Romidepsin

Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.

• ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).ICD-10: C85.90

• None. None ( 4 ).contraindicated

• 14 mg/m 2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Repeat cycles every 28 days provided that the patient continues to benefit from and tolerates the drug ( 2.1 ). • Discontinue or interrupt treatment (with or without dose reduction to 10 mg/m 2 ) to manage drug toxicity ( 2.2 ). • Reduce starting dose in patients with moderate and severe hepatic impairment ( 2.3 ). 2.1 Dosage Information The recommended dosage of romidepsin is 14 mg/m 2 administered intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle. Cycles should be repeated every 28 days provided that the patient continues to benefit from and tolerates the drug. 2.2 Dosage Modification Nonhematologic toxicities except alopecia • Grade 2 or 3 toxicity: Treatment with romidepsin should be delayed until toxicity returns to Grade 0-1 or baseline, then therapy may be restarted at 14 mg/m 2 . If Grade 3 toxicity recurs, treatment with romidepsin should be delayed until toxicity returns to Grade 0-1 or baseline and the dose should be permanently reduced to 10 mg/m 2 . • Grade 4 toxicity: Treatment with romidepsin should be delayed until toxicity returns to Grade 0-1 or baseline, then the dose should be permanently reduced to 10 mg/m 2 . • Romidepsin should be discontinued if Grade 3 or 4 toxicities recur after dose reduction.

• Myelosuppression: ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts during treatment with ISTODAX; interrupt and/or modify the dose as necessary ( 5.1 ). • Infections: Fatal and serious infections. Reactivation of DNA viruses (Epstein Barr and hepatitis B). Consider monitoring and prophylaxis in patients with evidence of prior hepatitis B ( 5.2 ). • Electrocardiographic (ECG) changes: Consider cardiovascular monitoring in patients with congenital long QT syndrome, a history of significant cardiovascular disease, and patients taking medicinal products that lead to significant QT prolongation. Ensure that potassium and magnesium are within the normal range before administration of ISTODAX ( 5.3 ). • Tumor lysis syndrome: Patients with advanced stage disease and/or high tumor burden are at greater risk and should be closely monitored and appropriate precautions taken ( 5.4 ). • Embryo-fetal toxicity: Can cause fetal harm. Advise females of reproductive potential and males with female partners of reproductive potential of potential risk to a fetus and to use effective contraception ( 5.5 , 8.1 , 8.3 ). 5.1 Myelosuppression Treatment with ISTODAX can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia. Monitor blood counts regularly during treatment with ISTODAX and modify the dose as necessary [see Dosage and Administration (2.2) and Adverse Reactions (6.1) ].

The following adverse reactions are described in more detail in other sections of the prescribing information. • Myelosuppression [see Warnings and Precautions (5.1) ] • Infections [see Warnings and Precautions (5.2) ] • Electrocardiographic Changes [see Warnings and Precautions (5.3) ] • Tumor Lysis Syndrome [see Warnings and Precautions (5.4) ] The most common adverse reactions (≥30%), excluding laboratory abnormalities, are nausea, fatigue, infections, vomiting, anorexia, electrocardiogram ST-T wave changes, dysgeusia, constipation and pruritis. Grade 3‐4 laboratory abnormalities (≥10%) include lymphopenia, neutropenia, anemia and thrombocytopenia ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Bristol-Myers Squibb at 1-800-721-5072 or the FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. The data in the WARNINGS AND PRECAUTIONS reflect exposure to ISTODAX in four clinical trials involving 363 patients with T-cell lymphoma, including 185 patients with CTCL. ISTODAX was administered as a single agent at a dosage of 14 mg/m 2 on days 1, 8, and 15 of a 28-day cycle. Among 363 patients who received ISTODAX, 21% were exposed for 6 months or longer and 13% were exposed for greater than one year.

8.1 Pregnancy Risk Summary Based on its mechanism of action and findings from animal studies, ISTODAX can cause embryo-fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on ISTODAX use in pregnant women to inform a drug associated risk of major birth defects and miscarriage. In an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes including embryo-fetal toxicity and malformations at exposures below those in patients at the recommended dose (see Data ). Advise pregnant women of the potential risk to a fetus and to avoid becoming pregnant while receiving ISTODAX and for at least 1 month after the last dose. The background risk of major birth defects and miscarriage for the indicated population is unknown. All pregnancies have a background risk of birth defect, loss, or other adverse outcomes. In the U.S. general population, the estimated background risk of major birth defects and miscarriage in clinically recognized pregnancies is 2-4% and 15-20%, respectively. Data Animal Data Romidepsin was administered intravenously to pregnant rats during the period of organogenesis at doses of 0.1, 0.2, or 0.5 mg/kg/day. Substantial resorption or postimplantation loss was observed at the high dose of 0.5 mg/kg/day, a maternally toxic dose.

Metabolism

In patients with T-cell lymphomas who received 14 mg/m 2 of romidepsin intravenously over a 4-hour period on days 1, 8, and 15 of a 28-day cycle, geometric mean values of the maximum plasma concentration (C max ) and the area under the plasma concentration versus time curve (AUC 0-∞ ) were 377 ng/mL and 1549 ng*hr/mL, respectively. Romidepsin exhibited linear pharmacokinetics across doses ranging from 1.0 (0.07 times the recommended dose) to 24.9 (1.76 times the recommended dose) mg/m 2 when administered intravenously over 4 hours in patients with advanced cancers.

