Thyrotropin alfa-rch, powder for injection
Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about Thyrogen.
It does not contain all the available information.
It does not take the place of talking to your treating physician or a trained health
All medicines have risks and benefits. Your treating physician has weighed the risks
of you taking Thyrogen against the benefits they expect it will have.
If you have any concerns about taking this medicine, ask your treating physician or
Keep this leaflet.
You may need to read it again.
What Thyrogen is used for
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.
Before you are given Thyrogen
When you must not be given it
Do not use Thyrogen if you have a known, severe allergic reaction to:
any of the ingredients listed at the end of this leaflet.
If you are not sure whether you should have Thyrogen, talk to your treating physician.
Before you are given it
Tell your treating physician if you have reacted to previous treatments with any of
severe allergic reaction
Tell your treating physician if you have allergies to:
any other medicines
any other substances, such as foods, preservatives or dyes
Tell your treating physician if you have heart disease.
Tell 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.
Tell your treating physician if you are breastfeeding.
It is not known whether Thyrogen passes into breast milk. Your doctor will discuss
the possible risks and benefits of having Thyrogen during breastfeeding.
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.
Taking other medicines
Tell your doctor if you are taking any other medicines, including any that you get
without a prescription from your pharmacy, supermarket or health food shop.
Some medicines and Thyrogen may interfere with each other. No studies have been carried
out on drug interactions.
Your treating physician will decide whether or not to give you Thyrogen.
How Thyrogen is 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 are given too much (overdose)
There have been no reported overdoses of Thyrogen.
Things you must 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.
After having 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.
Things to be careful of
Be careful driving or operating machinery 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.
Tell your treating physician as soon as possible if you do not feel well after having
Thyrogen may have unwanted side effects in a few people. All medicines can have side
effects. Sometimes they are serious, most of the time they are not. You may need urgent
medical treatment if you notice some side effects.
Ask your treating physician to answer any questions you may have.
Tell your treating physician if you notice any of the following and they worry you:
If you notice any of the following side effects, tell your treating physician immediately
or go to Emergency at your nearest hospital:
itchy rash or hives
The above list includes very serious side effects. You may need urgent medical attention
or hospitalisation. These side effects are very rare.
Other side effects not listed above may also occur in some patients. Tell your doctor
if you notice anything else that is making you feel unwell.
Do not be alarmed by this list of possible side effects. You may not experience any
of them. Tell your doctor or pharmacist if you notice anything that is making you
Thyrogen will be stored in the hospital.
What it 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.
sodium chloride, monobasic sodium phosphate monohydrate, dibasic sodium phosphate
heptahydrate and mannitol.
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
AUST R 79777
Thyrogen® is a registered trade mark of Genzyme Corporation, USA.
This leaflet was prepared in August 2019.