Romidepsin Injection
Romidepsin Injection is an intravenous (IV) cancer medicine used to treat cutaneous T-cell lymphoma (CTCL) in adults who have already tried at least one other whole-body treatment.
🧬 Where this information comes from Click to expand
The clinical label records used on this page are FDA-filed Structured Product Labeling (SPL) retrieved through openFDA. We identified 1 clinical label set within the page’s selected clinical scope after exact ingredient or ingredient-combination matching and applicable route/form matching. Forms, routes, brands, labelers, strengths, and NDC product-record counts are built separately from matching FDA National Drug Code Directory records. The linked DailyMed document is a representative official source for verification, not the page’s only clinical source. View the linked label on DailyMed →
Romidepsin Injection (Istodax) is a specialist cancer medicine, given into a vein (IV), for cutaneous T-cell lymphoma (a lymphoma that shows up in the skin) in adults who have already had at least one whole-body treatment; it blocks HDAC enzymes that switch genes on and off, and it is available generically. It is a fairly demanding treatment, and nausea, tiredness, poor appetite and taste changes are what most people notice. Watch above all for infection and low blood counts, and report fever, chills, unusual bruising or bleeding right away. It can also change heart tracings, so potassium and magnesium are checked before each treatment, and a pounding heartbeat or fainting needs prompt reporting.
Clinical pearls
- Estrogen-containing birth control may work less well, so use condoms or an IUD during treatment and for a month after.
- Rifampin should be avoided with romidepsin, and strong antifungals like ketoconazole mean closer watching for side effects.
- If you take warfarin, expect your INR (a clotting blood test) to be checked more often during treatment.
- Mention any past hepatitis B, since it or Epstein-Barr virus can reactivate and cause serious liver trouble.
Patient information guide A plain-language walkthrough of Romidepsin Injection, written from its FDA label.
What Romidepsin Injection is used for
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Romidepsin Injection has one supported use:
- Cutaneous T-cell lymphoma (CTCL) in adults who have received at least one prior systemic therapy
How Romidepsin Injection works
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Romidepsin is a histone deacetylase (HDAC) inhibitor. HDACs are enzymes that remove chemical tags from histones, which are proteins that help control gene activity. Blocking them changes gene expression.
In lab studies, this led some cancer cells to stop dividing and die. The exact way it works against cancer in people has not been fully worked out.
Romidepsin Injection dosage
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Romidepsin Injection is given into a vein over about 4 hours by a healthcare professional. It follows a 28-day cycle with treatment on three days in each cycle. Cycles repeat as long as you benefit and tolerate it.
- Doses may be delayed or lowered for side effects.
- People with moderate or severe liver impairment start at a lower dose.
- Follow your prescriber's plan.
Dosing details from the FDA-approved label
From the Romidepsin Injection prescribing information (“Dosage and Administration”). Doses are set by your prescriber for your product, condition, kidney function and age — never change a dose on your own.
- Recommended dosage (all patients)
- 14 mg/m2 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
- Dilute in 500 mL 0.9% Sodium Chloride Injection, USP before infusion; infuse over 4 hours
- Nonhematologic toxicities except alopecia: Grade 2 or 3 toxicity
- Delay treatment until toxicity returns to Grade 0 to 1 or baseline, then may restart at 14 mg/m2. If Grade 3 toxicity recurs, delay until Grade 0 to 1 or baseline and permanently reduce the dose to 10 mg/m2
- Discontinue if Grade 3 or 4 toxicities recur after dose reduction
- Nonhematologic toxicities except alopecia: Grade 4 toxicity
- Delay treatment until toxicity returns to Grade 0 to 1 or baseline, then permanently reduce the dose to 10 mg/m2
- Discontinue if Grade 3 or 4 toxicities recur after dose reduction
- Hematologic toxicities: Grade 3 or 4 neutropenia or thrombocytopenia
- Delay treatment until the specific cytopenia returns to ANC greater than or equal to 1.5 × 10^9/L and platelet count greater than or equal to 75 × 10^9/L or baseline, then may restart at 14 mg/m2
- Hematologic toxicities: Grade 4 febrile (greater than or equal to 38.5°C) neutropenia or thrombocytopenia that requires platelet transfusion
