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Eribulin Mesylate .5 mg/mL Injection — NDC 10019-0080-01 package photo
Label image from the product's FDA listing (DailyMed) — may show a different pack size or an older label revision.

Eribulin Mesylate .5 mg/mL Injection — NDC 10019-080-01 (Billing 10019-0080-01)

by Baxter Healthcare Company · 1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE

This is a package of Eribulin Mesylate .5 mg/mL Injection from Baxter Healthcare Company, marketed since Oct 2024 and currently FDA-listed. It is this product's only package size.

NDC 10019-0080-01
🏷️ FDA NDC (as labeled) 10019-080-01 billing pads the product segment with a zero
Rx only Generic On market Non-controlled ⇄ Compare with another NDC
🗂️ FDA directory synced Oct 1, 2026 · this listing last changed Jul 24, 2026 · sources: openFDA · FDA label (DailyMed) · FDA Orange & Purple Book · First Databank · CMS NADAC, ASP, Medicare & Medicaid · RxNorm
📋 All sources & update times →

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

Identity & classification

Regulatory identifiers FDA, NLM and CMS codes for this package

FDA NDC (as labeled) 10019-080-01
Product NDC 10019-080
11-digit billing NDC 10019008001
NCPDP billing unit ML — per mL (volume)
RxCUI 1045456
UNII AV9U0660CW
UPC 0310019080017
Application # ANDA217250
SPL Set ID 62690292-b1de-46f1-b6e8-012a725f8c63
Established class (EPC) Microtubule Inhibitor
Physiologic effect Microtubule Inhibition
DEA schedule Non-controlled
Marketing category ANDA
Marketing status On market
FDA listing status Listed (active directory)
Marketing start 2024-10-01
Route INTRAVENOUS
Dosage form INJECTION
Substance ERIBULIN MESYLATE
TE code (Orange Book) AP · RLD · RS

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

GPI-14 21500009202020
GCN Seq No 066838
GCN 29249
HICL code 037256
Ingredient (HICL) Eribulin Mesylate
HIC1 code V
Therapeutic class — broad (HIC1) Neoplasms
HIC2 code V3
Therapeutic class — intermediate (HIC2) Antineoplastic Drugs (Continued 1)
HIC3 code V3I
Therapeutic class — specific (HIC3) Antineoplastic - Microtubule Inhibitors
AHFS code 10:00.00.00
AHFS class Antineoplastic Agents
FDB label name ERIBULIN MESYLATE 1 MG/2 ML VL
FDB brand name Eribulin Mesylate
Legend status F — Federal legend — prescription drug or device
Quick answers
  • GSN (GCN sequence number): 066838
  • GCN: 29249
  • GPI-14 (Medi-Span): 21500009202020
  • HICL (First Databank): 037256
  • AHFS class code: 10:00.00.00
  • RxCUI (RxNorm): 1045456
Why two NDCs? The FDA registers this code as 10019-080-01 — a 5-3-2 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 product segment → 10019-0080-01. 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 Microtubule Inhibitor class.

Pharmacologic class Microtubule Inhibitor
Drug family (ATC) Other antineoplastic agents
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 ERIBULIN MESYLATE 1 MG/2 ML VL Ingredient Eribulin Mesylate
📖 What it is MedlinePlus · NLM

Eribulin injection is used to treat breast cancer that has spread to other parts of the body and that has already been treated with certain other chemotherapy medications. Eribulin is in a class of anticancer medications called microtubule dynamics inhibitors. It works by stopping the growth and spread of cancer cells.

Read the full MedlinePlus article ↗
📗 Our plain-language guide HelloPharmacist
  • It treats metastatic breast cancer after at least two earlier chemotherapy regimens, including an anthracycline and a taxane. It also treats unresectable or metastatic liposarcoma...
  • It's given through a vein by a healthcare professional. Each dose takes only a few minutes. You get it on Days 1 and 8 of a 21-day cycle, and your team follows the plan from your p...
  • Common ones are low blood counts, tiredness, hair loss, numbness or tingling, nausea, and constipation. Call your doctor right away for fever or signs of infection, or if numbness...
  • Eribulin can lower your white blood cells, which raises the risk of serious infection. Counts are checked before each dose. Your doctor may delay or lower a dose if needed.
📖 Read our full Eribulin 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 eachPer 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.
Medicare Part B allowsASP · J9179 $59.979 / J9179 unit —
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.

