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Clofarabine parenteral

Updated 2 Feb 2023 | Antimetabolites


Infusions of clofarabine.

Drugs List

  • clofarabine 20mg/20ml concentrate for solution for infusion vial
  • Therapeutic Indications


    Acute lymphoblastic leukaemia in relapsed or refractory paediatric patients

    Treatment of acute lymphoblastic leukaemia (ALL) in paediatric patients (aged 1 to 21 years at initial diagnosis), who have relapsed or are refractory after receiving at least two prior regimens.


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


    Children aged 1 to 21 years at initial diagnosis:
    The recommended dose is 52mg/metre squared of body surface area daily for 5 consecutive days.
    Body surface area must be accurately calculated using actual height and weight of the patient before the start of each cycle.

    Cycles should be repeated every 2 to 6 weeks following recovery to normal haematopoiesis (absolute neutrophil count (ANC) equal to or greater than 0.75 x 10 to the power of 9 per litre) and a return to baseline organ function. Most patients will respond after 1 or 2 cycles of treatment. The benefits and risks of continuing treatment after 2 cycles in patients who have not responded should be assessed by the treating physician. There is limited data on safety and efficacy when administered for more than 3 cycles.

    Patients with Renal Impairment

    Creatinine clearance greater than 60ml/minute:
    Dose as normal.

    Creatinine clearance between 30 and 60ml/minute:
    Reduce dose by 50%.

    Creatinine clearance less than 30ml/minute:
    Not recommended.

    Additional Dosage Information

    Dose modifications for haematological toxicity
    Absolute neutrophil count (ANC) remains below 0.75 x 10 to the power of 9 per litre 6 weeks from the start of treatment cycle:
    Perform bone marrow aspirate/ biopsy to determine possible refractory disease.
    If persistent leukaemia is not evident, reduce dose for next cycle by 25%.

    Absolute neutrophil count (ANC) remains below 0.5 x 10 to the power of 9 per litre for more than 4 weeks from the start of treatment cycle:
    Reduce dose for next cycle by 25%.

    Dose modifications for non-haematological toxicity
    Grade 3 non-haematological toxicity (excluding nausea and vomiting):
    First occurrence:
    Interrupt until toxicity resolves to baseline, or to a tolerable level where the benefit of restarting treatment outweighs any risks. Reduce dose by 25%.
    Second occurrence:
    Interrupt until toxicity resolves to baseline, or to a tolerable level where the benefit of restarting treatment outweighs any risks. Reduce dose by a further 25%.
    Third occurrence:
    Discontinue treatment.

    Grade 4 non-haematological toxicity:
    Discontinue treatment.

    Dose modifications due to infection
    First occurrence:
    Interrupt until infection is controlled. Restart at previous dose.
    Second occurrence:
    Interrupt until infection is controlled. Reduce dose by 25%.


    For intravenous infusion only.
    Administer over 2 hours. For patients weighing less than 20kg increase the infusion time.


    Children under 1 year
    Patients over 21 years
    Renal impairment - creatinine clearance below 30 ml/minute
    Severe hepatic impairment

    Precautions and Warnings

    Children weighing less than 20kg
    History of progenitor cell transplantation
    Neutrophil count below 0.75 x 10 to the power of 9 / L
    Restricted sodium intake
    Cardiovascular disorder
    Mild hepatic impairment
    Renal impairment - creatinine clearance 30-90 ml/minute

