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 FORTEO?
FORTEO contains the active ingredient teriparatide. FORTEO is used in adults to treat
osteoporosis in women after menopause and in men when other medicines are unsuitable
or when there is a high risk of fractures. It is also used to treat women and men
who have developed osteoporosis as a result of taking corticosteroids.
For more information, see Section
1. Why am I using FORTEO? in the full CMI.
2. What should I know before I use FORTEO?
Do not use if you have previously been treated with teriparatide for a total of 24
months or have ever had an allergic reaction to teriparatide 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 use FORTEO? in the full CMI.
3. What if I am taking other medicines?
4. How do I use FORTEO?
The usual dose is 20 mcg given once a day.
FORTEO is given by injection under the skin (subcutaneous) into the thigh or abdomen.
5. What should I know while using FORTEO?
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Things you should do
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Remind any doctor, dentist or pharmacist you visit that you are using FORTEO.
If you are going to have surgery, tell the surgeon or anaesthetist that you are using
this medicine. It may affect other medicines used during surgery.
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Things you should not do
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Do not stop using this medicine suddenly without checking with your doctor.
Do not give or share your medicine with anyone else, even if they have the same condition
as you and you have changed the needle.
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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 FORTEO
affects you.
Some patients may feel dizzy or experience light-headedness on standing up after injecting
FORTEO. If you feel dizzy or light-headed you should not drive or use machines until
you feel better.
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Looking after your medicine
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Keep your FORTEO pen in the refrigerator where the temperature stays between 2°C to
8°C. Do not allow your FORTEO pen to freeze. Do not use FORTEO if it has been frozen.
You should use a new needle for each injection. Do not store your pen with the needle
attached.
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6. Are there any side effects?
The most common side effects are discomfort around the area of injection, such as
redness of the skin, pain, swelling, itching, bruising or minor bleeding, feeling
sick (nausea), leg cramps, muscle spasms, weakness and lack of energy. The serious
side effects include allergic reactions such as shortness of breath, wheezing or difficulty
breathing, swelling of the face, lips or tongue, rash, itching or hives on the skin,
chest pain or discomfort, reduced urination due to reduced kidney function or kidney
failure, pneumonia, shortness of breath and serious back spasms. 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.
Active ingredient(s):
teriparatide (rbe)
Full Consumer Medicine Information (CMI)
This leaflet provides important information about using FORTEO. 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 FORTEO.
Where to find information in this leaflet:
1. Why am I using FORTEO?
FORTEO contains the active ingredient teriparatide (rbe). FORTEO is recombinant parathyroid hormone. It works by activating cells in the bone
to form new bone, making bones stronger and reducing the risk of fractures (breaks).
FORTEO is used in adults to treat:
osteoporosis in women after menopause
osteoporosis in men when other medicines are unsuitable or when there is a high risk
of fractures
osteoporosis due to corticosteroid use in women and men who are at high risk of fractures.
Osteoporosis is a disease which causes bones to become thin and fragile, gradually
making them weaker, more brittle and likely to break. This disease is especially common
in women after the menopause but can also occur in men. Osteoporosis is also common
in patients receiving corticosteroids (such as prednisone, cortisone).
Although it may have no symptoms at first, osteoporosis makes you more likely to break
bones, especially in your spine, hips and wrists and may cause back pain, loss of
height and a curved back.
Using this medicine each day will protect your bones by making them stronger and your
risk of fracture will be reduced.
2. What should I know before I use FORTEO?
Warnings
In rats that were treated with FORTEO for more than a quarter of their lifetime, teriparatide
caused some rats to develop osteosarcoma, a bone cancer. The potential to cause osteosarcoma
in rats was increased with higher doses and longer periods of treatment.
Osteosarcoma in humans is a serious but very rare cancer. Osteosarcoma occurs in about
4 out of every million people each year.
There is one report of osteosarcoma in a patient administered FORTEO for 14 months.
Due to the complex medical history, cause and effect between FORTEO and osteosarcoma
could not be established. At present, it is not known whether humans treated with
FORTEO would have an increased chance of getting osteosarcoma.
You should discuss any safety concerns you have about the use of FORTEO with your
doctor.
Do not use FORTEO if you:
have previously been treated with teriparatide for a total of 24 months.
are allergic to teriparatide, or any of the ingredients listed at the end of this
leaflet.
Always check the ingredients to make sure you can use this medicine.
Some of the symptoms of an allergic reaction may include:
shortness of breath
wheezing or difficulty breathing
swelling of the face, lips, tongue or other parts of the body
rash, itching or hives on the skin.
are pregnant or breastfeeding.
have high calcium levels in the blood (hypercalcaemia).
have severe kidney disease (severe renal impairment).
have ever had metabolic bone disease other than primary osteoporosis or glucocorticoid-induced
osteoporosis (osteoporosis caused by corticosteroids). This includes Paget’s disease
of the bone (disease with abnormal bone changes) or hyperparathyroidism (increase
in parathyroid hormone).
have unexplained high levels of a liver enzyme called alkaline phosphatase (ALP) in
the blood.
have ever had external beam or implant radiation therapy to the skeleton (radiation
therapy).
have ever had bone cancer or other cancers that have spread (metastasised) to your
bones.
have bones that have not finished growing (open epiphyses, the rounded portion of
the bone).
