teplizumab
What is the most important information I should know about teplizumab?
Tell your medical caregivers if you have symptoms of a serious side effect, such as fever, chills, trouble breathing, vomiting, or severe tiredness.
Call your doctor at once if you have fever, chills, sore throat, body aches, tiredness.
Also call your doctor at once if you have stomach pain (upper right side), itching, dark urine, or jaundice (yellowing of the skin or eyes).
What is teplizumab?
Teplizumab is used to delay the onset of stage 3 type 1 diabetes in people at least 8 years old with stage 2 type 1 diabetes.
Teplizumab may also be used for purposes not listed in this medication guide.
What should I discuss with my healthcare provider before receiving teplizumab?
Tell your doctor if you have:
- a serious infection or an infection that keeps returning or does not go away; or
- recently received or are scheduled to receive a vaccine.
May harm an unborn baby. Do not use if you are pregnant and for at least 30 days before a planned pregnancy. Tell your doctor if you become pregnant.
You should contact the Adverse Event reporting line at 1-844-778-2246 if exposed to teplizumab during pregnancy.
Do not breastfeed while using this medicine. If you are considering breastfeeding, use a breast pump and throw out any milk you collect during treatment with this drug and for at least 20 days after your last dose.
How is teplizumab given?
Follow all directions on your prescription label and read all medication guides or instruction sheets.
Teplizumab is injected into a vein for approximately 30 minutes. You will receive this medicine once a day for 14 days.
You will be given other medications to help prevent serious side effects.
You should receive all appropriate vaccines before you start using teplizumab.
Your blood will need to be tested before and during treatment with teplizumab.
Your treatment with teplizumab may be temporarily or permanently discontinued if you have certain side effects.
What happens if I miss a dose?
Call your doctor for instructions if you miss an appointment for your teplizumab injection.
What happens if I overdose?
Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.
What should I avoid while receiving teplizumab?
Avoid receiving an inactivated, mRNA, and "live" vaccine. The vaccine may not work as well while you are using teplizumab.
What are the possible side effects of teplizumab?
Get emergency medical help if you have signs of an allergic reaction: hives; difficult breathing; swelling of your face, lips, tongue, or throat.
Tell your medical caregivers if you have signs of cytokine release syndrome (CRS), a serious side effect: fever, chills, trouble breathing, confusion, severe vomiting or diarrhea, fast or irregular heartbeats, feeling light-headed or very tired.
Call your doctor at once if you have:
- signs of infection --fever, chills, sore throat, body aches, unusual tiredness, loss of appetite, bruising or bleeding; or
- liver problems --loss of appetite, stomach pain (upper right side), tiredness, itching, dark urine, clay-colored stools, jaundice (yellowing of the skin or eyes).
Common side effects may include:
- rash;
- headache; or
- fever, mouth sores, skin sores, sore throat, cough.
This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
What other drugs will affect teplizumab?
Other drugs may affect teplizumab, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all other medicines you use.
Where can I get more information?
Your doctor or pharmacist can provide more information about teplizumab.
Remember, keep this and all other medicines out of the reach of children, never share your medicines with others, and use this medication only for the indication prescribed.
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