Cladribine
Cladribine is an immunosuppressant medication primarily used to treat relapsing forms of multiple sclerosis (MS). It works by targeting and depleting B and T lymphocytes through interference with DNA synthesis, reducing the immune-mediated damage to the central nervous system. This medication is typically prescribed for patients with highly active relapsing MS who have had an inadequate response to other disease-modifying therapies.
Cladribine is an immunosuppressant that depletes lymphocytes to reduce disease activity in patients with relapsing multiple sclerosis.
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
- L01BB04
- RxNorm
- 44157
- Generic
- Cladribine
- Class
- atc-l01
- Brands
- Mavenclad
- 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
- 0.875 mg/kg per treatment course
- Maximum
- consult physician
- Frequency
- 2 treatment courses per year, 4-5 days per week
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.1 mg/kg daily
- Maximum
- consult physician
- Frequency
- once daily for 7 days
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 0.7 mg/kg per treatment course
- Maximum
- consult physician
- Frequency
- 2 treatment courses per year, 4-5 days per week
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
7 groupspregnancy
all trimestersavoid use
contraindicated during pregnancy; women of childbearing potential must use effective contraception during and for at least 6 months after treatment
pregnancy testing before treatment initiation
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid use
breastfeeding contraindicated during treatment and for at least 10 days after last dose
none required during treatment cessation period
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderlyuse with caution
generally not recommended for patients over 65 years; use only after careful benefit-risk assessment
increased monitoring for lymphopenia and infections
Use with caution and monitor for adverse effects.
pediatric_age
children adolescentsnot recommended
not indicated for use in patients under 18 years of age; safety and efficacy not established
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
severeavoid use
contraindicated in patients with severe renal impairment (creatinine clearance less than 30 mL/min)
renal function assessment before and during treatment
Use of this medication in this population requires careful consideration of risks and benefits.
renal_impairment
mild moderatedose reduction may be required
use with caution in mild to moderate renal impairment; dose adjustment may be necessary
regular monitoring of renal function and blood counts
Use with caution and monitor for adverse effects.
hepatic_impairment
mild moderateuse with caution
limited data available; use with caution in patients with mild to moderate hepatic impairment
monitor liver function tests and blood counts
Use with caution and monitor for adverse effects.
Statistics and clinical data
FDA approval year for MS
Mavenclad FDA approval for relapsing forms of multiple sclerosis
Drug class
ATC classification as L01BB02 (antimetabolites)
Common uses
Primary therapeutic indications
Mechanism of action
Pharmacological mechanism of action
Cladribine is used to treat relapsing forms of multiple sclerosis, including relapsing-remitting MS and active secondary progressive MS. It is specifically indicated for adult patients with high disease activity who have not responded adequately to other MS therapies.
Cladribine is a synthetic antimetabolite that interferes with DNA synthesis in lymphocytes. It selectively targets and depletes B and T lymphocytes, which are key drivers of the autoimmune response in MS. This lymphocyte depletion helps reduce inflammation and disease activity in the central nervous system.
As an immunosuppressant from the antineoplastic class (ATC-L01), cladribine reduces the body's ability to fight infections. Regular blood monitoring is required during treatment. It is administered in short annual courses rather than continuous daily dosing. The medication may increase risk of malignancies and should only be used in patients with highly active disease after careful benefit-risk assessment.
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