- Delay treatment until the specific cytopenia returns to less than or equal to Grade 1 or baseline, then permanently reduce the dose to 10 mg/m2
- Moderate hepatic impairment (bilirubin greater than 1.5 × ULN to less than or equal to 3 × ULN)
- 7 mg/m2 starting dose
- Monitor for toxicities more frequently
- Severe hepatic impairment (bilirubin greater than 3 × ULN)
- 5 mg/m2 starting dose
- Monitor for toxicities more frequently
- Mild hepatic impairment
- Dosage adjustment is not required
Read the label’s full dosing text
2 DOSAGE AND ADMINISTRATION 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 injection 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 injection should be delayed until toxicity returns to Grade 0 to 1 or baseline, then therapy may be restarted at 14 mg/m 2 . If Grade 3 toxicity recurs, treatment with romidepsin injection should be delayed until toxicity returns to Grade 0 to 1 or baseline and the dose should be permanently reduced to 10 mg/m 2 . Grade 4 toxicity: Treatment with romidepsin injection should be delayed until toxicity returns to Grade 0 to 1 or baseline, then the dose should be permanently reduced to 10 mg/m 2 . Romidepsin injection should be discontinued if Grade 3 or 4 toxicities recur after dose reduction. Hematologic toxicities Grade 3 or 4 neutropenia or thrombocytopenia: Treatment with romidepsin injection should be delayed until the specific cytopenia returns to ANC greater than or equal to 1.5 × 10 9 /L and platelet count greater than or equal to 75 × 10 9 /L or baseline, then therapy may be restarted at 14 mg/m 2 . Grade 4 febrile (greater than or equal to 38.5°C) neutropenia or thrombocytopenia that requires platelet transfusion: Treatment with romidepsin injection should be delayed until the specific cytopenia returns to less than or equal to Grade 1 or baseline, and then the dose should be permanently reduced to 10 mg/m 2 . 2.3 Dosage in Patients with Hepatic Impairment For patients with moderate or severe hepatic impairment, reduce the starting dose of romidepsin injection as shown in Table 1 and monitor for toxicities more frequently. Dosage adjustment is not required for patients with mild hepatic impairment.
Excerpted — the section continues on the label. Read the full Dosage and Administration section on DailyMed →
Romidepsin Injection side effects
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The most common side effects include:
Common side effects
- Nausea
- Vomiting
- Fatigue or weakness
- Infections
- Loss of appetite
- Changes in taste
- Constipation
- Itching
When to get medical help
- Call your doctor right away if you have fever, chills, cough, or other signs of infection. Serious and fatal infections have happened.
- Tell your care team about unusual bruising or bleeding, or about extreme tiredness or paleness. These can be signs of low blood counts.
- Report a fast, irregular or pounding heartbeat, fainting, or dizziness. The drug can cause heart tracing (ECG) changes.
- Tell your doctor if you have yellowing of the skin or eyes, or signs of liver trouble. Hepatitis B or Epstein-Barr virus can reactivate, and Epstein-Barr reactivation has led to liver failure.
- Report any new symptoms quickly if you have advanced disease or a lot of tumor. Tumor lysis syndrome (a rapid breakdown of cancer cells that upsets body chemistry) can occur.
- Tell your doctor right away if you become pregnant or think you might be.
Lab abnormalities such as low white cells, neutrophils, red cells, and platelets are also common. Seek help promptly for signs of infection, bleeding, or heart rhythm symptoms.
Romidepsin Injection warnings and precautions
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- Low blood counts: thrombocytopenia (low platelets), leukopenia (low white cells), and anemia. Blood counts are monitored.
- Infections: serious and fatal infections, including pneumonia and sepsis. Hepatitis B and Epstein-Barr virus can reactivate.
- ECG changes: monitoring may be needed with long QT syndrome, significant heart disease, or QT-prolonging drugs.
- Tumor lysis syndrome: higher risk with advanced disease or high tumor burden.
- Pregnancy: can cause fetal harm.
Romidepsin Injection interactions
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Several medicines can change romidepsin levels or be affected by it:
- Rifampin: raises romidepsin levels; avoid.
- Other strong CYP3A4 inducers: avoid when possible.
- Strong CYP3A4 inhibitors such as ketoconazole: can raise levels, so you are monitored for side effects.
- Warfarin or coumarin drugs: clotting tests should be checked more often.
- P-glycoprotein inhibitors: may raise romidepsin levels.
- Estrogen-containing contraceptives: may work less well.