Billing & reimbursement

FDA NDC (as labeled)10019-080-01
11-digit billing NDC10019-0080-01
Format5-3-2 as registered → padded to 5-4-2 for billing (zero added to the product segment)
HCPCS J-codeJ9179
DescriptorInjection, eribulin mesylate, 0.1 mg
Billing units / pkg10 units
How the units are derivedThis package is 2; the HCPCS unit is 0.1 MG, so one package = 10 billing units.
Medicare Part B spend (2026 (Q1))$3,085,262 · 1,689 claims · $1,826.68 per claim (all NDCs under J9179)
Crosswalk sourceCMS ASP NDC-HCPCS Crosswalk
Where does this data come from?
The HCPCS J-code crosswalk comes from the CMS ASP NDC-HCPCS crosswalk and the DMEPDAC (DME MAC) NDC-HCPCS crosswalk — free public CMS data. Billing units are derived from the code’s descriptor and the package amount.

Packaging — all sizes for this product

Package NDCDescription Marketing startMarketing endStatus
10019-0080-01 You're viewing this Main listing 1 VIAL, SINGLE-DOSE in 1 CARTON / 2 mL in 1 VIAL, SINGLE-DOSE 2024-12-01 — Active

Therapeutic equivalents

ProductLabelerPackNADAC/unitTEStatusPrice vs. this
Eribulin Mesylate .5 mg/mL 00143-9167-01 HIKMA 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 00781-3391-94 Sandoz 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mLthis 10019-0080-01 Baxter 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 39822-2080-01 XGen 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 40033-0364-01 Kindos 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 43598-0125-11 Dr. 1 vial — AP FDA listed —
Halaven 1 mg/2mL 43624-0002-01 BSP 3 ml — AP FDA listed —
eribulin mesylate .5 mg/mL 60505-6289-00 Apotex 1 vial — AP FDA listed —
eribulin mesylate .5 mg/mL 60505-6435-00 Apotex 1 vial — AP FDA listed —
Halaven .5 mg/mL 62856-0389-01 Eisai 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 68001-0656-41 BluePoint 1 vial — AP FDA listed —
eribulin mesylate .5 mg/mL 68083-0592-01 Gland 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 68462-0770-20 GLENMARK 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 70095-0080-01 Sun 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 71731-4171-01 Chia 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 72603-0368-01 Northstar 1 vial — AP FDA listed —
Eribulin Mesylate .5 mg/mL 81298-3890-01 Long 1 vial — AP 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

🏛️
2024
On the market since
Oct 2024
📍
2026
Currently FDA-listed
2 years listed
🔓
·
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.

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.

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

  • 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 QTT17582CB
    A strong acid used to adjust and maintain the proper pH level in liquid medicines, ensuring stability and preventing breakdown of active ingredients.
  • UNII 55X04QC32I
    A strong alkaline chemical used to adjust and maintain the pH balance of liquid medicines. It helps keep the medicine stable and ensures it stays effective during storage.
  • UNII 059QF0KO0R
    Water is a liquid solvent that dissolves and mixes ingredients together in liquid medicines, syrups, and injections. It helps distribute the active drug evenly throughout the product.

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

LabelerBaxter Healthcare Company
Application holderBAXTER HEALTHCARE CORP
FDA applicationANDA217250 (ANDA)
Labeler code10019
First marketedOct 2024
Product typeHuman Prescription Drug
Portfolio121 products on file
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 🧬 Pharmacokinetics 🧬 Pharmacodynamics 🔬 Clinical Studies 🧪 Nonclinical Toxicology 📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 📚 References 📄 Package Label / Principal Display Panel
🎯 Indications and Usage 156 words ▾

1 INDICATIONS AND USAGE Eribulin Mesylate Injection is a microtubule inhibitor indicated for the treatment of patients with: • Metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting. (1.1) • Unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

(1.2)

1.1Metastatic Breast Cancer Eribulin Mesylate Injection is indicated for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting [ see Clinical Studies (14.1) ] .

1.2Liposarcoma Eribulin Mesylate Injection is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen [ see Clinical Studies (14.2) ] .

