How does it work?

Fludara tablets and injection contain the active ingredient fludarabine phosphate, which is a type of chemotherapy medicine for cancer known as a 'cytotoxic antimetabolite'.

Cancers form when cells within the body multiply abnormally and uncontrollably. These cells spread, destroying nearby tissues. Fludarabine works by stopping the cancer cells from multiplying. It does this by inhibiting the production of the cells' genetic material, DNA and RNA. Both DNA and RNA are needed for growth and multiplication of cells. Fludarabine causes a deficiency of DNA and RNA in the cancer cells, and this causes the cells to grow in an unbalanced way, resulting in the death of the cells.

In most chemotherapy regimens, doses are administered in courses at various intervals to allow normal cells to recover from the adverse effects of the anticancer medicines between doses. However, during this period, cancer cells will also recover and start to replicate again. Successful treatment depends on the administration of the next course of therapy before the cancer has regrown to its previous size and the net effect is to decrease the amount of cancer with each successive course.

Fludarabine is used to treat a type of cancer of the white blood cells called chronic lymphocytic leukaemia (CLL).

Unfortunately, fludarabine can also affect normal, healthy cells, particularly those that multiply quickly, such as healthy blood cells. 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 also 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 who have enough healthy cells remaining in their bone marrow. Regular blood tests are needed to monitor the levels of blood cells.

Fludarabine phosphate can be given either by injection or slow infusion (drip) into the veins (intravenously), or by mouth as tablets.

What is it used for?

• Chronic lymphocytic leukaemia

Warning!

• Fludara tablets should be swallowed whole with water; they should not be broken or chewed. The tablets should not be handled by pregnant women.
• It is important to drink plenty of fluid while having treatment with this medicine.
• Chemotherapy medicines can decrease the number of blood cells in your blood. A low white blood cell count can increase your susceptibility to infections; a low red blood cell count causes anaemia and a low platelet count can cause problems with blood clotting. For this reason, you will need regular blood tests to monitor your blood cells during treatment with this medicine. Tell your doctor immediately if you experience any of the following symptoms during your treatment, as they may indicate problems with your blood cells: unexplained bruising or bleeding, purple spots, sore mouth or throat, mouth ulcers, high temperature (fever) or other signs of infection, or suddenly feeling tired, breathless, or generally unwell.
• Tell your doctor if you get any of the following side effects while having treatment with this medicine: cough, feeling breathless or wheezy, disturbance in your vision, blood in your urine, pain on passing urine, pain in your side, confusion or agitation.
• People who need a blood transfusion during treatment with this medicine should receive irradiated blood only.
• Your ability to become pregnant or father a child may be affected by taking this drug. It is important to discuss fertility with your doctor before starting treatment.
• There is insufficient information regarding the safety and efficacy of this medicine in children. It is not recommended for children.

Use with caution in

• People aged over 75 years
• Decreased kidney function
• Decreased liver function
• Anaemia
• Reduced platelet count in the blood (thrombocytopenia)
• Reduced numbers of white blood cells in the blood (granulocytopenia)
• People whose immune systems have a decreased ability to fight infection and disease, eg due to HIV infection or immunodeficiency syndromes
• History of infections that occur when the resistance of the body is low (opportunistic infections)
• Skin cancer

Not to be used in

• Moderate to severely decreased kidney function
• Decreased numbers of red blood cells in the bloodstream caused by an increase in their breakdown (haemolytic anaemia)
• Pregnancy
• Breastfeeding

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 must not be used during pregnancy, as it may be harmful to the unborn baby. In addition, pregnant women should not handle this medicine. Women who could get pregnant should use effective contraception to prevent pregnancy, and men should use effective contraception to prevent fathering a child, both during treatment, and for at least six months after treatment is finished. Seek medical advice from your doctor. Consult your doctor immediately if you become pregnant.
• This medicine may pass into breast milk. Mothers who need 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.

• Decrease in the number of white blood cells in the blood (neutropenia)
• Decrease in the number of platelets in the blood (thrombocytopenia)
• Decrease in the number of red blood cells in the blood (anaemia)
• Infections
• Pneumonia
• Nausea and vomiting (more likely with Fludara tablets than injection)
• Diarrhoea
• Fever (pyrexia)
• Inflammation of the lining of the mouth (stomatitis)
• Fatigue
• Weakness
• Loss of appetite
• Excessive fluid retention in the body tissues, resulting in swelling (oedema)
• Visual disturbances
• Disorder of the peripheral nerves causing weakness and numbness (peripheral neuropathy)
• Skin rashes
• Tumour lysis syndrome, where the body is unable to cope with all the waste products of the cancer cells killed by this medicine. This may lead to abnormal levels of salts in your blood and possibly kidney failure.
• Changes to the lungs, such as inflammation or stiffening
• Inability of the heart to pump blood efficiently (heart failure)
• Abnormal heart beats (arrhythmias)

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.

How can this medicine affect other medicines?

It is important to tell your doctor or pharmacist what medicines you are already taking, including those bought without a prescription and herbal medicines, before you start treatment with this medicine. Similarly, check with your doctor or pharmacist before taking any new medicines during treatment this one, to ensure that the combination is safe.

Chemotherapy decreases the body's immune response. This means that vaccines may be less effective if given during treatment, and live vaccines may cause serious infections. Live vaccines include: measles, mumps, rubella, MMR, oral polio, oral typhoid and yellow fever. If live vaccines are needed they should be postponed until at least six months after finishing chemotherapy.

The efficacy of fludarabine may be reduced by dipyridamole.

If pentostatin is taken with fludarabine there may be an increased risk of lung damage, which may be fatal. This combination is not recommended.

Other medicines containing the same active ingredient

There are currently no other medicines available in the UK that contain fludarabine as the active ingredient.