Overview: Tzield is a medicine used in certain people with type 1 diabetes to delay progression of diabetes. Common side effects may include headache, rash, vomiting, or diarrhea. Serious side effects are less common, but may include increased risk for infections and problems with your immune system. Contact your health care provider right away if you have fever, chills, feel like your glands are swollen, or any other sign of an infection. Tell your health care provider about all of your health conditions before you start using Tzield.
Uses
What is Tzield used for?
Tzield (teplizumab-mzwv) is commonly used in certain people with type 1 diabetes to delay the progression of the disease. Diabetes is a condition of high blood sugar, which happens when your body cannot make enough insulin on its own.
How Tzield Works for Type 1 Diabetes
How does Tzield work (mechanism of action)?
Tzield works by preventing your immune system from attacking your pancreas, an organ that makes insulin.
How is Tzield supplied (dosage forms)?
Tzield is available in an injectable form that is given by a health care provider.
How should I store Tzield?
Tzield is usually given by a health care provider in a hospital or clinic. You will not store it at home.
Side Effects
What are the most common side effects of Tzield?
The most common side effects of Tzield include the following. Tell your health care provider if you have any of these side effects that bother you.
- Headache
- Rash
- Low white blood cell counts or leukopenia (see below)
- Vomiting
- Diarrhea
- Increased liver enzyme blood levels
There may be other side effects of Tzield that are not listed here. Contact your health care provider if you think you are having a side effect of a medicine. In the U.S., you can report side effects to the FDA at www.fda.gov/medwatch or by calling 800-FDA-1088 (800-332-1088). In Canada, you can report side effects to Health Canada at www.health.gc.ca/medeffect or by calling 866-234-2345.
What are the serious side effects of Tzield?
While less common, the most serious side effects of Tzield are described below, along with what to do if they happen.
Cytokine Release Syndrome. Tzield can cause a dangerous and sometimes life-threatening problem called cytokine release syndrome. This problem occurs when your immune system responds too much. Your immune system may respond too much right away or several days after you get Tzield. Keep all appointments to have your blood checked. Get emergency help right away if you have any of the following symptoms of cytokine release syndrome.
- Fever
- Feeling tired or weak
- Dizziness
- Nausea, vomiting, or diarrhea
- Headache
- Muscle or joint pain
- Pale or yellowish skin
Infection. Tzield can increase the risk of infections, including serious infections. Call your health care provider right away if you have an infection or any of the following symptoms.
- Burning or stinging when you pee
- Cough or coughing up blood
- Fever, sweats, chills, or muscle aches
- Shortness of breath
- Diarrhea or stomach pain
- Weight loss
Reactivated Infections. Some types of microbes that cause infections (such as a viruses) can remain in the body after you recover from that infection. When a virus stays in the body but does not cause an infection, it is called a “latent” virus. Tzield may increase your risk of a latent virus becoming active again, causing an infection. This risk may be higher if your immune system is not working as well as it should be of if you have other health conditions. Before you start treatment with Tzield, your health care provider may run tests to look for any latent viruses. Your risk for these infections can least months after your last dose of Tzield. Tell your health care provider if you have ever had cytomegalovirus (CMV) or Epstein-Barr virus. Contact your health care provider right away if you have symptoms of a viral infection during treatment or after receiving Tzield, including the following.
- Fever
- Tiredness
- Swollen glands
Low Lymphocyte Cell Levels (Lymphopenia). Tzield may cause low lymphocyte levels, also called lymphopenia or lymphocytopenia. Lymphocytes are a type of white blood cell that helps prevent infection. Having a low level of lymphocytes may increase your risk of infection. Keep all appointments to have your blood checked. Tell your health care provider if you have any of the following symptoms of low lymphocyte levels.
- Fever, chills, or sweats
- Tiredness
- Sore throat, cough, or shortness of breath
- Mouth or throat sores
- Swollen lymph nodes
Severe Allergic Reactions. Tzield may cause allergic reactions, which can be serious. Stop using Tzield and get help right away if you have any of the following symptoms of a serious allergic reaction.
- Breathing problems or wheezing
- Racing heart
- Fever or general ill feeling
- Swollen lymph nodes
- Swelling of the face, lips, mouth, tongue, or throat
- Trouble swallowing or throat tightness
- Itching or skin rash
- Bumps on the skin called hives that can be red, pink, white, or brown depending on your skin tone
- Nausea or vomiting
- Dizziness, feeling lightheaded, or fainting
- Stomach cramps
- Joint pain
Warnings & Precautions
Who should not use Tzield?
Allergies to Ingredients. People who are allergic to any of the following should not use Tzield.
- Teplizumab-mzwv
- Tzield
- Any of the ingredients in the specific product dispensed
Your pharmacist can tell you all of the ingredients in Tzield.
Certain Viral Infections. You should not use Tzield if you have a viral infection, such as CMV or EBV. Tzield affects your immune system. Using Tzield when you have an active infection could make it harder for your body to get rid of these serious infections.
Immune System Problems. You should not use Tzield if your immune system is not working as well as it should be. Tzield affects your immune system. If your immune system is already slowed down, using Tzield may make things worse.
What should I know about Tzield before using it?
Take any medicine your health care provider gives you to take before getting Tzield. These medicines may help lower certain side effects that you may have from Tzield.
What should I tell my health care provider before using Tzield?
Tell your health care provider about all of your health conditions and any prescription or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using. This will help them know if Tzield is right for you.
In particular, make sure that you discuss any of the following.
Current and Past Health Conditions. Tell your health care provider if you have any of the following.
- Liver Problems
- Anemia
- Low platelets (thrombocytopenia)
- Current infection, such as mononucleosis
- Infection that does not go away or keeps coming back
- Down syndrome
- Heart disease
- Adrenal gland problems, including adrenal insufficiency
Vaccines. Talk with your health care provider about any vaccines that you may need. You should not receive certain vaccines right before, while using Tzield, or for some time after your last dose of Tzield. Tell your health care provider about any vaccines you have recently received or have scheduled.
Pregnancy. It is not known if or how Tzield could affect pregnancy or harm a fetus. Tell your health care provider if you are pregnant or plan to become pregnant. You should not get Tzield for at least 30 days before a planned pregnancy. If you become pregnant, stop using Tzield right away and contact your health care provider. Also, call the manufacturer at 800-633-1610 to report your pregnancy.
Breastfeeding. It is not known if Tzield passes into breast milk. Tell your health care provider if you are breastfeeding or plan to breastfeed. You may pump and throw away your milk during the time you get this medicine and for 20 days after your treatment. This will lower the amount of medicine your baby may get by breastfeeding.
How can I get more information about Tzield?
For more information about Tzield, you can visit the manufacturer’s website at www.tzield.com or call them at 800-633-1610.
Interactions
Does Tzield interact with foods or drinks?
There are no known interactions between Tzield and foods or drinks.
It is unknown if drinking alcohol will affect Tzield. There are no known interactions between Tzield and alcohol.
Does Tzield interact with other medicines (drug interactions)?
There are no known interactions between Tzield and other medicines. Always tell your health care provider about any prescriptions or over-the-counter (OTC) medicines, vitamins/minerals, herbal products, and other supplements you are using.
Overdose/Missed Dose
What should I do if I accidentally use too much Tzield?
If you or someone else has used too much Tzield, get medical help right away, call 911, or contact a Poison Control center at 800-222-1222.
What should I do if I miss a dose of Tzield?
Tzield is usually given by a health care provider in a hospital or clinic. Your health care provider will make sure you are receiving Tzield as scheduled.
If you miss an appointment to get your Tzield dose, call to make another appointment as soon as possible.
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