How to use Tzield 1 Mg/Ml Intravenous Solution

Read the Medication Guide provided by your pharmacist before you start receiving teplizumab and each time you get a treatment. If you have any questions, ask your doctor or pharmacist.

This medication is given by injection into a vein by a health care professional. It is given as directed by your doctor, usually once a day for 14 days. It is injected slowly into a vein over 30 minutes.

The dosage is based on your medical condition, body size, and response to treatment.

Before each dose, your doctor may direct you to take other medications to help prevent side effects. Carefully follow your doctor's directions for all your medications. Your doctor may stop your treatment for some time if you get serious side effects.

To get the most benefit, do not miss any doses. To help you remember, mark the days on the calendar when you need to receive the medication.

Side Effects

Headache may occur. If this effect lasts or gets worse, tell your doctor or pharmacist promptly.

Remember that this medication has been prescribed because your doctor has judged that the benefit to you is greater than the risk of side effects. Many people using this medication do not have serious side effects.

This medication may cause a serious reaction called cytokine release syndrome-CRS. Careful monitoring and prompt treatment may decrease your risk. Before treatment with this medication, tell your doctor your medical history, especially of any current/recent infection. Tell your doctor right away if you have any symptoms of CRS such as fever, severe nausea, tiredness, severe muscle/joint pain, or severe headache.

This medication may lower your ability to fight infections. This may make you more likely to get a serious (rarely fatal) infection or make any infection you have worse. Tell your doctor right away if you have any signs of infection (such as sore throat that doesn't go away, fever, chills, cough).

A very serious allergic reaction to this drug is rare. However, get medical help right away if you notice any symptoms of a serious allergic reaction, including: rash, itching/swelling (especially of the face/tongue/throat), severe dizziness, trouble breathing.

This is not a complete list of possible side effects. If you notice other effects not listed above, contact your doctor or pharmacist.

In the US - Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088 or at www.fda.gov/medwatch.

In Canada - Call your doctor for medical advice about side effects. You may report side effects to Health Canada at 1-866-234-2345.

Precautions

See also Side Effects section.

Before using teplizumab, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Before using this medication, tell your doctor or pharmacist your medical history, especially of: blood/bone marrow problems (such as low red/white blood cells and platelets), liver disease.

Teplizumab can make you more likely to get infections or may make current infections worse. Stay away from anyone who has an infection that may easily spread (such as chickenpox, COVID-19, measles, flu). Talk to your doctor if you have been exposed to an infection or for more details.

Tell your doctor your vaccine history and ask if you need to get any vaccines before starting treatment with this medication. Your doctor may direct you to have any required vaccines at least 2 to 8 weeks before starting this medication. Tell your health care professional that you are using or have used teplizumab before having any immunizations/vaccinations. Avoid contact with people who have recently received live vaccines (such as flu vaccine inhaled through the nose).

Before having surgery, tell your doctor or dentist about all the products you use (including prescription drugs, nonprescription drugs, and herbal products).

Tell your doctor if you are pregnant or plan to become pregnant. You should not become pregnant while using teplizumab. Teplizumab may harm an unborn baby. You should wait at least 30 days after the last dose of teplizumab before a planned pregnancy. If you become pregnant while taking this medication, talk to your doctor right away about the risks and benefits.

It is unknown if this drug passes into breast milk. Consult your doctor before breastfeeding.

Interactions

Drug interactions may change how your medications work or increase your risk for serious side effects. This document does not contain all possible drug interactions. Keep a list of all the products you use (including prescription/nonprescription drugs and herbal products) and share it with your doctor and pharmacist. Do not start, stop, or change the dosage of any medicines without your doctor's approval.

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Overdose

If someone has overdosed and has serious symptoms such as passing out or trouble breathing, call 911. Otherwise, call a poison control center right away. US residents can call their local poison control center at 1-800-222-1222. Canada residents can call a provincial poison control center.

Notes Notes

Attend a diabetes education program to learn more about how to manage your diabetes with medications, diet, exercise, and regular medical exams.

Learn the symptoms of high and low blood sugar and how to treat low blood sugar. Check your blood sugar regularly as directed.

Lab and/or medical tests (such as liver function, complete blood count) should be done before you start using this medication and while you are using it. Keep all medical and lab appointments. Consult your doctor for more details.

Missed Dose Missed Dose

It is important to get each dose of this medication as scheduled. If you miss a dose, ask your doctor or pharmacist right away for a new dosing schedule.

Storage Storage

Not applicable. This medication is given in a hospital or clinic and will not be stored at home.

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Selected from data included with permission and copyrighted by First Databank, Inc. This copyrighted material has been downloaded from a licensed data provider and is not for distribution, except as may be authorized by the applicable terms of use.

CONDITIONS OF USE: The information in this database is intended to supplement, not substitute for, the expertise and judgment of healthcare professionals. The information is not intended to cover all possible uses, directions, precautions, drug interactions or adverse effects, nor should it be construed to indicate that use of a particular drug is safe, appropriate or effective for you or anyone else. A healthcare professional should be consulted before taking any drug, changing any diet or commencing or discontinuing any course of treatment.