Tzield
Tzield (teplizumab or teplizumab-mzwv) is an injection for certain people 8 years and older with Type 1 diabetes. It helps slow down how fast people with stage 2 Type 1 diabetes move to stage 3. This means helping to delay when you start having diabetes symptoms and when you need to start considering insulin. Tzield (teplizumab) is a type of monoclonal antibody. It's given as an injection once daily through the vein for 14 days. You'll usually need to visit a treatment center for the injections. 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 certain people ages 8 years and older
How Tzield (teplizumab) works
Tzield (teplizumab) is an anti-CD3 monoclonal antibody. It attaches to proteins called CD3 that are found on immune cells. This is thought to help stop the immune cells from attacking and damaging the pancreas.
As a result, the medication might help protect the cells in the pancreas that make insulin. This might help slow down when diabetes symptoms like very high blood sugar and the risk of dangerous complications show up.
Drug facts
Side effects of Tzield (teplizumab)
The following side effects may get better over time as your body gets used to the medication. Let your healthcare provider know immediately if you continue to experience these symptoms or if they worsen over time.
Common Side Effects
- Low white blood cell counts (up to 73%)
- Rash (36%)
- Headache (11%)
Less Common Side Effects
- Nausea
- Diarrhea
- Inflammation of nose and throat (e.g., runny or stuffy nose, scratchy throat)
- Higher liver enzyme levels
Tzield (teplizumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Cytokine release syndrome (CRS): fever, nausea, tiredness, headache, muscle or joint pain
- Infection: fever, trouble breathing, cough, weakness, sweating, chills, diarrhea, stomach pain
- Allergic reaction: facial or throat swelling, trouble breathing, hives, rash, vomiting, fever
The following Tzield (teplizumab) 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 for finding support for Type 1 diabetes management
- Can consider for people at high risk of Type 1 diabetes (e.g., family history)
- Okay for children as young as 8 years old
Cons
- Must be given as an injection into the vein with the help of a trained healthcare professional
- Might raise the risk of infection
- Can't get vaccines several weeks before, during, and after treatment
- Not for people with Type 2 diabetes
Pharmacist tips for Tzield (teplizumab)
- Write down your appointments on your calendar so you remember when your Tzield (teplizumab) infusions are. If you miss your appointment, call the treatment center to reschedule it as soon as possible.
- Before each Tzield (teplizumab) treatment, your prescriber might have you take a fever medication, an antihistamine, or nausea medication. This helps lower your chance of having a reaction called cytokine release syndrome (CRS). Be sure to follow your prescriber's instructions when taking these medications.
- Each Tzield (teplizumab) infusion usually takes at least 30 minutes. Keep in mind that your appointment might take a bit longer. This is because your care team needs to prepare the medication before you receive it. They also might need to watch for any reactions after the infusion. It's helpful to plan accordingly and bring something to do to pass the time.
- Get any blood tests when your prescriber tells you to so they can track your blood cell counts and liver health. This helps your care team check for possible side effects of Tzield (teplizumab).
- Before you get any vaccines, tell the healthcare professional that you're taking or planning to take Tzield (teplizumab). This is important because the medication might affect how well vaccines work. To be safe, there's a certain period of time before starting Tzield (teplizumab) when it's safe to get vaccines. You could also wait until after you've completed the full treatment course. Specific timing recommendations depend on the type of vaccine. Your care team can help you figure out when the best time to get your vaccines is.
- If you need help while taking Tzield (teplizumab), talk to your prescriber. You can also join the manufacturer's assistance program. This program can give you tools, resources, and support to help you access the medication and stay on track with treatment.
Common questions about Tzield (teplizumab)
Yes, the FDA approved Tzield (teplizumab) in November 2022. The approval was based on clinical evidence that the medication works well and is safe for people 8 years and older with stage 2 Type 1 diabetes. Tzield (teplizumab) is the first medication available that can delay symptomatic Type 1 diabetes, also known as stage 3 Type 1 diabetes.
Tzield (teplizumab) is given once daily as an infusion into the veins. It's usually given by a trained healthcare professional at a treatment center. The infusion typically takes 30 minutes. The full treatment course takes 14 days. Ask your care team to learn more about the infusions and what to expect.
A small study showed that Tzield (teplizumab) helped delay stage 3 Type 1 diabetes (symptomatic diabetes) by about 4 years in some people. In comparison, a placebo (no medication) delayed symptomatic diabetes by about 2 years in others. Keep in mind that the study looked at people who had a high risk of getting Type 1 diabetes but weren't diagnosed with it yet. They had family members with Type 1 diabetes, diabetes-related autoantibodies in their blood, and high blood sugar. Talk to your prescriber to learn if this medication might help you.
