Patient Leaflet Updated 09-Apr-2024 | SANOFI
Fludara 50mg powder for solution for injection or infusion
Fludara 50 mg powder for solution for injection or infusion
Fludarabine phosphate
1. What Fludara is and what it is used for
2. What you need to know before you are given Fludara
3. How to use Fludara
4. Possible side effects
5. How to store Fludara
6. Contents of the pack and other information
Fludara contains the active substance fludarabine phosphate which stops the growth of new cancer cells. All cells of the body produce new cells like themselves by dividing. Fludara is taken up by the cancer cells and stops them dividing.
In cancers of the white blood cells (such as chronic lymphocytic leukaemia), the body produces 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 the normal disease fighting functions and may push aside healthy blood cells. This can result in infections, a decrease in number of red blood cells (anaemia), bruising, severe bleeding or even organ failure.
Fludara is used in the treatment of B-cell chronic lymphocytic leukaemia (B-CLL) in patients with sufficient healthy blood cell production.
First treatment for chronic lymphocytic leukaemia with Fludara should only be started in patients with advanced disease having disease-related symptoms or evidence of disease progression.
Tell your doctor, if you think any of these may apply to you.
Talk to your doctor before using Fludara.
Take special care with Fludara:
Your doctor may decide to not give you this medicine, or may take precautions.
Tell your doctor immediately
These may be signs of a reduction in the number of blood cells, which may be caused either by the disease itself or the therapy. It can last for up to a year, independent of whether or not you had treatment with Fludara before. During treatment with Fludara also your immune system may attack different parts of your body, or your red blood cells (called ‘autoimmune disorders’). These conditions can be life-threatening.
If this occurs your doctor will stop your treatment and you may receive further medication such as transfusion of irradiated blood (see below) and adrenocorticoids.
You will have regular blood tests during treatment and you will be closely monitored while you are being treated with Fludara.
If Fludara is used for a long time, its effects on the central nervous system are not known. However patients treated with the recommended dose for up to 26 courses of therapy were able to tolerate it.
When Fludara is used at the recommended dose, following the treatment with some other medications or at the same time as some other medications, the following adverse events have been reported: 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)).
In patients on doses four times greater than recommended blindness, coma and death have been reported. Some of these symptoms appeared delayed around 60 days or more after treatment had been stopped. In some patients receiving Fludara doses higher than the recommended dose, leukoencephalopathy (LE), acute toxic leukoencephalopathy (ATL) or posterior reversible leukoencephalopathy syndrome (RPLS) have also been reported. Same symptoms of LE, ATL or RPLS as above described could occur.
LE, ATL, and RPLS may be irreversible, life-threatening, or fatal.
Whenever LE, ATL or RPLS is suspected, your treatment will Fludara will be stopped for further investigations. If the diagnosis of LE, ATL, or RPLS is confirmed, you doctor will permanently discontinue your treatment with Fludara.
When your disease is very severe, your body may not be able to clear all the waste products from the cells destroyed by Fludara. This is called tumour lysis syndrome and can cause kidney failure and heart problems from the first week of treatment. Your doctor will be aware of this and may give you other medicines to help prevent it.
In case you need a blood transfusion your doctor will ensure that you only receive blood that has been treated by irradiation. There have been severe complications and even death, from transfusions of non-irradiated blood.
The safety and effectiveness of Fludara in children below the age of 18 years has not been established.
Therefore, Fludara is not recommended for use in children.
People over 65, will have regular tests for kidney function (see also section 3. How to use Fludara).
People over 75, will be monitored especially closely.
Tell your doctor if you are taking, have recently taken or might take any other medicines, including medicines obtained without a prescription.
It is especially important to tell your doctor about:
Pregnancy
Females: you must not become pregnant during treatment with Fludara 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. Your doctor will decide with you whether you should carry on taking Fludara.
Breast-feeding:
You must not breast-feed while you are treated with Fludara.
