Consumer Medicine Information
What is in this leaflet
This leaflet answers some common
questions about Aclasta.
It does not contain all the available
information. It does not take the
place of talking to your doctor or
The information in this leaflet was
last updated on the date listed on the
final page. More recent information
on the medicine may be available.
You should ensure that you speak
to your pharmacist or doctor to
obtain the most up-to-date
information on the medicine. You
can also download the most up-to-
date leaflet from
Those updates may contain important
information about the medicine and
its use of which you should be aware.
All medicines have risks and
benefits. Your doctor has weighed
the risks of you having Aclasta
against the benefits they expect it
will have for you.
If you have any concerns about
having this medicine, ask your
doctor or pharmacist.
Keep this leaflet.
You may need to read it again.
What Aclasta is used
The active ingredient in Aclasta is
zoledronic acid, which belongs to a
group of medicines called
Aclasta is used to treat osteoporosis
in postmenopausal women and in
men, to prevent additional fractures
in men or women who have recently
had a hip fracture, or to treat or
prevent osteoporosis in men and
women caused by treatment with
steroid medicines such as prednisone.
Aclasta is also used to treat Paget’s
disease of bone.
Osteoporosis is a disease which
causes bones to become less dense,
gradually making them weaker, more
brittle and likely to break. This is
common in women after menopause,
when a woman’s ovaries stop
producing the female hormone,
oestrogen, which keeps bones
healthy. It also occurs in men and
women with increasing age. Broken
bones may result from injury or
simple falls. Breaks may occur
during normal everyday activity,
such as lifting, or from minor injury
that would not ordinarily fracture
normal bone. Fractures in people
with osteoporosis usually occur at the
hip, spine or wrist. These can lead
not only to pain, but also to
considerable deformity and
disability, such as stooped posture
from curvature of the spine, and loss
Paget’s disease is a chronic disorder
which may affect various bones of
the skeleton. Bone is a living tissue
and, just like other parts of the body,
it is constantly being renewed. This
process is called bone remodelling.
In Paget’s disease, the bone material
breaks down more quickly than
usual, and new bone material grows
more quickly than usual and in a
disordered way. The new bone that is
formed may be thicker but weaker
than normal, which can cause pain
and may lead to fractures (broken
How does it work
Aclasta works by slowing down bone
resorption, which allows the bone-
forming cells time to rebuild normal
bone. This allows bone remodelling
to go back to normal and protects the
bones from being weakened.
Ask your doctor if you have any
questions about why this medicine
has been prescribed for you.
Your doctor may have prescribed it
for another reason.
Aclasta is only available with a
doctor’s prescription. It is not
There is not enough information to
recommend the use of this medicine
for children or adolescents.
Before you have
When you must not have it
You must not have Aclasta if you
have an allergy to:
zoledronic acid (the active
ingredient in Aclasta) or any of
the other ingredients listed at the
end of this leaflet
any other bisphosphonate
medicine such as alendronate
(e.g. Fosamax) or risedronate
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.
If you are not sure whether you are
allergic to other bisphosphonate
medicines, talk to your doctor.
Other bisphosphonate medicines
have been shown to cause breathing
difficulties in people with asthma
who are allergic to aspirin.
Do not have Aclasta if you have
low levels of calcium in your blood.
Your doctor may do a blood test to
check your calcium levels before you
Do not have Aclasta if you are
There is no information on use of this
medicine in pregnancy.
Do not breast-feed while you are
having treatment with Aclasta.
It is not known if the active
ingredient, zoledronic acid, passes
into the breast milk and could affect
Do not have Aclasta 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.
If you are not sure whether you
should be given this medicine, talk
to your doctor.
