Tzield
Tzield (teplizumab or teplizumab-mzwv) is a medication that's used in adults and children with Type 1 diabetes. It's used to help slow the worsening of their condition from having no symptoms (stage 2) to having symptoms (stage 3). This medication is given once daily as an injection through the veins for 14 days. It's typically given at a provider's office or infusion center. Common side effects include rash, low white blood cell count, and headache.
What is Tzield (teplizumab)?
What is Tzield (teplizumab) used for?
Delaying the worsening of Type 1 diabetes from stage 2 to stage 3 in people ages 8 years and older
How Tzield (teplizumab) works
In Type 1 diabetes, certain cells from your immune system attack and damage the cells in your pancreas that make insulin (the hormone that lowers blood sugar).
Tzield (teplizumab) is an anti-CD3 monoclonal antibody. The medication attaches to proteins called CD3 found on these immune cells and turns off their activity. As a result, Tzield (teplizumab) slows down the progression of your Type 1 diabetes and the development of symptoms (e.g., frequent thirst or hunger, frequent urination, weight loss).
Drug Facts
What are the side effects of Tzield (teplizumab)?
Common Side Effects
- Low white blood cell counts (up to 73%)
- Rash (36%)
- Headache (11%)
Other Side Effects
- Nausea
- Diarrhea
- Inflammation of nose and throat
Serious Side Effects
- A severe inflammatory problem called cytokine release syndrome (CRS): fever, nausea, tiredness, headache, muscle or joint pain
- Serious infection: fever, difficulty breathing, cough, weakness, sweating, chills, diarrhea, stomach pain
- Allergic reactions: facial or throat swelling, difficulty breathing, hives, rash, vomiting, fever
Source: DailyMed
The following side effects have also been reported
Side effects that you should report to your care team as soon as possible:
- Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
- Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
- Infection—fever, chills, cough, or sore throat
Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):
Pros and cons of Tzield (teplizumab)
Pros
Full treatment only takes 14 days
Can give you more time before starting insulin therapy and to find support for Type 1 diabetes management
Can consider using for people at high risk of Type 1 diabetes (e.g., family history)
Can use in children as young as 8 years old
Possible to receive Tzield (teplizumab) at home with a nurse there
Cons
Must be given as an injection by a healthcare provider
Might raise the risk of infection
Can't get vaccines several weeks before, during, and after treatment
Should be avoided during pregnancy
Not for people with Type 2 diabetes
Pharmacist tips for Tzield (teplizumab)
Make sure to mark your appointments on your calendar to see your provider to get your Tzield (teplizumab) infusions as well as any blood tests you'll need (e.g., complete blood count (CBC), liver function tests). This makes sure your providers can properly monitor you and also helps you remember to receive your treatments on time.
Your provider might give you fever medication, antihistamines, or nausea medication for you to take before your Tzield (teplizumab) infusion. These medications help lower your risk for developing an inflammatory reaction called cytokine release syndrome (CRS) during treatment.
Each Tzield (teplizumab) infusion typically takes at least 30 minutes. But your appointment might take a bit longer — your provider needs to prepare the medication before you receive it and might need to watch for any reactions after the infusion.
Before getting any vaccines, tell your provider that you're receiving or planning to receive Tzield (teplizumab). It's important that they help you with the timing of your vaccines and Tzield (teplizumab) treatment because this medication might affect how well vaccines work. To be safe, it's recommended that you get any live vaccines at least 2 months before starting Tzield (teplizumab) or after at least 1 year of completing treatment. You should get any non-live vaccines, like the flu shot or coronavirus (COVID-19) vaccine, at least 2 weeks before starting Tzield (teplizumab) or after at least 6 weeks of completing treatment.
If you miss your scheduled Tzield (teplizumab) infusion, contact your provider to get it as soon as possible.
If you need support during treatment with Tzield (teplizumab), contact or enroll in the manufacturer's assistance program. This program can provide you with tools, resources, and personalized support to help you with treatment access and with your treatment journey with Tzield (teplizumab).
Frequently asked questions about Tzield (teplizumab)
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What are the risks and warnings for Tzield (teplizumab)?
Tzield (teplizumab) can cause some serious health issues. This risk may be even higher for certain groups. If this worries you, talk to your doctor or pharmacist about other options.
