Drug Notebook

FDA Alerts

    Myelosuppression
  • Risk of severe bone marrow suppression. (See Hematologic Effects under Cautions.)
    Hemolysis
  • Possible life-threatening and sometimes fatal autoimmune hemolytic anemia after one or more courses of fludarabine therapy. Evaluate and monitor patients closely for hemolysis. (See Hematologic Effects under Cautions.)

    Neurotoxicity
  • Possible severe neurologic effects (e.g., blindness, coma, death) following administration of high dosages (96 mg/m2; approximately 4 times the currently recommended dosage for chronic lymphocytic leukemia [CLL]) to patients with acute leukemia. Risk of CNS effects in patients receiving relatively low dosages (e.g., equivalent to those currently recommended for CLL). (See Neurotoxicity under Cautions.)

      Pulmonary Toxicity
    • Possible fatal pulmonary toxicity associated with concomitant use of fludarabine and pentostatin. Do not use fludarabine concomitantly with pentostatin. (See Specific Drugs under Interactions.)
      Experience of Supervising Clinician
    • Use under supervision of a qualified clinician experienced in therapy with antineoplastic agents.

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What is the most important information I should know about fludarabine?

Do not use this medication without telling your doctor if you are pregnant. It could harm the unborn baby. Use effective birth control, and tell your doctor if you become pregnant during treatment.

Before you receive fludarabine, tell your doctor if you have kidney disease, bone marrow problems, or a history of a viral infection such as herpes zoster (shingles), Epstein-Barr, or a virus affecting the central nervous system.

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

Fludarabine can lower blood cells that help your body fight infections. This can make it easier for you to bleed from an injury or get sick from being around others who are ill. Avoid being near people who have colds, the flu, or other contagious illnesses. Your blood will need to be tested on a regular basis. Do not miss any scheduled appointments.

Do not receive a "live" vaccine while you are being treated with 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.

Contact your doctor at once if you develop signs of infection such as fever, chills, sore throat, flu symptoms, easy bruising or bleeding (nosebleeds, bleeding gums), loss of appetite, nausea and vomiting, mouth sores, or unusual weakness.

What is fludarabine?

Fludarabine is a cancer medication that interferes with the growth and spread of cancer cells in the body.

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

Fludarabine is usually given after other cancer medications have been tried without successful response to treatment.

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

What should I discuss with my healthcare provider before I receive fludarabine?

You should not use this medication if you are allergic to fludarabine, or if you are also being treated with a cancer medicine called pentostatin (Nipent).

If you have certain conditions, you may need a dose adjustment or special tests to safely receive fludarabine. Tell your doctor if you have:

  • kidney disease;
  • bone marrow problems; or

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

FDA pregnancy category D. Fludarabine can cause harm to an unborn baby. Do not receive fludarabine without telling your doctor if you are pregnant. It could harm the unborn baby. Use birth control to prevent pregnancy while you are receiving fludarabine, whether you are a man or a woman. Fludarabine use by either parent may cause birth defects. Tell your doctor if a pregnancy occurs during treatment with fludarabine. It is not known whether fludarabine passes into breast milk or if it could harm a nursing baby. Do not receive this medication without telling your doctor if you are breast-feeding a baby.
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