Adult Dosing
B-cell chronic lymphocytic leukemia
- 25 mg/m2 IV administered over 30 minutes for 5 consecutive days; repeat course every 28 days
- Additional 3 cycles should be administered after a maximum response is achieved and then the drug be discontinued
Note :- Adjust the dose based on evidence of hematologic or non-hematologic toxicity
Pediatric Dosing
- Safety and effectiveness in pediatric patients have not been established
[Outline]
Renal Dose Adjustment (Based on CrCl)
80 mL/min: No dose adjustments- 50-79 mL/min: 20 mg/m2 IV
- 30-49 mL/min: 15 mg/m2 IV
- <30 mL/min: Contraindicated
Hepatic Dose Adjustment
- Hepatic impairment: Dose adjustments not defined, caution advised
See Supplemental Patient Information
- At doses higher than medically recommended (96 mg/m2/day for 5-7 days), fludarabine may cause severe neurologic effects including blindness, coma, and death. Similar neurotoxicity, such as coma, seizures, agitation and confusion, has been reported in patients treated at doses recommended for chronic lymphocytic leukemia [US Black Box Warning]
- Therapy may cause severe bone marrow suppression leading to anemia, thrombocytopenia and neutropenia; monitor hematologic parameters carefully during therapy [US Black Box Warning]
- Several instances of trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia, occasionally resulting in death, have occurred in adult patients
- Duration of clinically significant cytopenia may range from approximately 2 months to 1 year
- Life-threatening and sometimes fatal incidence of autoimmune phenomena including hemolytic anemia, autoimmune thrombocytopenia/thrombocytopenic purpura (ITP), Evans syndrome, and acquired hemophilia have occurred after one or more cycles of treatment. Closely monitor and evaluate the patient for hemolysis; discontinue therapy if hemolysis occurs [US Black Box Warning]
- Closely monitor patients for signs of hematologic and non-hematologic toxicity. Periodic assessment of peripheral blood counts is recommended to detect anemia, neutropenia, and thrombocytopenia
- Transfusion-associated graft-versus-host disease may occur after transfusion of non-irradiated blood in patients treated with fludarabine. Fatal outcome as a consequence of this disease has been reported; to minimize the risk of this disease, administer irradiated blood in patients receiving, or who have received, fludarabine and require blood transfusion
- Avoid concomitant use with pentostatin for the treatment of refractory chronic lymphocytic leukemia, because there was an unacceptably high incidence of fatal pulmonary toxicity [US Black Box Warning]
- If fludarabine is used in pregnant women or if the patient becomes pregnant during therapy, the patient should be apprised of the potential hazard to the fetus
- Advise men with female sexual partners of childbearing potential to use contraception during and after fludarabine therapy discontinuation, as it may damage testicular tissue and spermatozoa, which may lead to loss of fertility and genetic defects in fetuses
- Instances of serious and occasionally fatal infections such as opportunistic infections and reactivations of latent viral infections such as herpes zoster, Epstein-Barr virus and JC virus have been reported during therapy. Consider prophylactic treatment in patients who are at increased risk of developing opportunistic infection such as patients with severe bone marrow suppression or immunodeficiency
- Therapy may cause weakness, fatigue, visual disturbances, confusion, agitation and seizures causing reduced ability to drive or use machines
- Tumor lysis syndrome has been associated with fludarabine therapy; use cautiously in patients at risk of developing this complication
- Not recommended for use in patients with CrCl <30 mL/min. Measure CrCl in elderly patients before initiating therapy
Cautions: Use cautiously in
- Renal impairment
- Hepatic impairment
- Myelosuppression
- Elderly patients
Supplemental Patient Information
- Instruct patients to perform periodic assessment of their blood count to determine the development of anemia, neutropenia, and thrombocytopenia
- Advise women of childbearing potential to avoid becoming pregnant during therapy
Pregnancy Category:D
Breastfeeding: As per manufacturer's data, because of the potential for serious adverse reactions including tumorigenicity in nursing infants, a decision should be made whether to discontinue nursing or to discontinue the drug, analyzing the importance of the drug to the mother.
Drug Name: Fludarabine phosphate 10 MG Oral Tablet
Ingredient(s): Fludarabine
Imprint: LN
Color(s): Pink
Shape: Oval
Size (mm): 0.00
Score: 1
Inactive Ingredient(s): microcrystalline cellulose / lactose monohydrate / colloidal anhydrous silicon dioxide / croscarmellose sodium / magnesium stearate / hypromellose / talc / titanium dioxide (e171) / ferric oxide pigment (red/e172, yellow/e172)
Drug Label Author:
Antisoma Research Limited
DEA Schedule:
Non-Scheduled
Drug Name: Oforta 10 MG Oral Tablet
Ingredient(s): Fludarabine
Imprint: LN
Color(s): Pink
Shape: Oval
Size (mm): 11.00
Score: 1
Inactive Ingredient(s): cellulose, microcrystalline / lactose monohydrate / silicon dioxide / croscarmellose sodium / magnesium stearate / hypromellose / talc / titanium dioxide / ferric oxide red / ferric oxide yellow
Drug Label Author:
sanofi-aventis U.S. LLC
DEA Schedule:
Non-Scheduled
