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Fludarabine parenteral

Updated 2 Feb 2023 | Antimetabolites


Powder or concentrate for solution for injection or infusion containing fludarabine

Drugs List

  • FLUDARA 50mg powder for solution for injection
  • fludarabine 50mg powder for solution for injection
  • fludarabine 50mg/2ml concentrate for solution for injection
  • Therapeutic Indications


    B cell chronic lymphocytic leukaemia

    Treatment of patients with B-cell chronic lymphocytic leukaemia (CLL) in patients with sufficient bone marrow reserves.

    Fludarabine should only be initiated as first line treatment in cases of advanced disease, Rai stages III/IV (Binet stage C), or Rai stages I/II (Binet stage A/B) where the patient has disease-related symptoms or evidence of progressive disease.

    Unlicensed Uses

    Conditioning prior to haematopoietic progenitor cell transplantation
    Leukaemia - acute lymphoblastic
    Leukaemia - acute myeloid

    In children with poor prognosis or relapsed acute myeloid leukaemia, relapsed acute lymphoblastic leukaemia and conditioning before bone marrow transplantation.


    Whilst the doses stated below are those recommended by the manufacturer, local cancer network protocols for the relevant indication should be consulted.

    Fludarabine is usually given for 6 cycles.


    The recommended dose is 25 mg fludarabine phosphate per square metre body surface area given daily for 5 consecutive days every 28 days, by the intravenous route.


    The recommended dose is 25 mg fludarabine phosphate per square metre body surface area given daily for 5 consecutive days every 28 days, by the intravenous route.

    Patients with Renal Impairment

    The manufacturers suggest the following dose adjustments:
    Creatinine clearance between 30 and 70 ml/minute: Reduce dose up to 50% and perform close haematological monitoring.
    Creatinine clearance below 30 ml/minute: Contraindicated.
    However, The Renal Drug Handbook suggests the following dose reductions:
    Glomerular filtration rate is between 30 and 70 ml/minute: 50 to 75% of normal dose.
    Glomerular filtration rate is between 10 and 30 ml/minute: 50 to 75% of normal dose.
    Glomerular filtration rate is less than 10 ml/minute: 50% of normal dose.


    For intravenous injection or infusion after dilution.


    Haemolytic anaemia
    Renal impairment - creatinine clearance below 30 ml/minute

    Precautions and Warnings

    Children under 18 years
    Patients over 65 years
    Hepatic impairment
    Immunodeficiency syndromes
    Renal impairment - creatinine clearance below 70ml/min
    Skin cancer

    Administration of live vaccines is not recommended
    Reduce dose in patients with creatinine clearance below 70ml/min
    Advise patient CNS effects may affect ability to drive or operate machinery
    Consult local policy on the safe use of anti-cancer drugs
    Must be diluted before use
    Patients who require blood transfusion should only receive irradiated blood
    Staff: Not to be handled by pregnant staff
    Treatment to be administered by or under supervision of specialist
    Elderly: Monitor renal function and consider dose modification
    Monitor for signs of neurological toxicity
    Monitor haematological parameters regularly throughout treatment
    Monitor patient closely for haemolysis
    Monitor patients for signs of tumour lysis syndrome
    Advise patient to report headaches, seizures, confusion, visual disturbance
    Discontinue treatment if haemolysis occurs
    Flare of pre-existing skin cancer lesions may occur during/after treatment
    Male & female: Contraception required during & for 6 months after treatment
    Advise patient to inform physician of any skin changes immediately

    Progressive Multifocal Leukoencephalopathy Syndrome (PML)
    Progressive multifocal leukoencephalopathy syndrome (PML) has been reported in some patients treated with this agent. If patients present with symptoms indicating PML such as worsening neurological, cognitive or behavioural signs or symptoms, an MRI should be performed. If PML is diagnosed with other agents it is normally recommended that treatment should be permanently discontinued.

    A crossover from initial treatment with fludarabine to chlorambucil for non-responders to fludarabine should be avoided. Most patients who have been resistant to fludarabine have shown resistance to chlorambucil.

    Pregnancy and Lactation


    Fludarabine is contraindicated in pregnancy.

    Insufficient data exists to support the safety of fludarabine in human pregnancy. Given the low molecular weights of the parent drug and active metabolite (365 and 269 respectively), the low plasma protein binding and the elimination half life, it is expected both compounds will cross the placenta.

    In animal studies placental transfer has been demonstrated and significant adverse effects were reported in the offspring such as cleft palate, exencephaly and vertebrae deformities.

