See Available Brands of Fludarabine in India

P - Contraindicated in Pregnancy
L - Contraindicated in lactation

It is a cytotoxic chemotherapeutic agent.

Pharmacodynamics

Fludarabine is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to the active triphosphate, 2-fluoro-ara-ATP which inhibits DNA polymerase and ribonucleotide reductase resulting in inhibition of DNA synthesis leading to cell death.

 Pharmacokinetics

 Metabolism: IV: Fludarabine phosphate is rapidly dephosphorylated in the serum to fludarabine which enters the tumor cells to be rephosphorylated to the active triphosphate derivative. Excretion: Mostly in the urine, about 60% of dose is excreted within 24 hr.
Fludarabine Indications / Fludarabine Uses

Treatment of patients with B-cell chronic lymphocytic leukaemia (CLL) with sufficient bone marrow reserve and who have not responded to or whose disease has progressed during and after treatment with atleast one alkylating agent containing regimen.

Fludarabine Adverse Reactions / Fludarabine Side Effects

Fever, chills, cough, dyspnoea, pneumonia; GI disturbances, stomatitis; oedema; tumour lysis syndrome; skin rashes; haemolytic anaemia, haemorrhagic cystitis; neurological disturbances including peripheral neuropathy, agitation, confusion, visual disturbances and coma. Progressive encephalopathy and blindness (high doses). Potentially Fatal: Myelosuppression. Fatal autoimmune haemolytic anemia.

Precautions

Information Not Available

 Special Precautions

Routine monitoring of blood counts and Hb conc. Monitor for signs of autoimmune haemolytic anaemia; elderly. Avoid contact with skin and eyes; avoid inhalation. Myelosuppression may be cumulative and severe increasing risk of opportunistic infections. Increased risk of tumour lysis syndrome in patients with high tumour burden.

 Other Drug Interactions

Co-administration with pentostatin may lead to pulmonary toxicity. Reduced metabolic activation of fludarabine with cytarabine. Reduced therapeutic efficacy with dipyridamole and other adenosine uptake inhibitors.

 Interactions

Information Not Available

 Dosage

 Oral

Chronic lymphocytic leukaemia

Adult: 40 mg/m2 BSA daily for 5 consecutive days. Courses may be repeated every 28 days, usually for up to 6 cycles.

Renal impairment: Avoid in severe impairment.

Intravenous

Chronic lymphocytic leukaemia

Adult: 25 mg/m2 BSA daily given by bolus inj or by IV infusion over 30 minutes for 5 consecutive days. Courses may be repeated every 28 days, usually for up to 6 cycles.

Renal impairment: Avoid in severe impairment.

Special Populations: Reduce dose by up to 50% in patients with mild to moderate renal impairment (creatinine clearance: 30-70 mL/min).

Food(before/after)

May be taken with or without food. (Swallow whole, do not break/chew/crush.)

List of Contraindications

Fludarabine and Pregnancy

Contraindicated in pregnancy

Fludarabine and Lactation

Contraindicated in lactation

Fludarabine and Children

Information Not Available

Fludarabine and Geriatic

Information Not Available

Fludarabine and Other Contraindications

Renal impairment (CrCl <30 mL/min); decompensated haemolytic anaemia. Pregnancy and lactation. Concomitant use of live vaccines.

Storage

Intravenous: Refrigerate at 2-8°C. Oral: Refrigerate at 2-8°C

Lab interference

Information Not Available