Fludarabine is used to treat B-cell chronic lymphocytic leukemia (CLL).

Fludarabine is usually given after other treatments have failed.

Fludarabine may also be used for purposes not listed in this medication guide.

In rare cases, fludarabine may cause serious side effects on your nervous system. Seek medical attention right away if you have any numbness or tingling, burning pain, or vision problems.

Fludarabine may also cause serious side effects on your red blood cells. Call your doctor right away if you feel weak or confused, or if you have pale or yellowed skin, or dark urine.

Fludarabine is given as an infusion into a vein. A healthcare provider will give you this injection.

Fludarabine is given in a 28-day treatment cycle. You may need to use the medicine only during the first 5 days of each cycle. Your doctor will determine how long to treat you with fludarabine.

This medicine must be given slowly, and the infusion can take at least 30 minutes to complete.

Fludarabine can be harmful if it gets in your eyes, mouth, or nose, or on your skin. If skin contact occurs, wash the area with soap and water or rinse the eyes thoroughly with plain water.

Fludarabine can increase your risk of bleeding or infection. You will need frequent medical tests. Your cancer treatments may be delayed based on the results.

If you need to have a blood transfusion, tell your caregivers ahead of time that you are being treated with fludarabine.

Usual Adult Dose for Chronic Lymphocytic Leukemia:

25 mg/m2 IV over 30 minutes for 5 days every 28 days; following a maximal tumor response, 3 additional cycles are recommended

Comments:
-The optimal duration of treatment has not been clearly established.
-The dose may be decreased or delayed for hematologic or nonhematologic toxicity.
-Physicians should consider delaying or discontinuing the drug if neurotoxicity occurs.

Use: For the treatment of adult patients with B-cell chronic lymphocytic leukemia (CLL) who have not responded to or whose disease has progressed during treatment with at least one standard alkylating-agent containing regimen; the safety and effectiveness of this drug in previously untreated or nonrefractory patients with CLL have not been established

You should not be treated with fludarabine if you are allergic to it.

Tell your doctor if you have ever had:

• kidney disease;

• bone marrow problems or a weak immune system;

• an infection;

• skin cancer; or

• a viral infection such as herpes zoster (shingles), Epstein-Barr, or a virus affecting the central nervous system.

Fludarabine may harm an unborn baby. Use effective birth control to prevent pregnancy, and tell your doctor if you become pregnant.

You should not breastfeed while you are receiving fludarabine.

Call your doctor for instructions if you miss an appointment for your fludarabine injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include fever, flu-like symptoms, numbness or tingling, vision loss, or loss of consciousness.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Do not receive a "live" vaccine while using fludarabine, and avoid coming into contact with anyone who has recently received a live vaccine. There is a chance that the virus could be passed on to you. Live vaccines include measles, mumps, rubella (MMR), rotavirus, typhoid, yellow fever, varicella (chickenpox), zoster (shingles), and nasal flu (influenza) vaccine.

Get emergency medical help if you have signs of an allergic reaction (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

In rare cases, fludarabine may cause serious side effects on your nervous system. Seek medical attention right away if you have any numbness or tingling, burning pain, or vision problems.

Fludarabine may cause serious side effects. Call your doctor at once if you have:

• agitation;

• sudden chest pain, wheezing, dry cough, feeling short of breath;

• bloody or tarry stools, coughing up blood or vomit that looks like coffee grounds;

• damage to red blood cells--confusion, weakness, pale or yellowed skin, dark colored urine;

• low blood cell counts--fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath; or

• signs of tumor cell breakdown--tiredness, weakness, muscle cramps, lower back pain, nausea, vomiting, diarrhea, blood in your urine, fast or slow heart rate, tingling in your hands and feet or around your mouth.

Common side effects of fludarabine may include:

• low blood cell counts;

• nausea, loss of appetite, vomiting, diarrhea;

• feeling weak or tired;

• mouth sores; or

• swelling in your hands or feet.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may affect fludarabine, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.