FLUDARABINE EBEWE®

FLUDARABINE EBEWE®

Active ingredient(s): Fludarabine phosphate

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Consumer Medicine Information (CMI)

This leaflet provides important information about using Fludarabine Ebewe. You should also speak to your doctor or pharmacist if you would like further information or if you have any concerns or questions about using Fludarabine Ebewe.

Where to find information in this leaflet:

1. Why am I using Fludarabine Ebewe?
2. What should I know before I use Fludarabine Ebewe?
3. What if I am taking other medicines?
4. How do I use Fludarabine Ebewe?
5. What should I know while using Fludarabine Ebewe?
6. Are there any side effects?
7. Product details

1. Why am I using Fludarabine Ebewe?

Fludarabine Ebewe contains the active ingredient Fludarabine phosphate. Fludarabine Ebewe 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.

Fludarabine Ebewe is used to stop 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.

Fludarabine Ebewe is 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.

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

2. What should I know before I use Fludarabine Ebewe?

Warnings

Do not use Fludarabine Ebewe if:

• you are allergic to Fludarabine phosphate, or any of the ingredients listed at the end of this leaflet. Always check the ingredients to make sure you can use this medicine.
• You are pregnant
• You are breast-feeding
• Your red blood cell count is low because of a type of anaemia (haemolytic anaemia)
• You have severe kidney problems

Check with your doctor if you:

• have allergies to any other medicines, foods, preservatives or dyes
• have or have had any of the following medical conditions:
  – low protein in the blood (hypoalbuminaemia).
  Your doctor will have told you if you have this
  – you feel very unwell, have unusual bruising, more bleeding than usual after injury, or if you seem to be catching a lot of infections
  – poor kidney function
  – enlarged liver or spleen, reduced liver function
  – skin cancer. If you have or have had skin cancer it may worsen or flare up again while you take Fludarabine Ebewe or afterwards
• take any medicines for any other condition
• Are over 75 years of age. Your doctor will administer Fludarabine Ebewe to you with caution and monitor your closely
• Are below 18 years of age. It is not recommended to give this medicine to a child under the age of 18 years.
• 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 Fludarabine Ebewe therapy. It is not known whether Fludarabine Ebewe decreases your fertility. Your doctor can discuss with you the risks and benefits involved.

During treatment, you may be at risk of developing certain side effects. It is important you understand these risks and how to monitor for them. See additional information under Section 6. Are there any side effects?

Pregnancy and breastfeeding

Do not take this medicine if you are pregnant.

You must not become pregnant during treatment with Fludarabine Ebewe because animal studies and very limited experience in humans have shown a possible risk of abnormalities in the unborn baby as well as early pregnancy loss or premature delivery. If pregnancy occurs during your treatment, you must immediately inform your doctor. It may affect your developing baby if you take it during pregnancy.

You must not breastfeed while you are treated with Fludarabine Ebewe.

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.

Fertility in males and females

• Females: you must use an effective method of contraception during and for 6 months after end of treatment, because Fludarabine Ebewe may be harmful for the unborn baby.
• Males: you are advised not to father a child during and after end of treatment and to seek advice on conservation of sperm prior to treatment because Fludarabine Ebewe may alter male fertility.
• Individual genetic counselling is required for male and female patient before start of Fludarabine Ebewe treatment.

3. What if I am taking other medicines?

Tell your doctor or pharmacist if you are taking any other medicines, including any medicines, vitamins or supplements that you buy without a prescription from your pharmacy, supermarket or health food shop.

Some medicines may interfere with Fludarabine Ebewe and affect how it works. These include:

• Pentostatin (deoxycoformycin) also used to treat B-CLL. Taking these two drugs together can lead to severe lung problems.
• Cytarabine (Ara-C) used to treat chronic lymphatic leukaemia
• Dipyridamole, used to prevent excessive blood clotting, or other similar drugs
• Live viral vaccines. It is recommended that patients do not receive live viral vaccines during and after treatment with Fludarabine Ebewe.

