INFORMATION FOR CONSUMERS

Consumer Medicine Information

The sponsor (pharmaceutical company) of this product has advised Medsafe that this product has either been discontinued or is no longer marketed in New Zealand.
Therefore this CMI may not be up to date.
Medsafe has elected to leave it on this web site because supplies of this product may still be available, and consumers should continue to have access to this product information in the interim.
You may be able to find a more current CMI containing the same medicine by returning to the main CMI page and searching by ingredient name.

AREDIA^®

30mg Injection
Disodium Pamidronate

What is in this leaflet

This leaflet answers some common questions about Aredia.

It does not contain all the available information. It does not take the place of talking to your doctor or pharmacist.

All medicines have risks and benefits. Your doctor has weighed the risks of you having

Aredia against the benefits they expect it will provide.

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

Keep this leaflet. You may need to read it again.

What Aredia is used for

Aredia is used to lower the amount of calcium in the blood when it becomes too high, as may happen in some forms of cancer.

Some cancers can speed up normal changes in bone so that the amount of calcium released from the bones into the blood is increased. Aredia belongs to a group of medicines called bisphosphonates, which strongly bind to bone. These medicines slow down the rate of bone change and help to restore the amount of calcium in the blood to normal.

Aredia can also be used in other conditions with increased bone changes or pain, including Paget's disease, advanced cancer of the bone marrow (called multiple myeloma) and advanced breast cancer where the cancer has spread to the bone from other parts of the body (called metastases).

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 purpose.

Aredia 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 Aredia

When you must not have it

Do not have Aredia if you have ever had an allergic reaction to:

disodium pamidronate (the active ingredient in Aredia) 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 can cause breathing difficulties in people with asthma who are allergic to aspirin.

Do not have Aredia 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 have it

Tell your doctor if you are pregnant or planning to become pregnant.
There is no information on use of this medicine in pregnancy. Your doctor can discuss with you the benefits and risks involved.

Tell your doctor if you are breast-feeding.
Breast-feeding is not recommended while you are having Aredia. It is not known if the active ingredient, disodium pamidronate, passes into the breast milk and could affect your baby.

Tell your doctor if:

you have a kidney or liver problem
you have a heart condition
you have asthma and are also allergic to aspirin
you have had surgery on your thyroid
you have a calcium deficiency or vitamin D deficiency (e.g. from your diet or as a result of digestive problems)
If you had or have pain, swelling or numbness of the jaw or a "heavy jaw feeling" or loosening of a tooth.

Your doctor may want to take special precautions if you have any of the above conditions.

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.
Some medicines and Aredia may interfere with each other. These include:

medicines that may have side effects on your kidneys
thalidomide, a medicine used to treat multiple myeloma
other bisphosphonate medicines
calcitonin
calcium supplements
vitamin supplements

You may need to take different amounts of your medicines or you may need to take different medicines. Your doctor and pharmacist have more information.

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

How Aredia is given

How it will be given

Aredia will be given by slow intravenous infusion into a vein. The dry powder in the vial is dissolved in sterile water and then put into an intravenous drip. An infusion may last several hours, depending on the dose given and whether or not you have kidney problems.

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

How much you need

The dose is usually between 30 mg and 90 mg, depending on the condition being treated.

The need for more doses will depend on how well your body responds to the treatment. If you have cancer in the bone you will usually receive a dose every 4 weeks. But if you are having chemotherapy every 3 weeks, Aredia can be given at the same time.

Since bisphosphonate medicines may cause damage to the kidneys, you will have a blood test before each dose to make sure this medicine is not affecting your kidneys.

If you have too much

Tell your doctor if you have any of the following symptoms. They may mean that the level of calcium in your blood has fallen too far.

unusual lightheadedness, dizziness or faintness
numbness or tingling sensation
muscle cramps

While you are having Aredia

Things you must do

Follow your doctor's instructions carefully and keep all appointments.
You will need regular blood tests to make sure the treatment is working. In the early stages of treatment for high blood calcium, these tests may be done several times a day. Regular blood tests can also find side effects before they become serious.

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

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

Tell any other doctor, dentist or pharmacist who treats you that you are having Aredia.

Things you must not do

Do not give this medicine to anyone else even if their symptoms seem to be the same as yours.

Do not use it to treat any other complaints unless your doctor tells you to.

Things to be careful of

Be careful driving, operating machinery or doing jobs that require you to be alert after you have a dose of Aredia until you know how it affects you. If you are returning home immediately after the infusion, arrange to have someone else drive.
This medicine may cause dizziness or sleepiness in some people, especially right after the infusion. It usually does not last longer than 24 hours.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are having Aredia.
All medicines can have side effects. Sometimes they are serious, most of the time they are not. You may need medical treatment if you get some of the side effects. If you are over 65 and you have a serious heart or kidney problem, you may be more likely to have unwanted effects from your treatment.

Do not be alarmed by these lists 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:

short-lasting fever and flu-like symptoms, sometimes with chills, tiredness and general discomfort
pain, redness and swelling at the site of the infusion
short-lasting pain in bones, joints or muscles
generalised pain
muscle cramps
indigestion, loss of appetite, feeling sick or vomiting
constipation or diarrhoea
headache
dizziness or lightheadedness
sleepiness or tiredness
feeling agitated or being unable to sleep
irritated eyes, blurred vision, eye pain, sensitivity to light, objects appearing yellow

Tell your doctor immediately or go to the Accident and Emergency Department at your nearest hospital if you notice any of the following:

signs of allergy such as rash, itching or hives on the skin; swelling of the face, lips, tongue or other part of the body; shortness of breath, wheezing or troubled breathing
constant "flu-like" symptoms (chills, fever, sore throat, aching joints, sores in mouth, swollen glands, tiredness or lack of energy, unusual bleeding or bruising) that could be a sign of blood problems
numbness, tingling or severe muscle cramps
swelling of ankles, feet or lower legs
fainting spells or seizures (fits)
confusion or hallucinations (seeing, hearing or feeling things that are not there)
decrease in amount of urine or bloody urine

The above side effects may be serious. You may need urgent medical attention.

Tell your doctor if you notice anything else that is making you feel unwell.
Some people may have other side effects not yet known or mentioned in this leaflet. Some side effects can only be found by laboratory testing.

After having Aredia

Storage

If you are keeping a supply of Aredia at home:

Store the medicine in a cool dry place below 30°C (room temperature).
Do not store Aredia 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 Aredia or it has passed its expiry date, return any unused medicine to your pharmacist.

Product description

What it looks like

Aredia is packaged in glass vials containing the active ingredient, disodium pamidronate, in a dry powder form. An ampoule containing water for injections is provided for use in dissolving the powder.

Ingredients

Aredia vials contain 30 mg of disodium pamidronate. The vials also contain mannitol and phosphoric acid.

Sponsor

Aredia is supplied in New Zealand by:

Novartis New Zealand Limited
Private Bag 19 999
43-45 Patiki Road
Avondale
AUCKLAND

Telephone: 0800 652 422

® = Registered Trademark

This leaflet was prepared on the 8^th of February 2005 based on the currently approved data sheet for this product.