Rani test Teplizumab Injection

What is this medication?

TEPLIZUMAB (tep LIZ oo mab) delays the onset of type 1 diabetes. It works by slowing down an overactive immune system. It is a monoclonal antibody.

This medicine may be used for other purposes; ask your health care provider or pharmacist if you have questions.

COMMON BRAND NAME(S): Tzield

What should I tell my care team before I take this medication?

They need to know if you have any of these conditions:

• Infection
• Liver disease
• Low platelet levels
• Low red blood cell levels
• Low white blood cell levels
• Recent or upcoming vaccine
• An unusual or allergic reaction to teplizumab, other medications, foods, dyes, or preservatives
• Pregnant or trying to get pregnant
• Breast-feeding

How should I use this medication?

This medication is injected into a vein. It is given by your care team in a hospital or clinic setting.

A special MedGuide will be given to you before each treatment. Be sure to read this information carefully each time.

Talk to your care team about the use of this medication in children. While it may be given to children as young as 8 years for selected conditions, precautions do apply.

Overdosage: If you think you have taken too much of this medicine contact a poison control center or emergency room at once.

NOTE: This medicine is only for you. Do not share this medicine with others.

What if I miss a dose?

It is important not to miss your dose. Call your care team if you are unable to keep an appointment.

What may interact with this medication?

• Live virus vaccines

This list may not describe all possible interactions. Give your health care provider a list of all the medicines, herbs, non-prescription drugs, or dietary supplements you use. Also tell them if you smoke, drink alcohol, or use illegal drugs. Some items may interact with your medicine.

What should I watch for while using this medication?

Your condition will be monitored carefully while you are receiving this medication.

You may need bloodwork while taking this medication.

This medication may increase your risk of getting an infection. Call your care team for advice if you get a fever, chills, sore throat, or other symptoms of a cold or flu. Do not treat yourself. Try to avoid being around people who are sick.

This medication can decrease the response to a vaccine. If you need to get vaccinated, tell your care team if you have received this medication within the last 6 to 52 weeks. Extra booster doses may be needed. Talk to your care team to see if a different vaccination schedule is needed.

Talk to your care team if you wish to become pregnant or think you might be pregnant.

Talk to your care team before breastfeeding. Changes to your treatment plan may be needed.

What side effects may I notice from receiving this medication?

Side effects that you should report to your care team as soon as possible:

• Allergic reactions—skin rash, itching, hives, swelling of the face, lips, tongue, or throat
• Fever, chills, unusual weakness or fatigue, loss of appetite, nausea, headache, dizziness, feeling faint or lightheaded, shortness of breath, fast or irregular heartbeat, which may be signs of cytokine release syndrome
• Infection—fever, chills, cough, or sore throat

Side effects that usually do not require medical attention (report these to your care team if they continue or are bothersome):

• Diarrhea
• Headache
• Nausea
• Skin rash

This list may not describe all possible side effects. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Where should I keep my medication?

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

NOTE: This sheet is a summary. It may not cover all possible information. If you have questions about this medicine, talk to your doctor, pharmacist, or health care provider.