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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.
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.
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.
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.
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.
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.
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Things you should do
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Remind any doctor, dentist or pharmacist that you are being given TEVIMBRA.
If you miss a dose of TEVIMBRA, call your doctor right away to reschedule your appointment.
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Driving or using machines
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Be careful before you drive or use any machines or tools until you know how TEVIMBRA
affects you.
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For more information, see Section 5. What should I know while being given TEVIMBRA? in the full CMI.
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.
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?
2. What should I know before I am given TEVIMBRA?
3. What if I am taking other medicines?
4. How is TEVIMBRA given?
5. What should I know while being given TEVIMBRA?
6. Are there any side effects?
7. Product details
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.
a kind of cancer called gastric/gastro-oesophageal junction adenocarcinoma (stomach
cancer) in adults.
a kind of head and neck cancer called nasopharyngeal cancer in adults.
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.
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.
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.
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.
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
may 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
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Serious side effects
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What to do
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Signs and symptoms of hormone problems
Fatigue, swelling at base of the neck, pain in front of the throat - possible symptoms
of thyroid inflammation (thyroiditis)
Frequent headaches, vision changes (either low vision or double vision), fatigue and/or
weakness, confusion, decreased blood pressure, dizziness - possible symptoms of inflammation
of the pituitary gland (hypophysitis)
Signs and symptoms of metabolism or nutrition problems
Increased blood sugar levels, thirst, dry mouth, frequent urination, tiredness, increased
appetite with weight loss, confusion, nausea, vomiting, fruity-smelling breath, difficulty
breathing and dry or flushed skin - potential symptoms of high blood sugar (hyperglycaemia)
High blood sugar, feeling more hungry or thirsty than normal, passing urine more often
than normal - possible symptoms of diabetes mellitus
Signs and symptoms of eye problems
Eye redness, eye pain and swelling - possible symptoms of inflammation of the uvea,
the layer beneath the white of the eyeball (uveitis)
Signs and symptoms of lung problems
Shortness of breath, cough or chest pain - potential symptoms of lung inflammation
(pneumonitis)
Difficulty breathing
Signs and symptoms of nerve problems
Serious inflammation of the nerves, which may cause difficulty breathing, sensation
of prickling or pins and needles in the fingers, toes, ankles or wrists, weakness
in the legs that spreads to the upper body, unsteady walking or inability to walk
or climb stairs, difficulty with facial movements including speaking, chewing or swallowing,
double vision or inability to move eyes, difficulty with bladder control or bowel
function, rapid heart rate and paralysis - Guillain-Barré syndrome
Signs and symptoms of heart problems
Chest pain, rapid or abnormal heartbeat, shortness of breath at rest or during activity,
fluid build-up with swelling of the legs, ankles and feet, tiredness - possible symptoms
of heart muscle inflammation (myocarditis)
Chest pain, fever, cough, palpitations - possible symptoms of inflammation of the
membrane around the heart (pericarditis)
Signs and symptoms of stomach and abdomen problems
Severe upper stomach pain, nausea, vomiting, fever, tender abdomen - possible symptoms
of inflammation of the pancreas (pancreatitis)
Diarrhoea or more bowel movements than normal, black tarry, sticky stools, blood or
mucus in stools, severe pain or tenderness in the stomach - possible symptoms of inflammation
of the intestines (colitis)
Signs and symptoms of liver problems
Nausea, vomiting, loss of appetite, pain on the right side of the stomach, yellowing
of the skin or the whites of the eyes, drowsiness, dark-coloured urine, bleeding or
bruising more easily than normal - possible symptoms of liver inflammation (hepatitis)
Signs and symptoms of infusion related problems
Chills or shaking, itching or rash, flushing, shortness of breath or wheezing, dizziness
or fever which may occur during infusion or up to 24 hours after infusion - possible
symptoms of infusion-related reactions
Signs and symptoms of skin problems
Itching or peeling skin, skin sores - possible symptoms of severe skin reactions or
erythema multiforme
Serious rash and reddening of the skin on upper body and quickly spreading to other
parts, blistering of the lips, eyes or mouth, skin peeling, sometimes with flu-like
symptoms such as, fever, sore throat, cough, and joint pain (all of these are possible
signs of one of the following skin conditions: Stevens-Johnson syndrome (SJS) or Toxic
epidermal necrolysis (TEN))
Signs and symptoms of brain and nervous system problems
Confusion, fever, memory problems or seizures - possible symptoms of inflammation
of the brain (encephalitis)
Signs and symptoms of muscle or joint problems
Muscle pain, stiffness, weakness, chest pain, or severe tiredness - possible symptoms
of muscle inflammation (myositis)
Joint pain, stiffness, swelling or redness, decreased range of motion in the joints
- possible symptoms of pain and inflammation in the joints (arthritis)
Signs and symptoms of kidney problems
Changes in the amount or colour of the urine, pain while urinating, pain in kidney
area - possible symptoms of inflammation of the kidneys (nephritis)
Signs and symptoms of blood-related problems
Bruising and bleeding (such as nosebleeds) - possible symptoms of low platelet count
(immune thrombocytopenia)
Signs and symptoms of bladder problems
Frequent or painful urination, urge to pass urine, blood in urine, pressure in lower
abdomen (inflammation of the bladder)
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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.
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Less serious side effects
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Less serious side effects
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What to do
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Signs and symptoms of hormone problems
Underactive thyroid gland which can cause tiredness, weight gain, skin and hair changes
(hypothyroidism)
Overactive thyroid gland which can cause hyperactivity, sweating, weight loss and
thirst (hyperthyroidism)
Signs and symptoms of lung problems
Cough
Difficulty breathing
Signs and symptoms of stomach and abdomen problems
Diarrhoea
Signs and symptoms of skin problems
Rash, itching
Skin colour changes in patches (vitiligo)
Signs and symptoms of muscle or joint problems
Joint pain (arthralgia), muscle pain (myalgia)
Signs and symptoms of mouth problems
Mouth sores or ulcers with gum inflammation (stomatitis)
Signs and symptoms of general problems
Tiredness
Fever
Signs and symptoms of blood-related problems
Muscle weakness and muscle spasms, palpitations or a change in your heartbeat (sign
of changes in level of potassium in the blood) (hypokalaemia)
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Speak to your doctor if you have any of these less serious side effects and they worry
you.
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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.
This medicine is only available with a doctor's prescription.
What TEVIMBRA contains
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Active ingredient
(main ingredient)
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tislelizumab
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Other ingredients
(inactive ingredients)
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Sodium citrate dihydrate
Citric acid monohydrate
Histadine hydrochloride monohydrate
Histadine
Trehalose dihydrate
Polysorbate-20
Water for injections
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You should not be given this medicine if you are allergic to any of these ingredients.