Fertility in males and females
Females: you must use an effective method of contraception during and for 6 months after end of treatment, because Fludara may be harmful for the unborn baby.
Males: You are advised not to father a child and must use an effective method of contraception during and at least for 3 months after end of treatment. You should seek advice on conservation of sperm prior to treatment because Fludara may alter male fertility.
Both men and women who are planning to have a child after treatment are advised to talk to a doctor before start of Fludara treatment.
Some people get tired, feel weak, have disturbed vision, become confused, or agitated or have seizures while they are treated with Fludara. Do not try to drive or operate machines until you are sure that you are not affected.
This medicine contains less than 1mmol sodium per dose, i.e, essentially sodium free.
Fludara should be administered under the supervision of a qualified doctor experienced in the use of anti-cancer therapy.
The dose you are given 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 fludarabine phosphate/m2 body surface area.
Fludara is given in the form of a solution as an injection or mostly as an infusion.
An infusion means that the medicine is given directly into the blood stream by a drip through a vein.
One infusion takes approximately 30 minutes.
Your doctor will make sure that Fludara is not given beside the vein (paravenously). However, if this happens, no severe local adverse events have been reported.
The dose will be given once a 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).
How long the treatment lasts depends on how successful your treatment is and how well you tolerate Fludara. The repeat course may be delayed if side effects are a problem.
You will have regular blood tests during your treatment. Your individual dose will be carefully adjusted according to the number of your blood cells and your response to the therapy. The dosage may be decreased if side effects are a problem.
If you have kidney problems or if you are over the age of 65, you will have regular tests to check your kidney function. If your kidneys do not work properly you may be given this medicine at a lower dose. If your kidney function is severely reduced you will not be given this medicine at all (see section 2).
If any of the Fludara 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 plenty of tap water. Avoid any exposure by inhalation.
If you may have received an overdose your doctor will stop the therapy and treat the symptoms. High doses can lead to a severely reduced number of blood cells.
For Fludara given intravenously it has been reported, that overdose can cause delayed blindness, coma and even death.
Your doctor will set the times at which you are to receive this medicine. Talk to your doctor as soon as possible, if you think you may have missed a dose.
You and your doctor may decide to stop your treatment with Fludara if the side effects are becoming too severe.
If you have any further questions on the use of this medicine, ask your doctor or pharmacist.
Like all medicines, this medicine can cause side effects, although not everybody gets them. If you are not sure what the side effects below are, ask your doctor to explain them to you.
Some side effects can be life-threatening. Tell your doctor immediately:
Very common side effects (may affect more than 1 in 10 people)
Common side effects (may affect up to 1 in 10 people)
Uncommon side effects (may affect up to 1 in 100 people)
Rare side effects (may affect up to 1 in 1,000 people)
Not known (frequency cannot be estimated from available data)
If you get any side effects, talk to your doctor or pharmacist. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme at: www.mhra.gov.uk/yellowcard or search for MHRA Yellow Card in the Google Play or Apple App Store. By reporting side effects you can help provide more information on the safety of this medicine.
Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date which is stated on the carton and vial label after “EXP”.
The expiry date refers to the last day of that month.
Unopened vials
This medicine does not require any special storage conditions.
Reconstituted and diluted solutions
Reconstituted Fludara should be used immediately or within 8 hours of reconstitution if stored at room temperature, or within 24 hours if stored at 2 °C to 8 °C.
Fludara is a sterile white powder for solution for injection or infusion provided in 10 ml glass vials.
The powder is reconstituted with water for injection and further diluted. The reconstituted solution is clear and colourless.
Fludara is available in packs containing 5 vials.
Marketing Authorisation Holder
Manufacturer
This leaflet was last revised in
July 2023
Local representative:
Sanofi, 410 Thames Valley Park Drive, Reading, Berkshire, RG6 1PT, UK
+44 (0)800 035 2525