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.

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).

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.

Usual Adult Dose for Diabetes Type 1:

Usual dose: Body surface area-based dosing by intravenous infusion once daily
Dosing:
-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

Duration of therapy: 14 days

Comments:
-Confirm the presence of Stage 2 type 1 diabetes by documenting at least two positive pancreatic islet cell autoantibodies and state of dysglycemia without overt hyperglycemia using an oral glucose tolerance test (OGTT); an alternate test may be used if OGTT is not available.
-Patients should not have type 2 diabetes.
-Complete blood count and liver enzyme tests should be done before initiating the treatment.
-This drug is not recommended in patients with:
---Lymphocyte count less than 1,000 lymphocytes/mcL
---Hemoglobin less than 10 g/dL or Platelet count less than 150,000 platelets/mcL
---Absolute neutrophil count less than 1,500 neutrophils/mcL
---Elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) greater than 2 times the upper limit of normal (ULN) or bilirubin greater than 1.5 times ULN
---Laboratory or clinical evidence of acute infection with Epstein-Barr virus (EBV) or cytomegalovirus (CMV)
---Active serious infection or chronic active infection other than localized skin infections
-All age-appropriate vaccination should be completed before initiating the treatment.
-Administer premedication before every dosing for the first 5 days with:
---A nonsteroidal anti-inflammatory drug (NSAID) or acetaminophen
---An antihistamine and/or an antiemetic
-If a dose is missed, resume the administration of remaining doses based on 14-day dosing schedule.
-Do not administer this drug twice on the same day.

Use: To delay the onset of Stage 3 type 1 diabetes in patients of 8 years or older

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 teplizumab. 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.

Call your doctor for instructions if you miss an appointment for your teplizumab injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Avoid receiving an inactivated, mRNA, and "live" vaccine. The vaccine may not work as well while you are using 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.

Teplizumab may cause serious side effects. 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 of teplizumab 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.

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.