Teplizumab-mzwv injection

Brand Name(s): Tzield®

WHY is this medicine prescribed?

Teplizumab-mzwv injection is used to slow the progression of Stage 2 Type 1 Diabetes Mellitus (T1DM) to Stage 3 T1DM in adults and children age 8 years and older. Teplizumab-mzwv is in a class of medications called monoclonal antibodies. It works by partly blocking the immune system's attack on insulin-making cells in the pancreas.

HOW should this medicine be used?

Teplizumab-mzwv injection comes as a solution (liquid) to be given by a doctor or nurse intravenously (into the vein). It is given once a day for 14 days. Each teplizumab-mzwv infusion will take about 30 minutes. Your doctor will prescribe you several medicines to take in the days leading up to your first injection to reduce the chance of adverse effects happening.

Your doctor will order labs for you prior to starting teplizumab-mzwv injection to help determine if this medication will be safe for you. You will also be asked to be up to date on vaccines before starting teplizumab-mzwv therapy.

Teplizumab-mzwv injection slows the progression of T1DM but does not cure it. It is important that you finish your course of teplizumab-mzwv even if you feel well.

Ask your pharmacist or doctor for a copy of the manufacturer's information for the patient.

Are there OTHER USES for this medicine?

This medication may be prescribed for other uses; ask your doctor or pharmacist for more information.

What SPECIAL PRECAUTIONS should I follow?

Before receiving teplizumab-mzwv,

• tell your doctor and pharmacist if you are allergic to teplizumab-mzwv, any other medications, or any of the ingredients in teplizumab-mzwv injection. Ask your pharmacist or check the Medication Guide for a list of the ingredients.
• tell your doctor and pharmacist what prescription and nonprescription medications, vitamins, nutritional supplements, and herbal products you are taking or plan to take while taking teplizumab-mzwv. Your doctor may need to change the doses of your medications or monitor you carefully for side effects.
• tell your doctor if you have or have ever had an infection, a suppressed immune system (difficulty or inability to fight infections), or liver disease.
• tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while you are receiving teplizumab-mzwv injection. You should use effective birth control to prevent pregnancy during your treatment with teplizumab-mzwv injection and for at least 30 days after your final dose. Talk to your doctor about birth control methods that will work for you. If you become pregnant while receiving teplizumab-mzwv injection, call your doctor immediately. Teplizumab-mzwv injection may harm the fetus.
• tell your doctor if you are breastfeeding or plan to breastfeed. You should not breastfeed while receiving teplizumab-mzwv injection and for at least 20 days after your final dose.
• if you are having surgery, including dental surgery, tell the doctor or dentist that you are receiving teplizumab-mzwv.
• do not have any vaccinations without talking to your doctor while or after receiving teplizumab-xcwv injection.

What SPECIAL DIETARY instructions should I follow?

Unless your doctor tells you otherwise, continue your normal diet.

What should I do IF I FORGET to take a dose?

If you miss an appointment to receive a teplizumab-mzwv injection, call your doctor as soon as possible.

What SIDE EFFECTS can this medicine cause?

Teplizumab-mzwv injection may cause side effects. Tell your doctor if any of these symptoms are severe or do not go away:

• rash
• headache

• fever, fatigue, muscle and joint pain, nausea, or headache
• new or worsening cough, chest pain, or shortness of breath
• diarrhea; bloody or black, tarry, sticky stools; or severe stomach pain or tenderness
• yellowing of your eyes or skin, bleeding or bruising easily, decreased appetite, dark (tea colored) urine, pain in the upper right part of the stomach, extreme tiredness, nausea or vomiting
• fever or flu-like symptoms
• swollen glands
• rash or itching, scaling or blistering skin

Teplizumab-mzwv injection may cause other side effects. Call your doctor if you have any unusual problems while taking this medication.

If you experience a serious side effect, you or your doctor may send a report to the Food and Drug Administration's (FDA) MedWatch Adverse Event Reporting program online (http://www.fda.gov/Safety/MedWatch) or by phone (1-800-332-1088).

What OTHER INFORMATION should I know?

Keep all appointments with your doctor and the laboratory. Your doctor may order certain lab tests to check your body's response to teplizumab-mzwv injection.

It is important for you to keep a written list of all of the prescription and nonprescription (over-the-counter) medicines you are taking, as well as any products such as vitamins, minerals, or other dietary supplements. You should bring this list with you each time you visit a doctor or if you are admitted to a hospital. It is also important information to carry with you in case of emergencies.

This report on medications is for your information only, and is not considered individual patient advice. Because of the changing nature of drug information, please consult your physician or pharmacist about specific clinical use.

The American Society of Health-System Pharmacists, Inc. represents that the information provided hereunder was formulated with a reasonable standard of care, and in conformity with professional standards in the field. The American Society of Health-System Pharmacists, Inc. makes no representations or warranties, express or implied, including, but not limited to, any implied warranty of merchantability and/or fitness for a particular purpose, with respect to such information and specifically disclaims all such warranties. Users are advised that decisions regarding drug therapy are complex medical decisions requiring the independent, informed decision of an appropriate health care professional, and the information is provided for informational purposes only. The entire monograph for a drug should be reviewed for a thorough understanding of the drug's actions, uses and side effects. The American Society of Health-System Pharmacists, Inc. does not endorse or recommend the use of any drug. The information is not a substitute for medical care.

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