Romidepsin
ISTODAX
What it isCyclic-peptide histone deacetylase inhibitor given IV for cutaneous T-cell lymphoma after prior systemic therapy.
Why this oneOffers an epigenetic, non–cross-resistant option in relapsed CTCL with an intermittent dosing schedule.
What limits itCytopenias and infection require CBC monitoring; correct potassium and magnesium and review CYP3A and QT-prolonging drugs.
FDA-approved for
- cutaneous T-cell lymphoma (2009)
FDA label
Read the full label on DailyMed ↗
| FDA dosing | Population | Start | Target | Max |
|---|---|---|---|---|
| Cutaneous T-cell lymphoma (CTCL) | Adults | 14 mg/m2 IV over 4 h on days 1, 8, 15 of a 28-day cycle | 14 mg/m2 per dose | 14 mg/m2 (reduce to 10 mg/m2 for toxicity) |
Renal Undefined
Hepatic Moderate (bilirubin >1.5-3x ULN): start 7 mg/m2; severe (>3x ULN): start 5 mg/m2; no adjustment for mild
Instructions
- 14 mg/m2 IV over 4 hours on days 1, 8, and 15 of each 28-day cycle; repeat every 28 days
- Dilute in 500 mL 0.9% sodium chloride before infusion; infuse over 4 hours
- Hazardous drug - follow special handling and disposal procedures
- Interrupt and/or reduce to 10 mg/m2 for Grade 2-3 nonhematologic or Grade 3-4 hematologic toxicity; discontinue if Grade 3-4 recurs after reduction
- Ensure potassium and magnesium are within normal range before administration
Cautions
- Myelosuppression (thrombocytopenia, neutropenia, anemia) - monitor blood counts
- Fatal and serious infections; reactivation of EBV and hepatitis B - consider monitoring and prophylaxis
- ECG changes/QT - monitor in long QT syndrome, cardiovascular disease, or QT-prolonging drugs; correct K/Mg
- Tumor lysis syndrome in high tumor burden
- Embryo-fetal toxicity
Adverse reactions
- Nausea
- Fatigue
- Infections
- Vomiting
- Anorexia
- ECG ST-T wave changes
- Dysgeusia
- Constipation
- Pruritus
- Lymphopenia, neutropenia, anemia, thrombocytopenia
Pregnancy Can cause fetal harm based on mechanism and animal data; avoid pregnancy and use effective contraception.
Lactation Advise not to breastfeed during treatment and for 1 week after the last dose.
NO BOXED WARNINGS
Principal risksevere cytopenias and infection
Cost, est. cash$5,000–$30,000+/month or cycle
Generic entry2026
Classes and tags
Clinical profile
Legacy pregnancy categoryD
Defining liabilityMyelosuppression and agent-specific hepatic, cardiac, pulmonary, neurologic or reproductive toxicity require oncology monitoring.
Mechanism of action: Romidepsin ballicule