    Contains more than 1 mmol (23 mg) sodium per dose
    Reduce dose in patients with creatinine clearance of 30-60ml/min
    Sodium content of formulation may be significant
    Advise ability to drive/operate machinery may be affected by side effects
    Consider premedication with a corticosteroid
    Consider premedication with hypouricaemic agent
    Give IV fluids throughout 5-day administration period
    Give pre-treatment counselling and consideration of oocyte cryopreservation
    Give pre-treatment counselling and consideration of sperm cryopreservation
    Maintain adequate hydration of patient prior / during treatment
    Treatment to be initiated and supervised by a specialist
    Consult local policy on the safe use of anti-cancer drugs
    Staff: Not to be handled by pregnant staff
    Monitor hepatic function before treatment and regularly during treatment
    Monitor renal function before treatment and regularly during treatment
    Monitor fluid balance
    Monitor for signs and symptoms of colitis
    Monitor full blood count regularly
    Monitor patients for signs of tumour lysis syndrome
    Monitor patients with cardiac disorders
    Monitor respiratory function
    Monitor weight and blood pressure
    Reduce dose if neutrophil count <500cells/cubic mm for more than 4 weeks
    Advise patient to report symptoms of infection immediately
    Advise patient to report unexplained fever, sore throat, bruising, bleeding
    Advise patient to seek medical advice if symptoms of dehydration occur
    Advise patients to report bleeding episodes
    Consider the use of anti-emetics before and during therapy
    Discontinue treatment if Stevens-Johnson Syndrome suspected
    Discontinue treatment if toxic epidermal necrolysis is suspected
    May affect immune response to live vaccines
    Potentially hepatotoxic
    Risk of developing opportunistic infections
    Discontinue if grade 3 toxicity recurs for 3rd time
    Discontinue if hypotension occurs, restart at lower dose and monitor
    Discontinue if patients show signs of SIRS/capillary leak syndrome
    Discontinue if serum creatinine increases
    Discontinue if severe skin reaction occurs
    Discontinue if substantial increase in bilirubin occurs
    Discontinue if there is a rise in liver enzymes
    Interrupt treatment and/or reduce dose for any grade 3 toxicity
    Interrupt treatment if severe infection develops
    Interrupt treatment if grade 4 non-haematological toxicity occurs
    Male & female: May cause infertility
    Male & female: Ensure adequate contraception during treatment
    Advise patient of risk of bleeding

    If hypotension develops (for any reason) during the 5 days of administration, treatment should be discontinued until baseline organ function has returned at which time clofarabine treatment can be restarted at a lower dose.

    Patients who have previously received a haematopoietic stem cell transplant (HSCT) may be at higher risk for hepatotoxicity suggestive of veno-occlusive disease (VOD) following treatment with clofarabine (40 mg/metre squared) when used in combination with etoposide and cyclophosphamide.

    The concomitant use of medicinal products that have been associated with hepatotoxicity should be avoided wherever possible.

    Pregnancy and Lactation


    Clofarabine is contraindicated during pregnancy.

    The manufacturer recommends that clofarabine should not be used during pregnancy. There are no data for the use of clofarabine in pregnant women. Animal studies have shown reproductive toxicity including teratogenicity. However, Briggs (2015) suggests that as lymphoblastic leukaemia is a potentially fatal disease, if considered essential, the teratogenic risk of clofarabine should be discussed with the patient and if informed consent is obtained treatment should not be withheld.


    Clofarabine is contraindicated during breastfeeding.

    The manufacturer recommends that breastfeeding should be discontinued prior to, during and following treatment with clofarabine. It is unknown if clofarabine is excreted in human breast milk. Based on its molecular weight, plasma protein binding and elimination half life presence in human breast milk is possible. Due to the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued prior to, during and following treatment with clofarabine.

    Side Effects

    Abdominal pain
    Acute renal failure
    Bone pain
    Candidiasis (mouth or throat)
    Capillary leak syndrome
    Decreased appetite
    Elevated amylase levels
    Elevated serum lipase
    Erythematous rash
    Exfoliative dermatitis
    Extremity pain
    Febrile neutropenia
    Feeling abnormal
    Hepatic failure
    Hepatobiliary disorders
    Herpes simplex
    Herpes zoster
    Hyperpigmentation of skin
    Hypersensitivity reactions
    Increase in serum ALT/AST
    Increased sweating
    Maculopapular rash
    Mental status changes
    Mouth ulcers
    Mucosal inflammation
    Multiorgan failure
    Neutropenic colitis
    Palmar-Plantar Erythrodysaesthesia syndrome
    Pericardial effusion
    Peripheral neuropathy
    Peripheral oedema
    Pruritic rash
    Renal failure
    Respiratory distress
    Septic shock
    Serum creatinine increased
    Skin disorder
    Stevens-Johnson syndrome
    Systemic inflammatory response syndrome (SIRS)
    Toxic epidermal necrolysis
    Tumour lysis syndrome
    Veno-occlusive disease
    Weight loss


    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: September 2019

    Reference Sources

    Drugs in Pregnancy and Lactation: A Reference Guide to Fetal and Neonatal Risk, 10th edition (2015) ed. Briggs, G. and Freeman, R., Wolters Kluwer Health, Philadelphia.

    Summary of Product Characteristics: Clofarabine 1mg/ml concentrate for solution for infusion. Consilient Health Ltd. Revised January 2021.

    NICE Evidence Services Available at: Last accessed: 18 November 2021

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