Ibrutinib
Ibrutinib is an oral targeted therapy that inhibits Bruton's tyrosine kinase (BTK), a protein essential for B-cell survival and proliferation. It is primarily used to treat various B-cell malignancies including chronic lymphocytic leukemia (CLL), mantle cell lymphoma, Waldenström's macroglobulinemia, and marginal zone lymphoma. By blocking BTK signaling, it disrupts cancer cell communication and growth, offering a chemotherapy-free treatment option for eligible patients.
Ibrutinib is an oral BTK inhibitor used to treat B-cell cancers by blocking a key signaling protein needed for cancer cell survival.
Key facts at a glance
- ATC
- L01EL01
- RxNorm
- 1442981
- Generic
- Ibrutinib
- Class
- atc-l01
- Brands
- Imbruvica
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- capsule, tablet, suspension
- 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
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second third trimesteravoid
discontinue therapy if pregnancy occurs
fetal monitoring recommended
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingavoid
do not breastfeed during treatment and for at least 1 week after last dose
none
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsnot established
safety and efficacy not established in patients under 18 years; use not recommended
not applicable
geriatric
elderlyno adjustment required
no specific dose adjustment needed based on age alone; monitor for adverse effects
routine monitoring for adverse effects
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno adjustment required
no dose adjustment needed for mild to moderate renal impairment
routine renal function monitoring
Use with caution and monitor for adverse effects.
renal_impairment
severeuse with caution
use with caution; limited clinical data available
close monitoring of renal function and adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno adjustment required
no dose adjustment for mild hepatic impairment (Child-Pugh Class A)
routine liver function monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
moderatereduce dose
reduce dose for moderate hepatic impairment (Child-Pugh Class B)
regular liver function monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
severeavoid
avoid use in severe hepatic impairment (Child-Pugh Class C)
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
Drug class
Targeted therapy for B-cell malignancies
FDA approval year
Initial FDA approval date
Common uses
Approved therapeutic indications
Mechanism of action
Pharmacological mechanism of action
Chronic lymphocytic leukemia (CLL)/small lymphocytic lymphoma (SLL), mantle cell lymphoma (MCL), Waldenström's macroglobulinemia, marginal zone lymphoma (MZL), and chronic graft-versus-host disease (cGVHD) in patients who have failed prior therapies.
Ibrutinib irreversibly binds to and inhibits Bruton's tyrosine kinase (BTK), a critical enzyme in the B-cell receptor signaling pathway. This blocks signals that promote B-cell proliferation, survival, and migration, leading to reduced cancer cell growth and spread.
Ibrutinib is taken orally once daily. Common side effects include diarrhea, fatigue, musculoskeletal pain, and increased risk of infections and bleeding. Patients should be monitored for atrial fibrillation and hypertension. Drug interactions are possible, particularly with strong CYP3A4 inhibitors and anticoagulants. Treatment may continue until disease progression or unacceptable toxicity.
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