2. What should I know before I am given TEPEZZA?
Do not use if you have ever had an allergic reaction to TEPEZZA 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. You must not use
this medicine if you are pregnant.
3. What if I am taking other medicines?
Some medicines may interfere with TEPEZZA and affect how it works.
4. How will I be given TEPEZZA?
The dose of TEPEZZA depends on your body weight.
A doctor or nurse will give you a diluted TEPEZZA solution by intravenous infusion
(drip into your vein).
5. What should I know while using TEPEZZA?
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Things you should do
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Remind any doctor, dentist, optometrist or pharmacist you visit that you are using
TEPEZZA.
Tell your doctor immediately if you become pregnant while taking TEPEZZA. If you are
a woman who is able to become pregnant, use suitable methods of contraception and
have pregnancy tests during treatment with TEPEZZA and for 6 months after your last
dose.
Speak to your doctor, nurse or hearing service if you notice changes in your hearing.
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Things you should not do
|
You must not use TEPEZZA if you are pregnant.
Do not stop treatment with TEPEZZA unless you have discussed this with your doctor.
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Driving or using machines
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Do not drive a car or operate machines if you experience symptoms that impair your
ability to drive or operate machinery
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Looking after your medicine
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TEPEZZA will be stored at the hospital or clinic in a refrigerator.
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6. Are there any side effects?
Very common side effects include high blood sugar, hearing impairment, muscle spasms,
nausea, hair loss, diarrhoea, headache, fatigue, menstrual disorders. Common side
effects include infusion-related reactions, change in the sense of taste, dry skin,
ear discomfort, COVID-19, nail disorder.
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):
teprotumumab
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using TEPEZZA. 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 TEPEZZA.
Where to find information in this leaflet:
1. Why am I being given TEPEZZA?
TEPEZZA contains the active ingredient teprotumumab. TEPEZZA is a humanised monoclonal antibody. Monoclonal antibodies attach to specific
proteins in your body. Teprotumumab is designed to bind to a protein called type 1
insulin-like growth factor receptor (IGF-1R). When teprotumumab binds to IGF-1R it
blocks its activation and signaling.
TEPEZZA is used to treat Thyroid Eye Disease. It works by blocking the pathways that
cause the inflammation associated with Thyroid Eye Disease.
2. What should I know before I am given TEPEZZA?
Warnings
Do not use TEPEZZA if:
you are allergic to teprotumumab, or any of the ingredients listed at the end of this
leaflet
you are pregnant
Always check the ingredients to make sure you can use this medicine.
Check with your doctor if you:
have any other medical conditions
take or might take any medicines (includes medicines obtained without a prescription
and herbal medicine) for any other conditions
have previously experienced problems after injections, such as breathlessness, increased
heart rate, increased blood pressure, headache or muscle pain
have previously experienced problems with your hearing
suffer from inflammatory bowel disease (IBD)
have pre-existing diabetes or impaired glucose tolerance
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
Check with your doctor if you are pregnant, think you may be pregnant or intend to
become pregnant. Check with your doctor if you have changes in your menstrual cycle
(periods) during treatment with TEPEZZA. You must not use this medicine if you are
pregnant. TEPEZZA may cause harm to your unborn baby. Your doctor should advise you
about using contraception during treatment with TEPEZZA and for at least 6 months
after the last dose of TEPEZZA. Your doctor will recommend that you have pregnancy
tests before, during and after treatment with TEPEZZA.
Breastfeeding
Talk to your doctor if you are breastfeeding or intend to breastfeed.
Children and adolescents
TEPEZZA is not recommended in children and adolescents under 18 years of age because
the safety and benefit have not been established in these patient populations.
Hearing
TEPEZZA may cause hearing loss or impairment. This is usually temporary but in a very
small number of people it can be permanent. Your doctor, nurse or hearing service
will assess your hearing before, during and after treatment with TEPEZZA.
You should stop smoking and avoid high intensity noises during treatment with TEPEZZA.
Speak to your doctor, nurse or hearing service if you notice any changes in your hearing.
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.
Taking medicines known to cause hearing damage may cause increased risk of hearing
loss during treatment with TEPEZZA.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect TEPEZZA.
4. How will I be given TEPEZZA?
How much you will be given
The dose of TEPEZZA depends on your body weight. The recommended dose is 10 mg per
kilogram of your body weight for the first dose. You will be given a further 7 infusions
at three weekly intervals with a recommended dose of 20 mg per kilogram of body weight.
