Romidepsin is a histone deacetylase inhibitor indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. It is available as injection and kits for intravenous use. MedsAcross supplies Romidepsin for export from India to licensed hospitals, importers and physicians acting for named patients, with the documents each country requires.
Information from the US FDA prescribing information, retrieved 12 November 2026. Not yet medically reviewed.How we review
From the regulator-approved product information. Each section names its source.
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.
Source: US FDA prescribing information
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. HDACs also deacetylate non-histone proteins, such as transcription factors. In vitro, romidepsin causes the accumulation of acetylated histones, and induces cell cycle arrest and apoptosis of some cancer cell lines with IC 50 values in the nanomolar range. The mechanism of the antineoplastic effect of romidepsin observed in nonclinical and clinical studies has not been fully characterized.
Source: US FDA prescribing information
• 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. • Discontinue or interrupt treatment (with or without dose reduction to 10 mg/m 2 ) to manage drug toxicity. • Reduce starting dose in patients with moderate and severe hepatic impairment.
Source: US FDA prescribing information
None. None.
Source: US FDA prescribing information
• 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. • 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. • 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.
Source: US FDA prescribing information
The following adverse reactions are described in more detail in other sections of the prescribing information. • Myelosuppression • Infections • Electrocardiographic Changes • Tumor Lysis Syndrome 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.
Source: US FDA prescribing information
• Carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in patients concurrently administered ISTODAX and warfarin or coumarin derivatives. • Monitor for toxicities related to increased romidepsin exposure when co-administering romidepsin with strong CYP3A4 inhibitors. • Avoid use with rifampin and strong CYP3A4 inducers.
Source: US FDA prescribing information
The carton must be stored at 20° to 25°C, excursions permitted between 15° to 30°C.
Source: US FDA prescribing information
For healthcare professionals and buyers. This is not medical advice. Treatment decisions belong to the prescriber.
2 presentations of Romidepsin, sorted by availability.
| Medicine | Manufacturer | Register | Availability |
|---|---|---|---|
| Istodax kit | Celgene | US FDA | Available on request |
| Romidepsin 27.5 mg/5.5 mL injectionIntravenousGeneric name | — | US FDA | Available on request |
1 brand names across 1 markets.
United States
Approval facts from US FDA, EMA and CDSCO data, and registration status by country where we hold register data.
| Register | Status | Source |
|---|---|---|
| US FDA | First approved 5 November 2009 | Drugs@FDA |
| EU (EMA) | Refused | EMA medicines data |
| India (CDSCO) | Not yet confirmed against CDSCO approval lists | — |
| United States | Registered | US FDA (NDC directory, openFDA)Checked 12 November 2026 |
Conditions linked to Romidepsin in public data. This is not a list of approved uses, see the clinical information.
Yes, on request. MedsAcross lists 2 presentations of Romidepsin and sources them for licensed hospitals, importers and physicians against valid import documents.
The catalogue lists 1 brand names for Romidepsin, including Istodax.
Yes. The US FDA first approved Romidepsin on 5 November 2009, according to Drugs@FDA.
No listed presentation of Romidepsin is recorded as needing a cold chain. Storage conditions are shown on each presentation page.
Romidepsin is classified under ATC code L01XX39 (Romidepsin).
Tell us the strength, quantity and destination country. Our team replies with availability, lead time and the import documents needed.