⏱️ Dosage and Administration ~3 min read ▾

2 DOSAGE AND ADMINISTRATION • Administer 1.4 mg/m 2 intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. (2.1) • Reduce dose in patients with hepatic impairment or with moderate or severe renal impairment. (2.1) • Do not mix with other drugs or administer with dextrose-containing solutions. (2.3)

2.1Recommended Dose The recommended dose of Eribulin Mesylate Injection is 1.4 mg/m 2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle. The recommended dose of Eribulin Mesylate Injection in patients with mild hepatic impairment (Child-Pugh A) is 1.1 mg/m 2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [ see Use in Specific Populations (8.6) ] . The recommended dose of Eribulin Mesylate Injection in patients with moderate hepatic impairment (Child-Pugh B) is 0.7 mg/m 2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [ see Use in Specific Populations (8.6) ] .

The recommended dose of Eribulin Mesylate Injection in patients with moderate or severe renal impairment (creatinine clearance (CLcr) 15-49 mL/min) is 1.1 mg/m 2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle [ see Use in Specific Populations (8.7) ] .

2.2Dose Modification Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose. Recommended dose delays • Do not administer Eribulin Mesylate Injection on Day 1 or Day 8 for any of the following: o ANC < 1,000/mm 3 o Platelets < 75,000/mm 3 o Grade 3 or 4 non-hematological toxicities. • The Day 8 dose may be delayed for a maximum of 1 week. o If toxicities do not resolve or improve to ≤ Grade 2 severity by Day 15, omit the dose. o If toxicities resolve or improve to ≤ Grade 2 severity by Day 15, administer Eribulin Mesylate Injection at a reduced dose and initiate the next cycle no sooner than 2 weeks later.

Recommended dose reductions • If a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume Eribulin Mesylate Injection at a reduced dose as set out in Table 1 . • Do not re-escalate Eribulin Mesylate Injection dose after it has been reduced. Table 1: Recommended Dose Reductions Event Description Recommended Eribulin Mesylate Injection Dose Permanently reduce the 1.4 mg/m 2 Eribulin Mesylate Injection dose for any of the following: 1.1 mg/m 2 ANC <500/mm 3 for >7 days ANC <1,000 /mm 3 with fever or infection Platelets <25,000/mm 3 Platelets <50,000/mm 3 requiring transfusion Non-hematologic Grade 3 or 4 toxicities Omission or delay of Day 8 Eribulin Mesylate Injection dose in previous cycle for toxicity Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m 2 0.7 mg/m 2 Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m 2 Discontinue Eribulin Mesylate Injection ANC = absolute neutrophil count.

Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.

2.3Instructions for Preparation and Administration Aseptically withdraw the required amount of Eribulin Mesylate Injection from the single-dose vial and administer undiluted or diluted in 100 mL of 0.9% Sodium Chloride Injection, USP. Do not dilute in or administer through an intravenous line containing solutions with dextrose. Do not administer in the same intravenous line concurrent with the other medicinal products.

Store undiluted Eribulin Mesylate Injection in the syringe for up to 4 hours at room temperature or for up to 24 hours under refrigeration at 4°C (40°F). Store diluted solutions of Eribulin Mesylate Injection for up to 4 hours at room temperature or up to 24 hours under refrigeration at 4°C (40°F). Discard unused portions of the vial.

💊 Dosage Forms and Strengths 40 words ▾

3 DOSAGE FORMS AND STRENGTHS Injection: 1 mg/2 mL (0.5 mg/mL) eribulin mesylate is a clear, colorless, sterile solution in a single-dose vial. Injection: 1 mg per 2 mL (0.5 mg per mL) eribulin mesylate in a single-dose vial (3)

⛔ Contraindications 5 words ▾

4 CONTRAINDICATIONS None. None (4)

⚠️ Warnings and Cautions ~3 min read ▾

5 WARNINGS AND PRECAUTIONS • Neutropenia : Monitor peripheral blood cell counts and adjust dose as appropriate. (5.1) • Peripheral Neuropathy : Monitor for signs of neuropathy. Manage with dose delay and adjustment.

(5.2) • Embryo-Fetal Toxicity : Can cause fetal harm. Advise females of reproductive potential of the potential risk to the fetus and to use effective contraception. (5.3 , 8.1 , 8.3) • QT Prolongation : Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities.

Avoid in patients with congenital long QT syndrome. (5.4)

5.1Neutropenia In Study 1, severe neutropenia (ANC < 500/mm 3 ) lasting more than one week occurred in 12% (62/503) of patients with metastatic breast cancer, leading to discontinuation in <1% of patients. Febrile neutropenia (fever ≥38.5°C with Grade 3 or 4 neutropenia) occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of febrile neutropenia [ see Adverse Reactions (6.1) ] . In Study 1, patients with alanine aminotransferase (ALT) or aspartate aminotransferase (AST) > 3 × ULN (upper limit of normal) experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal aminotransferase levels.