This medicine should not be used in children or in growing adults.
Check with your doctor if you:
have previously received teriparatide therapy for a total of 24 months. Treatment
with FORTEO should not exceed 24 months in a lifetime. This total of 24 months therapy
may have been made up of several shorter courses of FORTEO. If you are not sure if
you have previously received FORTEO, speak to your doctor or pharmacist.
You will be required to sign your consent that you understand the 24 month lifetime
limit. Keep this consent form as you may need to show this to your doctor in the future.
Your pharmacist may also ask to see your consent form.
have any other medical conditions like:
high calcium levels in the blood (pre-existing hypercalcaemia). FORTEO may cause an
increase in the amount of calcium in your blood or urine. Signs and symptoms of high
calcium in the blood may include:
continuing nausea,
vomiting,
constipation,
low energy,
muscle weakness.
if you suffer from kidney stones or have a history of kidney stones
low blood pressure (hypotension)
kidney disease (moderate renal impairment)
have allergies to any other medicines, foods, preservatives or dyes
narrowing of the spine that causes pain, numbness and weakness (spinal stenosis)
take any medicines for any other condition.
If you are not sure whether you should start using this medicine, talk to your doctor.
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.
Talk to your doctor if you are breastfeeding or intend to breastfeed.
FORTEO should not be used if you are pregnant or breastfeeding. If you are a woman
of childbearing potential, you should use effective methods of contraception during
treatment with FORTEO.
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 and FORTEO may interfere with each other. These include:
Diuretics, medicines used to help the kidneys get rid of salt and water by increasing
the amount of urine produced, such as hydrochlorothiazide and frusemide.
Anti-coagulants, medicines used to prevent blood clotting.
Digoxin, a medicine used to treat heart failure.
These medicines may be affected by FORTEO or may affect how well it works. You may
need different amounts of your medicines or you may need to use different medicines.
You can take calcium or vitamin D supplements (or both) while you are using FORTEO
if your diet does not provide enough. You should discuss with your doctor how much
calcium and vitamin D to take each day.
Your doctor and pharmacist have more information on medicines to be careful with or
avoid while using FORTEO.
Check with your doctor or pharmacist if you are not sure about what medicines, vitamins
or supplements you are taking and if these affect FORTEO.
4. How do I use FORTEO?
Carefully follow all directions given to you by your doctor or healthcare professional.
They may differ from the information contained in this leaflet. Read the user manual
for instructions on how to use the pen. Needles are not included with the pen. You
can use Becton Dickinson and Company's pen needles or their equivalent with the pen.
If you do not understand the user manual, ask your doctor or healthcare professional
for help.
How much to use
The usual dose is 20 mcg given once a day.
Follow the instructions provided by your doctor and use FORTEO until your doctor tells
you to stop.
When to use FORTEO
You can take FORTEO at any time of day.
To help you remember, take your medicine at about the same time each day.
How to inject FORTEO
FORTEO is given by injection under the skin (subcutaneous) into the thigh or abdomen.
You should always use a new needle for each injection.
Your healthcare professional (doctor or nurse) should teach you how to use the FORTEO
pen (multidose prefilled delivery device).
It is a good idea to refer to the user manual each time you inject this medicine.
How long to use FORTEO
The total duration of treatment with FORTEO should not exceed 24 months.
Continue using your medicine for as long as your doctor tells you.
This medicine helps to control your condition but does not cure it. It is important
to keep using your medicine even if you feel well.
If you forget to use FORTEO
If you miss your dose at the usual time, have it as soon as possible on that day.
Do not have more than one injection on the same day. Do not take a double dose to make up for the dose you missed.
This may increase the chance of you having an unwanted side effect.
If you are not sure what to do, ask your doctor or healthcare professional.
If you have trouble remembering to use your medicine, ask your healthcare professional
for some hints.
If you use too much FORTEO
If you think that you have used too much FORTEO, you may need urgent medical attention.
Symptoms of an overdose may include:
high blood serum calcium levels
dizziness or light-headedness on standing up
nausea
vomiting
dizziness
headache
feeling weak or tired
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.
You should do this even if there are no signs of discomfort or poisoning.
5. What should I know while using FORTEO?
Things you should do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using FORTEO.
If you are going to have surgery, tell the surgeon or anaesthetist that you are using
this medicine. It may affect other medicines used during surgery.
If you are about to have any blood tests, tell your doctor that you are using this
medicine.
