Consumer Medicine Information

ACLASTA^®

5mg / 100ml Solution for Infusion
Zoledronic Acid

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 pharmacist.

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 www.medsafe.govt.nz. 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 using Aclasta against the benefits they expect it will have for you.

If you have any concerns about using this medicine, ask your doctor or pharmacist.

Keep this leaflet with the medicine. You may need to read it again.

What Aclasta is used for

The active ingredient in Aclasta is zoledronic acid, which belongs to a group of medicines called bisphosphonates.

Aclasta is used to treat pagets disease of the bone and post menopausal osteoporosis.

In Paget's disease, the bone material breaks down too much, and new bone material grows too quickly, and in a disordered way. The bone material produced is weaker than normal. If the disease is not treated, bones may become deformed and painful, and may break. Aclasta works by returning the bone remodelling process to normal, and restoring strength to the 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. 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 of mobility. Aclasta works by strengthening bones, making them less likely to break. Since Aclasta works for a long time, you will not need another dose of Aclasta for a year.

Ask your doctor if you have any questions about why Aclasta has been prescribed for you.
Your doctor may have prescribed this medicine for another reason.

Aclasta is only available with a doctor's prescription. It is not addictive.

There is not enough information to recommend the use of this medicine in children.

Before you have Aclasta

When you must not use it

Do 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.

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 have Aclasta.

Do not have Aclasta if you are pregnant.
There is no information on use of this medicine in pregnancy.

Do not breastfeed while you are being treated with Aclasta.
It is not known if the active ingredient, zoledronic acid, passes into the breast milk and could affect your baby.

Do not have Aclasta after the expiry date printed on the pack or if the packaging is torn or shows signs of tampering.
In that case, return the medicine to your pharmacist.

Before you start to use it

Tell your doctor if

you have a kidney problem
you are on diuretic therapy (commonly called 'fluid tablets')
you have a calcium deficiency or vitamin D deficiency
you have taken other bisphosphonate medicines in the past
you are unable to take daily calcium supplements.
you have had some or all of your parathyroid or thyroid glands in your neck surgically removed.
you have had sections of your intestine removed.
you have or have had pain in the teeth, gums or jaw, swelling or numbness of the jaw or a "heavy feeling", loosening of a tooth or recent dental procedure.

It is advisable to have a dental check-up before you are treated with Aclasta. Tell your dentist you may be receiving Aclasta.

Tell your doctor if you need to have any dental treatment or dental surgery.
A dental condition called jaw osteonecrosis has been reported in some patients being treated with Aclasta or with other drugs in the same class as Aclasta. You may need to have dental treatments completed before starting it.

Taking other medicines

Tell your doctor if you are taking any other medicines, including medicines that you buy without a prescription from a pharmacy, supermarket or health food shop.
Other medicines may affect the way Aclasta works. Your doctor or pharmacist can tell you what to do if you are taking any other medicines.

If you have not told your doctor about any of these things, tell him/her before you use Aclasta.

How Aclasta is given

How it will be given

Aclasta will be given to you by infusion into a vein by your doctor or nurse once a year. This infusion will take at least 15 minutes.

You may also be given an infusion of fluids to ensure that you do not become dehydrated.

On the day of your treatment you should eat and drink normally, which includes drinking at least 2 glasses of fluid such as water, as directed by your doctor before receiving Aclasta

Follow all directions given to you by your doctor and pharmacist carefully.
These directions may differ from the information contained in this leaflet.

If you do not understand the instructions on the label, ask your doctor or nurse before you start.

How much is given

A 100 mL infusion will last at least 15 minutes.

If you forget to use it

It may be many months before you need another dose of Aclasta.

If you have trouble remembering when you may need another dose, ask your doctor or pharmacist for some hints. Your doctor will then decide whether you need another dose.

If you use too much (overdose)

Immediately telephone your doctor or the National Poisons Information Centre (telephone 0800 POISON or 0800 764 766), or go to theAccident and Emergency department at your nearest hospital if you think that an overdose has happened. Do this even if there are no signs of discomfort or poisoning.

While you are having Aclasta

Things you must do

Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may want you to have X-rays or bone density or blood or urine tests from time to time to make sure Aclasta is working and to prevent unwanted side effects from happening.