Patients with bilirubin > 1.5 × ULN also had a higher incidence of Grade 4 neutropenia and febrile neutropenia. In Study 2, severe neutropenia (ANC < 500/mm 3 ) lasting more than one week occurred in 12% (26/222) of patients with liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 0.9% of patients treated with Eribulin Mesylate Injection and fatal neutropenic sepsis in 0.9% [ see Adverse Reactions (6.1) ].

Monitor complete blood counts prior to each dose; increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration of Eribulin Mesylate Injection and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days [ see Dosage and Administration (2.2) ] . Clinical studies of Eribulin Mesylate Injection did not include patients with baseline neutrophil counts below 1,500/mm 3 .

5.2Peripheral Neuropathy In Study 1, Grade 3 peripheral neuropathy occurred in 8% (40/503) of patients, and Grade 4 in 0.4% (2/503) of patients with metastatic breast cancer (MBC). Peripheral neuropathy was the most common toxicity leading to discontinuation of Eribulin Mesylate Injection (5% of patients; 24/503) in Study 1. Neuropathy lasting more than one year occurred in 5% (26/503) of patients.

Twenty-two percent (109/503) of patients developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). In Study 2, Grade 3 peripheral neuropathy occurred in 3.1% (7/223) of Eribulin Mesylate Injection-treated patients. Peripheral neuropathy led to discontinuation of Eribulin Mesylate Injection in 0.9% of patients.

The median time to first occurrence of peripheral neuropathy of any severity was 5 months (range: 3.5 months to 9 months). Neuropathy lasting more than 60 days occurred in 58% (38/65) of patients. Sixty three percent (41/65) had not recovered within a median follow-up duration of 6.4 months (range: 27 days to 29 months).

Monitor patients closely for signs of peripheral motor and sensory neuropathy. Withhold Eribulin Mesylate Injection in patients who experience Grade 3 or 4 peripheral neuropathy, until resolution to Grade 2 or less [ see Dosage and Administration (2.2) ] .

5.3Embryo-Fetal Toxicity Based on findings from an animal reproduction study and its mechanism of action, Eribulin Mesylate Injection can cause fetal harm when administered to a pregnant woman. There are no adequate and well-controlled studies of Eribulin Mesylate Injection in pregnant women. In animal reproduction studies, eribulin mesylate caused embryo-fetal toxicity when administered to pregnant rats during orga… [Excerpted — this section continues on DailyMed.]

🤒 Adverse Reactions ~3 min read ▾

6 ADVERSE REACTIONS The most common adverse reactions (≥25%) in metastatic breast cancer were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation. (6.1) The most common adverse reactions (≥25%) in liposarcoma and leiomyosarcoma were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia. The most common (≥5%) Grade 3-4 laboratory abnormalities in liposarcoma and leiomyosarcoma were neutropenia, hypokalemia, and hypocalcemia.

(6.1) To report SUSPECTED ADVERSE REACTIONS, contact Baxter Healthcare Corporation at 1-866-888-2472 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, the adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in other clinical trials and may not reflect the rates observed in clinical practice. The following adverse reactions are discussed in detail in other sections of the labeling: • Neutropenia [ see Warnings and Precautions (5.1) ] • Peripheral neuropathy [ see Warnings and Precautions (5.2) ] • QT prolongation [ see Warnings and Precautions (5.4) ] In clinical trials, Eribulin Mesylate Injection has been administered to 1963 patients including 467 patients exposed to Eribulin Mesylate Injection for 6 months or longer.

The majority of the 1963 patients were women (92%) with a median age of 55 years (range: 17 to 85 years). The racial and ethnic distribution was White (72%), Black (4%), Asian (9%), and other (3%). Metastatic Breast Cancer The most common adverse reactions (≥25%) reported in patients receiving Eribulin Mesylate Injection were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.

The most common serious adverse reactions reported in patients receiving Eribulin Mesylate Injection were febrile neutropenia (4%) and neutropenia (2%). The most common adverse reaction resulting in discontinuation of Eribulin Mesylate Injection was peripheral neuropathy (5%). The adverse reactions described in Table 2 were identified in 750 patients treated in Study 1 .

