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Information for Consumers

Revised: 11 June 2015

Consumer Medicine Information

FLUDARA®

Fludarabine phosphate

What is in this leaflet

This leaflet answers some common questions about FLUDARA. 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 receiving FLUDARA against the benefits they expect it will have for you.

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

What FLUDARA is used for

This medicine is an anti-cancer drug approved to treat a form of leukaemia known as B-cell chronic lymphocytic leukaemia (B-CLL). This is a cancer of a type of white blood cells called lymphocytes.

Patients with B-CLL have too many abnormal white blood cells (lymphocytes) and lymph nodes start to grow in various parts of the body. The abnormal white blood cells cannot carry out their normal disease fighting functions, and may push aside healthy blood cells. This can result in infections, a decreased number of red blood cells (anaemia), bruising and/or bleeding.

FLUDARA is a medication that stops the growth of new cancer cells. All cells of the body produce new cells like themselves by dividing. To do this, the cells' genetic material (DNA) must be copied and reproduced. FLUDARA is predominantly taken up by the cancer cells and hinders the production of new DNA.

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.

The effects of FLUDARA have not been studied in children.

Before you are given FLUDARA

When you must not be given it

Do not have FLUDARA if you have an allergy to:

Some of the symptoms of an allergic reaction may include:

Do not have FLUDARA if you have any of the following medical conditions:

Do not take this medicine if you are pregnant.
It may affect your developing baby if you take it during pregnancy.

Do not breastfeed if you are taking this medicine.
It is possible that your baby may be affected if you breastfeed.

If you are not sure whether you should start taking this medicine, talk to your doctor.

Before you are given it

Tell your doctor if you have allergies to any other medicines, foods, preservatives or dyes.

Tell your doctor if you have or have had any of the following medical conditions:

Tell your doctor if you are over 75 years of age.
Your doctor will administer FLUDARA to you with caution and monitor you closely.

Tell your doctor if you are pregnant or plan to become a parent.
Men and women who may still be fertile must use a reliable form of contraception during treatment and for at least 6 months after stopping FLUDARA therapy. It is not known whether FLUDARA decreases your fertility. Your doctor can discuss with you the risks and benefits involved.

If you have not told your doctor about any of the above, tell him/her before you take FLUDARA.

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 shop.

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

These medicines may be affected by FLUDARA or may affect how well it works. You may need different amounts of your medicines, or you may need to take different medicines.

Your doctor may have more information on medicines to be careful with or avoid while taking this medicine.

How FLUDARA is given

FLUDARA should be administered under the supervision of a qualified physician experienced in the use of cancer therapy. The dose you should take depends on your body surface area. This is measured in square metres (m²), and is worked out by the doctor from your height and weight.

The recommended dose is 25 mg per square metre of body surface area. Your doctor will calculate your individual dose.

FLUDARA is injected into a vein (often in the arm) once each day for 5 consecutive days. This 5-day course of treatment will be repeated every 28 days until your doctor has decided that the best effect has been achieved (usually after 6 courses). Your doctor may adjust the dose and number of treatment days.

Keep all of your doctor's appointments so that your progress can be checked.
You will have blood tests after every treatment course. Your individual dose will be carefully adjusted according to the number of your blood cells and your response to the therapy.

If you are given too much (overdose)

The exact dose of FLUDARA is worked out by your doctor. The dose is determined by your weight and height. Overdosage is unlikely to occur. In case of an overdose your doctor will stop the therapy and treat the symptoms.

In cases of overdose, it is advisable to contact the Poisons Information Centre (Australia: 13 11 26; New Zealand: 0800 POISON or 0800 764766) for recommendations on the management and treatment of overdose.
Overdose can cause delayed blindness, coma and even death.

While you are using FLUDARA

Things you must do

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

Tell any other doctors, dentists, and pharmacists who treat you that you are taking this medicine.

If you are going to have surgery, tell the surgeon or anaesthetist that you are taking this medicine.
It may affect other medicines used during surgery.

If you notice anything new or unusual on your skin, suggestive of skin cancer, tell your doctor.
If you have or have had skin cancer it may worsen or flare up again while you take FLUDARA or afterwards. You may also develop skin cancer during or after FLUDARA therapy as it reduces your body's defence mechanisms.

If you are a fertile male or female of childbearing potential, ensure that you use a reliable form of birth control during treatment and for at least 6 months after treatment.

If you do become pregnant while taking this medicine, tell your doctor immediately.
The effects of this medicine on reproduction are unknown.

If you are about to have any blood tests, tell your doctor that you are taking this medicine.
It may interfere with the results of some tests.

If you need a blood transfusion, tell your doctor.
Your doctor will ensure that you receive blood that has been treated by irradiation. There have been severe complications and even death, from transfusion of non-irradiated blood.

Keep all of your doctor's appointments so that your progress can be checked.
Your doctor may do some tests from time to time to make sure the medicine is working and to prevent unwanted side effects.

Check with your doctor before receiving any vaccinations.
Live vaccinations should be avoided during and after treatment with FLUDARA.

Things to be careful of

Be careful driving or operating machinery until you know how FLUDARA affects you.
This medicine may cause fatigue, weakness, visual disturbances, confusion, agitation and whilst rare seizures in some people. If you have any of these symptoms, do not drive, operate machinery or do anything else that could be dangerous.

Side effects

Tell your doctor or pharmacist as soon as possible if you do not feel well while you are taking FLUDARA.

This medicine helps most people with B-cell chronic lymphocytic leukaemia (B-CLL), but it may have unwanted side effects. 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 lists of side effects.

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

Tell your doctor or pharmacist if you notice any of the following and they worry you:

The above list includes the more common side effects of your medicine. They are often mild or moderate problems that are short-lived and diminish during the course of treatment.

However, if you believe the side effect is of a more severe nature, tell your doctor as soon as possible.

Tell your doctor as soon as possible if you notice any of the following:

The above list includes serious side effects that may require medical attention.

If any of the following happen, tell your doctor immediately or go to Accident and Emergency at your nearest hospital:

The above list includes very serious side effects. You may need urgent medical attention or hospitalisation. These side effects are usually uncommon or rare.

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.

Keep all doctors appointments so your progress can be checked.
Some side effects (for example, blood disorders) can only be found when your doctor does tests on a regular basis.

After using FLUDARA

Storage

FLUDARA will be stored by your doctor under conditions advised by the manufacturer. Storage conditions are outlined below for your information.

FLUDARA vials: Store below 30°C. Reconstituted FLUDARA contains no antimicrobial preservative. To reduce microbiological hazards it is recommended that reconstitution and/or further dilution should be effected immediately prior to use and infusion commenced as soon as practicable after reconstitution. After reconstitution if storage is necessary, store in a refrigerator at 4°C for not more than 24 hours. Any solutions which are discoloured, hazy or contain visible particulate matter should not be used.

Product description

What it looks like

FLUDARA comes in a clear glass vial as a compressed "cake" of white powder which is dissolved with water before being used. FLUDARA is available in a carton containing 5 single dose vials.

Ingredients

Each FLUDARA vial contains 50 mg of fludarabine phosphate. It also contains mannitol and sodium hydroxide.

Sponsor

Bayer Australia Limited
ABN 22 000 138 714
875 Pacific Highway
Pymble NSW 2073

Bayer New Zealand Limited
3 Argus Place
Hillcrest
North Shore 0627
Auckland

Australian Registration number

AUST R 52666

This leaflet was prepared in March 2009

® Registered trademark of the Bayer Group, Germany

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