2. What should I know before I am given Tzield?
Do not use if you have ever had an allergic reaction to teplizumab or any of the ingredients
listed at the end of the CMI.
Talk to your doctor if you have any other medical conditions, take any other medicines,
or are pregnant or plan to become pregnant or are breastfeeding.
3. What if I am taking other medicines?
Some medicines may interfere with Tzield and affect how it works.
4. How will I be given Tzield?
You will be given Tzield into a vein (intravenously) as a drip infusion under the
supervision of your doctor or nurse.
5. What should I know while being given Tzield?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Tzield.
It is important to keep all appointments so that your doctor can see if Tzield works
for you.
Tell your doctor that you have had or are planning to get vaccinations.
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Things you should not do
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Do not stop your treatment with Tzield unless your doctor advises you to.
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Driving or using machines
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Tzield is not expected to affect your ability to drive and use machines. However,
if you feel tired, do not drive or use machines before discussing it with your doctor
or nurse.
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Looking after your medicine
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Tzield will be stored at the hospital or clinic in a refrigerator.
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6. Are there any side effects?
Serious side effects include Cytokine Release Syndrome (CRS) with symptoms such as
fever, feeling tired, muscle and joint pain, nausea, headache and increased liver
enzymes in your blood, and decrease in white blood cells (lymphocytes).
Tell your doctor or nurse straight away if you get any signs and symptoms of CRS during
treatment with Tzield.
This medicine is subject to additional monitoring. This will allow quick identification
of new safety information. You can help by reporting any side effects you may get.
You can report side effects to your doctor, or directly at www.tga.gov.au/reporting-problems .
Active ingredient(s):
teplizumab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Tzield. You should also speak to your doctor if you would like further information or if you
have any concerns or questions about using Tzield.
A Patient Guide is also available to you to provide important information for your
treatment with Tzield.
Where to find information in this leaflet:
1. Why am I being given Tzield?
Tzield contains the active ingredient teplizumab. It belongs to a group of specialised
proteins called ‘monoclonal antibodies’.
Tzield is a treatment for adults and children 8 years of age and older who have stage
2 type 1 diabetes (T1D) – to delay the onset of stage 3 T1D.
T1D is a disease that occurs when your own immune system attacks beta cells that produce
insulin in the pancreas. The destruction of these beta cells starts without any symptoms.
In stage 1 T1D your blood sugar level remains normal and in stage 2 T1D it becomes
elevated. Once stage 3 T1D is confirmed, you need to get insulin treatment to control
blood sugar level and prevent complications.
Tzield helps protect your beta cells by calming down the immune cells that attack
them. By preserving beta cell function, Tzield slows down the progression of T1D.
2. What should I know before I am given Tzield?
Warnings
Do not use Tzield if:
you are allergic to teplizumab, or any of the ingredients listed at the end of this
leaflet. Always check the ingredients to make sure you can use this medicine.
you had an inactivated or mRNA vaccine within 2 weeks prior to Tzield treatment.
you had a live vaccine within 8 weeks prior to Tzield treatment.
Check with your doctor if you:
have a serious infection or an infection that does not go away or that keeps coming
back.
Some patients who have had mononucleosis (Epstein-Barr virus infection) in the past,
may experience it again with Tzield treatment. Tell your doctor right away if you
have symptoms of infection such as fever, swollen glands, or fatigue.
have recently had or are planning to have a vaccine. Tzield may affect how well a
vaccine works. Tell your doctor or pharmacist that you are being treated with Tzield
before having a vaccine.
have any other medical conditions.
take any medicines for any other condition.
Your doctor will do blood tests to check your liver and your complete blood counts
before you start treatment and during treatment with Tzield.
During treatment, you may be at risk of developing certain side effects. It is important
you understand these risks and how to monitor for them. See additional information
under Section
6. Are there any side effects?
Children
The safety and efficacy of Tzield in children under 8 years of age have not been established.
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant. If you are
a woman who could become pregnant, your doctor may ask you to take a pregnancy test
before you start taking this medicine. Tzield may be harmful to unborn children when
taken by a woman during pregnancy. Your treatment with Tzield should be avoided during
pregnancy and for at least 30 days prior to planned pregnancy.
It is not known whether Tzield passes into breast milk. Tzield was detected in animal
milk. Talk to your doctor if you are breastfeeding or intend to breastfeed. If you
are breastfeeding, you may consider stopping breastfeeding and pumping and throwing
away breast milk during Tzield treatment and for 20 days after receiving Tzield treatment.
3. What if I am taking other medicines?
Tell your doctor if you are taking any other medicines, including any medicines, vitamins
or supplements that you buy without a prescription from your pharmacy, supermarket
or health food shop.
Some medicines may interfere with Tzield and affect how it works.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect Tzield.
