Fludarabine Actavis 50mg Lyophilisate
For Solution For Injection Or Infusion
Fludarabine phosphate
Read all of this leaflet carefully before you start using this medicine.
- Keep this leaflet. You may need to read it again.
- If you have any further questions, ask your doctor.
- This medicine has been prescribed for you. Do not pass it on to others. It may harm them, even if their symptoms are the same as yours.
- If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
In this leaflet:
- 1. What Fludarabine Actavis is and what it is used for
- 2. Before you use Fludarabine Actavis
- 3. How to use Fludarabine Actavis
- 4. Possible side effects
- 5. How to store Fludarabine Actavis
- 6. Further information
What Fludarabine Actavis Is And What It Is Used For
Fludarabine Actavis is an anti-cancer drug.
Fludarabine Actavis is used to treat chronic B-cell lymphocytic leukaemia (B-CLL) in patients with sufficient healthy blood cell production. This is a type of cancer of white blood cells (the cells are called lymphocytes).
First treatment for chronic lymphocytic leukaemia with Fludarabine Actavis should only be started in patients with advanced disease having disease related symptoms or evidence of disease progression.
All cells of the body produce new cells like themselves by dividing. For this purpose, the cell’ genetic material (DNA) must be copied and reproduced. Fludarabine Actavis works by hindering the production of new DNA. Therefore, when Fludarabine Actavis is taken up by the cancer cells, it stops the growth of new cancer cells.
In cancers of the white blood cells (as chronic lymphocytic leukaemia) many abnormal lymphocytes are produced. The abnormal lymphocytes either do not work properly or are too young (immature) to carry out the normal disease fighting functions of white blood cells. If there are too many of these abnormal lymphocytes, they push aside healthy blood cells in the bone marrow where most of the new blood cells are formed. Without enough healthy blood cells, infections, anaemia, bruising, excessive bleeding or even organ failure can result.
Before You Use Fludarabine Actavis
Do not use Fludarabine Actavis
- if you are allergic (hypersensitive) to fludarabine phosphate or any of the other ingredients of Fludarabine Actavis.
- if you are pregnant or breast feeding
- if your kidney function is severely impaired
- if you have a low number of red blood cells (haemolytic anaemia). Your doctor will have told you if you have this condition.
Take special care with Fludarabine Actavis
- If you are not feeling very well you should tell your doctor, as your doctor may decide not to give you this medicine, or may give you this medicine with caution. This is very important if your bone marrow is not working properly or if you are susceptible to infections.
- If you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections, tell your doctor. The number of normal blood cells may be reduced and so you will have regular blood tests during treatment.
- The disease itself and the therapy may cause a reduction of the number of blood cells and your immune system may attack different parts of your body (called ‘autoimmune phenomenon’). It may also be directed against your red blood cells (called ‘autoimmune haemolysis’). This condition can be life threatening. If this condition occurs you may receive further medication such as transfusion of blood (irradiated, see below) and corticosteroides.
- If you need a blood transfusion and you are being (or have been) treated with this medicine, you should mention this to the doctor. Your doctor will ensure that you receive blood only, which has gone through a special treatment (irradiation). There have been severe complications and even death reported when non-irradiated blood has been given.
- If you need to have stem cells collected and you are being (or have been) treated with this medicine, you should mention this to the doctor.
- If your liver does not work properly, your doctor may give you this medicine with caution.
- If you have any form of kidney disease or if you are over 70 years old, your kidney function should be checked regularly. If it is found that your kidneys do not work properly you may be given this medicine at a reduced dose. If your kidneys work at only a very low level you will not be given this medicine at all.
- There is little information on the effects of Fludarabine Actavis in patients aged 75 years and older. Your doctor will use it with caution if you are in this age group.
- If you have very severe chronic lymphocytic leukaemia, your body may not be able to get rid of all the waste products from the cells destroyed by Fludarabine Actavis. This may cause dehydration, kidney failure and heart problems. Your doctor will be aware of this and may give you other medicines to stop this happening.
- If you experience any unusual symptoms from the nervous system you should mention it to your doctor. This is because when used in patients at doses four times greater than the recommended dose, severe central nervous system (brain and spinal cord) effects including blindness, coma and death have been reported.
- If you have skin cancer, the damaged areas of your skin may become worse when you use this medicine. Tell your doctor if you notice any changes to your skin either while you are receiving this medicine or after you have finished the course of therapy.