    The use of all medication in pregnancy should be avoided whenever possible; particularly in the first trimester. Non-drug treatments should also be considered. When essential, a medication with the best safety record over time should be chosen, employing the lowest effective dose for the shortest possible time. Polypharmacy should be avoided. Teratogens taken in the pre-embryonic period, often quoted as lasting until 14 to 17 days post-conception, are believed to have an all-or-nothing effect. Where drugs have a short half-life, and when the date of conception is certain, this may allow women to be reassured where drug exposure has occurred within this time frame. Further advice may be available from the UK National Teratology Information Service (NTIS) and through ToxBase, available via password on the internet ( ) or if this is unavailable at the backup site ( ).


    Fludarabine is contraindicated during breastfeeding.

    Breastfeeding should be discontinued for the duration of fludarabine treatment. It is not known if the drug is excreted into human milk, but the properties of the drug and drug processing by the body suggest fludarabine will be excreted into the milk of breastfeeding mothers. Given the systemic toxicity of fludarabine across multiple body systems it would be wise to avoid use in breastfeeding.

    Neonates, infants born prematurely, those with low birth weight, those with an unstable gastrointestinal function or who have serious illnesses may require special consideration. For any infant, if a drug is prescribed to the nursing mother, it should be at the lowest practical dose and for the shortest time. When drug administration is unavoidable and breastfeeding is to continue, minimisation of exposure of the infant to the drug may sometimes be achieved by timing the maternal doses to just after a feeding episode. Infants exposed to drugs via breast milk should be monitored for unusual signs or symptoms. Interactions between the drug received by the infant from the mother's milk and medication prescribed for the infant should also be considered, for example, when the drug given to the infant may prevent metabolism of the drug received via breast milk.
    Specialist advice is available from the UK Drugs in Lactation Advisory Service at

    Side Effects

    Acquired haemophilia
    Acute myeloid leukaemia
    Alterations in hepatic enzymes
    Alterations in pancreatic enzymes
    Autoimmune disorders
    Bone marrow aplasia
    Bone marrow hypoplasia
    Cardiac failure
    Cerebral haemorrhage
    Evans' syndrome
    Flare up of pre-existing skin cancer lesions
    Gastro-intestinal haemorrhage
    Haemolytic anaemia
    Haemorrhagic cystitis
    Increased susceptibility to infection
    Interstitial pulmonary infiltrate
    Lymphoproliferative disorders
    Metabolic acidosis
    Myelodysplastic syndrome
    Optic neuritis
    Optic neuropathy
    Peripheral neuropathy
    Progressive multifocal leukoencephalopathy (PML)
    Pulmonary fibrosis
    Pulmonary haemorrhage
    Pulmonary toxicity
    Reactivation of Epstein Barr virus
    Reactivation of herpes zoster
    Renal failure
    Skin carcinoma
    Stevens-Johnson syndrome
    Thrombocytopenic purpura
    Toxic epidermal necrolysis
    Tumour lysis syndrome
    Visual disturbances


    It is strongly recommended that the UK National Poisons Information Service be consulted on cases of suspected or actual overdose where there is doubt over the degree of risk or about appropriate management.

    The following number will direct the caller to the relevant local centre (0844) 892 0111

    Information may be obtained if you have access to ToxBase the primary clinical toxicology database of the National Poisons Information Service. This is available via password on the internet ( ) or if this is unavailable at the backup site ( ).

    Further Information

    Last Full Review Date: March 2014

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 9th edition (2011) ed. Briggs, G., Freeman, R. and Yaffe, S. Lippincott Williams & Wilkins, Philadelphia.

    Martindale: The Complete Drug Reference, 37th edition (2011) ed. Sweetman, S. Pharmaceutical Press, London.

    Summary of Product Characteristics: Fludara 50 mg powder for solution for injection or infusion. Sanofi. Revised March 2011.

    Summary of Product Characteristics: Fludarabine 50 mg lyophilisate for solution for injection or infusion. Actavis UK Ltd. Revised November 2010.

    Summary of Product Characteristics: Fludarabine Phosphate 25 mg/ml Concentrate for solution for injection or infusion. Actavis UK Ltd. Revised June 2013.

    Summary of Product Characteristics: Fludarabine phosphate 50 mg powder for solution for injection or infusion. Hospira. Revised April 2011.

    The Renal Drug Handbook. 3rd edition. (2009) ed. Ashley, C and Currie, Radcliffe Publishing Ltd, Abingdon.

    NICE Evidence Services Available at: Last accessed: 17 August 2017

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