In Study 1, patients were randomized (2:1) to receive either Eribulin Mesylate Injection (1.4 mg/m on Days 1 and 8 of a 21-day cycle) or single agent treatment chosen by their physician (control group). A total of 503 patients received Eribulin Mesylate Injection and 247 patients in the control group received therapy consisting of chemotherapy [total 97% (anthracyclines 10%, capecitabine 18%, gemcitabine 19%, taxanes 15%, vinorelbine 25%, other chemotherapies 10%)] or hormonal therapy (3%). The median duration of exposure was 118 days for patients receiving Eribulin Mesylate Injection and 63 days for patients receiving control therapy.

Table 2 reports the most common adverse reactions occurring in at least 10% of patients in either group. Table 2: Adverse Reactions adverse reactions were graded per National Cancer Institute Criteria for Adverse Events version 4.0. with a Per-Patient Incidence of at Least 10% in Study 1 Adverse Reactions Eribulin Mesylate Injection n=503 Control Group n=247 All Grades ≥ Grade 3 All Grades ≥ Grade 3 Blood and lymphatic system disorders based upon laboratory data. Neutropenia 82% 57% 53% 23% Anemia 58% 2% 55% 4% Nervous system disorders Peripheral neuropathy includes peripheral neuropathy, peripheral sensorimotor neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia.

35% 8% 16% 2% Headache 19% <1% 12% <1% General disorders Asthenia/Fatigue 54% 10% 40% 11% Pyrexia 21% <1% 13% <1% Mucosal inflammation 9% 1% 10% 2% Gastrointestinal disorders Nausea 35% 1% 28% 3% Constipation 25% 1% 21% 1% Vomiting 18% 1% 18% 1% Diarrhea 18% 0 18% 0 Musculoskeletal and connective tissue disorders Arthralgia/Myalgia 22% <1% 12% 1% Back pain 16% 1% 7% 2% Bone pain 12% 2% 9% 2% Pain in extremity 11% 1% 10% 1% Metabolism… [Excerpted — this section continues on DailyMed.]

🔄 Drug Interactions 138 words ▾

7 DRUG INTERACTIONS

7.1Effects of Other Drugs on Eribulin Mesylate Injection No drug-drug interactions are expected with CYP3A4 inhibitors, CYP3A4 inducers or P-glycoprotein (P-gp) inhibitors. Clinically meaningful differences in exposure (AUC) were not observed in patients with advanced solid tumors when Eribulin Mesylate Injection was administered with or without ketoconazole (a strong inhibitor of CYP3A4 and a P-gp inhibitor) and when Eribulin Mesylate Injection was administered with or without rifampin (a CYP3A4 inducer) [ see Clinical Pharmacology (12.3) ] .

7.2Effects of Eribulin Mesylate Injection on Other Drugs Eribulin does not inhibit CYP1A2, CYP2C9, CYP2C19, CYP2D6, CYP2E1 or CYP3A4 enzymes or induce CYP1A2, CYP2C9, CYP2C19 or CYP3A4 enzymes at relevant clinical concentrations. Eribulin is not expected to alter the plasma concentrations of drugs that are substrates of these enzymes [ see Clinical Pharmacology (12.3) ] .

👥 Use in Specific Populations ~3 min read ▾

8 USE IN SPECIFIC POPULATIONS • Lactation: Do not breastfeed. (8.2) • Hepatic Impairment: A lower starting dose is recommended for patients with mild (Child-Pugh A) and moderate (Child-Pugh B) hepatic impairment. Patients with severe hepatic impairment (Child-Pugh C) were not studied. (8.6) • Renal Impairment: A lower starting dose is recommended for patients with moderate (CLcr 30‑49 mL/min) or severe (CLcr 15‑29 mL/min) renal impairment. (8.7)

8.1Pregnancy Risk Summary Based on findings from an animal reproduction study and its mechanism of action, Eribulin Mesylate Injection can cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology (12.1) ] . There are no available data on the use of Eribulin Mesylate Injection during pregnancy. In an animal reproduction study, eribulin mesylate caused embryo-fetal toxicity when administered to pregnant rats during organogenesis at doses below the recommended human dose [see Data] .

Advise pregnant women of the potential risk to a fetus. The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. 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 In an embryo-fetal developmental toxicity study, pregnant rats received intravenous infusion of eribulin mesylate during organogenesis (Gestation Days 8, 10, and 12) at doses approximately 0.04, 0.13, 0.43 and 0.64 times the recommended human dose, based on body surface area. Increased abortion and severe fetal external or soft tissue malformations, including the absence of a lower jaw and tongue, or stomach and spleen, were observed at doses 0.64 times the recommended human dose of 1.4 mg/m 2 based on body surface area.

