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ROMIDEPSIN 5 mg/mL Injection, Solution, Concentrate, 1 vial — NDC 70121-2250-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

ROMIDEPSIN 5 mg/mL Injection, Solution, Concentrate, 1 vial — NDC 70121-2250-1 (Billing 70121-2250-01)

by Amneal Pharmaceuticals LLC · 1 VIAL in 1 CARTON / 5.5 mL in 1 VIAL

This is a package of 1 vial of ROMIDEPSIN 5 mg/mL Injection, Solution, Concentrate from Amneal Pharmaceuticals LLC, marketed since Jun 2026 and currently FDA-listed. It is this product's only package size.

NDC 70121-2250-01
🏷️ FDA NDC (as labeled) 70121-2250-1 billing pads the package segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 8, 2026 · this listing last changed Oct 8, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

This page is curated, coded, and maintained by

Compiled from public FDA, CMS, DailyMed, NADAC, and related drug data sources. Editorial policy

NDC database record

One package, one record: these facts belong to NDC 70121-2250-1 alone.

Record
FDA NDC Directory package listing · Human prescription drug
Code segments
70121 labeler · 2250 product · 1 package
Package marketed since
Jun 2, 2026
Sample package
No — commercial package
Listing certified through
Dec 31, 2027
Barcode (UPC)
0370121225010
FDA record last changed
Oct 8, 2026

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 70121-2250-1
Product NDC 70121-2250
11-digit billing NDC 70121225001
NCPDP billing unit ML — per mL (volume)
RxCUI 2289413
UNII CX3T89XQBK
UPC 0370121225010
Application # ANDA219099
SPL Set ID 61894b77-f29c-4a81-ad85-bd3a698233a4
Established class (EPC) Histone Deacetylase Inhibitor
Mechanism of action Histone Deacetylase Inhibitors; Bile Salt Export Pump Inhibitors; Organic Anion Transporting Polypeptide 1B1 Inhibitors; Organic Anion Transporting Polypeptide 1B3 Inhibitors; Organic Anion Transporter 1 Inhibitors; Organic Cation Transporter 2 Inhibitors
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2026-06-02
Route INTRAVENOUS
Dosage form INJECTION, SOLUTION, CONCENTRATE
Substance ROMIDEPSIN

Drug-database identifiers Medi-Span GPI and First Databank GCN / HICL / AHFS classification

GCN Seq No 080845
GCN 47827
HICL code 036898
Ingredient (HICL) Romidepsin
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V3A
Therapeutic class — specific (HIC3) Antineoplast,Histone Deacetylase (Hdac) Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ROMIDEPSIN 27.5 MG/5.5 ML VIAL
FDB brand name Romidepsin
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 080845
  • GCN: 47827
  • HICL (First Databank): 036898
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 2289413
Why two NDCs? The FDA registers this code as 70121-2250-1 — a 5-4-1 layout, and that's what's printed on the package and shown on DailyMed. For insurance claims, every NDC is standardized to a uniform 11-digit 5-4-2 format by adding a zero to the package segment → 70121-2250-01. Same drug, same package — only the format differs.
Where does this data come from?
Identifiers from the FDA openFDA NDC Directory and Structured Product Labeling; RxCUI from RxNorm (NLM); GPI from Medi-Span; GCN / HIC / AHFS / legend from First Databank.

RxNorm drug class

This medicine belongs to the Histone Deacetylase Inhibitor class.

Pharmacologic class Histone Deacetylase Inhibitor
Drug family (ATC) Histone deacetylase (HDAC) inhibitors
How it works Histone Deacetylase Inhibitors, Organic Cation Transporter 2 Inhibitors, Organic Anion Transporting Polypeptide 1B1 Inhibitors, Organic Anion Transporting Polypeptide 1B3 Inhibitors
Where does this data come from?
Therapeutic classes from RxNorm RxClass (U.S. National Library of Medicine) — Established Pharmacologic Class (FDA), ATC drug family (WHO) and mechanism of action, matched by this product’s RxCUI.

Clinical

Label name ROMIDEPSIN 27.5 MG/5.5 ML VIAL Ingredient Romidepsin
📖 What it is MedlinePlus · NLM

Romidepsin injection is used to treat cutaneous T-cell lymphoma (CTCL; a group of cancers of the immune system that first appear as skin rashes) in people who have already been treated with at least one other medication. Romidepsin injection is in a class of medications called histone deacetylase (HDAC) inhibitors. It works by slowing the growth of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats cutaneous T-cell lymphoma (CTCL), a lymphoma that involves the skin. It is used in adults who have already had at least one other whole-body treatment.
  • It is given by IV into a vein over about 4 hours. You get it on three days in a 28-day cycle. Cycles continue as long as it helps you and you tolerate it.
  • How is it given, and how long does it take?
  • Nausea, vomiting, tiredness, loss of appetite, taste changes, constipation, and itching are common. Infections are common too. Your care team will check blood counts and watch your...
📖 Read our full Romidepsin Injection guide →
Where does this data come from?
Plain-language summary from MedlinePlus (U.S. National Library of Medicine); supplement & herbal interactions and nutrient depletion data from the Natural Medicines database; our full guide is HelloPharmacist editorial content.

Pricing

A drug doesn't have one price. Each row is a different public payment system, and none is what you'd pay at the counter — that depends on your insurance. The ⓘ on each row explains what it measures.

Price systemPer mLPer package
Retail pharmacies payNADAC · weekly Not in the retail survey — common for institutional, discontinued, or low-volume packs.
Medicaid paysCMS SDUD · 12 mo No recent Medicaid claims on file for this NDC — rare and low-volume NDCs are suppressed in the public data.
Medicare drug plans payPart D · quarterly No Part D plan price is available for this NDC in our data.
ℹ️
No price is published for this exact package yet. CMS surveys NADAC per package size, so a different pack of the same drug often has one.
Where does this data come from?
NADAC (National Average Drug Acquisition Cost) is the CMS weekly pharmacy-acquisition-cost survey — what pharmacies pay. ASP (Average Sales Price) is the CMS Medicare Part B drug-payment file, published quarterly. Medicaid pays is computed by us from CMS State Drug Utilization Data (total reimbursed ÷ units, trailing 12 months) — gross of rebates and inclusive of dispensing fees, so it reflects what Medicaid paid, not an acquisition cost. Medicare drug plans pay is the median negotiated point-of-sale unit cost across plans listing this NDC in the CMS quarterly Prescription Drug Plan pricing files, before rebates. The VA pays is the federal contract price (FSS, and the statutory Big 4 ceiling where listed) from the VA National Acquisition Center pharmaceutical price file. All are free public government data; each measures a different payer, so the figures are not directly comparable.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
70121-2250-01 You're viewing this Main listing 1 VIAL in 1 CARTON / 5.5 mL in 1 VIAL 2026-06-02 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Romidepsin 5 mg/mLthis 70121-2250-01 Amneal 1 vial — — FDA listed —
About this product: this is a generic version of the medicine. FDA equivalence ratings are shown when available, and other versions are listed above, least expensive first.
Where does this data come from?
Equivalents are other NDCs of the same ingredient, form and route from the openFDA NDC Directory, ranked least-expensive-first by NADAC. Therapeutic-equivalence (AB) ratings come from the FDA Orange Book; biologics use the FDA Purple Book for biosimilar & interchangeable status.

