Alectinib
Alectinib is a targeted therapy medication known as a tyrosine kinase inhibitor, used primarily to treat ALK-positive non-small cell lung cancer (NSCLC). It works by blocking abnormal proteins that promote cancer cell growth and division.
Alectinib is a targeted therapy for ALK-positive lung cancer that inhibits cancer cell growth by blocking ALK and RET proteins.
Key facts at a glance
- ATC
- L01ED03
- RxNorm
- 1727455
- Generic
- Alectinib
- Class
- atc-l01
- Brands
- Alecensa
- Availability
- rx
- Lactation
- unknown
- Routes
- oral
- Forms
- capsule
- 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
- 600mg twice daily with food
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- not established - not approved for pediatric use
- Maximum
- consult physician
- Frequency
- not applicable
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
- Usual dose
- 600mg twice daily with food
- Maximum
- consult physician
- Frequency
- every 12 hours
- Instructions
- Follow physician instructions
- Duration limits
- as prescribed
- Monitoring
- standard
Overdose information
Special Populations
9 groupspregnancy
first trimesteravoid if possible
Alectinib is not recommended during pregnancy. Based on its mechanism of ALK inhibition, it may cause fetal harm. Women of reproductive potential should use effective contraception during treatment and for at least 5 months after the last dose.
regular fetal monitoring
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second and third trimesteravoid if possible
Continue to avoid use during second and third trimester unless benefits significantly outweigh risks. Consider switching to alternative therapy.
regular fetal monitoring and ultrasound assessments
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue breastfeeding
It is not known whether alectinib is excreted in human breast milk. Due to the potential for serious adverse reactions in nursing infants, breastfeeding should be discontinued during treatment and for at least 1 week after the last dose.
monitor infant for adverse reactions
Use of this medication in this population requires careful consideration of risks and benefits.
pediatric_age
children and adolescentsno recommended dose established
The safety and efficacy of alectinib in pediatric patients (children and adolescents <18 years) have not been established. Use only in clinical trials or when specifically prescribed by a pediatric oncologist.
close monitoring in clinical trial setting
geriatric
elderly 65 years and olderno initial dose adjustment required
No significant differences in safety or efficacy were observed between patients ≥65 years and younger patients. However, elderly patients may have increased susceptibility to certain adverse effects and should be monitored closely.
regular monitoring of hepatic function and for adverse effects
Use with caution and monitor for adverse effects.
renal_impairment
mild renal impairmentno dose adjustment required
No dose adjustment is required for patients with mild renal impairment (CrCl 60-89 mL/min). Continue standard dosing.
routine renal function monitoring
renal_impairment
moderate severe renal impairmentno specific dose adjustment in labeling
Alectinib is primarily eliminated as unchanged drug. For patients with moderate to severe renal impairment (CrCl 15-59 mL/min), caution is advised. Close monitoring is recommended.
regular monitoring of renal function
Use with caution and monitor for adverse effects.
hepatic_impairment
mild hepatic impairmentno dose adjustment required
No dose adjustment is recommended for patients with mild hepatic impairment (Child-Pugh A). Standard dosing applies.
routine hepatic function monitoring
hepatic_impairment
moderate severe hepatic impairmentuse with caution
Alectinib is metabolized in the liver. For patients with moderate to severe hepatic impairment (Child-Pugh B or C), use with caution. Consider dose reduction and close monitoring of hepatic function.
frequent hepatic function monitoring including bilirubin and transaminases
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Alectinib is classified as an ALK inhibitor and tyrosine kinase inhibitor
Primary indication
FDA-approved indication for alectinib
Mechanism of action
Primary pharmacodynamic mechanism
FDA approval year
First FDA approval date for Alecensa
Alectinib is indicated for the treatment of adults with ALK-positive metastatic non-small cell lung cancer (NSCLC), both in patients who have progressed on or are intolerant to crizotinib and as first-line therapy.
Alectinib is a tyrosine kinase inhibitor that targets ALK and RET proteins. It inhibits ALK phosphorylation and downstream signaling proteins STAT3 and AKT, decreasing tumor cell viability and slowing cancer growth.
Alectinib requires confirmed ALK-positive status via an FDA-approved test before use. Common side effects may include fatigue, constipation, and muscle pain. Patients should be monitored for liver enzyme elevations and respiratory symptoms. The medication may cause photosensitivity and should be taken with food.
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