Intense inflammatory problem
Some people taking Tzield (teplizumab) developed an overactive inflammatory problem called cytokine release syndrome (CRS). In studies, this problem typically happened during the first 5 days of taking the medication. But it can happen any time during treatment and even up to about a month after the last dose of Tzield (teplizumab). Symptoms of CRS include fever, nausea, tiredness, headache, and muscle or joint pain. It can also affect your liver, so your provider will check your liver health through blood work during treatment.
To help lower your risk for CRS and to manage its symptoms, your provider might give you other medications to take before your Tzield (teplizumab) infusion. These medications include fever medication, antihistamines, or nausea medication. If you experience any symptoms of CRS during or shortly after your Tzield (teplizumab) treatment, contact your provider right away. Depending on how severe your symptoms are, your provider might give you medications to treat the symptoms, you might need to delay a couple of doses of Tzield (teplizumab), or you might need to stop treatment altogether.
Risk of serious infections
Risk factors: Active or chronic (long-term) infection | Taking medications that weaken the immune system
Tzield (teplizumab) can affect your body's ability to fight off germs, which can raise your risk of infection. In studies, some people treated with Tzield (teplizumab) developed bacterial or viral infections, though there were rare cases of serious infections, like pneumonia. Tzield (teplizumab) isn't recommended for people who currently have an infection or a long-lasting infection. The risk of developing infections might be higher in people taking medications that weaken your immune system. If you start having symptoms of an infection (e.g., fever, cough, difficulty breathing, diarrhea, weakness, sweating, chills) while taking Tzield (teplizumab), contact a provider as soon as possible so you can be tested for an infection and get treated. You might have to stop taking Tzield (teplizumab) so your body can fight the infection.
Low white blood cell counts
Tzield (teplizumab) can lower the amount of white blood cells (WBCs) you have in your blood. This can raise your risk for infections. During treatment, your provider will order blood draws to track your WBC counts closely. In studies, WBC counts slowly went back up as people continued taking Tzield (teplizumab) and went back to normal a few weeks after they completed the full treatment course. It's important to be aware of signs of infection. Let your provider know if you experience fever, chills, body aches, tiredness, cough, or sore throat.
Allergic reactions
It's possible to get allergic reactions when you're taking Tzield (teplizumab). Symptoms of these allergic reactions can include fever, joint pain, facial or throat swelling, hives, rash, vomiting, and difficulty breathing. Contact a provider right away if you get any of these symptoms because you might need to get treated for the allergic reaction.
Tzield (teplizumab) dosage forms
Typical dosing for Tzield (teplizumab)
Tzield (teplizumab) is given as a 30-minute infusion through the veins once per day for 14 days. Your provider will calculate the dose based on your body surface area (BSA, in units of m2), which takes into account your height and weight.
The dosing schedule is as follows:
Day 1: 65 mcg/m2
Day 2: 125 mcg/m2
Day 3: 250 mcg/m2
Day 4: 500 mcg/m2
Days 5 through 14: 1,030 mcg/m2
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References
Best studies we foundCenters for Disease Control and Prevention. (2023). Know the signs and symptoms of infection.
Elkon, K., et al. (2008). Nature and functions of autoantibodies. Nature Clinical Practice: Rheumatology.
Flint, B., et al. (2023). Body surface area. StatPearls.
Herold, K. C., et al. (2019). An anti-CD3 antibody, teplizumab, in relatives at risk for type 1 diabetes. The New England Journal of Medicine.
Insel, R. A., et al. (2015). Staging presymptomatic type 1 diabetes: A scientific statement of JDRF, the Endocrine Society, and the American Diabetes Association. Diabetes Care.
Provention Bio. (n.d.). Provention Bio Compass.
Provention Bio, Inc. (2023). Tzield- teplizumab-mzwv injection [package insert]. DailyMed.
Sanofi-Aventis U.S. LLC. (n.d.). How is Tzield given?
Sanofi-Aventis U.S. LLC. (n.d.). Understanding early-stage type 1 diabetes (T1D).
Shimabukuro-Vornhagen, A., et al. (2018). Cytokine release syndrome. Journal for Immunotherapy of Cancer.
U.S. Food and Drug Administration. (2023). Fast track, breakthrough therapy, accelerated approval, priority review.
U.S. Food and Drug Administration. (2023). FDA approves first drug that can delay onset of type 1 diabetes.
You and Your Hormones. (2021). Insulin.
You and Your Hormones. (2021). Pancreas.
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