Before you have it
Tell your doctor if you have been
or are being treated with:
which contains the same
active ingredient as in Aclasta
another bisphosphonate medicine
prior to Aclasta
diuretic therapy (commonly
called ‘fluid tablets’)
Tell your doctor if:
you have a kidney problem. This
medicine is not suitable for some
people with a kidney problem.
you have a calcium deficiency or
a vitamin D deficiency
you are unable to take daily
calcium or vitamin D
you have had some or all of your
parathyroid or thyroid glands in
your neck surgically removed
you have had sections of your
you have or have had pain,
swelling or numbness of the jaw
or loosening of a tooth or any
other oral issues
you had or have joint stiffness,
aches and pains and difficulty in
movement (especially of the hip,
thigh, knee or upper arm)
you are under dental treatment or
will undergo dental surgery. Your
doctor will check your oral health
before you start treatment with
Aclasta. It is important to have
good dental hygiene, routine
dental care and regular dental
check-ups. Discuss with your
doctor any planned dental surgery
such as a tooth extraction. Tell
your dentist that you are being
treated with Aclasta.
you have or have had uveitis or
iritis (inflammatory conditions of
Taking other medicines
Tell your doctor, nurse or
pharmacist if you are taking any
other medicines, including
medicines that you buy without a
prescription from your pharmacy,
supermarket or health food shop.
Some medicines and Aclasta can
interfere with each other. These
medicines that may affect your
kidneys such as fluid tablets
aminoglycoside medicines used
to treat severe infections.
You may need to take different
amounts of these medicines or you
may need to take different medicines.
Your doctor or pharmacist has more
How Aclasta is given
Follow all directions given to you
by your doctor, nurse and
These directions may differ from the
information contained in this leaflet.
If you do not understand the
instructions, ask your doctor,
nurse or pharmacist for help
before treatment starts.
Make sure you drink enough fluids
before and after the treatment with
Aclasta as directed by your doctor.
Two glasses of fluid (such as water)
before and after the infusion are
usually enough. This will help to
You may eat normally on the day
you are treated with Aclasta.
How it will be given
Aclasta will be given to you by
infusion into a vein by your doctor or
nurse once a year. The infusion will
take at least 15 minutes.
How much is given
A 100mL infusion will last at least
How long treatment will last
For osteoporosis, each dose of
Aclasta lasts one year. Your
doctor will check your condition
and may prescribe further annual
For Paget’s disease, each dose of
Aclasta may work for longer than
one year. Your doctor will let you
know if you need to be treated
If you have too much
Immediately telephone your doctor
or Poisons and Hazardous
Chemicals National Information
Centre, Dunedin (telephone 0800
POISON or 0800 764 766), or go to
Accident and Emergency at your
nearest hospital if you think that
an overdose has happened. Do this
even if there are no signs of
discomfort or poisoning.
Tell your doctor if you have any of
the following symptoms:
numbness or tingling sensation,
especially around the mouth
shortness of breath.
These symptoms may mean the level
of calcium in your blood has fallen
While you are being
Things you must do
If you get a headache, fever or
other flu-like symptoms in the first
three days after you are given
Aclasta, take paracetamol if your
doctor has told you to.
Some people get short-lasting flu-like
symptoms after having Aclasta.
Paracetamol can provide some relief.
Take calcium and vitamin D
supplements if your doctor has told
Most people with osteoporosis do
not get enough calcium and
vitamin D in their diet and
supplements are needed to help
strengthen your bones.
If you are being treated with
Aclasta for Paget’s disease, your
doctor should advise corrective
treatment for a vitamin D
deficiency and that you take
calcium and vitamin D
supplements for at least the first
ten days after you have Aclasta to
reduce the risk of low calcium
levels in your blood.
Keep all of your doctor’s
appointments so that your progress
can be checked.
Your doctor may want you to have
X-rays, bone density scans or blood
tests from time to time to make sure
Aclasta is working and to prevent
unwanted side effects from
Tell your doctor immediately if
you become pregnant while having
treatment with this medicine.
Your doctor can discuss with you the
risks of having it while you are
Tell your doctor and dentist
immediately about any dental
symptoms you get while you are
being treated with Aclasta. This
may include persistent pain,
swelling, loosening of a tooth
and/or non-healing sores or
discharge (pus or oozing).
A dental condition called jaw
osteonecrosis has been reported,
primarily in patients being treated
with this type of medicine for other
If you are about to be started on
any new medicine, remind your
doctor and pharmacist that you
are being treated with Aclasta.
Tell any other doctor, dentist or
pharmacist who treats you that
you are having Aclasta.