No. Tzield (teplizumab) is only approved for people with Type 1 diabetes. It helps stop your immune cells from damaging insulin-producing cells in your pancreas. Type 2 diabetes is different from Type 1 diabetes because it's not caused by the same thing. Type 1 diabetes happens when your own immune system damages the pancreas. But Type 2 diabetes develops when the body doesn't respond well to insulin anymore. So, Tzield (teplizumab) wouldn't be helpful for people with Type 2 diabetes.
No. Tzield (teplizumab) only slows down Type 1 diabetes from stage 2 to stage 3. There are three stages of Type 1 diabetes. Stage 1 is when your own immune system starts attacking the cells in your pancreas that make insulin. Your blood sugar is still normal, and you don't have have diabetes symptoms. Stage 2 is when your blood sugar starts getting high, but you sstill don't have symptoms. Stage 3 is when you start having the typical symptoms of Type 1 diabetes. This includes feeling thirsty or hungry a lot or needing to urinate often. At this point, your body can't make its own insulin anymore. So, you'll eventually need to start lifelong insulin injections. Tzield (teplizumab) might help give you extra time before you need insulin. It might also give you more time to find support and learn how to manage Type 1 diabetes.
Tzield (teplizumab) is made by a company called Provention Bio, Inc.. They're working with another pharmaceutical company named Sanofi to launch the medication.
No, you shouldn't take Tzield (teplizumab) during pregnancy. You should also avoid taking the medication at least 30 days before trying to get pregnant. We don't know for sure if it's safe because there aren't enough good studies about this. If you get pregnant within 30 days before treatment or during treatment, tell your prescriber right away. Report the pregnancy to the manufacturer by calling 1-800-633-1610.
Talk to your prescriber or obstetrician-gynecologist (OB-GYN) about the risks and benefits of breastfeeding while taking Tzield (teplizumab). They might tell you to pump and dump your breast milk during treatment and for 20 days after treatment ends. This is because we don't know if the medication gets into breast milk and how it might affect your baby.
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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 reaction (cytokine release syndrome)
Some people taking Tzield (teplizumab) have had an inflammatory reaction called cytokine release syndrome (CRS). In studies, this usually happened in the first 5 days of treatment. But it can happen at any time, even up to about a month after the last dose.
CRS can cause symptoms like fever, nausea, tiredness, headache, and muscle or joint pain. To help prevent this, your prescriber might give you other medications to take before each Tzield (teplizumab) infusion. These might include fever medication, antihistamines, or nausea medication. CRS can also affect your liver. So, your prescriber will check your blood work during treatment to make sure your liver is okay.
If you have any signs of CRS during or after treatment, call your care team right away. What happens next depends on how severe your symptoms are. Your prescriber might give you medications to treat the symptoms, stop treatment for a few days, or stop it completely.
Risk of serious infections
- Risk factors: Active or chronic (long-term) infection | Taking medications that weaken the immune system
Tzield (teplizumab) can make it harder for your body to fight off germs. This can raise your risk of infections. In studies, some people treated with Tzield (teplizumab) had bacterial or viral infections. There were rare cases of serious infections, like pneumonia, cellulitis, and sepsis.
Talk to your prescriber about any infections you currently have. Tzield (teplizumab) isn't recommended if you have a serious or long-lasting infection. Your prescriber can make sure the treatment is safe for you.
Look out for signs of an infection while taking Tzield (teplizumab). If you have a fever, cough, trouble breathing, feel weak, sweat a lot, or have chills, call your care team right away. It's important to get examined for an infection and get treated if needed. You might have to stop taking Tzield (teplizumab) so your body can fight the infection as best as it can.
Low white blood cell counts
Tzield (teplizumab) can lower the amount of white blood cells (WBCs) in your blood. This can put you at risk of getting infections. In studies, WBC counts slowly went back up as people continued their 14-day treatment. WBC counts generally went back to normal a few weeks after completing the full treatment course.
Your prescriber will closely track your WBC counts through blood draws during treatment. Also be aware of signs of infection. Tell your care team if you have a fever, chills, body aches, tiredness, cough, or sore throat. It's important to get any infections treated to stay healthy.
Allergic reactions
It's possible to have an allergic reaction while taking Tzield (teplizumab). This can include serum sickness, which can look like fever, rash, joint pain, and swollen lymph nodes. Other allergic reactions can include a swollen face or throat, hives, vomiting, or trouble breathing. Get medical help right away if you have any of these signs while taking this medication.
Tzield (teplizumab) dosage
Typical dosage for Tzield (teplizumab)
Tzield (teplizumab) is given as a 30-minute infusion through the vein once per day for 14 days.
Your prescriber will calculate the dose based on your body surface area (BSA, in units of m2). They'll take 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