fludarabine phosphate: clinical use

Prescribing considerations

• Prescribing should be supervised by a clinician experienced in antineoplastic therapy.
• Assess marrow reserve, immune function, infection history, renal function and overall fitness.
• Consider tumour-lysis precautions in patients with a large disease burden.
• Ensure the transfusion service knows that irradiated cellular blood components are required.
• Use cautiously in hepatic impairment and older or clinically frail patients.

Contraindications and cautions

• Hypersensitivity to fludarabine phosphate or an excipient
• Severe renal impairment with creatinine clearance below the product threshold
• Decompensated haemolytic anaemia
• Breastfeeding

Monitoring

• Full blood count and clinical evidence of cumulative myelosuppression
• Renal function, including before treatment and particularly in older adults
• Infection and opportunistic or reactivated viral disease
• Haemolysis and other autoimmune phenomena
• Neurological or visual toxicity
• Tumour lysis in at-risk patients
• Clinical response and non-haematological toxicity

Clinical pharmacology

Fludarabine phosphate is a prodrug converted to fludarabine and then intracellular fludarabine triphosphate. The active metabolite inhibits enzymes involved in DNA synthesis and repair, with additional effects on RNA and protein synthesis. Elimination is substantially renal.

Formulation and product differences

• The selected product is an oral film-coated tablet that must be swallowed whole.
• Food does not meaningfully alter overall oral exposure.
• Nausea and vomiting have been reported more often with oral than intravenous fludarabine.
• The oral formulation contains lactose and is essentially sodium-free.

Tablet

Route: Oral

Strengths: 10 mg