Check with your doctor or pharmacist if you are not sure about what medicines, vitamins or supplements you are taking and if these affect Fludarabine Ebewe.

4. How do I use Fludarabine Ebewe?

How much is given

• The dosage of Fludarabine Ebewe that is correct for you will be exactly worked out by your specialist.
• Because of the complexity of CLL and the possible side effects of Fludarabine Ebewe, it should only be prescribed by specialist doctors with experience with similar medications.
• If you have any concerns about the dosage you receive, ask your doctor.

How is Fludarabine Ebewe given

• Fludarabine Ebewe must only be given by a doctor or nurse.
• Fludarabine Ebewe is injected into a vein (often in the arm) once each day for 5 consecutive days. This 5 day course is then repeated once every 28 days.

If you are given too much Fludarabine Ebewe

Your doctor will decide what dose of Fludarabine Ebewe you need, and this will be administered in the clinic or hospital under close supervision from nursing and medical staff.

The dose is determined by your weight and height. The risk of overdose in these circumstances is low. In the event of overdose occurring, your doctor will stop the therapy and decide on the necessary treatment. If you think that you have been given too much Fludarabine Ebewe, you may need urgent medical attention. Overdose can cause delayed blindness, coma and even death.

You should immediately:

• phone the Poisons Information Centre
  (by calling 13 11 26), or
• contact your doctor, or
• go to the Emergency Department at your nearest hospital.

You should do this even if there are no signs of discomfort or poisoning.

5. What should I know while using Fludarabine Ebewe?

Things you should do

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

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.

Females: you must not become pregnant during treatment with Fludarabine Ebewe and must use an effective method of contraception during and for 6 months after end of treatment, because Fludarabine Ebewe may be harmful for the unborn baby. If pregnancy occurs during your treatment, you must immediately inform your doctor.

Males: you are advised not to father a child during and after end of treatment and to seek advice on conservation of sperm prior to treatment because Fludarabine Ebewe may alter male fertility.

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 Fludarabine Ebewe.

Call your doctor straight away if you:

• Notice anything new or unusual on your skin, suggestive of skin cancer
• If you have or have had skin cancer it may worsen or flare up again while you take Fludarabine Ebewe or afterwards. You may develop skin cancer during or after Fludarabine Ebewe therapy as it reduces your body’s defence mechanisms.

Remind any doctor, dentist or pharmacist you visit that you are using Fludarabine Ebewe.

Things you should not do

• Fludarabine Ebewe must not be administered if you are pregnant unless clearly indicated by your doctor
• Do not use Fludarabine Ebewe to treat any other complaints unless your doctor tells you to
• Do not give this medicine to anyone else, even if they have the same condition as you
• Do not take any additional medicines without the advice of your doctor or pharmacist
• If you stop getting it administered suddenly, your condition may worsen.

Driving or using machines

Be careful before you drive or use any machines or tools until you know how Fludarabine Ebewe affects you.

Fludarabine Ebewe may cause fatigue, weakness, visual disturbances, confusion, agitation and whist 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.

Drinking alcohol

Tell your doctor if you drink alcohol.

Looking after your medicine

Fludarabine Ebewe will be stored appropriately at the pharmacy or on the ward. The injection is kept in a refrigerator where the temperature stays between 2°C and 8°C.

Store it in a cool dry place away from moisture, heat or sunlight; for example, do not store it:

• in the bathroom or near a sink, or
• in the car or on window sills.

Keep it where young children cannot reach it.

Getting rid of any unwanted medicine

If you no longer need to use this medicine or it is out of date, take it to any pharmacy for safe disposal.

Do not use this medicine after the expiry date.

6. Are there any side effects?

All medicines can have side effects. If you do experience any side effects, most of them are minor and temporary. However, some side effects may need medical attention.

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

See the information below and, if you need to, ask your doctor or pharmacist if you have any further questions about side effects.