Availability & generic status

🏛️
2026
First FDA approval
Jun 2026
📍
2026
Currently FDA-listed
listed with the FDA
🔓
·
Generic on the market
this product is a generic
✅This is a generic drug

This product is an FDA-approved generic. Other versions of the same drug are listed under Therapeutic equivalents, least expensive first.

🛡️ Latest patent/protection date listed: FDA patent/protection data lists protections through Dec 2026. This may affect when a full generic version becomes widely available, but it is not a guaranteed launch date.
📅 FDA approved Jun 2, 2026 RLD RS ⏳ ~0.2 yr to latest listed protection

Why the date isn’t exact: Generic timing can change because patents may be challenged, settled, licensed, added, removed, or worked around with a narrower label — and FDA approval does not always mean a pharmacy can get the generic today.

Patents & exclusivity — FDA Orange Book
Exclusivity CGT
2026
Today
LOE
Substance patent Formulation patent Method-of-use patent Exclusivity Pediatric +6mo
🏛️FDA exclusivity
FDA-granted marketing protection. It’s separate from patents and may be shorter than patent protection.
🧪Product / substance patents
Patents covering the active ingredient, product, formulation, or related drug features.
🎯Method-of-use patents
Patents covering specific approved uses. These can sometimes be carved out with a “skinny label,” but not always.
🛈 What do these terms mean?
Patent
Legal protection listed in the Orange Book that may delay generic approval or launch. Issued by the U.S. Patent & Trademark Office.
Substance patent
Covers the active drug molecule itself — the hardest to design around. A generic generally can’t launch until it expires.
Formulation (product) patent
Covers a specific formulation or dosage form. A generic can sometimes work around it with a different formulation.
Method-of-use patent
A patent covering one specific approved use of the drug — not necessarily the whole molecule. A generic can sometimes launch with a “skinny label” that carves out the protected use and keeps the others.
Skinny label
A generic label that omits a still-patented use when the FDA allows it — letting a generic reach the market for the unprotected uses.
Exclusivity
FDA-granted marketing protection, separate from patents — e.g. 5-yr new chemical entity, 7-yr orphan drug, or a +6-month pediatric extension.
Paragraph IV
A generic applicant’s formal challenge to a listed patent. It can potentially lead to earlier generic entry, but often involves litigation or a settlement.
RLD / RS
Reference Listed Drug — the brand product the FDA uses as the reference for generic applications. Reference Standard — the product the FDA expects generics to compare against in bioequivalence testing.
TE / AB rating
FDA therapeutic-equivalence rating. An AB rating generally means the FDA considers a generic therapeutically equivalent to — and substitutable for — the brand.
LOE (loss of exclusivity)
The latest patent or exclusivity currently listed — the loss-of-exclusivity / latest-listed-protection date shown on this page. Paragraph-IV challenges and settlements can move the real date earlier; FDA approval and a manufacturer’s decision to market can move it later.

Built from the FDA Orange Book. The bars above are scaled to each protection’s expiry; the red LOE marker is the last one to lapse.

FDA exclusivity
CodeWhat it grantsExpires
CGTFDA-granted marketing exclusivityDec 7, 2026
Common questions
Is there a generic version of ROMIDEPSIN 27.5 MG/5.5 ML VIAL?
Yes — an FDA-approved generic equivalent is listed in the FDA Orange Book for ROMIDEPSIN 27.5 MG/5.5 ML VIAL. See the alternatives section for substitutable, lower-cost products.
The FDA approved a generic — why can’t I get it at my pharmacy yet?
FDA approval and pharmacy availability are two different things. The FDA can approve a generic years before it actually reaches pharmacies, because the brand company may still hold patents or have a settlement that delays the launch. A manufacturer also has to choose to make and sell it, and have supply ready. So a drug can be “FDA-approved generic exists” and still be brand-only at the counter today.
Why do different websites show different generic release dates?
Generic availability is not based on one single date. Some sources use the first exclusivity expiration, some use the last product patent, and others use the latest method-of-use patent. Patent challenges, settlements, licenses, and label carve-outs can also change the real-world launch date. This page shows the underlying Orange Book dates so you can see why estimates may differ.
What does “FDA listed” mean?
It means the product appears in the FDA’s official NDC directory. That’s a good sign a product exists and is intended for the U.S. market, but on its own it does not confirm a pharmacy can fill it today. Where we have recent retail pricing data (NADAC) for a product, we label it “Availability likely” instead.
What does a patent or protection date mean here?
It’s the latest date currently listed in the FDA Orange Book for a patent or exclusivity on the brand product. It can affect when a full generic version becomes widely available — but it is not a guaranteed generic launch date. Generics sometimes arrive earlier (through a settlement or patent challenge) or later (a manufacturer still has to make and sell one).
What does “current Orange Book estimate” mean?
It means we are using the latest patent and exclusivity dates currently listed in the FDA Orange Book. It is not a guaranteed launch date.
Can a generic come out before the last patent expires?
Sometimes. A generic company may challenge a patent, settle with the brand manufacturer, receive a license, or obtain approval with a narrower label that avoids a patented use. In other cases, the last listed protection may delay full-label generic competition.
Can a generic come out after the listed dates?
Yes. Even after patents or exclusivity expire, a generic still needs FDA approval and a manufacturer must choose to market it. Supply, litigation, business decisions, or regulatory issues can delay actual availability.
What is the difference between patents and exclusivity?
Patents are legal protections usually issued by the U.S. Patent and Trademark Office. FDA exclusivity is marketing protection granted by the FDA. They are separate, and either one can affect generic timing.
Why are there multiple patent dates?
One drug can have several patents covering different things: the active ingredient, a formulation, a manufacturing process, or a specific approved use. That is why a page may show several expiration dates instead of one simple generic date.
Built from FDA Orange Book patent and exclusivity data. Dates are refreshed from public FDA data when available; the marker is max(latest patent expiry, latest exclusivity expiry). Paragraph-IV settlements and first-filer 180-day exclusivity can shift the real date; a method-of-use patent may allow an earlier skinny-label generic for non-protected indications. Generic launch timing is an estimate, not a guarantee.
Where does this data come from?
Patents and exclusivity from the FDA Orange Book (small-molecule drugs), refreshed from public FDA data. Generic launch timing is an estimate, not a guarantee.

Inactive Ingredients / Excipients

Inactive ingredients, also called excipients, are components of the drug product other than the active ingredient. They may include fillers, dyes, coatings, preservatives, flavors, or other formulation ingredients.

🧪 Avoiding an ingredient? See Romidepsin Injection inactive ingredients by manufacturer: every current product's list side by side, so you can ask your pharmacy for the version that does not list it.

💡 Tap an ingredient (hover on desktop) to see what it is and why it’s used.