Increased embryo-fetal death/resorption, reduced fetal weights, and minor skeletal anomalies consistent with developmental delay were also reported at doses at or above a maternally toxic dose of approximately 0.43 times the recommended human dose.

8.2Lactation Risk Summary There is no information regarding the presence of eribulin mesylate or its metabolites in human milk, the effects on the breastfed infant, or the effects on milk production. No lactation studies in animals were conducted. Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with Eribulin Mesylate Injection and for 2 weeks after the final dose.

8.3Females and Males of Reproductive Potential Contraception Females Based on findings from an animal reproduction study and its mechanism of action, Eribulin Mesylate Injection can cause fetal harm when administered to a pregnant woman [ see Use in Specific Populations (8.1) ] . Advise females of reproductive potential to use effective contraception during treatment with Eribulin Mesylate Injection and for at least 2 weeks following the final dose. Males Based on its mechanism of action, advise males with female partners of reproductive potential to use effective contraception during treatment with Eribulin Mesylate Injection and for 3.5 months following the final dose.

Infertility Males Based on animal data, Eribulin Mesylate Injection may result in damage to male reproductive tissues leading to impaired fertility of unknown duration [ see Nonclinical Toxicology (13.1) ] .

8.4Pediatric Use The safety and effectiveness of Eribulin Mesylate Injection in pediatric patients have not been established. The safety and effectiveness of Eribulin Mesylate alone or in combination with irinotecan in pediatric patients were assessed but not established in three open-label studies (NCT02171260, NCT03441360, and NCT03245450) in 77 pediatric patients aged 2 to <17 years with relapsed or refractory solid tumors and lymphomas, excluding central nervous system tumors. No new safety signals were observed in these studie… [Excerpted — this section continues on DailyMed.]

🤰 Pregnancy ~1 min read ▾

8.1Pregnancy Risk Summary Based on findings from an animal reproduction study and its mechanism of action, Eribulin Mesylate Injection can cause fetal harm when administered to a pregnant woman [ see Clinical Pharmacology (12.1) ] . There are no available data on the use of Eribulin Mesylate Injection during pregnancy. In an animal reproduction study, eribulin mesylate caused embryo-fetal toxicity when administered to pregnant rats during organogenesis at doses below the recommended human dose [see Data] .

Advise pregnant women of the potential risk to a fetus. The estimated background risks of major birth defects and miscarriage for the indicated populations are unknown. 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 In an embryo-fetal developmental toxicity study, pregnant rats received intravenous infusion of eribulin mesylate during organogenesis (Gestation Days 8, 10, and 12) at doses approximately 0.04, 0.13, 0.43 and 0.64 times the recommended human dose, based on body surface area. Increased abortion and severe fetal external or soft tissue malformations, including the absence of a lower jaw and tongue, or stomach and spleen, were observed at doses 0.64 times the recommended human dose of 1.4 mg/m 2 based on body surface area.

Increased embryo-fetal death/resorption, reduced fetal weights, and minor skeletal anomalies consistent with developmental delay were also reported at doses at or above a maternally toxic dose of approximately 0.43 times the recommended human dose.

🧒 Pediatric Use 105 words ▾

8.4Pediatric Use The safety and effectiveness of Eribulin Mesylate Injection in pediatric patients have not been established. The safety and effectiveness of Eribulin Mesylate alone or in combination with irinotecan in pediatric patients were assessed but not established in three open-label studies (NCT02171260, NCT03441360, and NCT03245450) in 77 pediatric patients aged 2 to <17 years with relapsed or refractory solid tumors and lymphomas, excluding central nervous system tumors. No new safety signals were observed in these studies.

The pharmacokinetics (PK) of eribulin were within range of values of adult patients with metastatic liposarcoma or other tumors given the same dose per body surface area.

🧓 Geriatric Use 110 words ▾

8.5Geriatric Use Study 1 did not include sufficient numbers of subjects with metastatic breast cancer aged 65 years and older to determine whether they respond differently from younger subjects. Of the 827 subjects who received the recommended dose and schedule of Eribulin Mesylate Injection in clinical studies with advanced breast cancer, 15% (121/827) were 65 and older, and 2% (17/827) patients were 75 and older. No overall differences in safety were observed between these subjects and younger subjects.