Tell your doctor immediately if you become pregnant while having treatment with Aclasta.
Your doctor can discuss with you the risks of having it while you are pregnant.

Tell your doctor and dentist immediately about any dental symptoms including pain or unusual feeling in your teeth or gums, or any dental infections.
A dental condition called jaw osteonecrosis has been reported in some patients being treated with Aclasta or other drugs in the same class as Aclasta.

Tell your dentist that you are being treated with Aclasta.
Your dentist may need to take special precautions.

If you are about to be started on any new medicine, remind your doctor and pharmacist that you are having treatment with Aclasta.

Tell any other doctor 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.
No studies on the effects on the ability to drive and use machines have been performed.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are using Aclasta.
All medicines can have side effects. Sometimes they are serious, but most of the time they are not. You may need medical treatment if you get some of the side effects.

Do not be alarmed by this list of possible side effects. You may not experience any of them.

Ask your doctor or pharmacist to answer any questions you may have.

Tell your doctor if you notice any of the following side effects and they worry you:

flu-like symptoms
fever, chills
headache/ dizziness
indigestion
nausea / vomiting
stomach discomfort
bone pain
aching muscles, muscle tenderness or weakness and numbness not caused by exercise
back pain
joint swelling, pain and/or stiffness
diarrhoea
tiredness
shortness of breath
tingling sensation
drowsiness
tremor
taste disturbance
spinning sensation
dry mouth
inflammation of oesophagus
eating disorder
conjunctivitis, redness, itching and pain in the eyes.
thirst

Tell your doctor immediately or go to Accident and Emergency at your nearest hospital if any of the following happen after you receive the Aclasta infusion:

a severe reaction at the site of injection
swelling of the face, lips, tongue or throat
swelling of other parts of the body such as legs or ankles
tightness in the chest, wheezing or troubled breathing
hives or an itchy skin rash
fast heartbeat
fainting

You may be having a serious allergic reaction to Aclasta and may need urgent medical attention or hospitalisation. Allergic reactions are rare.

Contact your doctor immediately if you notice any of these symptoms of low blood calcium after having Aclasta

numbness or tingling sensations (especially in the area around the mouth)
muscle spasms.

Some patients may experience low blood calcium after having Aclasta infusion.

Tell your doctor or dentist if you have jaw pain, toothache or any dental problem.

Tell your doctor if you notice anything else that is making you feel unwell.
Other side effects not listed above may happen in some people.

After having Aclasta

Because most people do not get enough calcium and vitamin D in their diet, it is important to take calcium and vitamin D supplements (for example, tablets) as directed by your doctor.

After having an Aclasta infusion, it is strongly recommended that you take calcium for a total of 1000 mg calcium a day to keep your blood calcium at a healthy level.

Ask your doctor or pharmacist if you are unsure about this.

Tell your doctor if you have had surgery to remove some or all of your parathyroid or thyroid glands in your neck, or if you had sections of your intestine removed, or are unable to take calcium supplements.

You should continue regular dental cleanings and practice good oral hygiene after you have been treated with Aclasta.

Tell your dentist you are having Aclasta.

Storage

If you are keeping a supply of Aclasta at home:

Store the medicine in a cool dry place at room temperature.
Do not store Aclasta or any other medicine in the bathroom or near a sink.
Do not leave it in the car or on window sills.

Keep the medicine where young children cannot reach it.
A locked cupboard at least one-and-a-half metres above the ground is a good place to store medicines.

Disposal

If you no longer need Aclasta or it has passed its expiry date, return any unused medicine to your pharmacist.

Product description

What it looks like

Aclasta solution for infusion is supplied in a 100 mL transparent plastic bottle. Aclasta is supplied as packs containing one bottle.

Ingredients

Aclasta solution for infusion contains the active ingredient zoledronic acid. Aclasta also contains mannitol, sodium citrate, water for injections.

Sponsor

Aclasta is supplied in New Zealand by:

NOVARTIS New Zealand Limited
Private Bag 47 909
Ponsonby
6-8 Mackelvie Street
Grey Lynn
AUCKLAND

Telephone 0800 652 422

® = Registered Trademark

This leaflet was prepared on 20^th February 2008 based the current data sheet for this product.

INFORMATION FOR CONSUMERS