Adult: 25 mg/m2 daily via IV bolus inj or IV infusion over 30 minutes for 5 consecutive days every 28 days. Continue treatment until achieving the best response (usually 6 cycles). Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guidelines).
Oral B cell chronic lymphocytic leukaemia
Adult: 40 mg/m2 daily for 5 consecutive days every 28 days. Continue treatment until achieving the best response (usually 6 cycles). Dose reduction, dosing interruption, or discontinuation may be required according to individual safety and tolerability (refer to detailed product guidelines).
What are the brands available for Fludarabine in Hong Kong?
Fludarabine phosphate May be taken with or without food. Swallow whole, do not break/chew/crush.
Reconstitution
Powder for solution for inj or infusion: Reconstitute a vial labelled as 50 mg with 2 mL sterile water for inj to achieve a concentration of 25 mg/mL. IV inj: Further dilute the required dose with 10 mL of NaCl 0.9% solution. IV infusion: Further dilute the required dose with 100 mL of NaCl 0.9% solution. Instructions for reconstitution may vary among individual products and between countries (refer to specific product guidelines).
Contraindications
Decompensated haemolytic anaemia. Severe renal impairment (CrCl <30 mL/min). Lactation.
Special Precautions
Patient with documented infection, fever, severe bone marrow function impairment, immunodeficiency, history of opportunistic infection. Avoid vaccination with live vaccines during and after treatment. Hepatic and moderate renal (CrCl 30-70 mL/min) impairment. Elderly. Pregnancy.
Adverse Reactions
Significant: Severe bone marrow suppression (e.g. anaemia, thrombocytopenia, neutropenia); tumour lysis syndrome; new-onset or exacerbation of skin cancer. Eye disorders: Visual disturbances. Gastrointestinal disorders: Vomiting, diarrhoea, nausea, stomatitis. General disorders and administration site conditions: Fever, fatigue, weakness, oedema, chills, malaise, mucositis. Metabolism and nutrition disorders: Anorexia. Nervous system disorders: Peripheral neuropathy. Respiratory, thoracic and mediastinal disorders: Cough. Skin and subcutaneous tissue disorders: Rash. Potentially Fatal: Autoimmune phenomena (e.g. haemolytic anaemia, autoimmune thrombocytopenia or thrombocytopenic purpura, Evans syndrome, acquired haemophilia); leucoencephalophathy, acute toxic leucoencephalopathy, reversible posterior leucoencephalopathy syndrome; serious opportunistic infections and reactivations of latent viral infections (e.g. herpes zoster, Epstein-Barr virus); progressive multifocal leucoencephalopathy due to John Cunningham (JC) virus; transfusion-associated graft-versus-host disease (after transfusion of non-irradiated blood). Rarely, trilineage bone marrow hypoplasia or aplasia resulting in pancytopenia; neurotoxicity.
This drug may cause fatigue, weakness, confusion, seizures, agitation and visual disturbances; if affected, do not drive or operate machinery. Women with childbearing potential and men with partners who could become pregnant must use effective contraception during therapy and for at least 6 months after stopping the treatment.
Monitoring Parameters
Monitor CBC with differential, platelet count; serum albumin, AST, ALT, serum creatinine, uric acid. Assess for signs and symptoms of haemolysis, infection, neurotoxicity and tumour lysis syndrome.
May decrease therapeutic effect with dipyridamole and other adenosine uptake inhibitors. May diminish the therapeutic effect of live vaccines. Potentially Fatal: Increased risk of pulmonary toxicity with pentostatin; concomitant use is not recommended.
Action
Description: Mechanism of Action: Fludarabine is a synthetic purine antagonist antimetabolite. It is rapidly dephosphorylated to 2-fluoro-ara-A and then phosphorylated intracellularly by deoxycytidine kinase to form the active triphosphate, 2-fluoro-ara-ATP. This active metabolite inhibits the DNA polymerase, ribonucleotide reductase, DNA primase and DNA ligase, resulting in the inhibition of DNA synthesis. Pharmacokinetics: Absorption: Bioavailability: 50-65% (oral). Time to peak plasma concentration: 1-2 hours (oral). Distribution: Plasma protein binding: Approx 19-29%. Metabolism: Rapidly dephosphorylated in the plasma into 2-fluoro-ara-A (active metabolite), which then enters the tumour cells and is phosphorylated by deoxycytidine kinase to form 2-fluoro-ara-ATP (active triphosphate derivative). Excretion: Mainly via urine. Elimination half-life: Approx 20 hours.
Chemical Structure
Fludarabine
Source: National Center for Biotechnology Information. PubChem Compound Summary for CID 657237, Fludarabine. https://pubchem.ncbi.nlm.nih.gov/compound/Fludarabine. Accessed June 25, 2024.
Storage
Tab: Store below 25°C. Solution for inj or infusion: Store between 2-8°C. Do not freeze. This is a cytotoxic drug. Follow applicable procedures for receiving, handling, administration, and disposal. Storage recommendations may vary among individual products and between countries (refer to specific product guidelines).
L01BB05 - fludarabine ; Belongs to the class of antimetabolites, purine analogues. Used in the treatment of cancer.
References
Anon. Fludarabine Phosphate. AHFS Clinical Drug Information [online]. Bethesda, MD. American Society of Health-System Pharmacists, Inc. https://www.ahfscdi.com. Accessed 14/05/2024.Buckingham R (ed). Fludarabine Phosphate. Martindale: The Complete Drug Reference [online]. London. Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/05/2024.Fludara 50 mg Powder for Solution for Injection or Infusion (Sanofi B.V.). MHRA. https://products.mhra.gov.uk. Accessed 14/05/2024.Fludara Oral 10 mg Film-coated Tablets (Sanofi B.V.). MHRA. https://products.mhra.gov.uk. Accessed 14/05/2024.Fludarabine Phosphate 25 mg/mL Concentrate for Solution for Injection/Infusion (Teva UK Limited). MHRA. https://products.mhra.gov.uk. Accessed 14/05/2024.Fludarabine Phosphate Injection (Areva Pharmaceuticals). DailyMed. Source: U.S. National Library of Medicine. https://dailymed.nlm.nih.gov/dailymed. Accessed 14/05/2024.Fludarabine Sandoz 50 mg/2 mL Concentrate for Solution for Injection or Infusion (Sandoz Products Malaysia Sdn. Bhd.). National Pharmaceutical Regulatory Agency - Ministry of Health Malaysia. https://www.npra.gov.my. Accessed 15/05/2024.Fludarabine. UpToDate Lexidrug, Lexi-Drugs Multinational Online. Waltham, MA. UpToDate, Inc. https://online.lexi.com. Accessed 14/05/2024.Joint Formulary Committee. Fludarabine Phosphate. British National Formulary [online]. London. BMJ Group and Pharmaceutical Press. https://www.medicinescomplete.com. Accessed 14/05/2024.Pharmacy Retailing (NZ) Ltd t/a Healthcare Logistics. Fludara Oral 10 mg Film Coated Tablet data sheet 14 February 2023. Medsafe. http://www.medsafe.govt.nz. Accessed 14/05/2024.
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