Things to be careful of
Be careful driving or operating
machinery until you know how
Aclasta affects you.
Aclasta has no known effect on the
ability to drive or use machines but,
as a general precaution, if you are
travelling home by car after the
infusion, arrange to have someone
Tell your doctor or pharmacist as
soon as possible if you do not feel
well while you are
All medicines can have side effects.
Sometimes they are serious, most of
the time they are not. You may need
medical attention if you get some of
the side effects.
Do not be alarmed by the following
list of side effects. You may not
experience any of them.
Ask your doctor or pharmacist to
answer any questions you may
Tell your doctor or pharmacist if
you notice any of the following and
they worry you:
short-lasting fever, sometimes
with flu-like symptoms,
headache, chills, pain or aching
in the muscles or joints. Take
paracetamol if your doctor has
told you to. Paracetamol can
provide some relief.
redness, swelling or pain where
the needle for the infusion was
upset stomach, abdominal pain,
loss of appetite or other eating
disorder, thirst or heartburn
nausea, vomiting, diarrhoea,
with possible dehydration
dry mouth, toothache or sore
lack of energy, tiredness and
lack of interest, weakness,
dizziness, low blood pressure
pain in your back, neck,
shoulders, arms, legs or chest
muscles, swollen or stiff joints,
muscle stiffness, weakness or
spasm, tingling or numbness of
your hands or feet
swollen fingers or lower legs due
to fluid build-up
swollen, red, painful or itchy
eyes or sensitivity of the eyes to
pink eye (conjunctivitis)
palpitations (feeling of fast,
forceful and/or irregular
heartbeat), which may be
accompanied by dizziness and
Contact your doctor if you
experience pain, weakness or
discomfort in your thigh, hip or
groin as this may be an early
indication of a possible fracture of
the thigh bone.
Unusual fracture of the thigh bone
particularly in patients on long-term
treatment for osteoporosis may
Tell your doctor and dentist
immediately about any dental
symptoms you get after you have
Aclasta. This may include:
pain in the mouth, teeth and jaw,
swelling of sores inside the
mouth, numbness or a feeling of
heaviness in the jaw, or loosening
of a tooth. These could be signs
of bone damage in the jaw
Tell your doctor immediately or go
to Accident and Emergency at
your nearest hospital if you notice
any of the following after you have
signs of allergy such as rash,
itching or hives on the skin;
swelling of the face, throat, lips,
tongue or other part of the body;
shortness of breath, difficulty
breathing or swallowing;
tightness of the chest.
signs that the level of calcium in
your blood may have fallen too
far, such as muscle spasms,
numbness or tingling sensation,
especially around the mouth,
shortness of breath
signs that the level of
phosphorus in your blood may
have fallen too far, such as
muscle problems and weakness,
confusion, irritation, and
signs that your kidneys may not
be working properly, such as
decreased urine output.
The above side effects may be
serious. You may need urgent
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 (e.g. effects on kidney
function and on the level of calcium
in the blood) can only be found by
After having Aclasta
It is unlikely you will have to store
Aclasta at home.
If you do have to store it:
Store the medicine in a cool dry
place at room temperature
Do not store Aclasta or any other
medicine in the bathroom or near
Do not leave it in the car or on a
Heat and dampness can destroy some
Keep the medicine where young
children cannot reach it.
A locked cupboard at least one-and-
a-half metres above the floor is a
good place to store medicines.
Each Aclasta vial is to be used for
one injection only and then
If you no longer need Aclasta or it
has passed its expiry date, return
any unused medicine to your
What it looks like
Aclasta solution for infusion is
supplied in a transparent plastic vial
containing 100mL of a clear,
colourless solution. Aclasta is
supplied as packs containing one
Each vial of Aclasta contains 5mg of
zoledronic acid. Each vial also
water for injections.
Aclasta is supplied in New Zealand
Novartis New Zealand Limited
109 Carlton Gore Road
PO Box 99102
Telephone 0800 354 335
Web site: www.novartis.com.au
Date of preparation
This leaflet was prepared in
December 2016 .
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Internal Document Code
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