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Tzield is the brand name for teplizumab-mzwv and is available as an intravenous infusion.

Tzield is available as a 2 mg per 2 mL (1 mg/mL) single-dose vial.

Tzield is a monoclonal antibody that is used to delay the worsening of Type 1 diabetes from stage 2 to stage 3 in certain people ages 8 years and older.

Tzield is an anti-CD3 monoclonal antibody that attaches to CD3 proteins found on immune cells. This is thought to help stop the immune cells from attacking and damaging the pancreas. As a result, Tzield slow the progression of Type 1 diabetes.

Your prescriber will calculate the dose of Tzield based on your body surface area (BSA, in units of m2). It will then be given as a 30-minute infusion through the vein once a day for 14 days.

Tzield is a safe and effective treatment when used for FDA licensed indications. However, like all medications, they may give you unwanted side effects. You should always discuss potential side effects with your physician to ensure the medication is suitable and right for you.

Common side effects of Tzield:

• Low white blood cell counts
• Rash
• Headache

Serious side effects are rare with Tzield. Contact your healthcare provider immediately if you experience any of the following:

• Cytokine release syndrome (CRS): fever, nausea, tiredness, headache, muscle or joint pain
• Infection: fever, trouble breathing, cough, weakness, sweating, chills, diarrhea, stomach pain
• Allergic reaction: facial or throat swelling, trouble breathing, hives, rash, vomiting, fever

There are no major drug interactions listed for this medication. However, always let your physician and pharmacist know about any other medications or supplements (including prescribed and over-the-counter medications, vitamins, and dietary or herbal supplements) that you are currently taking.

Sanofi-Aventis U.S.

You shouldn’t take Tzield during pregnancy. You should also avoid taking it at least 30 days before trying to get pregnant. If you get pregnant within 30 days before treatment or during treatment, tell your prescriber right away. Report the pregnancy to the manufacturer by calling 1-800-633-1610.

• Teplizumab-Mzwv