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Fludarabine Dosage

Medically reviewed on October 20, 2017.

Applies to the following strengths: 10 mg; 25 mg/mL; 50 mg

Usual Adult Dose for Chronic Lymphocytic Leukemia

IV:
25 mg/m2 IV once over 30 minutes for 5 days every 28 days. Following a maximal tumor response, 3 additional cycles are recommended.

Oral:
40 mg/m2 once daily for 5 days every 28 days
Fludarabine phosphate 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.

Usual Adult Dose for non-Hodgkin's Lymphoma

25 mg/m2/day for 5 days every 28 days

Usual Pediatric Dose for Malignant Disease

Solid tumors: 7 to 9 mg/m2 IV bolus followed by 20 to 27 mg/m2/day continuous IV infusion for 5 days

Usual Pediatric Dose for Leukemia

Acute leukemia: 10 mg/m2 IV once over 15 minutes followed by continuous IV infusion of 30.5 mg/m2/day for 5 days or 10.5 mg/m2 IV once over 15 minutes followed by continuous IV infusion of 30.5 mg/m2/day for 2 days followed by cytarabine.

Usual Pediatric Dose for Stem Cell Transplant Conditioning

Reduced-intensity conditioning regimen prior to allogenic hematopoietic stem cell transplantation: 30 mg/m2/day for 5 days

Renal Dose Adjustments

CrCl 30-70 mL/min/1.73 m2:
Reduce dose by 20% and monitor closely for toxicity

CrCl less than 30 mL/min/1.73 m2:
IV: Not recommended for use
Oral (adults): Administer 50% of dose.

Liver Dose Adjustments

Caution is recommended

Dose Adjustments

The recommended dose of fludarabine may depend on whether other cytotoxic agents are coadministered. Reference to specific protocols is recommended.

Delay or decrease doses in cases of hematologic or other serious toxicities. In case of hemolysis, treatment should be discontinued.

Neurotoxicity: Consider treatment delay or discontinuation

Precautions

US BOXED WARNINGS:
-This drug should be administered under the supervision of a qualified physician experienced in the use of antineoplastic therapy. It can severely suppress bone marrow function. When used at high doses in patients with acute leukemia, it 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 4 times greater (96 mg/m2/day for 5 to 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.
-Life-threatening and sometimes fatal autoimmune phenomena such as hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have been reported after one or more cycles of therapy. Patients should be monitored for hemolysis.
-When this drug is given in combination with pentostatin (deoxycoformycin) for the treatment of refractory chronic lymphocytic leukemia (CLL), there is an unacceptably high incidence of fatal pulmonary toxicity; therefore, this combination is not recommended.

Consult WARNINGS section for additional precautions.

Dialysis

There are no data specifically regarding use in dialysis. However, the following guidelines should be noted:

CrCl less than 30 mL/min/1.73 m2:
IV: Not recommended for use
Oral (adults): Administer 50% of dose

Other Comments

It is recommended to monitor the CBC with differential, platelet count, AST, ALT, creatinine, serum albumin, and uric acid during therapy.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

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