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(fludarabine phosphate) Tablets for Oral Use.
WARNING: CNS TOXICITY, HEMOLYTIC ANEMIA, AND PULMONARY TOXICITY
Severe neurologic effects, including blindness, coma, and death were observed in dose-ranging studies in patients with acute leukemia when fludarabine phosphate was administered at high doses. This severe central nervous system toxicity occurred in 36% of patients treated with doses approximately four times greater (96 mg/m2/day for 5 days to 7 days) than the recommended intravenous dose (25 mg/m2/day). Similar severe central nervous system toxicity has been rarely ( ≤ 0.2%) reported in patients treated at doses in the range of the dose recommended for chronic lymphocytic leukemia. [See WARNINGS AND PRECAUTIONS] Periodic neurological assessments are recommended.
Instances of life-threatening and sometimes fatal autoimmune hemolytic anemia have been reported after one or more cycles of treatment with fludarabine phosphate. Patients undergoing treatment with Oforta™ (fludarabine phosphate tablets) should be evaluated and closely monitored for hemolysis. [See WARNINGS AND PRECAUTIONS]
High incidence of fatal pulmonary toxicity was observed in a clinical investigation using fludarabine phosphate in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL). Therefore, the use of Oforta™ (fludarabine phosphate tablets) in combination with pentostatin is not recommended [See WARNINGS AND PRECAUTIONS]
The chemical name for fludarabine phosphate is 9H-Purin-6-amine, 2-fluoro-9-(5-O-phosphono-β-D-arabinofuranosyl)(2-fluoro-ara-AMP). The molecular formula of fludarabine phosphate is C10H13FN5O7P (MW 365.2) and the structure is provided in Figure 1
Figure 1: Chemical Structure of Fludarabine Phosphate
Oforta™ (fludarabine phosphate tablets) for oral administration contain fludarabine phosphate, a fluorinated nucleotide analog of the antiviral agent vidarabine, 9-beta -D-arabinofuranosyladenine (ara-A) that is relatively resistant to deamination by adenosine deaminase. Each tablet contains 10 mg of the active ingredient fludarabine phosphate. The tablet core consists of microcrystalline cellulose, lactose monohydrate, colloidal anhydrous silicon dioxide, croscarmellose sodium and magnesium stearate. The film-coat contains hypromellose, talc, titanium dioxide (E171) and ferric oxide pigment (red/E172, yellow/E172).
What are the possible side effects of fludarabine (Oforta)?
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:
- pale or yellowed skin, dark colored urine;
- fast or slow heart rate, weak pulse, trouble concentrating, feeling tired or short of breath;
- easy bruising, unusual bleeding (nose, mouth, vagina, or rectum), purple or red pinpoint spots under your skin;
- fever, chills, body aches, flu symptoms, sores in your mouth and throat,...
What are the precautions when taking fludarabine phosphate tablets (Oforta)?
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.
This medication should not be used if you have certain medical conditions. Before using this medicine, consult your doctor or pharmacist if you have: hemolytic anemia, severe kidney disease.
Before using this medication, tell your doctor or pharmacist your medical history, especially of: current infections, certain infections (opportunistic infections such as fungal infections), certain virus conditions (herpes, chickenpox), blood disorders (e.g., anemia, clotting problems), immune system problems, kidney problems,...
Last reviewed on RxList: 8/5/2009
This monograph has been modified to include the generic and brand name in many instances.
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