No specific information is available on the treatment of overdosage of ISTODAX. Toxicities in a single-dose study in rats or dogs, at intravenous romidepsin doses up to 2.2-fold the recommended human dose based on the body surface area, included irregular respiration, irregular heartbeat, staggering gait, tremor, and tonic convulsions. In the event of an overdose, it is reasonable to employ the usual supportive measures, e.g., clinical monitoring and supportive therapy, if required. There is no known antidote for ISTODAX and it is not known if ISTODAX is dialyzable.

• Nov 5, 2009NDANDA022393Bristol-myers
• Oct 12, 2021ANDAANDA206254Fresenius Kabi Usa
• Jun 2, 2026ANDAANDA219099Amneal

1. 1Death1257.6%
2. 2Nausea1217.3%
3. 3Thrombocytopenia1207.3%
4. 4Peripheral T-cell Lymphoma Unspecified1167.0%
5. 5Pyrexia1046.3%
6. 6Drug Ineffective895.4%
7. 7Anaemia804.8%
8. 8Fatigue804.8%
9. 9Vomiting774.7%
10. 10Platelet Count Decreased734.4%
11. 11Electrocardiogram Qt Prolonged704.2%
12. 12Disease Progression643.9%
13. 13Product Storage Error623.8%
14. 14Atrial Fibrillation613.7%
15. 15Neutropenia613.7%

The 10 most recently updated of 105 ClinicalTrials.gov registrations naming Romidepsin as an intervention. Registration is not evidence of efficacy or safety — reference crosswalk only.

• Efficacy and Safety of Oral Azacitidine (CC-486) Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory Angioimmunoblastic T Cell Lymphoma
  Completed · Phase 3 · Interventional · 93 enrolled · Celgene
  NCT03703375updated 2026-06-12
• Romidepsin and Lenalidomide in Treating Patients With Previously Untreated Peripheral T-Cell Lymphoma
  Completed · Phase 2 · Interventional · 30 enrolled · Northwestern University
  NCT02232516updated 2026-06-12
• Evaluation of the Safety and the Tolerability of a Combination of Two HIV Inducers in Patients With Undetectable Viral Load
  Completed · Phase 1 · Interventional · 9 enrolled · ANRS, Emerging Infectious Diseases
  NCT05230368updated 2026-06-11
• Study of Ixazomib and Romidepsin in Peripheral T-cell Lymphoma (PTCL)
  Terminated · Phase 1 · Phase 2 · Interventional · 11 enrolled · University of Michigan Rogel Cancer Center
  NCT03547700updated 2026-05-06
• Trial of Duvelisib in Combination With Either Romidepsin or Bortezomib in Relapsed/Refractory T-cell Lymphomas
  Completed · Phase 1 · Interventional · 114 enrolled · Memorial Sloan Kettering Cancer Center
  NCT02783625updated 2026-04-24
• Efficacy and Safety of Oral Azacitidine Compared to Investigator's Choice Therapy in Patients With Relapsed or Refractory AITL
  Completed · Phase 3 · Interventional · 86 enrolled · The Lymphoma Academic Research Organisation
  NCT03593018updated 2026-04-23
• Romidepsin, Gemcitabine, Dexamethasone and Cisplatin in the Treatment of Peripheral T-Cell and Diffuse Large B-Cell Lymphoma
  Completed · Phase 1 · Interventional · 21 enrolled · Canadian Cancer Trials Group
  NCT01846390updated 2026-03-27
• Study Investigating Intravesical HDAC Inhibition to Improve Response to Immuno-Oncology Agents
  Suspended · Phase 1 · Interventional · 12 enrolled · H. Lee Moffitt Cancer Center and Research Institute
  NCT06963346updated 2026-03-09
• Romidepsin, CC-486 (5-azacitidine), Dexamethasone, and Lenalidomide (RAdR) for Relapsed/Refractory T-cell Malignancies
  Completed · Phase 1 · Interventional · 26 enrolled · National Cancer Institute (NCI)
  NCT04447027updated 2026-01-30
• Randomized Phase IIB Trial of Oral Azacytidine Plus Romidepsin Versus Investigator's Choice in PTCL
  Recruiting · Phase 2 · Interventional · 50 enrolled · University of Virginia
  NCT04747236updated 2026-01-21

Frequently asked questions

How does Romidepsin work?

Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs catalyze the removal of acetyl groups from acetylated lysine residues in histones, resulting in the modulation of gene expression.

What is Romidepsin used for?

According to FDA labeling, Romidepsin carries indications including: ISTODAX is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. ISTODAX is a histone deacetylase (HDAC) inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy ( 1 ).. This is a reference summary of labeled uses, not medical advice or a treatment recommendation.

What class of drug is Romidepsin?

Romidepsin is classified as Histone deacetylase (HDAC) inhibitors, Histone Deacetylase Inhibitor, Bile Salt Export Pump Inhibitors, Histone Deacetylase Inhibitors, Organic Anion Transporter 1 Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors, Organic Cation Transporter 2 Inhibitors, Increased Cellular Death.

What are the brand names for Romidepsin?

Romidepsin is marketed under brand names including Istodax.

What are the contraindications for Romidepsin?

Romidepsin labeling lists contraindications including: None. None ( 4 ).. Always consult the full prescribing information and a clinician.