Less serious side effects

Less serious side effects

What to do

Infections with symptoms of: Fever Severe chills Sore throat Mouth ulcers Symptoms of anaemia such as: Tiredness Headaches Being short of breath when exercising Dizziness Looking pale Other: Some bruising Loss of appetite leading to weight loss Numbness or weakness in the arms and legs Cough Nausea, vomiting, diarrhoea Sore mouth or gums Weakness and/or generally feeling unwell Swelling due to excessive fluid retention

Speak to your doctor if you have any of these less serious side effects and they worry you.

Serious side effects

Serious side effects

What to do

Bleeding related Severe bruising More bleeding than usual after injury Vomiting blood or material that looks like coffee grounds, bleeding from the back passage, black sticky bowel motions (stools) or bloody diarrhoea Infection related You seem to be catching a lot of infections Symptoms of pneumonia such as fever, chills, shortness of breath, cough and phlegm that may be blood stained Eyes related Visual disturbances Sudden dimming or loss of vision Allergy related Sudden signs of allergy such as rash, itching or hives on the skin, swelling of the face, lips, tongue or other parts of the body, shortness of breath, wheezing or trouble breathing Skin related Anything new or unusual on your skin such as mole, freckle or sore; a spot, mole or freckle that has changed in colour, shape or size Red to brownish urine, rash or any blisters on your skin Signs of Stevens-John syndrome, such as skin and/or mucous membrane reaction with redness, inflammation, blistering and erosion Signs of toxic epidermal necrolysis which starts with painful red areas, then large blisters and ends with peeling of layers of skin. This is accompanied by fever and chills, aching muscles and generally feeling unwell Head or neurology related Seizures, unconsciousness Neurological disorders manifested by headache, feeling sick (nausea) and vomiting, seizures, visual disturbances including vision loss, changes in mental status (thinking abnormal, confusion, altered consciousness), and occasionally neuromuscular disorders manifested by muscle weakness in your limbs (including irreversible partial or complete paralysis) (symptoms of leukoencephalopathy, acute toxic leukoencephalopathy or posterior reversible leukoencephalopathy syndrome (RPLS)) Heart related Symptoms of heart disease such as shortness of breath, and swelling of the feet or legs due to fluid build-up Abnormal heartbeat (irregular, fast or slow) Lungs related Difficulty breathing, shortness of breath, severe cough, sharp chest pains Bleeding in the lungs Others Signs of tumour lysis syndrome such as pain in one side of the body under the rib cage, little or no urine, drowsiness, nausea, vomiting, breathlessness, irregular heart beat, loss of memory, loss of consciousness Inflammation of the bladder, which can cause pain when passing urine, and can lead to blood in the urine (haemorrhagic cystitis)

Call your doctor straight away, or go straight to the Emergency Department at your nearest hospital if you notice any of these serious side effects.

Tell your doctor or pharmacist if you notice anything else that may be making you feel unwell.

Other side effects not listed here may occur in some people.

Keep all doctor’s 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.

Reporting side effects

After you have received medical advice for any side effects you experience, you can report side effects to the Therapeutic Goods Administration online at www.tga.gov.au/reporting-problems. By reporting side effects, you can help provide more information on the safety of this medicine.

Always make sure you speak to your doctor or pharmacist before you decide to stop taking any of your medicines.

7. Product details

This medicine is only available with a doctor’s prescription.

What Fludarabine Ebewe contains

Active ingredient (main ingredient)	Fludarabine phosphate (50mg in 2mL)
Other ingredients (inactive ingredients)	dibasic sodium phosphate dihydrate nitrogen sodium hydroxide water for injections

Do not take this medicine if you are allergic to any of these ingredients.

What Fludarabine Ebewe looks like

Fludarabine Ebewe – clear, colourless to almost colourless solution, in a clear glass vial. Pack size of 1, 5 and 10 vials (Aust R 135540).

Who distributes Fludarabine Ebewe

Sandoz Pty Ltd
ABN 60 075 449 553
54 Waterloo Road
Macquarie Park, NSW 2113
Tel: 1800 726 369

This leaflet was prepared in March 2023.