Acalabrutinib
Acalabrutinib is a targeted cancer therapy that inhibits Bruton tyrosine kinase (BTK), an enzyme essential for B-cell survival and proliferation. It is used to treat certain hematologic malignancies, particularly mantle cell lymphoma and chronic lymphocytic leukemia, by blocking signaling pathways that cancer cells depend on for growth.
Acalabrutinib is a BTK inhibitor used to treat blood cancers like mantle cell lymphoma and CLL by blocking signals cancer cells need to survive.
Key facts at a glance
- ATC
- L01EL02
- RxNorm
- 1986808
- Generic
- Acalabrutinib
- Class
- atc-l01
- Brands
- Calquence
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- tablet, capsule
- Regions
- US, EU, CN, JP
- Monitoring
- —
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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
- 100mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not established
- Maximum
- consult physician
- Frequency
- not applicable
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 100mg twice daily
- Maximum
- consult physician
- Frequency
- every 12 hours
- 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 mother
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
discontinue therapy if pregnancy occurs or consider alternative treatments
regular fetal growth monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
avoid use near delivery; consider risks vs benefits carefully
fetal monitoring and assessment of placental function
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot applicable
do not breastfeed during treatment and for at least 2 weeks after last dose
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children under 18not established
safety and efficacy not established in pediatric patients; use only in clinical trials
not applicable
geriatric
elderly 65 and overno specific dose adjustment required
use standard dosing; monitor for adverse events including infections and cardiac arrhythmias
regular monitoring of blood counts, liver function, and cardiac function
Use with caution and monitor for adverse effects.
renal_impairment
severe renal impairmentuse with caution; no specific dose modification in label
monitor renal function closely; consider risks vs benefits
monitor renal function tests regularly
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate hepatic impairmentno specific dose adjustment recommended in label
use with caution; monitor for increased exposure
monitor liver function tests and for signs of toxicity
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Bruton's tyrosine kinase inhibitor class
FDA approval year
Initial FDA approval date
Common uses
Approved therapeutic indications
Mechanism of action
Molecular mechanism of action
Acalabrutinib is approved for the treatment of mantle cell lymphoma (MCL) in patients who have received at least one prior therapy, as well as chronic lymphocytic leukemia (CLL) and small lymphocytic lymphoma (SLL). It may also be used for other B-cell malignancies as determined by a treating oncologist.
Acalabrutinib is a small-molecule inhibitor of Bruton tyrosine kinase (BTK). It forms a covalent bond with a cysteine residue in the BTK active site, irreversibly inhibiting BTK enzymatic activity. This blocks B-cell receptor signaling pathways that are critical for B-cell activation, proliferation, and survival.
Common side effects may include headache, diarrhea, fatigue, and myalgia. Patients should be monitored for signs of bleeding, infections, and cardiac arrhythmias. Treatment should be overseen by an oncologist or hematologist experienced with cancer therapies. Drug interactions with strong CYP3A4 inhibitors may require dose adjustments.
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