Interactions listed in the FDA-approved label
From the Romidepsin Injection prescribing information (“Drug Interactions”): what the manufacturer studied or reported to the FDA.
- Warfarin or coumarin derivatives: Prolongation of PT and elevation of INR were observed in a patient receiving romidepsin concomitantly with warfarin. Monitor PT and INR more frequently in patients concurrently receiving romidepsin injection and warfarin.
- Strong CYP3A4 inhibitors: Strong CYP3A4 inhibitors increase concentrations of romidepsin. Monitor for toxicity related to increased romidepsin exposure and follow the dose modifications for toxicity when romidepsin injection is initially co-administered with strong CYP3A4 inhibitors.
- Rifampin: Rifampin (a potent CYP3A4 inducer) increased the concentrations of romidepsin. Avoid co-administration of romidepsin injection with rifampin.
- Other potent CYP3A4 inducers: Potent CYP3A4 inducers are a concern with romidepsin per the label. Avoid use when possible.
Read the label’s full interactions text
7 DRUG INTERACTIONS Warfarin: Carefully monitor prothrombin time (PT) and International Normalized Ratio (INR) in patients receiving concurrent warfarin or coumarin derivatives. ( 7.1 ) CYP3A4 inhibitors: Monitor for toxicities related to increased romidepsin exposure when co-administering romidepsin with strong CYP3A4 inhibitors. ( 7.2 ) CYP3A4 inducers: Avoid use with rifampin and strong CYP3A4 inducers. ( 7.3 ) 7.1 Warfarin or Coumarin Derivatives Prolongation of PT and elevation of INR were observed in a patient receiving romidepsin concomitantly with warfarin. Monitor PT and INR more frequently in patients concurrently receiving romidepsin injection and warfarin [see Clinical Pharmacology (12.3) ] . 7.2 Drugs That Inhibit CYP3A4 Enzymes Strong CYP3A4 inhibitors increase concentrations of romidepsin [see Clinical Pharmacology (12.3) ] . Monitor for toxicity related to increased romidepsin exposure and follow the dose modifications for toxicity [see Dosage and Administration (2.2) ] when romidepsin injection is initially co-administered with strong CYP3A4 inhibitors. 7.3 Drugs That Induce CYP3A4 Enzymes Rifampin (a potent CYP3A4 inducer) increased the concentrations of romidepsin [see Clinical Pharmacology (12.3) ] . Avoid co-administration of romidepsin injection with rifampin. The use of other potent CYP3A4 inducers should be avoided when possible.
Not a complete list. The label covers the interactions the manufacturer studied or reported, and our own interaction database does not cover every medicine either. Bring your full medication list, including vitamins and herbal products, to your pharmacist.
Before taking Romidepsin Injection
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- Tell your doctor if you are pregnant or could become pregnant. A pregnancy test is done within 7 days before starting.
- Use effective birth control during treatment and for 1 month after the last dose. Use a non-estrogen method.
- Do not breastfeed during treatment and for 1 week after the last dose.
- Tell your doctor about liver problems, hepatitis B history, heart disease, or long QT syndrome.
- Not established in children.
- Older adults showed no overall differences, though some may be more sensitive.
Romidepsin Injection overdose
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There is no specific information on treating romidepsin overdose and no known antidote. In animal studies, high doses caused irregular breathing, irregular heartbeat, staggering, tremor, and convulsions. Treatment is supportive, such as clinical monitoring and supportive care.
What Romidepsin Injection does in the body
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At the doses studied, romidepsin did not cause large changes in the QTc interval (a heart rhythm measurement), but small increases could not be ruled out. It also raised heart rate in a concentration-dependent, delayed way. The average peak increase was about 20 beats per minute, around 6 hours after the infusion started.
How your body processes Romidepsin Injection
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Romidepsin is highly bound to proteins in the blood (92% to 94%). It is broken down mainly by the liver enzyme CYP3A4. Its half-life is about 3 hours, and it did not build up with repeated dosing. Clearance decreases as liver impairment worsens. Age, gender, race, and kidney impairment did not affect how the body handled it.
How to store Romidepsin Injection
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Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) in the carton . Protect from light.
Written from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
Supplements & herbs that interact with Romidepsin Injection
135 supplements and herbal products have documented interactions with Romidepsin Injection in the licensed clinical database we use. Most are manageable — but your pharmacist should know about everything you take, including vitamins and herbals.
