Clofarabine
Clofarabine is a chemotherapy medication classified as a purine nucleoside analog used primarily to treat acute lymphoblastic leukemia (ALL) in pediatric patients who have relapsed or not responded to other treatments. The drug works by interfering with DNA synthesis and repair, leading to cancer cell death.
Clofarabine is an IV chemotherapy agent used to treat relapsed or refractory acute lymphoblastic leukemia in children by disrupting cancer cell DNA synthesis.
Key facts at a glance
- ATC
- L01BB06
- RxNorm
- 44151
- Generic
- Clofarabine
- Class
- atc-l01
- Brands
- Clolar
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- Regions
- US, EU, CN, JP
- Monitoring
- —
This page is for informational purposes only.
Do not use this information to diagnose yourself or to replace a physician's advice. Always consult a qualified healthcare provider before starting, stopping, or changing any medication. If you believe you are experiencing a medical emergency, call your local emergency number immediately.
Dosage and administration
- Usual dose
- 500mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 250mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
8 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the fetus
regular fetal monitoring and ultrasound examinations
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteruse only if clearly needed
use only when benefits outweigh potential risks to fetus
regular fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteruse only if clearly needed
use only when benefits outweigh potential risks; consider timing of delivery
regular fetal monitoring and assessment of fetal well-being
Use with caution and monitor for adverse effects.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 2 weeks after last dose
monitor infant for signs of toxicity
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsuse approved pediatric dosing
approved for pediatric patients 1-21 years with relapsed or refractory acute lymphoblastic leukemia; monitor closely for tumor lysis syndrome and cytokine release
monitor CBC, renal function, hepatic function, and hydration status; monitor for tumor lysis syndrome
Use with caution and monitor for adverse effects.
geriatric
elderlystart at lower end of dosing range
use with caution due to limited data in patients over 65 years; assess renal and hepatic function before treatment
monitor renal function, hepatic function, and hematologic parameters closely
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderatereduce dose in moderate impairment
dose reduction recommended in patients with moderate renal impairment (CrCl 30-60 mL/min); avoid use in severe impairment
monitor renal function closely before and during treatment
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderatereduce dose in moderate impairment
use with caution in hepatic impairment; dose reduction may be necessary; avoid in severe hepatic impairment
monitor hepatic function closely before and during treatment
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
FDA approval information for Clofarabine (Clolar)
Drug class
Drug class classification for Clofarabine
Primary indication
Primary therapeutic indication for Clofarabine
Clofarabine is indicated for the treatment of pediatric patients (ages 1-21) with relapsed or refractory acute lymphoblastic leukemia (ALL) who have previously received at least two prior treatment regimens. It is typically used when other chemotherapy options have failed.
Clofarabine is a purine nucleoside analog that is metabolized intracellularly to its active 5'-triphosphate form. This active metabolite inhibits DNA polymerase, ribonucleotide reductase, and DNA synthesis, leading to termination of chain elongation and apoptosis in rapidly dividing cancer cells.
Clofarabine is administered by intravenous infusion and carries significant risks including severe bone marrow suppression, hepatotoxicity, nephrotoxicity, and capillary leak syndrome. It should only be used by healthcare professionals experienced in chemotherapy. Close monitoring of blood counts, liver and kidney function is required during treatment. Pregnancy must be avoided during treatment due to potential fetal harm.
Contraindications
Conditions and patient states where this medication should be avoided or used with caution.
Do not use (1)
Known allergy to this medication or its components
Use caution (1)
Consult healthcare provider for benefits vs risks assessment
Official drug label
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This information is for educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment.
This content is for general informational and educational purposes only and is not a substitute for professional medical advice, diagnosis, or treatment. Always seek the guidance of a qualified healthcare provider with any questions you have about a medical condition, and never disregard professional medical advice or delay seeking it because of something you read here.
If you think you may have a medical emergency, call your local emergency number or go to the nearest emergency department immediately.
Medically reviewed by WellAlly Editorial Team Last reviewed July 26, 2026. · Read our editorial policy