TEVIMBRA®
Consumer Medicine Information (CMI) summary
The full CMI on the next page has more details. If you are worried about being given this medicine, speak to your doctor or pharmacist.
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This medicine is new or being used differently. Please report side effects. See the full CMI for further details.WARNING: Important safety information is provided in a boxed warning in the full CMI. Read before being given this medicine.
1. Why am I being given TEVIMBRA?
TEVIMBRA contains the active ingredient tislelizumab. TEVIMBRA is used to treat different kinds of cancer.
For more information, see Section 1. Why am I being given TEVIMBRA? in the full CMI.
2. What should I know before I am given TEVIMBRA?
You should be not given TEVIMBRA if you have ever had an allergic reaction to tislelizumab 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.
For more information, see Section 2. What should I know before I am given TEVIMBRA? in the full CMI.
3. What if I am taking other medicines?
Some medicines may interfere with TEVIMBRA and affect how it works.
A list of these medicines is in Section 3. What if I am taking other medicines? in the full CMI.
4. How is TEVIMBRA given?
- Your doctor will give you TEVIMBRA every 3 weeks.
- You will receive TEVIMBRA through an IV for about 60 minutes for your first treatment, and 30 minutes each following treatment.
- Your doctor will determine how many treatments you need.
More instructions can be found in Section 4. How is TEVIMBRA given? in the full CMI.
5. What should I know while being given TEVIMBRA?
Things you should do |
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Driving or using machines |
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For more information, see Section 5. What should I know while being given TEVIMBRA? in the full CMI.
6. Are there any side effects?
Like all medicines, TEVIMBRA can cause side effects, however not everybody will experience them. Your doctor will discuss potential side effects with you and explain the risks and benefits of your treatment.
When you are given TEVIMBRA you can have some serious side effects.
For more information, including what to do if you have any side effects, see Section 6. Are there any side effects? in the full CMI.
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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.TEVIMBRA®
Active ingredient: tislelizumab
Consumer Medicine Information (CMI)
This leaflet provides important information about using TEVIMBRA. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using TEVIMBRA.
Where to find information in this leaflet:
1. Why am I being given TEVIMBRA?
TEVIMBRA contains the active ingredient tislelizumab. TEVIMBRA is an immune checkpoint inhibitor that works by helping your immune system fight your cancer.
TEVIMBRA is used to treat:
- a kind of cancer called oesophageal carcinoma in adults.
- a kind of lung cancer called non-small cell lung cancer in adults.
2. What should I know before I am given TEVIMBRA?
Warnings
You should not be given TEVIMBRA if:
- you are allergic to tislelizumab, or any of the ingredients listed at the end of this leaflet.
- Always check the ingredients to make sure you can receive this medicine.
Check with your doctor if you have or have had:
- an autoimmune disease (a condition where the body attacks its own cells)
- inflammation of the liver (hepatitis) or other liver problems
- inflammation of the kidney (nephritis)
- pneumonia or inflammation of your lungs (pneumonitis)
- inflammation of the large bowel (colitis)
- serious rash
- problems with hormone producing glands (including the adrenal, pituitary, and thyroid glands)
- diabetes mellitus
- a solid organ transplant
- infusion-related reaction
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?
Pregnancy and breastfeeding
Check with your doctor if you are pregnant or intend to become pregnant.
TEVIMBRA may cause harm to your unborn baby.
You must use effective contraception methods for at least 4 months following your last TEVIMBRA treatment if you are a woman who could become pregnant.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Do not breastfeed whilst being treated with TEVIMBRA.
3. What if I am taking other medicines?
Tell your doctor or pharmacist 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.
It is especially important to tell your doctor or pharmacist if you take other medicines that make your immune system weak, such as some steroids.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect TEVIMBRA.
4. How is TEVIMBRA given?
How much is given
- Your doctor will give you TEVIMBRA through an IV for about 60 minutes for your first treatment, and about 30 minutes each following treatment.
When TEVIMBRA is given
- You will be given TEVIMBRA every 3 weeks.
- Your doctor will decide how many treatments you need.
If you miss a dose
- If you miss a dose of TEVIMBRA, call your doctor to reschedule as soon as possible.
- It is important that you do not miss a dose of this medicine.
5. What should I know while being given TEVIMBRA?
Things you should do
Tell any other doctors, dentists or pharmacists you visit that you are being given TEVIMBRA.
If you are about to be started on any new medicine, tell your doctor, dentist or pharmacist that you are being given TEVIMBRA
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TEVIMBRA affects you.
Fatigue has been reported following administration of TEVIMBRA.
Looking after your medicine
TEVIMBRA is usually stored in the pharmacy or on the ward. It is unlikely that you will be asked to store TEVIMBRA yourself.
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.
When you are given TEVIMBRA, you can have some serious side effects.
These side effects can sometimes become life-threatening and can lead to death. They made happen at any time during treatment, or after your treatment has ended. It is possible that you may experience more than one side effect at the same time.
If you have any of the following symptoms, call or see your doctor right away.
Serious side effects
Serious side effects |
What to do |
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Signs and symptoms of hormone problems
Signs and symptoms of metabolism or nutrition problems
Signs and symptoms of eye problems
Signs and symptoms of lung problems
Signs and symptoms of nerve problems
Signs and symptoms of heart problems
Signs and symptoms of stomach and abdomen problems
Signs and symptoms of liver problems
Signs and symptoms of infusion related problems
Signs and symptoms of skin problems
Signs and symptoms of muscle or joint problems
Signs and symptoms of kidney problems
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Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects. |
Less serious side effects
Less serious side effects |
What to do |
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Signs and symptoms of hormone problems
Signs and symptoms of lung problems
Signs and symptoms of stomach and abdomen problems
Signs and symptoms of skin problems
Signs and symptoms of muscle or joint problems
Signs and symptoms of mouth problems
Signs and symptoms of general problems
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Speak to your doctor if you have any of these less serious side effects and they worry you. |
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 TEVIMBRA contains
Active ingredient (main ingredient) |
tislelizumab |
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Other ingredients (inactive ingredients) |
Sodium citrate dihydrate Citric acid monohydrate Histadine hydrochloride monohydrate Histadine Trehalose dihydrate Polysorbate-20 Water for injections |
You should not be given this medicine if you are allergic to any of these ingredients.
What TEVIMBRA looks like
TEVIMBRA concentrated solution for infusion is a clear to slightly opalescent, colourless to slightly yellow solution in a glass vial.
AUST R 391176
Who distributes TEVIMBRA
TEVIMBRA is supplied in Australia by
BeiGene AUS Pty Ltd
Level 4, 275 George St
Sydney NSW 2000
Australia
This leaflet was prepared in August 2024.