April 26, 2017
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(fludarabine) for Injection


FLUDARA (fludarabine) FOR INJECTION should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. FLUDARA (fludarabine) FOR INJECTION can severely suppress bone marrow function. When used at high doses in doseranging studies in patients with acute leukemia, FLUDARA (fludarabine) FOR INJECTION was associated with severe neurologic effects, including blindness, coma, and death. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m²/day for 5-7 days) than the recommended dose. Similar severe central nervous system toxicity, including coma, seizures, agitation and confusion, has been reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia.

Instances of life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported to occur after one or more cycles of treatment with FLUDARA (fludarabine) FOR INJECTION. Patients undergoing treatment with FLUDARA (fludarabine) FOR INJECTION should be evaluated and closely monitored for hemolysis.

In a clinical investigation using FLUDARA (fludarabine) FOR INJECTION in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there was an unacceptably high incidence of fatal pulmonary toxicity. Therefore, the use of FLUDARA (fludarabine) FOR INJECTION in combination with pentostatin is not recommended.


FLUDARA FOR INJECTION contains fludara (fludarabine) bine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-p-D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each vial of sterile lyophilized solid cake contains 50 mg of the active ingredient fludara (fludarabine) bine phosphate, 50 mg of mannitol, and sodium hydroxide to adjust pH to 7.7. The pH range for the final product is 7.2-8.2. Reconstitution with 2 mL of Sterile Water for Injection, USP, results in a solution containing 25 mg/mL of fludara (fludarabine) bine phosphate intended for intravenous administration.

The chemical name for fludara (fludarabine) bine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-0-phosphono- 0-D-arabino-furanosyl) (2-fluoro-ara-AMP). The molecular formula of fludara (fludarabine) bine phosphate is C10H13FN5O7P (MW 365.2) and the structure is:

 (fludara (fludarabine) bine phosphate) Structural Formula Illustration

What are the possible side effects of fludarabine (Fludara)?

Get emergency medical help if you have any of these signs of an allergic reaction: hives; difficulty breathing; swelling of your face, lips, tongue, or throat.

Call your doctor at once if you have a serious side effect such as:

  • 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;
  • pale or yellowed skin, dark colored urine;
  • cough with yellow or green mucus, stabbing chest pain, feeling short of...

Read All Potential Side Effects and See Pictures of Fludara »

What are the precautions when taking fludarabine (Fludara)?

Before using fludarabine, tell your doctor or pharmacist if you are allergic to it; or if you have any other allergies. This product may contain inactive ingredients, which can cause allergic reactions or other problems. Talk to your pharmacist for more details.

Tell your doctor your medical history, especially of: current infections, certain virus illnesses (herpes, chickenpox), blood disorders (e.g., anemia, clotting problems), kidney problems.

Do not have immunizations/vaccinations without the consent of your doctor, and avoid contact with people who have recently received oral polio vaccine or flu vaccine inhaled through the nose.

Wash your hands well to prevent the spread of infections. Avoid contact with people who have illnesses that may spread to others...

Read All Potential Precautions of Fludara »

Last reviewed on RxList: 8/18/2010
This monograph has been modified to include the generic and brand name in many instances.

Fludara - User Reviews

Fludara User Reviews

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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