How does it work?

Fludarabine phosphate is one of a group of anti-cancer medicines called 'cytotoxic antimetabolites'. Cancers form when cells within the body multiply abnormally and uncontrollably. These cells then spread and destroy nearby tissues. Fludarabine works by slowing down the process of cell multiplication. It does this by disturbing the production of a component of DNA and RNA, the genetic material of the cell. Both DNA and RNA are needed for the growth and multiplication of cells, so fludarabine prevents cancer cells spreading, and also kills them by causing abnormal growth. Unfortunately, fluorouracil also affects normal, healthy cells, in particular those that multiply quickly. It can therefore produce serious side effects during long-term treatment. Although the aim of treating leukaemia with fludarabine is to kill the cancerous blood cells, the most important side effect is on the bone marrow, where blood cells are made. Fludarabine decreases the production of normal blood cells, which can leave people susceptible to infection. Fludarabine is, therefore, only used to treat chronic lymphocytic leukaemia in people with sufficient bone marrow reserve. Regular blood tests are needed to monitor the levels of blood cells. Fludarabine phosphate can be given either by injection or slow infusion into the veins (intravenously), or by mouth as tablets. It is used when leukaemia has not responded to, or has progressed, during treatment with another type of anti-cancer medicine called an alkylating agent, eg chlorambucil.

What is it used for?

Chronic lymphocytic leukaemia

Warning!

It is recommended that regular blood tests are performed to check levels of the blood components.

There is insufficient information regarding the safety and efficacy of this medicine in children. It is not recommended for children.

Women who are pregnant should not handle this medicine.

Handle this medicine with care; avoid direct contact with bare skin

Effective contraception should be used by women who themselves, or whose male partners, are receiving treatment with this medicine. Contraception should be continued for at least 6 months after the medicine is stopped. Consult your doctor immediately if you become pregnant.

Swallow these tablets whole with water - do not chew, crush or break them.

Use with caution in

Anaemia

Decreased blood cell production by the bone marrow

Decreased liver function

Elderly people over 75 years

History of infections that occur when the resistance of the body is low (opportunistic infections)

Lower than normal numbers of certain white blood cells in the blood (granulocytopenia)

People who are receiving blood transfusions

People whose immune systems have a decreased ability to fight infection and disease, eg due to diseases such as leukaemia, lymphoma, HIV infection or immunodeficiency syndromes

Reduced platelet count in the blood

Skin cancer

Not to be used in

Breastfeeding

Decreased kidney function

Decreased numbers of red blood cells in the bloodstream caused by an increase in their breakdown (haemolytic anaemia)

Pregnancy

This medicine should not be used if you are allergic to one or any of its ingredients. Please inform your doctor or pharmacist if you have previously experienced such an allergy. If you feel you have experienced an allergic reaction, stop using this medicine and inform your doctor or pharmacist immediately.

Pregnancy and Breastfeeding

Certain medicines should not be used during pregnancy or breastfeeding. However, other medicines may be safely used in pregnancy or breastfeeding providing the benefits to the mother outweigh the risks to the unborn baby. Always inform your doctor if you are pregnant or planning a pregnancy, before using any medicine.

This medicine should not be used during pregnancy as it may be harmful to the unborn baby. Seek medical advice from your doctor.

It is not known whether this medicine passes into breast milk. Mothers who need to take this medicine should not breastfeed. Seek medical advice from your doctor.

Side effects

Medicines and their possible side effects can affect individual people in different ways. The following are some of the side effects that are known to be associated with this medicine. Because a side effect is stated here, it does not mean that all people using this medicine will experience that or any side effect.

Rash

Diarrhoea

Fatigue

Decreased production of blood cells by the bone marrow (bone marrow suppression)

Increased susceptibility to infections

Fever (pyrexia)

Disorder of the peripheral nerves causing weakness and numbness (peripheral neuropathy)

Nausea and vomiting

Scarring and stiffening of the lungs causing breathlessness (pulmonary fibrosis)

Loss of appetite

Excessive fluid retention in the body tissues, resulting in swelling (oedema)

Blindness

Coma

Pneumonia

Inability of the heart to pump blood efficiently (heart failure)

Visual disturbances

Excessive breakdown of red blood cells that reduces red blood cell count (haemolytic anaemia)

The side effects listed above may not include all of the side effects reported by the drug's manufacturer. For more information about any other possible risks associated with this medicine, please read the information provided with the medicine or consult your doctor or pharmacist.

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