Fludara sterile lyophilised solid cake for Solution

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 cell’s genetic material (DNA) must be copied and reproduced. FLUDARA is taken up by the cancer cells and hinders the production of new DNA. FLUDARA is used in the treatment of B-cell chronic lymphocytic leukaemia (B-CLL) in patients with sufficient healthy blood cell production.

Your doctor will examine you and ask you about your medical history in order to decide whether you can receive FLUDARA. Do not receive FLUDARA:

• If you are allergic (hypersensitive) to fludarabine phosphate or any of the other ingredients of FLUDARA (see WHAT FLUDARA CONTAINS).
• If you have severely reduced kidney function.
• If the number of your red blood cells is reduced due to breaking down of these cells.

FLUDARA is not recommended for use in children under the age of 18 since it has not been established if it is safe in children and adolescents.

Take special care with FLUDARA:

• If your bone marrow is working very poorly, or if you have a poorly functioning or depressed immune system or a history of infections due to depressed immune system. Tell your doctor if any of the conditions listed above apply before your treatment. Your doctor may decide not to give you FLUDARA, or may give you some additional treatment.
• If you feel unwell, have unusual bruising, more bleeding than usual after an injury, or if you seem to be catching a lot of infections. These may be signs of a reduction in the number of your 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 a treatment with FLUDARA before. You will have regular blood tests during treatment and you will be closely monitored while you are being treated with FLUDARA. Inform your doctor if any of these apply before you start treatment.
• If during treatment your urine turns red to brownish, or you have a rash or any blisters on your skin, inform your doctor immediately.
• During or after treatment with FLUDARA your body may produce an abnormal immune response and may attack substances or tissues normally present in your body (called “autoimmune phenomenon”), or your red blood cells (called “autoimmune haemolysis”). 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.
• If you notice any unusual symptoms of your nervous system such as disturbed vision, headache, confusion or seizures (fits), tell your doctor.

FLUDARA should be administered under supervision of a doctor qualified and experienced in the use of cancer (anti-neoplastic) therapy. The dose you receive depends on how big you are. It varies with your body surface area. This is measured in square meters (m²) and is calculated from your weight and height.

FLUDARA is given in the form of a solution directly in the bloodstream through a vein (as an injection or infusion over approximately 30 minutes). How long the treatment with FLUDARA lasts depends on how successful it is, and how well you tolerate FLUDARA. If side effects are a problem, the repeat course may be delayed and/or the dosage may be decreased. 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 the number of your blood cells is too low, your next treatment cycle may be postponed for up to two weeks or your dose may be decreased.

FLUDARA can have side effects. Not all side effects reported for FLUDARA are included in this leaflet. Should your general health worsen or if you experience any untoward effects while receiving FLUDARA, please consult your doctor qualified and experienced in the use of FLUDARA.

If any of the following happens, stop receiving FLUDARA and tell your doctor immediately or go to the casualty department at your nearest hospital:

• Swelling of the hands, feet, ankles, face, lips, mouth or throat, which may cause difficulty in swallowing or breathing.
• Rash or itching.
• Fainting.
• Yellowing of the skin and eyes, also called jaundice.

These are all very serious side effects. If you have them, you may have had a serious allergic reaction to FLUDARA. You may need urgent medical attention or hospitalisation.

Store at or below 30 °C.

Do not remove from outer carton until required for use.

STORE ALL MEDICINES OUT OF REACH OF CHILDREN.

Do not use after the expiry date printed on the label or carton.

Return all unused medicine to your pharmacist.

Do not dispose of unused medicine in drains and sewerage systems (e.g. toilets).