Consumer Medicine Information (CMI) summary
The
full CMI on the next page has more details. If you are worried about using this medicine,
speak to your doctor or pharmacist.
1. Why am I using Thyrogen?
Thyrogen contains the active ingredient thyrotropin alfa. Thyrogen is used to help
in the detection of thyroid cancer cells. Thyrogen is also used in the treatment of
thyroid cancer in combination with radioactive iodine. For more information, see Section
1. Why am I using Thyrogen? in the full CMI.
2. What should I know before Thyrogen is given?
Do not use if you have ever had an allergic reaction to thyrotropin alfa 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 Thyrogen and affect how it works.
4. How do I use Thyrogen?
Your treating physician will decide on the dose that is most suitable.
Your treating physician will give you two injections of Thyrogen into the muscle of
your buttock. The second injection will be given to you a day after the first one.
5. What should I know while using Thyrogen?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using Thyrogen.
Keep appointments with your treating physician.
Have tests when your treating physician says to.
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Things you should not do
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Do not use Thyrogen if you have a known, severe allergic reaction to Thyrogen or any
of its ingredients
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Driving or using machines
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Be careful driving or operating machinery until you know how Thyrogen affects you.
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Looking after your medicine
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Thyrogen will be stored in the hospital.
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6. Are there any side effects?
Less serious side effects include headache, fatigue, nausea, weakness, vomiting, dizziness,
chills, numbness/tingling, fever and diarrhoea. More serious side effects include
hoarse voice, difficulty breathing, noisy breathing and itchy rash or hives.
Active ingredient:
Thyrotropin alfa
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using Thyrogen. 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 Thyrogen.
Where to find information in this leaflet:
1. Why am I using Thyrogen?
Thyrogen contains the active ingredient Thyrotropin alfa. Thyrogen is a human thyroid
stimulating hormone (TSH) manufactured using biotechnology processes.
Thyrogen is used together with a blood test and/or a whole body scan to help in the
detection of thyroid cancer cells in patients who have had all or part of their thyroid
gland removed as a result of thyroid cancer.
Thyrogen is also used in the treatment of thyroid cancer in combination with radioactive
iodine to kill any remaining thyroid cancer cells or normal thyroid tissue after removal
of your thyroid. This also allows the doctors to detect more easily any thyroid cancers that may remain
after your treatment.
Thyrogen helps your remaining thyroid cells and the cancer cells take up the radioactive
iodine so that they will all be killed by the radiation treatment.
How it works
After you have had your cancer operation, your treating physician will need to test
you to make sure that there are no remaining cancer cells in your body or that the
cancer has not come back or spread to other parts of your body.
Your treating physician will give you thyroid hormone replacement treatment to replace
the hormone that your thyroid gland used to make because you have had all or part
of your thyroid gland removed.
Having this replacement treatment will also mean that your pituitary gland will produce
less of a hormone called thyroid stimulating hormone (TSH).
TSH sticks to the thyroid cancer cells.
For the cancer cell detection tests to be accurate there needs to be a certain amount
of TSH in your body. The thyroid hormone replacement treatment that you are getting
means that your body will not be making enough TSH for the tests.
Thyrogen imitates TSH made by your body and makes sure that there is enough TSH in
your body for the tests. For detection of thyroid cancer cells, Thyrogen will be given
to you about 3 days before your blood test and/or whole body scan so that your doctor
can find any thyroid cancer cells that might be in your body. For treatment of thyroid
cancer, Thyrogen is given to you one day before your dose of radioiodine and up to
several days before your scan.
2. What should I know before Thyrogen is given?
Warnings
Do not use Thyrogen if:
you are allergic to Thyrogen, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Check with your doctor or pharmacist if you:
have reacted to previous treatments with any of the following: severe allergic reaction;
difficulty breathing
take any medicines for any other condition
have allergies to: any other medicines; any other substances, such as foods, preservatives
or dyes
Tell your treating physician if you have heart disease.
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 treating physician if you are pregnant or intend to become pregnant.
Thyrogen may cause harm to your unborn baby. Your treating physician will discuss
the possible risks and benefits of having Thyrogen during pregnancy.
Talk to your treating physician if you are breastfeeding or intend to breastfeed.
It is not known whether Thyrogen passes into breast milk. Your doctor will discuss
the possible risks and benefits of having Thyrogen during breastfeeding.
Children
The safety of Thyrogen in children has not been studied.
If your child has been prescribed Thyrogen, you may wish to discuss this with your
child's treating physician.
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.
Some medicines may interfere with Thyrogen and affect how it works.
No studies have been carried out on drug interactions.
Your treating physician will decide whether or not to give you Thyrogen.
Check with treating physician if you are not sure about what medicines, vitamins or
supplements you are taking and if these affect Thyrogen.
4. How is Thyrogen given?
Your treating physician will give you two injections of Thyrogen into the muscle of
your buttock. The second injection will be given to you a day after the first one.
Your treating physician will decide on the dose that is most suitable.
If you use too much Thyrogen (overdose)
There have been no reported overdoses of Thyrogen.
5. What should I know while, or after, being given Thyrogen?
Things you should do
Keep appointments with your treating physician.
It is important to have your Thyrogen injections at the times your treating physician
has told you. This will make sure that there is the right amount of Thyrogen in your
body for the cancer cell detection tests to be accurate. It is also important so that
the right amount of Thyrogen is present when you have your radioactive iodine treatment
after your thyroid surgery.
Remind any doctor, dentist or pharmacist you visit that you have been given Thyrogen.
Have tests when your treating physician says to.
You are being given Thyrogen to make sure that the tests you will be having can detect
any thyroid cancer cells in your body so it is important to have the tests when your
doctor tells you to.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how Thyrogen
affects you.
The effect of Thyrogen on your ability to drive a car or operate machinery has not
been studied. Make sure that you know how you react to Thyrogen before you drive
a car or operate machinery or do anything else that may be dangerous if you are dizzy,
light-headed, tired or drowsy.
Thyrogen may cause dizziness in some people.
Looking after your medicine
Thyrogen will be stored in the hospital.
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 treating physician, doctor
or pharmacist if you have any further questions.
Less 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.
7. Product details
This medicine is only available with a doctor's prescription.
What Thyrogen contains
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Active ingredient
(main ingredient)
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thyrotropin alfa
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Other ingredients
(inactive ingredients)
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sodium chloride
monobasic sodium phosphate monohydrate
dibasic sodium phosphate heptahydrate
mannitol
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Do not take this medicine if you are allergic to any of these ingredients.
What Thyrogen looks like
Thyrogen is a white to off-white powder before it is prepared for injection and a
clear, colourless solution after it has been prepared for injection. (Aust R 79777).
Who distributes Thyrogen
Thyrogen® is registered by:
sanofi-aventis australia pty ltd
12-24 Talavera Road
Macquarie Park NSW 2113 Australia
Toll Free Number (medical information): 1800 818 806
This leaflet was prepared in April 2021.
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