Romidepsin
Romidepsin is an intravenous histone deacetylase (HDAC) inhibitor used to treat certain types of lymphoma, specifically cutaneous T-cell lymphoma (CTCL) and peripheral T-cell lymphoma (PTCL). It works by blocking HDAC enzymes, which leads to changes in gene expression and protein function that can inhibit cancer cell growth and promote cancer cell death.
Romidepsin is an HDAC inhibitor chemotherapy drug used to treat certain cutaneous and peripheral T-cell lymphomas.
Key facts at a glance
- ATC
- L01XH02
- RxNorm
- 877510
- Generic
- Romidepsin
- Class
- atc-l01
- Brands
- Istodax
- 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
10 groupspregnancy
first trimesteravoid if possible
avoid use during pregnancy unless benefits outweigh risks to the mother justify potential fetal risk
regular fetal monitoring via ultrasound
Use of this medication in this population requires careful consideration of risks and benefits.
pregnancy
second trimesteravoid if possible
use only if clearly needed and benefits outweigh potential risks
fetal monitoring
Use with caution and monitor for adverse effects.
pregnancy
third trimesteravoid if possible
consider risks versus benefits; discuss delivery planning
fetal monitoring and growth assessments
Use with caution and monitor for adverse effects.
lactation
breastfeedingdiscontinue breastfeeding
do not breastfeed during treatment and for at least 1 week after last dose
not applicable
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 only in clinical trials
not applicable
geriatric
elderly 65 yearsno specific dose adjustment required
use with caution; monitor for adverse effects; starting at standard dose but consider comorbidities
regular monitoring of blood counts and cardiac function
Use with caution and monitor for adverse effects.
renal_impairment
mild moderateno dose adjustment required
no dose adjustment needed for CrCl >=30 mL/min
standard monitoring
renal_impairment
severeuse with caution
use with caution; limited data in severe renal impairment (CrCl <30 mL/min)
closely monitor renal function and for adverse effects
Use with caution and monitor for adverse effects.
hepatic_impairment
mildno specific dose adjustment
use with caution; monitor liver function tests
monitor liver function tests regularly
Use with caution and monitor for adverse effects.
hepatic_impairment
moderate severeconsider dose reduction
use with caution; dose reduction may be required; avoid in severe hepatic impairment if possible
frequent liver function monitoring and dose adjustment based on tolerance
Use with caution and monitor for adverse effects.
Statistics and clinical data
Drug class
Pharmacological classification based on mechanism of action
FDA approval year
Regulatory approval information for cutaneous T-cell lymphoma
Common uses
Approved therapeutic indications
Mechanism of action
Pharmacodynamic mechanism of action
Romidepsin is FDA-approved for the treatment of cutaneous T-cell lymphoma (CTCL) in patients who have received at least one prior systemic therapy, and for peripheral T-cell lymphoma (PTCL) in patients who have received at least one prior treatment.
Romidepsin inhibits histone deacetylase (HDAC) enzymes, which normally remove acetyl groups from lysine residues in histones and transcription factors. By blocking HDACs, romidepsin alters gene expression patterns and affects multiple cellular processes, including cell cycle regulation, apoptosis, and cellular differentiation, leading to anticancer effects in malignant T-cells.
Romidepsin is administered by intravenous infusion, typically weekly for 3 out of 4 weeks. Important safety concerns include potential cardiac toxicity (QT prolongation, arrhythmias), myelosuppression, and tumor lysis syndrome. Treatment requires regular monitoring of blood counts, electrolytes, and cardiac function. Drug interactions may occur with strong CYP3A4 inhibitors or inducers. Common side effects include nausea, fatigue, vomiting, and hematologic abnormalities.
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