4. How will I be given Tzield?
How Tzield will be given
You will be given Tzield into a vein (intravenously) as a drip infusion under the
supervision of your doctor or nurse.
The dose you will receive is based on your body surface area which takes into account
both your height and weight.
How often Tzield will be given
Tzield will be given once every day for 14 days. Each infusion will last at least
30 minutes.
Medicines given before a Tzield infusion
For the first 5 days of treatment, your doctor or nurse will give you the following
medicines:
Medicine to reduce pain and fever
Medicine to reduce allergic reactions
Medicine to reduce sickness and nausea
These medicines may help reduce symptoms of Cytokine Release Syndrome (CRS) such as
fever, headache, muscle and joint pain, or feeling sick (nausea). Your doctor or nurse
may decide to continue with this treatment for longer, if needed.
If you miss a Tzield infusion
If you miss a scheduled infusion, your doctor or nurse will continue your treatment
on the next scheduled day. You will not receive 2 infusions on the same day.
If you are given too much Tzield
Your doctor or nurse will determine the correct dose for you to receive so an overdose
is unlikely. If you receive too much (an overdose) your doctor or nurse will treat
and monitor your side effects.
You can also contact the Poisons Information Centre (phone: 13 11 26) if you have
any concerns.
5. What should I know while being given Tzield?
Things you should do
Keep your medical appointments
It is important to have your infusion of Tzield at the appropriate time to ensure
that you do not miss an infusion.
Remind any doctor, nurse, pharmacist or dentist you visit that you are being given
Tzield
Cytokine Release Syndrome (CRS)
Tell your doctor or nurse right away if you get any signs and symptoms of CRS during
treatment with Tzield. The signs and symptoms may start during the first 5 days of
treatment and may include:
Fever
Feeling tired
Muscle and joint pain
Feeling sick (nausea)
Headache
Increased liver enzymes and bilirubin in your blood
Decrease in white blood cells (lymphocytes)
This can happen after your first dose.
This can affect how well your body can fight infections.
Some people may get longer and more severe decreases in white blood cells.
Your white blood cell counts will start to go back to normal after your fifth dose
of Tzield.
Your doctor or nurse may pause or stop your treatment if you get liver problems, have
a serious infection, or if your blood counts stay too low.
Driving or using machines
Tzield is not expected to affect your ability to drive and use machines. However,
if you feel tired, do not drive or use machines before discussing it with your doctor
or nurse.
Looking after your medicine
Tzield will be stored at the hospital or clinic in a refrigerator at 2°C-8°C.
Getting rid of any unwanted medicine
Your doctor or nurse will dispose Tzield that you no longer need or use.
6. Are there any side effects?
All medicines can have side effects. If you do experience any side effects, most of
them are minor and temporary. However, some side effects may need medical attention.
Your doctor will do blood tests to check your liver enzyme and your complete blood
counts before you start treatment and during treatment with Tzield.
See the information below and, if you need to, ask your doctor or pharmacist if you
have any further questions about side effects.
Less serious side effects
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Less serious side effects
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What to do
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General body:
Fever
Feeling tired
Chills
Pain
Illness
Nervous system:
Headache
Digestive system:
Feeling sick (nausea)
Diarrhoea
Vomiting
Skin:
Rash
Itchy skin
Red and itchy raised bumps (hives)
Breathing and chest:
Inflamed nose and throat
Blood test - related:
Increase in liver enzyme levels
Decrease in number of red blood cells
Decrease in number of blood platelets (thrombocytopenia)
Decrease in blood bicarbonate and blood calcium levels
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Speak to your doctor or nurse if you have any of these symptoms.
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Serious side effects
Tell your doctor or pharmacist if you notice anything else that may be making you
feel unwell.
Other side effects not listed here may occur in some people.
Reporting side effects
After you have received medical advice for any side effects you experience, you can
report side effects to the Therapeutic Goods Administration online at
www.tga.gov.au/reporting-problems . By reporting side effects, you can help provide more information on the safety of
this medicine.
Always make sure you speak to your doctor or pharmacist before you decide to stop
taking any of your medicines.
7. Product details
This medicine is only available with a doctor's prescription.
What Tzield contains
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Active ingredient
(main ingredient)
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teplizumab
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Other ingredients
(inactive ingredients)
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dibasic sodium phosphate
monobasic sodium phosphate monohydrate
polysorbate 80
sodium chloride
water for injections
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Do not take this medicine if you are allergic to any of these ingredients.
What Tzield looks like
Tzield is a clear, colourless solution for intravenous infusion in a vial (2 mg/2
mL).
Tzield is supplied in a pack of 1 vial.
Aust R 476208
Who distributes Tzield
Tzield is supplied in Australia by:
sanofi-aventis australia pty ltd
Level 23, Tower 3
300 Barangaroo Ave
Barangaroo NSW 2000
Toll Free No: 1800 818 806
This leaflet was prepared in May 2026.