Asciminib
Asciminib is an antineoplastic agent classified as an ABL/BCR-ABL1 tyrosine kinase inhibitor used in the treatment of chronic myeloid leukemia (CML). It works by specifically binding to the ABL myristoyl pocket of the BCR::ABL1 fusion protein, inhibiting its kinase activity. This medication is typically prescribed for patients with Philadelphia chromosome-positive CML who have failed or are intolerant to other tyrosine kinase inhibitors.
Asciminib is a targeted therapy for chronic myeloid leukemia that inhibits the BCR::ABL1 fusion protein through a unique myristoyl pocket binding mechanism.
Key facts at a glance
- ATC
- L01EA06
- RxNorm
- 2584304
- Generic
- Asciminib
- Class
- atc-l01
- Brands
- Scemblix
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- 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
- 400mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 40mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 400mg once daily
- Maximum
- consult physician
- Frequency
- once daily
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 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 trimesteravoid if possible
continue avoiding use unless benefits significantly outweigh risks
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
third trimesteravoid if possible
discontinue if possible prior to delivery
fetal monitoring and assessment of labor planning
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingnot applicable
avoid breastfeeding during treatment and for at least 2 weeks after last dose
infant monitoring for adverse effects
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children adolescentsnot applicable
not approved for use in pediatric patients under 18 years of age
not applicable
Use of this medication in this population requires careful consideration of risks and benefits.
geriatric
elderly 65no specific dose adjustment required
use with caution due to potential comorbidities and concomitant medications
regular monitoring of blood counts and organ function
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno initial dose adjustment required
monitor renal function during treatment
periodic assessment of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno initial dose adjustment required
use with caution and monitor liver function tests
regular liver function monitoring
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severeconsider dose reduction
use with caution, consider dose reduction based on tolerability
frequent liver function monitoring
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Asciminib is a BCR-ABL allosteric inhibitor that binds to the myristoyl pocket of BCR-ABL, distinct from ATP-competitive TKIs
FDA approval year
Asciminib (Scemblix) was FDA approved in October 2021
Primary indication
Therapeutic indication for Asciminib
Mechanism of action
Unique allosteric mechanism differentiating it from ATP-competitive TKIs
Treatment of Philadelphia chromosome-positive chronic myeloid leukemia (CML) in adult patients who have received prior tyrosine kinase inhibitor therapy and require an alternative treatment option.
Asciminib is a selective allosteric inhibitor that binds to the ABL myristoyl pocket of the BCR::ABL1 fusion protein, inhibiting ABL1 kinase activity. This mechanism differs from ATP-competitive tyrosine kinase inhibitors and demonstrates activity against wild-type BCR::ABL1.
Asciminib should be taken as directed by a healthcare provider. Common side effects may include fatigue, headache, and musculoskeletal pain. Regular monitoring of hematologic parameters and liver function is recommended during treatment. Drug interactions with CYP3A4 substrates should be considered.
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