Fludarabine Phosphate

Cytostatic · Antimetabolite

Indications

B-cell chronic lymphocytic leukaemia (CLL) after initial treatment with an alkylating agent has failed.

Dosage

Adults: 50 mg IV daily for 5 days every 28 days. See literature. Children: Not recommended.

Administration

IV: Administer IV 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 2°C-8°C. Reconstituted vials are stable for 16 days at room temperature of 15°C-30°C.

Adverse Effects

Myelosuppression (which may be cumulative) and immunosuppression (with an increased risk of opportunistic infection). Idiosyncratic CNS and pulmonary toxicity have been rarely reported. Infection, cough, GI upset, fever, fatigue, weakness, blood dyscrasias, myelodysplastic syndromes, acute myeloid leukaemia, anorexia, peripheral neuropathy, visual disturbances, stomatitis, rash, oedema, chills, malaise. Reports of autoimmune reactions, skin cancer, tumour lysis syndrome.

Risk Factor (Pregnancy/Lactation)

Pregnancy: Positive evidence of risk: Use only when no safer alternative exists for a serious problem. Lactation: Contraindicated or not recommended. Contraindications: Decompensated haemolytic anaemia, severe renal impairment (CrCl<30m1/min). Precautions: Risk of leukoencephalopathy. Monitor for haematologic and non-haematologic toxicity, incl haemolysis and CNS effects. Transfusion, myelosuppression, immunodeficiency, history of opportunistic infection, hepatic or moderate renal impairment (CrC130-70 mL/min). Elderly (>75 years).

Interactions

Pentostatin, ethanol, live vaccines. Dipyridamole and other adenosine uptake inhibitors.

Advice to Patient

Take oral form with or without meals. Swallow whole, do not chew or crush tablets. Contact prescriber if there is pain or numbness in extremities, increased fatigue, severe GI disturbance, diarrhoea, fever, chills, bleeding or bruising, sore throat, muscle weakness or pain, difficulty or pain on urination, vaginal discharge, difficulty in breathing, unusual cough. Avoid alcohol during therapy. Take sufficient amount of fluids (2-3 litres per day) to maintain hydration, unless restricted by the prescriber. Take small, frequent meals to maintain good nutritional status. Avoid highly crowded places to prevent infection. Do not get vaccinated without consulting prescriber. Using soft toothbrush, cotton swabs, regular mouth care may help to prevent mouth sores.

Pharmacokinetics

Metabolism: Rapidly and completely dephosphorylated in plasma. Bioavailability: Oral: 50%-65%. Half-life elimination: Triphasic. Terminal: 20 hrs. Time to peak, plasma: 4 hrs. Excretion: Urine (40%-60%).

Brands with this active ingredient

Compiled by Healify Pharmacy from published drug references. How we compile it →

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