Clinical studies of Eribulin Mesylate Injection did not include a sufficient number of subjects in Study 2 aged 65 years and older to determine whether they respond differently from younger subjects.

🆘 Overdosage 45 words ▾

10 OVERDOSAGE Overdosage of Eribulin Mesylate Injection has been reported at approximately 4 times the recommended dose, which resulted in Grade 3 neutropenia lasting seven days and a Grade 3 hypersensitivity reaction lasting one day. There is no known antidote for Eribulin Mesylate Injection overdose.

🧬 Clinical Pharmacology ~3 min read ▾

12 CLINICAL PHARMACOLOGY

12.1Mechanism of Action Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G 2 /M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage. In addition, eribulin treatment of human breast cancer cells caused changes in morphology and gene expression as well as decreased migration and invasiveness in vitro.

In mouse xenograft models of human breast cancer, eribulin treatment was associated with increased vascular perfusion and permeability in the tumor cores, resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype.

12.2Pharmacodynamics Cardiac Electrophysiology The effect of Eribulin Mesylate Injection on the QTc interval was assessed in an open-label, uncontrolled, multicenter, single-arm dedicated QT trial. A total of 26 patients with solid tumors received 1.4 mg/m 2 of Eribulin Mesylate Injection on Days 1 and 8 of a 21-day cycle. A delayed QTc prolongation was observed on Day 8, with no prolongation observed on Day 1.

The maximum mean QTcF change from baseline (95% upper confidence interval) was 11.4 (19.5) ms.

12.3Pharmacokinetics The pharmacokinetics (PK) of eribulin is linear with a mean elimination half-life of approximately 40 hours, a mean volume of distribution of 43 L/m 2 to 114 L/m 2 and mean clearance of

1.16 L/hr/m 2 to

2.42L/hr/m 2 over the dose range of 0.25 mg/m 2 to 4.0 mg/m 2 . The human plasma protein binding of eribulin at concentrations of 100 ng/mL to 1,000 ng/mL ranges from 49% to 65%. Eribulin exposure after multiple dosing is comparable to that following a single dose.

No accumulation of eribulin is observed with weekly administration. Elimination Metabolism Unchanged eribulin was the major circulating species in plasma following administration of 14 C-eribulin to patients. Metabolite concentrations represented <0.6% of parent compound, confirming that there are no major human metabolites of eribulin.

Cytochrome P450 3A4 (CYP3A4) negligibly metabolizes eribulin in vitro. Excretion Eribulin is eliminated primarily in feces unchanged. After administration of 14 C-eribulin to patients, approximately 82% of the dose was eliminated in feces and 9% in urine.

Unchanged eribulin accounted for approximately 88% and 91% of total eribulin in feces and urine, respectively. Specific Populations Age, Sex, and Race/Ethnicity : Based on a population pharmacokinetic analysis, no clinically meaningful differences in the pharmacokinetics of eribulin were observed based on age, sex, or race. Hepatic Impairment In a study evaluating the effect of hepatic impairment on the PK of eribulin, eribulin exposures increased by 1.8-fold in patients with mild hepatic impairment (Child-Pugh A; n=7) and by 2.5-fold in patients with moderate (Child-Pugh B; n=5) hepatic impairment as compared to patients with normal hepatic function (n=6).

Administration of Eribulin Mesylate Injection at a dose of 1.1 mg/m 2 to patients with mild hepatic impairment and 0.7 mg/m 2 to patients with moderate hepatic impairment resulted in similar exposure to eribulin at a dose of 1.4 mg/m 2 to patients with normal hepatic function [ see Dosage and Administration (2.1) , Use in Specific Populations (8.6) ] . Renal Impairment In a study evaluating the effect of renal impairment on the PK of eribulin, patients with moderate (CLcr 30-49 mL/min; n=7) and severe renal impairment (CLcr 15-29 mL/min; n=6) had 1.5-fold higher eribulin dose-normalized exposures compared to that in patients with normal renal function (CLcr ≥ 80 mL/min; n=6).

There were no clinically meaningful changes in patients with mild renal impairment (CLcr 50-79 mL/min; n=27) [ see Dosage and Administration (2.1) , Use in Specific Populations (8.7) ] . Drug… [Excerpted — this section continues on DailyMed.]