  • UNII 7QWA1RIO01
    A synthetic form of vitamin E used as an antioxidant in medicines. It prevents oils and fats in the formulation from breaking down, helping the drug remain stable and effective during storage.
  • UNII 3K9958V90M
    A liquid solvent derived from fermentation or chemical synthesis. In medicines, alcohol dissolves active ingredients, helps preserve the product, and improves how the body absorbs certain drugs.
  • UNII C67P1734QJ
    Povidone K17 is a synthetic polymer made from polyvinyl pyrrolidone. It acts as a binder to hold tablet ingredients together and as a disintegrant to help the tablet break apart in the digestive system.
  • UNII 6DC9Q167V3
    Propylene glycol is a clear liquid derived from petroleum or vegetable sources. It acts as a solvent, humectant, and preservative in medicines, helping dissolve active ingredients and maintain product stability.

4 inactive ingredients listed in the exact product block matched to this NDC.

Where does this data come from?
Data sourced from official FDA Structured Product Labeling (SPL) via DailyMed — ingredient classCode="IACT" elements from the exact product block matched by this NDC. Label-section narrative from DailyMed / the openFDA label index is shown separately when available.

Inactive ingredient FAQ

Are inactive ingredients the same for every manufacturer?
No. Inactive ingredients can differ by manufacturer, dosage form, strength, and package / product version.
Why might an inactive ingredient be missing?
Some SPLs do not provide a complete structured inactive-ingredient list, and older or unusual labels may only include the information in narrative text.
Can inactive ingredients matter?
Yes. They can matter for allergies, intolerances, dyes, gluten / lactose concerns, preservatives, and formulation differences — but confirm with a pharmacist or the manufacturer when it’s clinically important.

Manufacturer & labeler

LabelerAmneal Pharmaceuticals LLC
Application holderAMNEAL EU LTD
FDA applicationANDA219099 (ANDA)
Labeler code70121
First marketedJun 2026
Product typeHuman Prescription Drug
Portfolio490 products on file

More NDCs from Amneal Pharmaceuticals LLC labeler code 70121

The labeler markets the product; the application holder owns the FDA approval. They’re often the same company but can differ (e.g. a repackager or an authorized generic). A mailing address / phone appears here when the manufacturer includes it in the product’s FDA label (not all do).
Where does this data come from?
Labeler, application holder and registered establishment from the FDA openFDA NDC Directory and Drugs@FDA; address/contact from the product’s FDA label.

Full prescribing information FDA SPL

The complete FDA label for this product — the official prescribing information, verbatim, section by section. Very long sections are excerpted here and marked; the full text is on DailyMed (linked in the sources below). Jump with a chip, search within the label, or expand everything.
🎯 Indications and Usage ⏱️ Dosage and Administration 💊 Dosage Forms and Strengths ⛔ Contraindications ⚠️ Warnings and Cautions 🤒 Adverse Reactions 🔄 Drug Interactions 👥 Use in Specific Populations 🤰 Pregnancy 🧒 Pediatric Use 🧓 Geriatric Use 🆘 Overdosage 🧬 Clinical Pharmacology 🧬 Mechanism of Action 📦 How Supplied / Storage and Handling 📋 Description 💬 Information for Patients 🍼 Nursing Mothers 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Patient Package Insert 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 60 words ▾

1 INDICATIONS AND USAGE Romidepsin injection is indicated for the treatment of cutaneous T-cell lymphoma (CTCL) in adult patients who have received at least one prior systemic therapy. Romidepsin injection 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 )

⏱️ Dosage and Administration ~3 min read ▾

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 )

2.1Dosage 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.

2.2Dosage 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 .

2.3Dosage 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. Table 1: Recommendations for Starting Dose in Patients with Moderate and Severe Hepatic Impairment Hepatic Impairment Bilirubin Levels Romidepsin Injection Dose Moderate greater than 1.5 × ULN to less than or equal to 3 × ULN 7 mg/m 2 Severe greater than 3 × ULN 5 mg/m 2 ULN = Upper limit of normal.

2.4Instructions for Preparation and Intravenous Administration Romidepsin injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1 Romidepsin injection must be diluted with 0.9% Sodium Chloride Injection, USP before intravenous infusion.

Extract the appropriate amount of romidepsin injection from the vial to deliver the desired dose, using proper aseptic technique. Before intravenous infusion, dilute romidepsin injection in 500 mL 0.9% Sodium Chloride Injection, USP. Infuse over 4 hours.

Discard unused portion. The diluted solution is compatible with polyvinyl chloride (PVC), ethylene vinyl acetate (EVA), polyethylene (PE) infusion bags as well as glass bottles, and is chemically stable for up to 24 hours when stored at room temperature. However, it should be administered as soon after dilution as possible.

Parenteral drug products should be inspected visually for particulate matter and discoloration before administration, whenever solution and container permit.

💊 Dosage Forms and Strengths 26 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 27.5 mg/5.5 mL (5 mg/mL) in single-dose vial. Injection: 27.5 mg/5.5 mL (5 mg/mL) in single-dose vial. ( 3 )

⛔ Contraindications 7 words ▾

4 CONTRAINDICATIONS None. None. ( 4 )

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS Myelosuppression: Romidepsin can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia; monitor blood counts during treatment with romidepsin injection; 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 romidepsin injection.

( 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 )

5.1Myelosuppression Treatment with romidepsin can cause thrombocytopenia, leukopenia (neutropenia and lymphopenia), and anemia. Monitor blood counts regularly during treatment with romidepsin injection and modify the dose as necessary [see Dosage and Administration (2.2) and Adverse Reactions (6.1) ] .

5.2Infections Fatal and serious infections have been reported in clinical trials of romidepsin, including pneumonia, sepsis, and viral reactivation, including reactivation of Epstein Barr and hepatitis B viruses. These infections can occur during and following treatment. The risk of life-threatening infections may be greater in patients with a history of prior treatment with monoclonal antibodies directed against lymphocyte antigens and in patients with disease involvement of the bone marrow [see Adverse Reactions (6.1) ] .

Reactivation of hepatitis B virus infection was reported in 1% of patients in clinical trials. In patients with evidence of prior hepatitis B infection, consider monitoring for reactivation, and consider antiviral prophylaxis. Reactivation of Epstein Barr viral infection leading to liver failure has occurred in recipients of romidepsin including after ganciclovir prophylaxis.

5.3Electrocardiographic Changes Several treatment-emergent morphological changes in ECGs (including T-wave and ST-segment changes) have been reported in clinical studies. The clinical significance of these changes is unknown [see Adverse Reactions (6.1) ] . In patients with congenital long QT syndrome, patients with a history of significant cardiovascular disease, and patients taking anti-arrhythmic medicines or medicinal products that lead to significant QT prolongation, consider cardiovascular monitoring of ECGs at baseline and periodically during treatment.

Confirm that potassium and magnesium levels are within normal range before administration of romidepsin injection [see Adverse Reactions (6.1) ] .