- Men, and women who may still be fertile, must use a reliable form of contraception during, and for at least 6 months after stopping treatment.
- Check with your doctor about any vaccinations you may need, because live vaccinations should be avoided during and after treatment with Fludarabine Actavis.
Using other medicines
Please tell your doctor if you are taking or have recently taken any other medicines, including medicines obtained without a prescription. This is especially important if you are taking a drug called pentostatin or deoxycoformycin (also used to treat chronic lymphocytic leukaemia) as a combination with Fludarabine Actavis is not recommended. Some drugs, e.g. dipyridamole (used to prevent excessive blood clotting) may reduce the effectiveness of Fludarabine Actavis.
Pregnancy and breast-feeding
Ask your doctor or pharmacist for advice before taking any medicine.
You must not be given Fludarabine Actavis if you are pregnant because animal studies and limited experience in humans have shown a possible risk of abnormalities in the developing foetus. If you are a woman who may still be fertile, you must avoid becoming pregnant during treatment and for at least 6 months after stopping treatment. However, if you do become pregnant inform your doctor immediately.
Men who are treated with Fludarabine Actavis and can father a child must use a reliable form of contraception during, and for at least 6 months after stopping treatment.
It is not known if this medicine appears in the breast milk of women treated with Fludarabine Actavis. However, in animal studies the medicinal product was found in breast milk. Therefore you must not breast feed during your treatment with this medicine.
Driving and using machines
The effect of treatment with Fludarabine Actavis on the ability to drive or use machines has not been evaluated. Fludarabine Actavis may although influence the ability to drive and use machineries since side effects like tiredness, weakness, agitation, seizures and visual disturbances have been observed.
Important information about some of the ingredients of Fludarabine Actavis
This medicine contains less than 1 mmol sodium (23mg) per ml, i.e. essentially ‘sodium-free’.
How To Use Fludarabine Actavis
Fludarabine Actavis should be administered under the supervision of a qualified doctor experienced in cancer therapy.
The dose you are given depends on the size of your body. It varies with your body surface area. Technically this is measured in square metres, but actually is worked out from your height and weight. The recommended dose is 25mg per square metre of body surface. This will be given either as an injection or as an infusion (with a drip) into a vein once a day for 5 consecutive days every 28 days. This five day course of treatment will be repeated every 28 days until your doctor has decided that the best effect has been achieved.
The dosage may be decreased or the repeat course delayed if side effects are a problem. If you have kidney problems you will receive a reduced dose and you will have regular blood tests.
The safety of this drug in children has not been established.
If any of the Fludarabine Actavis solution comes into contact with your skin or the lining of your nose or mouth, wash the area thoroughly with soap and water. If the solution gets into your eyes, rinse them thoroughly with lots of water. Try not to breathe in any fumes coming from the solution.
If you use more Fludarabine Actavis than you should
In the case of an overdose your doctor will stop the therapy and treat the symptoms.
Symptoms of an overdose can be blindness which may not appear until later, coma and death due to irreversible toxicity to the central nervous system. High doses can also lead to a severly reduced number of blood cells.
If you forget to use Fludarabine Actavis
Your doctor will set the times at which you are to receive this medicine. If you think you may have missed a dose, contact your doctor as soon as possible.
If you have any further questions on the use of this product, ask your doctor or pharmacist.
Possible Side Effects
Like all medicines, Fludarabine Actavis can cause side effects, although not everybody gets them.
Below is a list of possible side effects classified by the parts of the body they affect and by how common they are.
Common means less than 1 in 10 but more than 1 in every 100 people are likely to get these. Uncommon means less than 1 in every 100 but more than 1 in 1,000 people are likely to get these. Rare means less than 1 in every 1,000 people are likely to get these.
Body as a whole
Common: Fever, chills, infection, general feeling unwell, weakness and feeling tired (fatigue).
Heart
Rare: Heat failure, abnormal heart beat (arrhythmia). If you have chest pain or suddenly become aware of your heart beat (palpitations), tell your doctor immediately.
Blood production and lymph system
A reduction in the number of blood cells (anaemia, low numbers of red blood cells, neutropenia, low numbers of white blood cells, and thrombocytopenia, low numbers of blood clotting factors called platelets) occurs in most patients treated with this medicine.
Uncommon: During or after use of this medicine your immune system may attack different parts of your body (called ‘autoimmune phenomenon’), and it may also be directed against your red blood cells (called ‘autoimmune haemolysis’), see also section “Take special care with Fludarabine Actavis”.
