if:
- You have stage 2 type 1 diabetes.
- You do not have type 2 diabetes.
Your health care provider will order blood tests for specific immune markers against the beta cells (autoantibodies) and an oral sugar tolerance test to confirm you have stage 2 type 1 diabetes. They will also test your blood for cell counts and liver enzymes to ensure Tzield is right for you.
Having a relative with type 1 diabetes makes it more likely for you to have the condition, but most people with type 1 diabetes do not have family members with it.
How Was Tzield Studied for Treating Type 1 Diabetes?
One clinical study, TN-10, was done to look at the benefits and risks of Tzield in people with stage 2 type 1 diabetes.
The main question this study wanted to answer was: Can Tzield prevent or delay type 1 diabetes from advancing to stage 3 in people at high risk?
To learn this, the researchers measured how long it took for people in the study who got Tzield to show symptoms of diabetes (reach stage 3), compared to those who did not get it.
What medicines did the people in the study take?
About half of the people in the study were randomly selected to get Tzield, and the other half got a placebo. The placebo was a mixture of salt and water (saline). It looked like Tzield but didn’t contain any medicine. Neither the people in the study nor the health care providers knew who got Tzield or the placebo.
Who was included in the study?
To take part in the study, people had to:
- Be 8 to 45 years old
- Have a first- or second-degree relative with type 1 diabetes
- Have abnormal sugar tolerance results 7 weeks before the study started
- Have at least two specific autoantibodies against beta cells
Who was excluded from the study?
People could not be in this study if they:
- Had stage 3 type 1 diabetes
- Had abnormal blood cell count or liver enzymes
- Had current infections
- Had a history of HIV, hepatitis B, or hepatitis C infections
- Were pregnant or breastfeeding
What was the study population?
- A total of 76 people were in this study.
- The age of the people in the study ranged from 8 to 45 years. About 72% of them were 18 years or younger.
- About 45% of the people in the study were female, and about 55% were male.
- About 97% of the people in the study were White, 1% were Asian, 1% said they were multiracial, and 3% reported they were of Hispanic or Latino ethnicity.
- More than half of the people in the study had siblings with type 1 diabetes.
A total of 44 people got Tzield and 32 people got the placebo.
How long was the study?
People got the study medicine once daily for 2 weeks. Researchers then followed up with them for up to 5 years by randomly checking their blood sugar levels every 3 months and doing regular oral sugar tolerance tests every 6 months. This continued until they reached stage 3 and showed symptoms, which happened at different times for each person.
What Were the Main Benefits of Tzield Seen in the Study?
- People who got Tzield in the study reached stage 3 type 1 diabetes about 2 years later than those who got the placebo. On average, people who got Tzield reached stage 3 in about 4 years, compared to about 2 years in those who got the placebo.
- Tzield was most effective in the first 2 years after it was given. Especially within the first year, a far smaller number of people who received Tzield progressed to stage 3 type 1 diabetes, compared to those who got the placebo.
- At the end of the study, 57% of the people who got Tzield were still free of diabetes symptoms, compared to 28% of those who got the placebo.
What Are the Possible Side Effects of Tzield, and How Can I Prevent or Manage Them?
The common side effects of Tzield include:
Rash
A rash might mean that you’re having an allergic reaction to Tzield. It is usually mild and will go away on its own. Keep your skin moisturized and try not to scratch. Instead, try using a cold compress, taking a cool shower, or having an oatmeal bath to calm the itch. If it still bothers you, your pharmacist may suggest non-prescription medicines, like an antihistamine (for example, cetirizine, diphenhydramine, or loratadine) or a cream, like hydrocortisone, to help you with the itch and redness.
If the rash gets worse and you have swelling in your tongue or throat and trouble breathing, call 911 right away.
A drop in white blood cells (lymphopenia)
Tzield can cause a drop in your white blood cell counts after the first IV. You won’t feel any different because of it, but it could make you more likely to get infections. Your white blood cell counts usually go back to normal after a few weeks.
Your health care provider will check your white blood cells regularly. If the number gets too low or you get serious infections, they will prescribe medicines to treat the infection or tell you to stop Tzield, if needed.
Headache
You might have a mild headache while getting Tzield, but it usually goes away on its own. Your pharmacist may suggest taking acetaminophen or ibuprofen to help. Be sure to let your health care provider know if the headache doesn’t go away or gets worse.
Tzield can cause serious side effects, including cytokine release syndrome and serious infections.
Cytokine release syndrome
Medicines like Tzield, which affect the immune system, can sometimes cause a sudden release of immune substances called cytokines into the blood. This reaction is called cytokine release syndrome and may happen during the first days of getting Tzield. Cytokine release syndrome can cause a fever, nausea, or a headache, or make you feel very tired. Your health care provider will give you medicines during the first days of getting Tzield to help make these symptoms milder. These medicines may include painkillers (acetaminophen, ibuprofen, or naproxen), antihistamines, or medicines for nausea. Let your health care provider know right away if you have any of the symptoms while getting Tzield or after you have finished the course of IVs.
Severe drop in white blood cells
If the number of white blood cells gets too low or takes too long to return to normal, you can get serious infections. Let your health care provider know if you have symptoms of an infection, like a fever, runny nose, coughing, feeling very tired, or any skin infections. They may give you medicines for the infection or tell you to stop Tzield if needed.
These are not all the possible side effects of Tzield. Contact your health care provider for medical advice about side effects if you are having symptoms that bother you. You can report side effects to the FDA at 800-FDA-1088 (800-332-1088). You can also report side effects to the drugmaker, Provention Bio, at 800-633-1610.
How Do I Know if Tzield Is Working?
Tzield works to delay when you reach stage 3 of type 1 diabetes and start having diabetes symptoms, so you may not notice any change after getting it. You will get Tzield as a one-time course, with IVs once a day for 2 weeks. After that, your health care provider will regularly order tests to see if and how your diabetes is progressing.
Do not stop your Tzield IVs or change your IV schedule unless your health care provider tells you to do so.
How Do Other Medicines Interact With Tzield?
Tell your pharmacist and other health care providers about all the other prescription and non-prescription medicines, vitamins, supplements, and herbal products you take before starting Tzield.
Tzield may make vaccines less effective. Some vaccines may not be safe for people on Tzield. Before getting any vaccine, tell your health care provider that you are getting Tzield. If you have finished your IVs, tell them when you got your last dose.
Tzield may interact with other medicines or conditions. Talk to your health care provider before starting any other prescription and non-prescription medicines, vitamins, supplements, and herbal products while you are on Tzield.
How Can I Get Tzield?
You will need a prescription from a health care provider. Tzield is only available at specialty pharmacies, and your health care provider will arrange for you to get it.
If you need help paying for Tzield, the drugmaker may be able to assist you. Check out https://www.tzield.com/tzield-compass-support-programto learn more about getting help with costs, your insurance coverage, and where to find clinics for your Tzield IVs. You can also contact the drugmaker at 844-778-2246.
