Tzield
Tzield (teplizumab or teplizumab-mzwv) is an injection for certain adults and children 1 year of age and older with Type 1 diabetes. It helps slow how fast Type 1 diabetes gets worse. For people in stage 2, it can delay the progression to stage 3 (when you start having symptoms of diabetes). This means you might be able to wait longer before you have to start using insulin. Tzield (teplizumab) is a type of monoclonal antibody. It's given as an infusion through a vein once a day for 14 days. 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 1 year of age and older
How Tzield (teplizumab) works
Tzield (teplizumab) is an anti-CD3 monoclonal antibody. It attaches to proteins called CD3 found on immune cells. This is thought to help stop these immune cells from attacking and damaging your 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, show up. It might also delay the risk of dangerous complications.
Drug facts
| Common Brands | Tzield |
|---|---|
| Drug Class | Anti-CD3 monoclonal antibody |
| Controlled Substance Classification | Not a controlled medication |
| Generic Status | No lower-cost generic available |
| Availability | Prescription only |
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
Note: Side effects were from people 8 years and up. Side effects were similar for children 1 to 8 years of age.
Tzield (teplizumab) serious side effects
Contact your healthcare provider immediately if you experience any of the following.
- Epstein-Barr virus (EBV) or cytomegalovirus (CMV): tiredness, fever, sore throat, swollen lymph nodes in the neck, rash, yellow skin or eyes
- Other infection: fever, trouble breathing, cough, weakness, sweating, chills, diarrhea, stomach pain
- Cytokine release syndrome (CRS): fever, nausea, tiredness, headache, muscle or joint 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 1 year old
Cons
- Must be given as an infusion 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 or other forms of 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 give you a fever medication, an antihistamine, or nausea medication. This helps lower your chance of having a reaction called cytokine release syndrome (CRS). Follow your prescriber's instructions when taking these medications.
- Plan accordingly for your Tzield (teplizumab) infusion visits and bring something to do to pass the time. Give yourself time to get settled. Your care team also needs to prepare the medication before you receive it. Then, each infusion takes at least 30 minutes for people 8 years and older. And for children 1 to 8 years old, each infusion takes at least 2 hours.
- Tzield (teplizumab) can raise your risk of infections. Watch for signs like tiredness, fever, sore throat, weakness, chills, and swollen lymph nodes in the neck. If this happens during treatment or within 2 months after, call your care team so you can get checked out. Early treatment is important to keep you safe and healthy.
- Be sure to get any tests when your prescriber tells you to. This helps track your blood cell counts and liver health. It also helps watch for signs of serious infections. This helps your care team check for possible side effects of Tzield (teplizumab).
- Before getting any vaccines, tell your care team that you're taking or planning to take Tzield (teplizumab). This medication might affect how well vaccines work. There's a certain period of time before starting Tzield (teplizumab) when it's safe to get vaccines. You could also wait until after treatment. Specific timing recommendations depend on the type of vaccine. Your care team can help you figure out the best time to get your vaccines.
- If you're thinking about becoming pregnant: Talk to your prescriber. You should avoid taking Tzield (teplizumab) at least 30 days before trying to get pregnant. This is because it's not clear if it's safe during pregnancy. If you get pregnant within 30 days before or during treatment, let your care team know right away. Tell the manufacturer about the pregnancy by calling 1-800-633-1610.
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.
Risk of having viral infections come back
Some people taking Tzield (teplizumab) have had old viral infections come back. These Epstein-Barr virus (EBV) and cytomegalovirus (CMV). This "reactivation" can happen during treatment or within 2 months after. These infections can be very severe or even life-threatening.
The risk might be higher if your immune system is weak. Also, many serious cases happened in people who kept taking Tzield (teplizumab) had very low white blood cell counts.
Before you start Tzield (teplizumab), your prescriber will check for EBV and CMV. This is done through testing and a medical examination. Tzield (teplizumab) isn't recommended if you have any signs or symptoms of EBV or CMV.
Then during treatment, your prescriber will regularly monitor your white blood cell counts. They'll also watch for signs of EBV and CMV while you're taking Tzield (teplizumab) and for at least 2 months after your last infusion.
Watch for signs and symptoms of EBV and CMV. This includes tiredness, fever, sore throat, swollen lymph nodes in the neck, rash, or yellow skin or eyes. If you notice this, tell your prescriber right away so they can check. If you have EBV or CMV, you'll need to stop Tzield (teplizumab).
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 to monitor for this.
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 infusion.
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.
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 an infusion through a 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