5.4Tumor Lysis Syndrome Tumor lysis syndrome (TLS) has been reported to occur in recipients of romidepsin, including in 1% of patients with tumor stage CTCL. Patients with advanced stage disease and/or high tumor burden are at greater risk, should be closely monitored, and managed as appropriate.

5.5Embryo-Fetal Toxicity Based on its mechanism of action and findings from animal studies, romidepsin injection can cause fetal harm when administered to a pregnant woman. In an animal reproductive study, romidepsin was embryocidal and caused adverse developmental outcomes at exposures below those in patients at the recommended dose of 14 mg/m 2 . Advise females of reproductive potential to use effective contraception during treatment and for 1 month after the last dose.

Advise males with female partners of reproductive potential to use e… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The following clinically significant 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 pruritus.

Grade 3 to 4 laboratory abnormalities (≥ 10%) include lymphopenia, neutropenia, anemia and thrombocytopenia. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Amneal Pharmaceuticals LLC at 1-877-835-5472 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.

6.1Clinical 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 romidepsin in four clinical trials involving 363 patients with T-cell lymphoma, including 185 patients with CTCL. Romidepsin 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 romidepsin, 21% were exposed for 6 months or longer and 13% were exposed for greater than one year. Cutaneous T-Cell Lymphoma The safety of romidepsin was evaluated in 185 patients with CTCL in 2 single arm clinical studies in which patients received a dosage of 14 mg/m 2 on days 1, 8, and 15 of a 28-day cycle. Treatment continued as long as the patient benefitted from and tolerated the drug.

The mean duration of treatment in these studies was 5.6 months (range: < 1 month to 83.4 months). Common Adverse Reactions Table 2 summarizes the most frequent adverse reactions (> 20%) regardless of causality using the National Cancer Institute-Common Terminology Criteria for Adverse Events (NCI-CTCAE, Version 3.0). Due to methodological differences between the studies, the AE data are presented separately for Study 1 and Study 2.

Adverse reactions are ranked by their incidence in Study 1. Laboratory abnormalities commonly reported (> 20%) as adverse reactions are included in Table 2. Table 2: Adverse Reactions Occurring in > 20% of Patients in Either CTCL Study (N=185) Adverse Reactions n (%) Study 1 (n = 102) Study 2 (n = 83) All grades Grade 3 or 4 All grades Grade 3 or 4 Any adverse reactions 99 (97) 36 (35) 83 (100) 68 (82) Nausea 57 (56) 3 (3) 71 (86) 5 (6) Asthenia/Fatigue 54 (53) 8 (8) 64 (77) 12 (14) Infections 47 (46) 11 (11) 45 (54) 27 (33) Vomiting 35 (34) 1 (< 1) 43 (52) 8 (10) Anorexia 23 (23) 1 (< 1) 45 (54) 3 (4) Hypomagnesemia 22 (22) 1 (< 1) 23 (28) 0 Diarrhea 20 (20) 1 (< 1) 22 (27) 1 (1) Pyrexia 20 (20) 4 (4) 19 (23) 1 (1) Anemia 19 (19) 3 (3) 60 (72) 13 (16) Thrombocytopenia 17 (17) 0 54 (65) 12 (14) Dysgeusia 15 (15) 0 33 (40) 0 Constipation 12 (12) 2 (2) 32 (39) 1 (1) Neutropenia 11 (11) 4 (4) 47 (57) 22 (27) Hypotension 7 (7) 3 (3) 19 (23) 3 (4) Pruritus 7 (7) 0 26 (31) 5 (6) Hypokalemia 6 (6) 0 17 (20) 2 (2) Dermatitis/Exfoliative dermatitis 4 (4) 1 (< 1) 22 (27) 7 (8) Hypocalcemia 4 (4) 0 43 (52) 5 (6) Leukopenia 4 (4) 0 38 (46) 18 (22) Lymphopenia 4 (4) 0 47 (57) 31 (37) Alanine aminotransferase increased 3 (3) 0 18 (22) 2 (2) Aspartate aminotransferase increased 3 (3) 0 23 (28) 3 (4) Hypoalbuminemia 3 (3) 1 (< 1) 40 (48) 3 (4) Electrocardiogram ST-T wave changes 2 (2) 0 52 (63) 0 Hyperglycemia 2 (2) 2 (2) 42 (51) 1 (1) Hyponatremia 1 (< 1) 1 (< 1) 17 (20) 2 (2) Hypermagnesemia 0 0 22 (27) 7 (8) Hypophosphatemia 0 0 22 (27) 8 (10) Hyperuricemia 0 0 27 (33) 7 (8) Serious Adverse Reactions Infections were the most common type of SAE reported in both studies with 8 patients (8%) in… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 191 words ▾

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 )

7.1Warfarin 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) ] .

7.2Drugs 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.

7.3Drugs 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.

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS

8.1Pregnancy Risk Summary Based on its mechanism of action and findings from animal studies, romidepsin injection can cause embryo-fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on romidepsin 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 romidepsin 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% to 4% and 15% to 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.

Adverse embryo-fetal effects were noted at romidepsin doses of ≥ 0.1 mg/kg/day, with systemic exposures (AUC) ≥ 0.2% of the human exposure at the recommended dose of 14 mg/m 2 /week. Drug-related fetal effects consisted of reduced fetal body weights, folded retina, rotated limbs, and incomplete sternal ossification.

8.2Lactation Risk Summary There are no data on the presence of romidepsin or its metabolites in human milk, the effects on the breastfed child, or the effects on milk production. Because many drugs are excreted in human milk and because of the potential for serious adverse reactions in the breastfed child, advise lactating women not to breastfeed during treatment with romidepsin injection and for 1 week after the last dose.

8.3Females and Males of Reproductive Potential Romidepsin injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Perform pregnancy testing in females of reproductive potential within 7 days prior to initiating therapy with romidepsin injection. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with romidepsin injection and for 1 month after the last dose.

Romidepsin may reduce the effectiveness of estrogen-containing contraceptives. Therefore, alternative methods of non-estrogen containing contraception (e.g., condoms, intrauterine devices) should be used in patients receiving romidepsin injection. Males Advise males with female partners of reproductive potential to use effective contraception during treatment with romidepsin injection and for 1 month after the last dose.

Infertility Based on findings in animals, romidepsin has the potential to affect male and female fertility [see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use The safety and effectiveness of romidepsin injection in pediatric patients have not been established.

8.5Geriatric Use Of the 186 patients with CTCL who received romidepsin in clinical studies, 51 (28%) were 65 years of age and older, while 16 (9%) were 75 years of age. No overall differences in safety or effectiveness were observed between patients 65 years or age and over and younger patients; however, greater sensitivity of some older individuals cannot be ruled out.

8.6Hepatic Impairment In a hepatic impairment study, romidepsin was evaluated in 19 patients with advanced cancer and mild (8), moderate (5), or severe (6) hepatic impairment. There were 4 deaths during the first cycle of treatment: 1 patient with mild hepatic impairment, 1 patie… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on its mechanism of action and findings from animal studies, romidepsin injection can cause embryo-fetal harm when administered to a pregnant woman [see Clinical Pharmacology (12.1) ] . There are no available data on romidepsin 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 romidepsin 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% to 4% and 15% to 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.

