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• Fludarabine Phosphate
  

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  Fludarabine Phosphate

  

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  2.1 Chronic Lymphocytic Leukemia (CLL)

  The oral dose is different than the intravenous dose.

  The recommended adult dose of fludarabine phosphate is 40 mg/m2 administered by mouth daily for five consecutive days. Each 5-day course of treatment should commence every 28 days. Dosage may be decreased or delayed based on evidence of hematologic or nonhematologic toxicity. Physicians should consider delaying or discontinuing the drug if neurotoxicity occurs. Fludarabine phosphate film-coated tablets can be taken either on an empty stomach or with food. The tablets have to be swallowed whole with water; they should not be chewed or broken.

  The following table provides guidance for determining the number of tablets of fludarabine phosphate to be administered based on body surface area (BSA):

  TABLE 1: SUGGESTED NUMBER OF TABLETS TO BE ADMINISTERED Body Surface Area (BSA) Calculated Total Dose Equivalent to 40 mg/m2 BSA (rounded up or down to nearest 10 mg) Total Number of Tablets 0.75 – 0.88 30 mg 3 0.89 – 1.13 40 mg 4 1.14 – 1.38 50 mg 5 1.39 – 1.63 60 mg 6 1.64 – 1.88 70 mg 7 1.89 – 2.13 80 mg 8 2.14 – 2.38 90 mg 9 2.39 – 2.50 100 mg 10

  A number of clinical settings may predispose to increased toxicity from fludarabine phosphate. These include advanced age, renal insufficiency, and bone marrow impairment. Such patients should be monitored closely for excessive toxicity and the dose modified accordingly. The optimal duration of treatment has not been clearly established. It is recommended that three additional cycles of fludarabine phosphate be administered following the achievement of a maximal response and then the drug should be discontinued.

  2.2 Renal Impairment

  Reduce dose by 20% in patients with mild to moderate renal impairment (creatinine clearance 30 to 70 mL/min/1.73 m2). [See Warnings and Precautions (5.7)]

  Reduce dose by 50% in patients with severe renal impairment (creatinine clearance < 30 mL/min/1.73 m2). [See Warnings and Precautions (5.7)]

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