- Major · 7
- Moderate · 100
- Minor · 28
Educational information from a licensed clinical database (Natural Medicines) — see our data sources & update cadence. Not medical advice: an interaction being documented does not mean it will happen to you; do not start or stop medications or supplements without professional guidance.
Romidepsin Injection: pharmacist answers to common questions
Quick, plain-English answers to the questions patients ask most about Romidepsin Injection — the kind of thing our pharmacy team would talk through with you at the counter.
What is Romidepsin Injection for?
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How is it given, and how long does it take?
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What side effects should I expect?
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When should I call my doctor?
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Can I take my other medicines with it?
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What about pregnancy or breastfeeding?
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Is Romidepsin Injection available over the counter?
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When was Romidepsin Injection first available?
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Answers drafted from the FDA-approved label with AI and reviewed by our pharmacy team. How we use AI →
More about Romidepsin Injection on HelloPharmacist
Romidepsin Injection forms and strengths (how it comes)
Romidepsin Injection is available in 1 form. Different forms and brands can have different approved uses, doses, schedules, and directions. Follow the instructions for your exact product, and do not switch forms without guidance from your prescriber or pharmacist.
Injection
How this form is used
- ROMIDEPSIN injection is used to treat cutaneous T-cell lymphoma (CTCL) in adults who have had at least one prior systemic therapy.
- ROMIDEPSIN injection must be diluted in 0.9% sodium chloride before it is given into a vein.
- ROMIDEPSIN injection is infused over 4 hours, on days 1, 8, and 15 of a 28-day cycle.
- ROMIDEPSIN injection is a hazardous drug, so special handling and disposal procedures are followed.
Romidepsin Injection on the U.S. market: products, makers and brands
How Romidepsin Injection appears in the FDA’s National Drug Code Directory — including its dosage forms, strengths, brand names, manufacturers, and FDA-listed product records. These are directory records, not sales or prescription volume.
1 company lists 1 Romidepsin Injection product record with the FDA, mostly as injection; the earliest marketing or approval year on record is 2009. Brand names on the directory include Istodax; the rest are generics.
How widely Romidepsin Injection is used (Medicaid data)
A general measure of how commonly Romidepsin Injection is prescribed, based on Medicaid — one of the largest public drug programs. The figure below is prescriptions filled in Q1–Q4 2025, summed across every form and brand of the drug.
Think of this as a proxy for how widely Romidepsin Injection is used, drawn from freely available public data. Medicaid is just one program — these numbers don’t include Medicare, other government coverage, or commercial and cash-pay prescriptions, so real-world use is higher than what’s shown here.
How commonly is Romidepsin Injection prescribed? Of the 1,601 medications we measure, Romidepsin Injection ranks #1,488 by Medicaid prescriptions — more than 7% of them.
Utilization by Romidepsin Injection product
Pick a product to see its own Medicaid numbers. Each chip is one clinical product — a specific strength & dosage form as defined by RxNorm — with brand-name and generic versions combined.
romidepsin 10 MG Injection
Summed across the 2 of 8 listed NDC products with Medicaid activity — every brand and generic of this exact strength & form. RxNorm 877513
Shares are of the Medicaid prescriptions shown here. Product grouping follows RxNorm (the National Library of Medicine’s drug terminology), so “one product” means one strength & dosage form regardless of manufacturer. Dollar figures are gross Medicaid reimbursement before mandatory rebates — rebates (often large, especially for brand-name drugs) are confidential, so actual net cost to Medicaid is lower than shown.
Source: Medicaid State Drug Utilization Data (CMS), aggregated by generic ingredient — summed across every NDC (all brands, strengths, salt forms and dosage forms) of Romidepsin Injection, and across all states and both fee-for-service and managed-care claims. A general popularity signal; it excludes Medicare, commercial insurance and cash prescriptions, so it is not total U.S. use. Based on the 2 of 8 listed Romidepsin Injection NDCs with Medicaid activity.