Adverse embryo-fetal effects were noted at romidepsin doses of ≥ 0.1 mg/kg/day, with systemic exposures (AUC) ≥ 0.2% of the human exposure at the recommended dose of 14 mg/m 2 /week. Drug-related fetal effects consisted of reduced fetal body weights, folded retina, rotated limbs, and incomplete sternal ossification.

🧒 Pediatric Use 17 words ▾

8.4Pediatric Use The safety and effectiveness of romidepsin injection in pediatric patients have not been established.

🧓 Geriatric Use 63 words ▾

8.5Geriatric Use Of the 186 patients with CTCL who received romidepsin in clinical studies, 51 (28%) were 65 years of age and older, while 16 (9%) were 75 years of age. No overall differences in safety or effectiveness were observed between patients 65 years or age and over and younger patients; however, greater sensitivity of some older individuals cannot be ruled out.

🆘 Overdosage 90 words ▾

10 OVERDOSAGE No specific information is available on the treatment of overdosage of romidepsin. 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 romidepsin and it is not known if romidepsin is dialyzable.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action 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 IC50 values in the nanomolar range. The mechanism of the antineoplastic effect of romidepsin observed in nonclinical and clinical studies has not been fully characterized.

12.2Pharmacodynamics Cardiac Electrophysiology At doses of 14 mg/m 2 as a 4-hour intravenous infusion and at doses of 8 (0.57 times the recommended dose), 10 (0.71 times the recommended dose) or 12 (0.86 times the recommended dose) mg/m 2 as a 1-hour infusion, no large changes in the mean QTc interval (> 20 milliseconds) from baseline based on Fridericia correction method were detected. Small increase in mean QT interval (< 10 milliseconds) and mean QT interval increase between 10 to 20 milliseconds cannot be excluded.

Romidepsin was associated with a delayed concentration-dependent increase in heart rate in patients with advanced cancer with a maximum mean increase in heart rate of 20 beats per minute occurring at the 6-hour time point after start of romidepsin infusion for patients receiving 14 mg/m 2 as a 4-hour infusion.

12.3Pharmacokinetics 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 1,549 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.

Distribution Romidepsin is highly protein bound in plasma (92% to 94%) over the concentration range of 50 ng/mL to 1,000 ng/mL with α1-acid-glycoprotein (AAG) being the principal binding protein. Romidepsin is a substrate of the efflux transporter P-glycoprotein (P-gp, ABCB1). In vitro , romidepsin accumulates into human hepatocytes via an unknown active uptake process.

Romidepsin is not a substrate of the following uptake transporters: BCRP, BSEP, MRP2, OAT1, OAT3, OATP1B1, OATP1B3, or OCT2. In addition, romidepsin is not an inhibitor of BCRP, MRP2, MDR1 or OAT3. Although romidepsin did not inhibit OAT1, OCT2, and OATP1B3 at concentrations seen clinically (1 μmol/L), modest inhibition was observed at 10 μmol/L.

Romidepsin was found to be an inhibitor of BSEP and OATP1B1. Metabolism Romidepsin undergoes extensive metabolism in vitro primarily by CYP3A4 with minor contribution from CYP3A5, CYP1A1, CYP2B6, and CYP2C19. At therapeutic concentrations, romidepsin did not competitively inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 in vitro .

At therapeutic concentrations, romidepsin did not cause notable induction of CYP1A2, CYP2B6 and CYP3A4 in vitro . Therefore, pharmacokinetic drug-drug interactions are unlikely to occur due to CYP450 induction or inhibition by romidepsin when co-administered with CYP450 substrates. Excretion Following 4-hour intravenous administration of romidepsin at 14 mg/m 2 on days 1, 8, and 15 of a 28-day cycle in patients with T-cell lymphomas, the terminal half-life (t 1/2 ) was approximately 3 hours.

No accumulation of plasma concentration of romidepsin was observed after repeated dosing. Drug Interactions Ketoconazole Following co-administration of 8 mg/m 2 romidepsin (4-hour infusion) with ketoconazole, the overall romidepsin exposure was increased by approximately 25% and 10% for AUC 0-∞ and C max , respectively, compared to romidepsin alone, and the differenc… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 88 words ▾

12.1Mechanism of Action 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 IC50 values in the nanomolar range. The mechanism of the antineoplastic effect of romidepsin observed in nonclinical and clinical studies has not been fully characterized.

📦 How Supplied / Storage and Handling 88 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING How Supplied Romidepsin Injection is supplied as a sterile, clear, colorless to pale yellow solution available in single-dose vial in the following carton packaged strength. 27.5 mg/5.5 mL (5 mg/mL) 1 Single-Dose Vial in 1 Carton: NDC 70121-2250-1 Storage and Handling Store at 20° to 25°C (68° to 77°F); excursions permitted between 15° to 30°C (59° to 86°F) in the carton [see USP Controlled Room Temperature]. Protect from light.

Romidepsin injection is a hazardous drug. Follow applicable special handling and disposal procedures. 1

📋 Description 111 words ▾

11 DESCRIPTION Romidepsin, a histone deacetylase (HDAC) inhibitor, is a bicyclic depsipeptide. At room temperature, romidepsin is a white to off-white crystalline powder and is described chemically as (1S,4S,7Z,10S,16E,21R)-7-ethylidene-4,21-bis(1-methylethyl)-2-oxa-12,13-dithia-5,8,20,23-tetraazabicyclo[8.7.6]tricos-16-ene-3,6,9,19,22-pentone. The molecular formula is C 24 H 36 N 4 O 6 S 2 .

The molecular weight is 540.7 g/mol and the structural formula is: Romidepsin injection is intended for intravenous infusion only after dilution with 0.9% Sodium Chloride, USP. Romidepsin injection is a sterile, clear, colorless to pale yellow solution and is supplied in single-dose vial. Each mL contains romidepsin, 5 mg; povidone, 10 mg; DL-alpha-tocopherol, 0.05 mg; dehydrated alcohol, 157.8 mg (20% v/v) and propylene glycol, 828.8 mg.

1

💬 Information for Patients ~2 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Low Blood Counts Advise patients that treatment with romidepsin injection can cause low blood counts and that frequent monitoring of hematologic parameters is required. Patients should be instructed to report fever or other signs of infection, significant fatigue, shortness of breath, or bleeding [see Warnings and Precautions (5.1) ] .

Infections Advise patients that infections may occur during treatment with romidepsin injection. Advise patients to report fever, cough, shortness of breath with or without chest pain, burning on urination, flu-like symptoms, muscle aches, or worsening skin problems. Advise patients to report any previous history of hepatitis B before starting romidepsin injection [see Warnings and Precautions (5.2) ] .

Tumor Lysis Syndrome Advise patients of the risk of tumor lysis syndrome (especially those with advanced stage disease and/or high tumor burden) to maintain high fluid intake for at least 72 hours after each dose [see Warnings and Precautions (5.4) ] . Nausea and Vomiting Advise patients that nausea and vomiting are common following treatment with romidepsin injection. Prophylactic antiemetics are recommended for all patients.

