Consumer Medicine Information
What is in this leaflet
This leaflet answers some common questions about FORTEO. It does not contain all
the available information and does not take the place of talking to your doctor or
health care professional.
All medicines have risks and benefits. Your doctor has weighed the risks of you using
FORTEO against the benefits they expect it will have for you.
If you have any concerns about using this medicine, ask your doctor or health care
Keep this leaflet with the medicine.
You may need to read it again.
What is the most important information I should know about FORTEO?
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
What FORTEO is used for
FORTEO is used to treat osteoporosis in women after menopause and in men.
Osteoporosis is a disease which causes bones to become less dense, gradually making
them weaker, more brittle and likely to break. This disease is especially common
in women after the menopause. 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.
This medicine is a recombinant parathyroid hormone.
It works by activating cells in the bone to form new bone. Using this medicine each
day will protect your bones by making them stronger and your risk of fracture will
Ask your doctor if you have any questions about why this medicine has been prescribed
Your doctor may have prescribed it for another reason.
This medicine is available only with a doctor's prescription.
This medicine is not expected to affect your ability to drive a car or use machinery.
Some patients may feel dizzy after injecting FORTEO. If you feel dizzy you should
not drive or use machines until you feel better.
Before you use FORTEO
Your health care professional should teach you how to use the FORTEO pen. You should
also read the user manual for information on how to use the pen before beginning therapy.
Read the user manual and package leaflet each time you get a new pen, in case something
When you must not use it
Do not use FORTEO if:
you have previously received FORTEO therapy for a total of 24 months. 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
you have ever had Paget's disease of the bone, irradiations, open epiphysis, increased
you have an allergy to any medicine containing teriparatide or any of the ingredients
listed at the end of this leaflet.
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.
Do not use this medicine after the expiry date printed on the pack or if the packaging
is torn or shows signs of tampering.
If it has expired or is damaged, return it to your pharmacist for disposal.
If you are not sure whether you should start using this medicine, talk to your doctor.
Before you start to use it
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.
Tell your doctor if you have allergies to any other medicines, foods, preservatives
Tell your doctor if you have or have had any of the following medical conditions:
high calcium levels in the blood (pre-existing hypercalceamia). Signs and symptoms
of high calcium in the blood may include continuing nausea, vomiting, constipation,
low energy, or muscle weakness. FORTEO may cause an increase in the amount of calcium
in your blood or urine.
bone disorders other than osteoporosis (including hyperparathyroidism)
high levels of alkaline phosphatase
have had radiation therapy
calculi or stones (mineral deposits) in the urinary tract
low blood pressure
* kidney disease.
This medicine should not be used in children or in young adults if their bones have
not finished growing (open epiphyses).
Tell your doctor if you are pregnant or plan to become pregnant or are breast-feeding.
This medicine may affect your developing baby. It is not known whether this medicine
passes into breast milk. Your doctor can discuss with you the risks and benefits
Before you start using FORTEO, tell your doctor about any of the above conditions.
Taking other medicines
Tell your doctor or pharmacist if you are taking any other medicines, including any
that you get without a prescription from your pharmacy, supermarket or health food
Some medicines and FORTEO may interfere with each other, e.g.
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 (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 your medicine.
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 this medicine.
How to use FORTEO
Carefully follow all directions given to you by your doctor or health care 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 health care professional
How much to use
The usual dose is 20 mcg given once a day.
How to use it
FORTEO is given by injection under the skin (subcutaneous) into the
thigh or abdomen.
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.
When to use it
You can take FORTEO at any time of day.
To help you remember, use your medicine at about the same time each day.
Using it at the same time each day will have the best effect.
How long to use it
The safety and efficacy of FORTEO have not been evaluated beyond 2 years (median treatment
is 19 months in postmenopausal women).
Use of the drug for more than 24 months lifetime duration is not recommended.
You will be required to sign your consent that you understand the 24 month lifetime
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 it
Have it as soon as possible on that day. Do not have more than one injection on the
same day. Then go back to using your medicine as you would normally.
Do not have double injections to make up for the injection that 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 health care professional.
If you have trouble remembering to use your medicine, ask your health care professional
for some hints.
If you have too much (overdose)
Immediately telephone your doctor or the Poisons Information Centre (telephone 13
11 26) for advice, or go to Accident and Emergency at the nearest hospital, if you
think that you or anyone else may have had too much FORTEO. Do this even if there
are no signs of discomfort or poisoning. 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 and headache may also
While you are using FORTEO
Things you must do
If you are about to be started on any new medicine, remind your doctor and pharmacist
that you are using FORTEO.
Tell any other doctors, dentists and health care professionals who treat you that
you are using this medicine.
If you are going to have surgery, tell the surgeon or anaesthetist that you are using
It may affect other medicines used during surgery.
If you become pregnant while using this medicine, tell your doctor immediately.
If you are about to have any blood tests, tell your doctor that you are using this
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.
Things you must not do
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.
Do not stop using your medicine without checking with your doctor.
Tell your doctor or health care professional as soon as possible if you do not feel
well while you are using FORTEO.
This medicine helps most people with osteoporosis, but it may have unwanted side effects
in a few people. Most of the side effects are mild.
Ask your doctor or health care professional to answer any questions you may have.
Tell your doctor or health care professional if you notice any of the following and
they worry you:
* 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
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
The above list includes the more common side effects of your medicine.
Tell your doctor or pharmacist if you notice anything that is making you feel unwell.
Other side effects not listed above may also occur in some people. Some of these
side effects (for example, a high amount of uric acid or calcium levels in the blood)
can only be found when your doctor does tests from time to time to check your progress.
Allergic reactions may occur in some people. This may be seen as shortness of breath,
wheezing or difficulty breathing, swelling of the face, lips or tongue, rash, itching
or hives on the skin.
After using FORTEO
Keep your FORTEO pen in the refrigerator where the temperature stays between 2 degrees
to 8°C. Do not allow FORTEO to freeze. Do not use FORTEO if it has been frozen.
Keep it where children cannot reach it.
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.
You should use a new needle for each injection. 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.
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.
FORTEO is a clear and colourless liquid. Do not use if solid particles appear or
if the solution is cloudy or coloured.
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.
If the expiry date on this medicine has passed, ask your pharmacist what to do with
any medicine that is left over.
What it 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.
FORTEO is available in packs of one.
FORTEO contains 250 mcg/mL of teriparatide as the active ingredient. It also contains:
glacial acetic acid
water for injections
hydrochloric acid may have been added to adjust product pH
sodium hydroxide may have been added to adjust product pH.
FORTEO is a product of:
Eli Lilly Australia Pty Limited
112 Wharf Road
WEST RYDE NSW 2114
® = Registered Trademark
Australian Registration Number:
AUST R 80333
This leaflet was revised in May 2019