Rare: Myelodysplastic syndrome: In a small percentage of cancer patients treated with fludarabine phosphate other types of cancer have developed that relate to the blood (myelodysplastic syndrom (MDS)). The majority of patients with this cancer were previously, or at the same time or later treated with cancer drugs (alkylating agents) or received radiation therapy. It is well known that in such cases there is a risk for secondary cancers. If Fludarabine Actavis was given as the only therapy, development of MDS was not increased.
In rare cases, the production of blood cells is severely reduced, but most of these patients received other cancer treatments before or with this medicine. This may lead to an increased risk of (serious) infections, caused by organisms, that usually do not cause disease in healthy persons.
Tell your doctor immediately:
- if you feel unusually tired or breathless
- if you notice any unusual bruising or excessive bleeding after injury
- if you seem to be catching a lot of infections or
- if you have a rash or any blisters on your skin.
Nervous system
Common: Numb or weak limbs (peripheral neuropathy).
Uncommon: Confusion.
Rare: Agitation, coma and seizures.
Eye disorders
Common: Disturbed vision.
Rare: Pain in eyes (optic neuritis, optic neuropathy), blindness.
Respiratory disorders
Common: Inflammation of the lung (pneumonia).
Uncommon: Other allergic type reactions in the lungs (pulmonary hypersensitivity) associated with shortness of breath and cough. If you experience any difficulty in breathing, have a cough or have chest pain tell your doctor immediately.
Digestive system
Common: Feeling sick (nausea), being sick (vomiting), loss of appetite, diarrhoea, inflammation of the lining of the mouth (stomatitis).
Uncommon: Bleeding in the stomach or intestines.
Kidney and urinary disorders
Rare: Inflammation of the bladder (cystitis), which can cause pain when passing urine, and can lead to blood in the urine.
Skin and subcutaneous disorders
Common: Skin rashes
Rare: Red, blistered, broken and/or inflamed skin (Stevens-Johnson syndrome or toxic epidermal necrolysis (Lyell’s syndrome)).
Metabolic and nutritional disorders
Common: Swelling in parts of the body due to fluid retention (oedema).
Uncommon: Changes in the proteins (enzymes) found in your liver or pancreas. A condition called tumour lysis syndrome may occur where the body is unable to cope with all the waste products of the cells killed by Fludarabine Actavis. This may lead to abnormal levels of waste products in your blood and possibly kidney failure. If you notice a pain in your side or blood in your urine, tell your doctor immediately.
If any side effects get serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.
How To Store Fludarabine Actavis
Keep out of the reach and sight of children.
Store below 25°C.
Do not use Fludarabine Actavis after the expiry date which is stated on the carton and vial after EXP.
Further Information
What Fludarabine Actavis contains
- The active substance is fludarabine phosphate
- The other ingredients are mannitol and sodium hydroxide.
What Fludarabine Actavis looks like and contents of the pack
Each vial contains 50mg fludarabine phosphate as a powder for injection or infusion. The powder will be made up into a solution before it is given to you. 1 ml of reconstituted solution contains 25mg fludarabine phosphate.
Pack sizes
1 x 50mg vial
5 x 50mg vial
Not all pack sizes may be marketed.
Marketing Authorisation Holder
Manufacturer
This medicinal product is authorised in the Member States of the EEA under the following names:
Belgium: Fludarabin Actavis 50 mg poeder voor oplossing voor injectie
Czech Republic: Fludarabin Actavis 50 mg
Germany: Fludarabin-Actavis 50 mg Pulver zur Herstellung einer Injektions- oder Infusionslösung
Denmark: Fludarabin Actavis
Spain: Fludarabina Actavis 50mg polvo para solución para inyectable o perfusión
Finland: Fludarabin Actavis
Ireland: Fludarabine Actavis 50mg Lyophilisate For Solution For Injection Or Infusion
Iceland: Fludarabin Actavis
Italy: Fludarabina Actavis
Netherlands: Fludarabinefosfaat Actavis 50mg
Norway: Fludarabin Actavis
Portugal: Fludarabina Actavis
Sweden: Fludarabin Actavis
United Kingdom: Fludarabine Actavis 50mg Lyophilisate For Solution For Injection Or Infusion
This leaflet was last revised in February 2008.
If you would like a leaflet with larger text, please contact 01271 311257.
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