Composition
Inj 50 mg: Fludarabine phosphate 50 mg; powder in vial,
Indications & Dosage
Initial treatment of advanced B-cell chronic lymphocytic leukaemia (CLL), First-line treatment in patients with sufficient bone-marrow reserves: BY IV INJ: Adult: 50 mg daily for 5 days every 28 days, usually givenfor 6 cycles. See product literature. Children: Not recommended.
Administration
Administer over 15-30 min or continuous infusion. Reconstitute vials with SWFI, NS, or D5W to a concentration of 10-25 mg/ml. Standard IV dilution: 50-100 ml D5W or NS.
Compatibility
Stable in D5W, NS, SWFI
Stability
Store intact vials under refrigeration at 2C-8C. Reconstituted vials are stable for 16 days at room temperature of 15C-30C.
Contraindications
Haemolytic anaemia
Precautions
Use with caution in renal insufficiency, fever, documented infection or pre-existing hematological disorder or CNS disorders or peripheral neuropathy. Increased susceptibility to skin cancer, worsening of existing skin cancer
Interactions
Pentostatin, ethanol.
Pregnancy
Positive evidence of risk: Avoid
Lactation
Contraindicated. Discontinue breast-feeding.
Side Effects
Acutemyeloid, leukaemia,anorexia, chills, cough, diarrhoea, fever, immunosuppression, malaise, myelodysplastic syndrome, myelosupression, oedema, peripheral neuropathy, pneumonia, rash, visualdisturbances, weakness, autoimmune disorder, confusion, fibrosis,haemorrhage, immune-mediated haemolytic anaemia,neutropenia, pneumonitis, pulmonary toxicity, thrombocytopenia, alopecia, bone-marrow suppression, extravasation, haemorrhagic cystitis, hyperuricaemia, nausea, oral mucositis, thromboembolism, tumourlysis syndrome, vomiting. Rare: Agitation, arrhythmia, blindness, coma, heart failure, optic neuropathy, seizures, skin cancer, Stevens- Johnson syndrome, toxic epidermal necrolysis