A guide to using Fludara
This leaflet gives you some information about Fludara. Please talk to your doctor if you have any questions or worries about your treatment with Fludara either before you start or while you are being treated.
What is chronic Iymphocytic leukaemia?
Fludara is used to treat chronic Iymphocytic leukaemia (CLL) This is a cancer of the type of white blood cells called lymphocytes Too many lymphocytes are produced and they either don't 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 cells they push aside (displace) healthy blood cells in the bone marrow where most new blood cells are formed and in the blood stream and organs as well Without enough healthy blood cells, infections, anaemia, bruising, excessive bleeding (haemorrhaging) or even organ failure can result
The name of your medicine is: Fludara (fludarabine phosphate)
What does Fludara contain?
Each vial of Fludara contains 50mg fludarabine phosphate (equivalent to 39.05mg fludarabine) in a powder for injection It also contains the inactive ingredients mannitol (E421) and sodium hydroxide
Each pack of Fludara contains 5 x 50mg vials
How does Fludara works?
In order for both normal and leukaemia cells to grow and produce more cells like themselves the cells' genetic material (DNA) must be copied and reproduced Fludara works by interfering with the production of new DNA. Therefore, when Fludara is taken up by the
leukaemia cells it stops the growth of new leukaemia cells
Fludara is a cytotoxic (anti-cancer) drug.
Who is responsible for Fludara?
The product licence is held by:
Schering Health Care Ltd
The Brow, Burgess Hill
West Sussex RH1 5 9NE
Fludara is manufactured on behalf of Schering AG, Berlin, Germany by:
Ben Venue Laboratories Bedford. Ohio, USA
Uses
Fludara is used in the treatment of chronic Iymphocytic leukaemia This is a cancer of the white blood cells called lymphocytes
Fludara is used in patients with chronic Iymphocytic leukaemia if the first treatment has not worked, or has stopped working
Reasons for not using Fludara
If you are pregnant or breast feeding, if you know you are allergic (hypersensitive) to any of the ingredients of this medicine or if your kidneys work at only a very low level you should not be given Fludara
What you should know before you are given Fludara
Fludara should not be used with another drug called pentostatin or deoxycoformycin
The number of normal blood cells may also be reduced and you will have regular blood tests during treatment If you notice any unusual bruising, excessive bleeding after injury or if you seem to be catching a lot of infections tell your doctor. In extremely rare cases death has resulted
from the reduction in red blood cells.
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 Fludara at a reduced dose. If your kidneys work at only a very low level you will not be given Fludara. If you are over 75 years old, Fludara will be given with caution .
If you have very severe chronic Iymphocytic leukaemia your body may not be able to get rid of all the waste products from the cells destroyed by Fludara This may cause dehydration, kidney failure and heart problems Your doctor will be aware of this and may give you other drugs to stop this happening
When used in patients with acute leukaemia at doses four times greater than the recommended dose for chronic Iymphocytic leukaemia a third of patients experienced severe central nervous system (brain and spinal cord) effects including blindness, coma and death Such effects have only very rarely been reported in patients having the recommended dose for chronic Iymphocytic leukaemia However, you should mention to your doctor any unusual symptoms you experience.
The effect on the central nervous system of long-term use of Fludara is unknown but some people have received the recommended dose for up to I 5 courses 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