This medicine can cause small, temporary increases in blood calcium levels. If blood
samples are taken, this needs to be done at least 16 hours after the last injection.
Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests (like bone mineral density tests and blood tests) from
time to time to make sure the medicine is working and to prevent unwanted side effects.
Call your doctor straight away if you:
become pregnant while using this medicine.
Remind any doctor, dentist or pharmacist you visit that you are using FORTEO.
Things you should not do
Do not stop using this medicine suddenly without checking with your doctor.
Do not use FORTEO to treat any other complaints unless your doctor tells you to.
Do not give or share your medicine with anyone else, even if they have the same condition
as you and you have changed the needle.
Driving or using machines
Be careful before you drive or use any machines or tools until you know how FORTEO
affects you.
This medicine is not expected to affect your ability to drive a car or use machinery.
Some patients may feel dizzy or experience light-headedness on standing up after injecting
FORTEO. If
you feel dizzy or light-headed you should not drive or use machines until you feel
better.
Looking after your medicine
Keep your FORTEO pen in the refrigerator where the temperature stays between 2°C to
8°C.
Do not allow your FORTEO pen to freeze. Do not use FORTEO if it is or has been frozen.
You should have your FORTEO injection shortly after you take the pen out of the refrigerator
as described in the user manual. Put the pen back into the refrigerator immediately
after you have used it.
Do not use the FORTEO pen 28 days after the first injection, even if it has been stored
in the refrigerator.
Do not store your pen with the needle attached. If you do this, it may allow solution
to leak from the pen and air bubbles to form in the cartridge.
FORTEO is a clear and colourless liquid. Do not use if solid particles appear or if
the solution is cloudy or coloured.
Follow the instructions in the user manual on how to take care of your medicine properly.
Keep it where young children cannot reach it.
When to discard your medicine
Each FORTEO pen can be used for up to 28 days after the first injection. After the
28-day use period, discard the pen even if it contains some unused solution.
Empty FORTEO pens and any needles should be disposed of in a 'sharps' container or
similar puncture proof container composed of hard plastic or glass.
Ask your doctor or nurse where you can dispose of the container once it is full.
Getting rid of any unwanted medicine
If 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 FORTEO after the expiry date printed on the pack has passed or if the packaging
is torn or shows signs of tampering.
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
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Less serious side effects
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What to do
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Body as a whole:
pain
headache
weakness and lack of energy
neck pain
problems with teeth
leg cramps
muscle spasms in the leg or back sometimes shortly after the first dose
joint pain
muscle pain
Injection site related:
discomfort around the area of injection, such as
redness of the skin,
pain,
swelling,
itching
bruising or minor bleeding at the injection site.
Heart related:
increased blood pressure
feeling faint
Stomach related:
feeling sick (nausea)
constipation
diarrhoea
heartburn and indigestion
vomiting
disorder of the digestion system
Nervous system related:
dizziness (light-headedness) after injection. If you become dizzy (light-headed) after
your injection, you should sit or lie down until you feel better. If you do not feel
better, you should call a doctor before you continue treatment
low mood, lack of interest in activities (depression)
trouble sleeping (insomnia)
feeling of spinning (vertigo)
Respiratory system related:
stuffy, running nose, sneezing
increased coughing
sore throat
Skin related:
rash
sweating
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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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Serious side effects
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Serious side effects
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What to do
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Allergic reactions:
Symptoms of an allergic reaction may include:
shortness of breath,
wheezing or difficulty breathing,
swelling of the face, lips or tongue,
rash, itching or hives on the skin and
chest pain
Heart related:
chest pain or discomfort
Kidney related:
reduced urination due to reduced kidney function or kidney failure
Respiratory system related:
pneumonia (inflammation in the lungs) that can cause a cough, shortness of breath
and chest pain
shortness of breath
Muscle related:
serious back spasms
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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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Other changes you may not be aware of:
high amount of uric acid in the blood
high calcium levels in the blood
low level of red blood cells in blood (anaemia) which can make you feel lethargic
and very tired.
These changes can only be found when your doctor does tests from time to time to check
your progress.
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 FORTEO contains
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Active ingredient
(main ingredient)
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teriparatide
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Other ingredients
(inactive ingredients)
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glacial acetic acid
sodium acetate
mannitol
metacresol
water for injections
hydrochloric acid
sodium hydroxide
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Do not take this medicine if you are allergic to any of these ingredients.
What FORTEO looks like
FORTEO is a clear and colourless liquid. It is supplied in a 2.4mL cartridge contained
in a prefilled delivery device (pen) that delivers 20 mcg per dose and contains dosing
for 28 treatment days. (AUST R 80333).
FORTEO is available in packs of one.
Who distributes FORTEO
Eli Lilly Australia Pty Ltd
Level 9, 60 Margaret Street
Sydney NSW 2000
This leaflet was prepared in December 2024.