Fludarabine
Fludarabine is a chemotherapy medication used primarily to treat certain blood cancers, including chronic lymphocytic leukemia (CLL) and low-grade lymphoid malignancies. It works by interfering with DNA synthesis in cancer cells, ultimately preventing their replication and growth. This medication is typically administered under specialist supervision in a controlled clinical setting.
Fludarabine is an antineoplastic agent used to treat blood cancers by inhibiting cancer cell DNA synthesis.
This medication carries a boxed (black box) warning — the strongest type of FDA warning. Review the full prescribing information before use.
Key facts at a glance
- ATC
- L01BB05
- RxNorm
- 24698
- Generic
- Fludarabine
- Class
- atc-l01
- Brands
- —
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- injection, tablet
- 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
- 40mg/m2 once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 30mg/m2 once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 25mg/m2 once 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 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
third trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks; consider timing delivery
regular fetal monitoring and ultrasound examinations
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 6 months after last dose
N/A
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyno specific dose adjustment required but monitor closely
use with caution due to increased risk of neurological toxicity and myelosuppression
regular monitoring of blood counts and renal function
Use with caution and monitor for adverse effects.
pediatric_age
childrenweight-based dosing required
use in pediatric patients for acute lymphoblastic leukemia and other malignancies under close supervision
frequent blood count monitoring and assessment for neurotoxicity
Use with caution and monitor for adverse effects.
renal_impairment
moderate to severereduce dose based on creatinine clearance
adjust dose according to creatinine clearance; contraindicated if CrCl < 30 mL/min
monitor renal function before and during treatment; regular CBC monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
mild to moderateno specific recommendation; use with caution
use with caution; limited clinical data in hepatic impairment
monitor liver function tests and blood counts
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year
Original FDA approval for Fludarabine phosphate
Drug class
Chemotherapeutic agent classification
Primary indications
Approved therapeutic indications
Mechanism of action
Pharmacological mechanism
Fludarabine is primarily indicated for the treatment of chronic lymphocytic leukemia (CLL), particularly in patients who have not responded to standard therapies. It is also used for other low-grade lymphoid malignancies and may be utilized in certain conditioning regimens prior to bone marrow transplantation.
Fludarabine phosphate is converted in the body to its active form, 2-fluoro-ara-ATP. This metabolite inhibits key enzymes required for DNA synthesis, including DNA polymerase alpha and ribonucleotide reductase. By blocking these enzymes, the drug prevents cancer cells from synthesizing and repairing DNA, leading to cell death.
Fludarabine is a potent immunosuppressant and can cause significant bone marrow suppression, increasing the risk of infections and bleeding. Neurotoxicity has been reported at higher doses. Treatment requires careful monitoring of blood counts and organ function. It should only be administered by healthcare professionals experienced in chemotherapy.
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