Advise patients to report these symptoms so that appropriate treatment can be instituted [see Adverse Reactions (6.1) ] . Embryo-Fetal Toxicity Advise patients that romidepsin injection can cause fetal harm when administered during pregnancy [see Warnings and Precautions (5.5) and Use in Specific Populations (8.1) ] . Contraception Advise females of reproductive potential to use effective contraception during treatment with romidepsin injection and for 1 month after the last dose.

Advise males with female partners of reproductive potential to use effective contraception during treatment with romidepsin injection and for 1 month after the last dose [ Use in Specific Populations (8.3) ] . Lactation Advise lactating women not to breastfeed during treatment with romidepsin injection and for 1 week after the last dose [see Use in Specific Populations (8.2) ] . Infertility Advise females and males of reproductive potential that romidepsin injection may cause infertility [see Nonclinical Toxicology (13.1) ] .

Manufactured by: Amneal Oncology Pvt. Ltd. Telangana 509301, INDIA Distributed by: Amneal Pharmaceuticals LLC Bridgewater, NJ 08807 Rev.

09-2025-00

🍼 Nursing Mothers 146 words ▾

8.3Females and Males of Reproductive Potential Romidepsin injection can cause fetal harm when administered to a pregnant woman [see Use in Specific Populations (8.1) ] . Pregnancy Testing Perform pregnancy testing in females of reproductive potential within 7 days prior to initiating therapy with romidepsin injection. Contraception Females Advise females of reproductive potential to use effective contraception during treatment with romidepsin injection and for 1 month after the last dose.

Romidepsin may reduce the effectiveness of estrogen-containing contraceptives. Therefore, alternative methods of non-estrogen containing contraception (e.g., condoms, intrauterine devices) should be used in patients receiving romidepsin injection. Males Advise males with female partners of reproductive potential to use effective contraception during treatment with romidepsin injection and for 1 month after the last dose.

Infertility Based on findings in animals, romidepsin has the potential to affect male and female fertility [see Nonclinical Toxicology (13.1) ] .

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics 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 1,549 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.

Distribution Romidepsin is highly protein bound in plasma (92% to 94%) over the concentration range of 50 ng/mL to 1,000 ng/mL with α1-acid-glycoprotein (AAG) being the principal binding protein. Romidepsin is a substrate of the efflux transporter P-glycoprotein (P-gp, ABCB1). In vitro , romidepsin accumulates into human hepatocytes via an unknown active uptake process.

Romidepsin is not a substrate of the following uptake transporters: BCRP, BSEP, MRP2, OAT1, OAT3, OATP1B1, OATP1B3, or OCT2. In addition, romidepsin is not an inhibitor of BCRP, MRP2, MDR1 or OAT3. Although romidepsin did not inhibit OAT1, OCT2, and OATP1B3 at concentrations seen clinically (1 μmol/L), modest inhibition was observed at 10 μmol/L.

Romidepsin was found to be an inhibitor of BSEP and OATP1B1. Metabolism Romidepsin undergoes extensive metabolism in vitro primarily by CYP3A4 with minor contribution from CYP3A5, CYP1A1, CYP2B6, and CYP2C19. At therapeutic concentrations, romidepsin did not competitively inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1, or CYP3A4 in vitro .

At therapeutic concentrations, romidepsin did not cause notable induction of CYP1A2, CYP2B6 and CYP3A4 in vitro . Therefore, pharmacokinetic drug-drug interactions are unlikely to occur due to CYP450 induction or inhibition by romidepsin when co-administered with CYP450 substrates. Excretion Following 4-hour intravenous administration of romidepsin at 14 mg/m 2 on days 1, 8, and 15 of a 28-day cycle in patients with T-cell lymphomas, the terminal half-life (t 1/2 ) was approximately 3 hours.

No accumulation of plasma concentration of romidepsin was observed after repeated dosing. Drug Interactions Ketoconazole Following co-administration of 8 mg/m 2 romidepsin (4-hour infusion) with ketoconazole, the overall romidepsin exposure was increased by approximately 25% and 10% for AUC 0-∞ and C max , respectively, compared to romidepsin alone, and the difference in AUC 0-∞ between the 2 treatments was statistically significant. Rifampin Following co-administration of 14 mg/m 2 romidepsin (4-hour infusion) with rifampin, the overall romidepsin exposure was increased by approximately 80% and 60% for AUC 0-∞ and C max , respectively, compared to romidepsin alone, and the difference between the 2 treatments was statistically significant.

Co-administration of rifampin decreased the romidepsin clearance and volume of distribution by 44% and 52%, respectively. The increase in exposure seen after co-administration with rifampin is likely due to rifampin’s inhibition of an undetermined hepatic uptake process that is predominant for the disposition of romidepsin. Drugs that inhibit P-glycoprotein Drugs that inhibit p-glycoprotein may increase the concentration of romidepsin.

Specific Populations Effect of Age, Gender, Race or Renal Impairment The pharmacokinetics of romidepsin was not influenced by age (27 years to 83 years), gender, race (white vs. black) or mild (estimated creatinine clearance 50 mL/min to 80 mL/min), moderate (estimated creatinine clearance 30 mL/min to 50 mL/min), or severe (estimated creatinine clearance < 30 mL/min) renal impairment. The effect of end-stage renal disease (estimated creatine clearance less than 15 mL/min) on romidepsin pharmacokinetics has not been studied.

Hepatic Impairment Romidepsin clearance decreased with increased severity of hepatic impairment. In patients with cancer… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 136 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology At doses of 14 mg/m 2 as a 4-hour intravenous infusion and at doses of 8 (0.57 times the recommended dose), 10 (0.71 times the recommended dose) or 12 (0.86 times the recommended dose) mg/m 2 as a 1-hour infusion, no large changes in the mean QTc interval (> 20 milliseconds) from baseline based on Fridericia correction method were detected. Small increase in mean QT interval (< 10 milliseconds) and mean QT interval increase between 10 to 20 milliseconds cannot be excluded.

Romidepsin was associated with a delayed concentration-dependent increase in heart rate in patients with advanced cancer with a maximum mean increase in heart rate of 20 beats per minute occurring at the 6-hour time point after start of romidepsin infusion for patients receiving 14 mg/m 2 as a 4-hour infusion.

🔬 Clinical Studies ~2 min read ▾

14 CLINICAL STUDIES Romidepsin was evaluated in 2 multicenter, single-arm clinical studies in patients with CTCL (Study 1 [NCT00106431] and Study 2 [NCT00007345]). Overall, 167 patients with CTCL were treated in the US, Europe, and Australia. Study 1 included 96 patients with confirmed CTCL after failure of at least 1 prior systemic therapy.

Study 2 included 71 patients with a primary diagnosis of CTCL who received at least 2 prior skin directed therapies or one or more systemic therapies. Patients were treated with romidepsin at a starting dose of 14 mg/m 2 infused over 4 hours on days 1, 8, and 15 every 28 days. In both studies, patients could be treated until disease progression at the discretion of the investigator and local regulators.

