Belinostat
Belinostat is an anticancer medication classified as a histone deacetylase (HDAC) inhibitor, primarily used to treat relapsed or refractory peripheral T-cell lymphoma. It works by blocking enzymes that remove acetyl groups from histones, leading to accumulation of acetylated histones and proteins that trigger cell cycle arrest and cancer cell death.
Belinostat is a targeted cancer therapy that inhibits HDAC enzymes to stop the growth of certain types of T-cell lymphoma.
Key facts at a glance
- ATC
- L01XH04
- RxNorm
- 1543543
- Generic
- Belinostat
- Class
- atc-l01
- Brands
- Beleodaq
- Availability
- rx
- Lactation
- unknown
- Routes
- —
- Forms
- injection
- 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
11 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
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
third trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the mother
regular fetal monitoring and assessment for preterm labor
Use of this medication in this population requires careful consideration of risks and benefits.
lactation
breastfeedingdiscontinue nursing
discontinue breastfeeding during treatment and for at least 2 weeks after last dose
monitor infant for adverse effects
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
closely monitor growth and development if used
geriatric
elderly 65 and olderno specific adjustment
no dose adjustment required but monitor for increased susceptibility to adverse effects
regular monitoring of renal function, hepatic function, and hematologic parameters
Use with caution and monitor for adverse effects.
renal_impairment
mild to moderateno specific adjustment
no dose adjustment for mild to moderate renal impairment; monitor renal function
regular monitoring of renal function and electrolytes
Use with caution and monitor for adverse effects.
renal_impairment
severeuse with caution
use with caution in severe renal impairment; consider dose reduction based on tolerability
frequent monitoring of renal function and drug-related adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno specific adjustment
no dose adjustment for mild hepatic impairment; monitor hepatic function
regular monitoring of liver function tests
Use with caution and monitor for adverse effects.
hepatic_impairment
moderateno specific adjustment
no dose adjustment for moderate hepatic impairment; monitor closely
frequent monitoring of liver function tests and bilirubin
Use with caution and monitor for adverse effects.
hepatic_impairment
severeavoid if possible
avoid use in severe hepatic impairment unless benefits outweigh risks
frequent hepatic function monitoring if used
Use of this medication in this population requires careful consideration of risks and benefits.
Statistics and clinical data
FDA approval year
FDA approval for treatment of peripheral T-cell lymphoma
Drug class
Mechanism of action classification
Approved indication
Therapeutic indication
Route of administration
Method of drug delivery
Belinostat is indicated for the treatment of patients with relapsed or refractory peripheral T-cell lymphoma (PTCL), a rare and aggressive type of non-Hodgkin lymphoma.
As an HDAC inhibitor, belinostat blocks histone deacetylase enzymes, preventing the removal of acetyl groups from lysine residues on histones and other proteins. This accumulation of acetylated histones alters gene expression, induces cell cycle arrest, and promotes apoptosis in cancer cells.
Belinostat is administered via intravenous infusion and carries risks of serious side effects including nausea, vomiting, fatigue, and blood disorders. Regular monitoring of blood counts and liver function is required during treatment. It should only be used under the supervision of healthcare professionals experienced in cancer chemotherapy.
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