Compare Romidepsin Injection products
A representative set of FDA-listed product records for Romidepsin Injection — across manufacturers, strengths, and dosage forms, grouped by form with each product’s manufacturer and how the FDA approved it. The same medicine may be made and packaged by different companies, so a single drug can have many directory entries. (It’s also why a refill can look different — a new shape, color, or box — even though it contains the same medication.)
| Strength | Route | Manufacturer / Labeler | Category ⓘ | Details |
|---|---|---|---|---|
| 💊Injection | ||||
| 5 mg/mL | Intravenous | Amneal Pharmaceuticals LLC | ANDA | View NDC → |
Showing 1 of 1 products — FDA National Drug Code Directory. See every product, package size and price: browse all 1 Romidepsin Injection NDCs →
Romidepsin Injection side effects reported to the FDA (FAERS)
After a medicine reaches the market, patients, doctors and drugmakers can send the FDA reports of problems they think may be linked to it. Here’s what’s been reported for Romidepsin Injection — a signal of what to watch for, not proof the drug caused it.
Source: openFDA, from the FDA Adverse Event Reporting System (FAERS). These are voluntary reports — they don’t prove the drug caused the effect, and counts reflect how often something was reported, not how often it actually happens. Reports also often name the very problem the medicine is taken for — a common reason to file one is that the drug didn’t help — so for a pain reliever you may see “pain” high on the list; that points to why the report was filed, not to the drug causing the symptom. This counts every report that lists Romidepsin Injection in any role, so the total runs higher than the FDA’s official dashboard, which counts only cases where the drug is the suspect. For the authoritative figures, see the FDA FAERS Public Dashboard. Always talk to your pharmacist or doctor.
Romidepsin Injection FDA approval history
How Romidepsin Injection went from FDA review to the pharmacy shelf — the key milestones in its regulatory journey.
Source: Drugs@FDA.
Romidepsin Injection recall history
A recall is when a specific batch of a medicine is pulled from the market — usually a manufacturing issue, not a problem with the drug itself. Class I is most serious, Class III least.
The FDA’s enforcement reports list no Romidepsin recalls since July 2021.
✅No Romidepsin recalls on record since July 2021Source: FDA enforcement (recall) reports, via openFDA; our copy was last updated Sep 24, 2026.
RxNorm Concept Web — From Ingredient to Every Form and Strength
This page starts with one ingredient concept (IN). The branches below show its dose-form concepts (SCDF), then the available clinical drug and strength concepts (SCD). Combination products remain separate concepts with their own pages.
RxCUI 877510 1 dose form · 2 strengths
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Dose form (SCDF) Injection RxCUI 1724267In current FDA listings
Look up RxCUI 877510 in the RxCUI Atlas →
RxNorm is the U.S. National Library of Medicine’s normalized drug vocabulary. Its concept hierarchy can include forms that are not currently marketed; the status on each branch compares that concept with current FDA listings. RxCUIs identify vocabulary concepts, not individual packages or manufacturers.
Romidepsin Injection supply and shortage status
Whether Romidepsin Injection is in short supply in the U.S. right now, plus any shortage history the FDA has on record. A shortage usually reflects a manufacturing or demand issue — not a safety problem with the drug.
Source: openFDA, from the FDA Drug Shortages database.
Romidepsin Injection brand names
Romidepsin Injection is sold under one brand name in the FDA directory — Istodax. A brand and its generic contain the same active ingredient; the brand name belongs to one company's product.
Who makes Romidepsin Injection: manufacturers and labelers
One company lists Romidepsin Injection products with the FDA. By number of product records, the largest are Amneal Pharmaceuticals LLC. Labelers include manufacturers and repackagers; the product in your bottle depends on which one your pharmacy stocks.
Romidepsin Injection drug class (RxNorm)
Romidepsin Injection belongs to the Histone Deacetylase Inhibitor class.
Classified by RxNorm RxClass — the U.S. National Library of Medicine's standardized drug-classification service (Established Pharmacologic Class from the FDA, the ATC drug family from the WHO, and mechanism of action). Reference only, not medical advice.
Sources for this Romidepsin Injection page
Core label, product, RxNorm, safety, and utilization data on this page come from the sources identified below. AI-written, editorial, and licensed sections are labeled separately.
How this page is built
HelloPharmacist combines public FDA and NLM records and does not author the underlying clinical facts. The plain-language sections are written with AI from the FDA-approved label text and reviewed by our pharmacy team before publication. Amneal Pharmaceuticals LLC is the representative DailyMed label linked for verification and dates. This is general education, not medical advice: always talk to your doctor or pharmacist about your own medicines. How we build and review drug pages →