Objective disease response was evaluated according to a composite endpoint that included assessments of skin involvement, lymph node and visceral involvement, and abnormal circulating T-cells (“Sézary cells”). The primary efficacy endpoint for both studies was overall objective disease response rate (ORR) based on the investigator assessments, and was defined as the proportion of patients with confirmed complete response (CR) or partial response (PR). CR was defined as no evidence of disease and PR as ≥ 50% improvement in disease.

Secondary endpoints in both studies included duration of response and time to response. Baseline Patient Characteristics Demographic and disease characteristics of the patients in Study 1 and Study 2 are provided in Table 3. Table 3: Baseline Patient Characteristics (CTCL Population) Characteristic Study 1 (N = 96) Study 2 (N = 71) Age N 96 71 Mean (SD) 57 (12) 56 (13) Median (Range) 57 (21, 89) 57 (28, 84) Sex, n (%) Men 59 (61) 48 (68) Women 37 (39) 23 (32) Race, n (%) White 90 (94) 55 (77) Black 5 (5) 15 (21) Other/Not Reported 1 (1) 1 (1) Stage of Disease at Study Entry, n (%) IA 0 (0) 1 (1) IB 15 (16) 6 (9) IIA 13 (14) 2 (3) IIB 21 (22) 14 (20) III 23 (24) 9 (13) IVA 24 (25) 27 (38) IVB 0 (0) 12 (17) Number of Prior Skin-Directed Therapies Median (Range) 2 (0, 6) 1 (0, 3) Number of Prior Systemic Therapies Median (Range) 2 (1, 8) 2 (0, 7) Clinical Results Efficacy outcomes for CTCL patients are provided in Table 4.

Median time to first response was 2 months (range 1 to 6) in both studies. Median time to CR was 4 months in Study 1 and 6 months in Study 2 (range 2 to 9). Table 4: Clinical Results for CTCL Patients Response Rate Study 1 (N = 96) Study 2 (N = 71) ORR (CR + PR), n (%) [95% Confidence Interval] 33 (34) [25, 45] 25 (35) [25, 49] CR, n (%) [95% Confidence Interval] 6 (6) [2, 13] 4 (6) [2, 14] PR, n (%) [95% Confidence Interval] 27 (28) [19, 38] 21 (30) [20, 43] Duration of Response (months) N 33 25 Median (range) 15 (1, 20 * ) 11 (1, 66 * ) * Denotes censored value.

🧪 Nonclinical Toxicology ~2 min read ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been performed with romidepsin. Romidepsin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Romidepsin was not clastogenic in an in vivo rat bone marrow micronucleus assay when tested to the maximum tolerated dose (MTD) of 1 mg/kg in males and 3 mg/kg in females (6 and 18 mg/m 2 in males and females, respectively).

These doses were up to 1.3-fold the recommended human dose, based on body surface area. Based on nonclinical findings, male and female fertility may be compromised by treatment with romidepsin. In a 26-week toxicology study, romidepsin administration resulted in testicular degeneration in rats at 0.33 mg/kg/dose (2 mg/m 2 /dose) following the clinical dosing schedule.

This dose resulted in AUC 0-∞ values that were approximately 2% the exposure level in patients receiving the recommended dose of 14 mg/m 2 /dose. A similar effect was seen in mice after 4 weeks of drug administration at higher doses. Seminal vesicle and prostate organ weights were decreased in a separate study in rats after 4 weeks of daily drug administration at 0.1 mg/kg/day (0.6 mg/m 2 /day), approximately 30% the estimated human daily dose based on body surface area.

Romidepsin showed high affinity for binding to estrogen receptors in pharmacology studies. In a 26-week toxicology study in rats, atrophy was seen in the ovary, uterus, vagina and mammary gland of females administered doses as low as 0.1 mg/kg/dose (0.6 mg/m 2 /dose) following the clinical dosing schedule. This dose resulted in AUC 0-∞ values that were 0.3% of those in patients receiving the recommended dose of 14 mg/m 2 /dose.

Maturation arrest of ovarian follicles and decreased weight of ovaries were observed in a separate study in rats after 4 weeks of daily drug administration at 0.1 mg/kg/day (0.6 mg/m 2 /day). This dose is approximately 30% the estimated human daily dose based on body surface area.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility ~1 min read ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been performed with romidepsin. Romidepsin was not mutagenic in vitro in the bacterial reverse mutation assay (Ames test) or the mouse lymphoma assay. Romidepsin was not clastogenic in an in vivo rat bone marrow micronucleus assay when tested to the maximum tolerated dose (MTD) of 1 mg/kg in males and 3 mg/kg in females (6 and 18 mg/m 2 in males and females, respectively).

These doses were up to 1.3-fold the recommended human dose, based on body surface area. Based on nonclinical findings, male and female fertility may be compromised by treatment with romidepsin. In a 26-week toxicology study, romidepsin administration resulted in testicular degeneration in rats at 0.33 mg/kg/dose (2 mg/m 2 /dose) following the clinical dosing schedule.

This dose resulted in AUC 0-∞ values that were approximately 2% the exposure level in patients receiving the recommended dose of 14 mg/m 2 /dose. A similar effect was seen in mice after 4 weeks of drug administration at higher doses. Seminal vesicle and prostate organ weights were decreased in a separate study in rats after 4 weeks of daily drug administration at 0.1 mg/kg/day (0.6 mg/m 2 /day), approximately 30% the estimated human daily dose based on body surface area.

Romidepsin showed high affinity for binding to estrogen receptors in pharmacology studies. In a 26-week toxicology study in rats, atrophy was seen in the ovary, uterus, vagina and mammary gland of females administered doses as low as 0.1 mg/kg/dose (0.6 mg/m 2 /dose) following the clinical dosing schedule. This dose resulted in AUC 0-∞ values that were 0.3% of those in patients receiving the recommended dose of 14 mg/m 2 /dose.

Maturation arrest of ovarian follicles and decreased weight of ovaries were observed in a separate study in rats after 4 weeks of daily drug administration at 0.1 mg/kg/day (0.6 mg/m 2 /day). This dose is approximately 30% the estimated human daily dose based on body surface area.

📚 References 9 words ▾

15 REFERENCES 1. OSHA Hazardous Drugs. OSHA . http://www.osha.gov/SLTC/hazardousdrugs/index.html]

📄 Patient Package Insert ~3 min read ▾

PATIENT INFORMATION Romidepsin (roe ” mi dep ’ sin) Injection For Intravenous Use What is romidepsin injection? Romidepsin injection is a prescription medicine used to treat adults with a type of cancer called cutaneous T-cell lymphoma (CTCL) after at least one other type of medicine by mouth or injection has been tried. It is not known if romidepsin injection is safe and effective in children.

Before receiving romidepsin injection, tell your healthcare provider about all of your medical conditions, including if you: have any heart problems, including an irregular or fast heartbeat, or a condition called QT prolongation. have liver problems, including a history of hepatitis B have problems with the amount of potassium or magnesium in your blood are pregnant or plan to become pregnant. Romidepsin injection can harm your unborn baby. Females who are able to become pregnant: Your healthcare provider will perform a pregnancy test within 7 days before you start treatment with romidepsin injection.