When you will be given TEPEZZA
A doctor or nurse will give you a diluted TEPEZZA solution by intravenous infusion
(drip into your vein). The first two infusions will usually last about 90 minutes.
If these are well-tolerated further infusions may be given to you over a period of
60 minutes. If they are not well-tolerated, the minimum time for the remaining 6 infusions
should stay at 90 minutes.
If a dose of TEPEZZA is missed
Your doctor will decide when you should be given your next dose of TEPEZZA. You should
discuss this with your doctor.
If too much TEPEZZA is given
As TEPEZZA is given to you under the supervision of your doctor, it is unlikely that
you will receive too much. If this happens, your doctor will monitor you for any signs
or symptoms of side effects, and treat these symptoms if necessary.
However, if you experience severe side effects after being given this medicine, tell
your doctor or nurse immediately.
You may need urgent medical attention.
You should immediately:
phone the Poisons Information Centre
(by calling
13 11 26), or
contact your doctor, or
go to the Emergency Department at your nearest hospital.
5. What should I know while using TEPEZZA?
Things you should do
Remind any doctor, dentist, optometrist or pharmacist you visit that you are using
TEPEZZA.
Tell your doctor immediately if you become pregnant while having TEPEZZA. If you are
a woman who is able to become pregnant, use suitable methods of contraception during
treatment with TEPEZZA and for 6 months after your last dose.
Tell your doctor if you have changes in your menstrual cycle (periods) while having
TEPEZZA so they can check you are not pregnant.
Speak to your doctor, nurse or hearing service if you notice any changes in your hearing.
Call your doctor straight away if you:
If you have an allergic reaction, the signs may include: difficulty in breathing or
chest pain. You could also experience redness or flushing of the skin or a rash, chills
and shivering, feeling or being sick, swelling, light headedness, fast heartbeat and
loss of consciousness.
Things you should not do
You must not use TEPEZZA if you are pregnant.
Do not stop treatment with TEPEZZA unless you have discussed this with your doctor.
If you have the below pre-existing conditions:
Hearing impairment
Treatment with TEPEZZA may worsen your hearing if you have problems with hearing.
Your doctor, nurse or hearing service will monitor your hearing while you are being
treated with TEPEZZA. Speak to your doctor, nurse or hearing service if you notice
changes in your hearing.
Inflammatory bowel disease (IBD)
It is possible that TEPEZZA may cause a worsening of your symptoms. Your doctor or
nurse will monitor you for any signs of a flare of the disease and if necessary, discontinue
treatment with TEPEZZA.
Diabetes or impaired glucose tolerance
TEPEZZA may cause hyperglycaemia or increased blood glucose. Your doctor or nurse
will monitor glucose levels whilst you are being treated with TEPEZZA. If you have
diabetes your doctor will ensure that your diabetes is under control before starting
TEPEZZA.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how TEPEZZA
affects you.
Do not drive a car or operate machines if you experience symptoms that impair your
ability to drive or use machinery.
Looking after your medicine
Follow the instructions in the carton on how to take care of your medicine properly.
TEPEZZA will be stored by the healthcare professionals at the hospital or clinic in
a refrigerator.
Store TEPEZZA in a refrigerator (2°C – 8°C). Do not freeze.
Keep TEPEZZA in the original pack to protect from light.
Keep it where young children cannot reach it.
Getting rid of any unwanted medicine
TEPEZZA is for single use in one patient only. Any residue will need to be discarded.
Your doctor or nurse will dispose of TEPEZZA that is no longer used.
In the unlikely event you no longer need to use this medicine or it is out of date,
take it to any pharmacy for safe disposal.
Do not use this medicine after the expiry date.
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.
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
Possibly serious side effects
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 TEPEZZA contains
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Active ingredient
(main ingredient)
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teprotumumab
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Other ingredients
(inactive ingredients)
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histidine
histidine hydrochloride monohydrate
polysorbate 20
trehalose dihydrate
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Do not use this medicine if you are allergic to any of these ingredients.
What TEPEZZA looks like
TEPEZZA is a white to off white powder containing 500 mg of teprotumumab supplied
in a single-dose vial. Each pack contains one vial.
(AUST R 444610).
Who distributes TEPEZZA
Amgen Australia Pty Ltd
Level 11, 10 Carrington St
Sydney NSW 2000
Ph: 1800 803 638
To check for CMI updates and obtain the latest version scan this QR code:
This leaflet was prepared in April 2025.