Teplizumab-mzwv (tep-LIZ-oo-mab - mzwv)

Delays the onset of Stage 3 type 1 diabetes in patients with stage 2 type 1 diabetes.

Brand Name(s):

Tzield

When This Medicine Should Not Be Used:

How to Use This Medicine:

Injectable

• Your doctor will prescribe your dose and schedule. This medicine is given through a needle placed in a vein. It must be given slowly, so the needle will have to remain in place for at least 30 minutes.
• A nurse or other health provider will give you this medicine.
• Your doctor will give you other medicines (including an NSAID or acetaminophen, allergy medicine, and medicine to prevent nausea or vomiting) for the first 5 days of treatment to help reduce the side effects.
• This medicine should come with a Medication Guide. Ask your pharmacist for a copy if you do not have one.
• Missed dose: Call your doctor or pharmacist for instructions.

Drugs and Foods to Avoid:

Ask your doctor or pharmacist before using any other medicine, including over-the-counter medicines, vitamins, and herbal products.

• This medicine may interfere with vaccines. Ask your doctor before you get a flu shot or any other vaccines. Live virus vaccines should not be given for at least 8 weeks before start of treatment, during treatment, or up to 52 weeks after treatment. Non-live vaccines should not be given for at least 2 weeks before start of treatment, during treatment, or for at least 6 weeks after treatment.

Warnings While Using This Medicine:

• It is not safe to take this medicine during pregnancy. It could harm an unborn baby. Tell your doctor right away if you become pregnant. You should not receive this medicine if you are pregnant and for at least 30 days before a planned pregnancy.
• Your doctor may tell you to stop breastfeeding, and pump and discard your breast milk for at least 20 days after you receive this medicine.
• Tell your doctor if you have liver disease, blood problems, or any type of infection.
• This medicine may cause the following problems:
  • Cytokine release syndrome (CRS)
  • Serious infections
• This medicine may make you bleed, bruise, or get infections more easily. Take precautions to prevent illness and injury. Wash your hands often.
• Your doctor will do lab tests at regular visits to check on the effects of this medicine. Keep all appointments.

Possible Side Effects While Using This Medicine:

Call your doctor right away if you notice any of these side effects:

• Allergic reaction: Itching or hives, swelling in your face or hands, swelling or tingling in your mouth or throat, chest tightness, trouble breathing
• Fever, chills, cough, runny or stuffy nose, sore throat, body aches
• Headache, muscle or joint pain, nausea, tiredness
• Unusual bleeding, bruising, or weakness

If you notice other side effects that you think are caused by this medicine, tell your doctor

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088