You should avoid becoming pregnant during treatment with romidepsin injection and for 1 month after the last dose. You should use effective birth control (contraception) during treatment with romidepsin injection and for 1 month after your last dose. Romidepsin injection may affect the way estrogen-containing birth control works.

Talk to your healthcare provider for information about other types of birth control to use during treatment with romidepsin injection. Tell your healthcare provider right away if you become pregnant or think you may be pregnant during treatment with romidepsin injection. Males with a female partner who can become pregnant: Romidepsin injection can harm the unborn baby of your partner.

You should use effective birth control (contraception) and avoid fathering a child during treatment with romidepsin injection and for 1 month after the last dose. Talk to your healthcare provider if this is a concern for you. Romidepsin injection may cause fertility problems in males and females.

Talk to your healthcare provider if this is a concern for you. are breastfeeding or plan to breastfeed. It is not known if romidepsin passes into your breast milk. You should not breastfeed during treatment with romidepsin injection and for 1 week after the last dose.

Talk to your healthcare provider about the best way to feed your baby while you are being treated with romidepsin injection. Tell your healthcare provider about all of the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Some medicines may affect how romidepsin injection works, or romidepsin injection may affect how other medicines work.

Especially tell your healthcare provider if you take or use: warfarin sodium (Coumadin, Jantoven) or any other blood thinner medicine. Ask your healthcare provider if you are not sure if you are taking a blood thinner. Your healthcare provider may want to test your blood more often. a medicine to treat abnormal heartbeats St.

John’s wort ( Hypericum perforatum ) Dexamethasone (a steroid) Medicine for: tuberculosis (TB) seizures (epilepsy) bacterial infections (antibiotics) fungal infections (antifungals) HIV (AIDS) depression Know the medicines you take. Keep a list of them and show it to your healthcare provider and pharmacist when you get a new medicine. How will I receive romidepsin injection?

Romidepsin injection will be given to you by your healthcare provider or nurse as an intravenous injection into your vein usually over 4 hours. Romidepsin injection is usually given on Day 1, Day 8, and Day 15 of a 28-day cycle of treatment. Your healthcare provider will decide how long you will receive treatment with romidepsin injection.

Your healthcare provider may decrease your dose, or delay or stop your treatment with romidepsin injection if you have certain side effects. What are the possible side effects of romidepsin injection? Romidepsin injection may cause serious side effects, inc… [Excerpted — this section continues on DailyMed.]

📄 Package Label / Principal Display Panel 46 words ▾

PRINCIPAL DISPLAY PANEL NDC 70121-2250-1 Romidepsin Injection, 27.5 mg/5.5 mL (5 mg/mL) For In tr avenous Infusion After Dilution Only MUST be diluted in 500 mL of 0.9% Sodium Chloride Injection, USP before use. Single-Dose Vial - Discard Unused Portion CAUTION: Cytotoxic Agent Sterile label carton

Source: FDA Structured Product Labeling, mirrored from DailyMed / openFDA. Prefer the government’s original formatting? View this label on DailyMed ↗

Medicare Part D spend CMS · PART D · 2025 (Q1-Q4)

Medicare Part D (outpatient prescription) spending for Romidepsin — the program that covers self-administered drugs. 1 manufacturer.
⚠️ Drug-level data: CMS publishes Part D spending by drug, not by NDC — these figures combine every manufacturer, strength and package size sold under the name Romidepsin. That’s a different level of aggregation than the Medicaid card above, which is specific to this exact 11-digit NDC (pack size included), so the two aren’t directly comparable.
Total Part D spend
$362K
Claims incl. refills
18
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$20,111.08
💵 About the dollar figures: spending is what Part D plans paid before confidential manufacturer rebates, so the program’s real net cost is lower. A blank patient count means fewer than 11 people — CMS hides counts that small to protect privacy. Source: CMS Medicare Quarterly Part D Spending by Drug (data.cms.gov), updated quarterly.

About this NDC listing & data coverage

Finished prescription product
What data is (and isn’t) available for this NDC — tap to expand
NDC identity (package / product / labeler codes) ✓ Available
Labeler ✓ Available
Product & package description ✓ Available
Marketing category & status ✓ Available
Active ingredient / dosage form / route ✓ Available
FDA label (SPL via DailyMed) ✓ Available
Package photos ✓ Available
Inactive ingredients (structured) ✓ Available
NADAC pharmacy acquisition price (CMS) — Not published for this NDC CMS publishes NADAC only for NDCs reported in its retail-pharmacy survey.
Orange Book / therapeutic-equivalence data ✓ Available
HCPCS J-code billing crosswalk — Not published for this NDC Most self-administered / retail products have no J-code — that is normal.
Medicaid utilization (CMS SDUD) — Not published for this NDC CMS reports utilization only for NDCs with Medicaid claims above its privacy threshold.
“Not published” reflects what the public FDA / CMS / NLM sources provide for this exact package code — it is a property of the data feeds, not a judgment about the product.

Questions about this listing

Why is there no price listed?
The pricing shown on our NDC pages comes from CMS NADAC, a voluntary survey of retail community pharmacy invoices. CMS does not publish a NADAC for every NDC — packages outside the retail survey (institutional and hospital products, bulk packages, discontinued items, and many OTC items) may never receive one. A missing price reflects the survey's scope, not this product's actual cost, and does not mean the product is free or unavailable.
Is the NDC printed on the package the same as the 11-digit billing NDC?
Yes, they identify this exact package in different formats. The form printed on the packaging and shown on DailyMed is the one the FDA registered. Insurance claims use a fixed 11-digit 5-4-2 format, so the short segment is padded with a leading zero and the dashes are dropped. The Identity section at the top of this page lists each form of this code.
Is this package still being marketed?
Yes, per the latest FDA NDC Directory data on this page: this package is listed as actively marketed, with no marketing end date reported by Amneal Pharmaceuticals LLC. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Amneal Pharmaceuticals LLC is the labeler of record for this NDC — the company under whose FDA-assigned code the package is listed. The labeler may be the manufacturer itself or a distributor marketing the product under its own code.
Do I need a prescription for this product?
This NDC is listed with FDA as a prescription product, so it is dispensed under a prescriber's order. Your pharmacist can tell you whether any over-the-counter forms of the same medication exist.
This page identifies an FDA-listed package (the NDC) and reports public regulatory and pricing data about the listing. It is reference information, not a medical recommendation — talk to your pharmacist or prescriber about your own medication.
Where does this data come from?
Listing facts (marketing category, packager status, marketing dates) from the FDA openFDA NDC Directory; label availability from DailyMed; pricing coverage from CMS NADAC; equivalence scope from the FDA Orange Book.
← 70121-1755-01 · Amneal 70121-2308-04 · Amneal →
For educational and professional reference only — not medical advice. Pricing reflects published NADAC and CMS ASP (free public data) and may differ from your acquisition cost; always verify before billing or dispensing.