🧬 Mechanism of Action 119 words ▾

12.1Mechanism of Action Eribulin inhibits the growth phase of microtubules without affecting the shortening phase and sequesters tubulin into nonproductive aggregates. Eribulin exerts its effects via a tubulin-based antimitotic mechanism leading to G 2 /M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage. In addition, eribulin treatment of human breast cancer cells caused changes in morphology and gene expression as well as decreased migration and invasiveness in vitro.

In mouse xenograft models of human breast cancer, eribulin treatment was associated with increased vascular perfusion and permeability in the tumor cores, resulting in reduced tumor hypoxia, and changes in the expression of genes in tumor specimens associated with a change in phenotype.

📦 How Supplied / Storage and Handling 61 words ▾

16 HOW SUPPLIED/STORAGE AND HANDLING NDC 10019-080-01 Injection: 1 mg/2 mL, in a single-dose vial. One vial per carton. Store at 25°C (77°F); excursions permitted to 15° to 30° C (59° to 86° F). Do not freeze or refrigerate. Store the vials in their original cartons. Eribulin Mesylate Injection is a cytotoxic drug. Follow applicable special handling and disposal procedures. 1

📋 Description 191 words ▾

11 DESCRIPTION Eribulin Mesylate Injection contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okadai . The chemical name for eribulin mesylate is 11,15:18,21:24,28-Triepoxy-7,9-ethano-12,15-methano-9 H ,15 H -furo[3,2- i ]furo[2',3':5,6]pyrano[4,3- b ][1,4]dioxacyclopentacosin-5(4 H )-one, 2-[(2 S )-3- amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2 R ,3 R ,3a S ,7 R ,8a S ,9 S ,10a R ,11 S ,12 R ,13a R ,13b S ,15 S ,18 S ,21 S ,24 S ,26 R ,28 R ,29a S )-, methanesulfonate (salt).

It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C 40 H 59 NO 11 •CH 4 O 3 S. Eribulin mesylate has the following structural formula: Eribulin Mesylate Injection is a clear, colorless, sterile solution for intravenous administration.

Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v). Sodium hydroxide or hydrochloric acid may be used for pH adjustment.

Eribulin Structural Formula

💬 Information for Patients ~3 min read ▾

17 PATIENT COUNSELING INFORMATION Advise the patient to read the FDA-approved patient labeling (Patient Information). Neutropenia Advise patients to contact their health care provider for a fever of 100.5°F or greater or other signs or symptoms of infection such as chills, cough, or burning or pain on urination [ see Warnings and Precautions (5.1) ] . Peripheral Neuropathy Advise patients to inform their healthcare providers of new or worsening numbness, tingling and pain in their extremities [ see Warnings and Precautions (5.2) ] .

Embryo-Fetal Toxicity • Advise females of reproductive potential of the potential risk to a fetus and to inform their healthcare provider of a known or suspected pregnancy [ see Warnings and Precautions (5.3) , Use in Specific Populations (8.1) ] . • Advise females of reproductive potential to use effective contraception during treatment with Eribulin Mesylate Injection and for at least 2 weeks after the final dose [ see Use in Specific Populations (8.3) ] . • Advise males with female partners of reproductive potential to use effective contraception during treatment with Eribuin Mesylate Injection and for 3.5 months following the final dose [ see Use in Specific Populations (8.3) ] .

Lactation Advise women not to breastfeed during treatment with Eribuin Mesylate Injection and for 2 weeks after the final dose [ see Use in Specific Populations (8.2) ] . Manufactured for: Baxter Healthcare Corporation Deerfield, IL 60015 USA Product of Germany HA-30-02-157 Baxter is a registered trademark of Baxter International Inc. Revised: 10/2024 PATIENT INFORMATION Eribulin Mesylate Injection, for intravenous use What is the most important information I should know about Eribulin Mesylate Injection?

Eribulin Mesylate Injection can cause serious side effects, including: • Low white blood cell count (neutropenia) . This can lead to serious infections that could lead to death. Your healthcare provider will check your blood cell counts before you receive each dose of Eribulin Mesylate Injection and during treatment.

Call your healthcare provider right away if you develop any of these symptoms of infection: • Numbness, tingling, or pain in your hands or feet (peripheral neuropathy) . Peripheral neuropathy is common with Eribulin Mesylate Injection and sometimes can be severe. Tell your healthcare provider if you have new or worsening symptoms of peripheral neuropathy. • Your healthcare provider may delay, decrease your dose, or stop treatment with Eribulin Mesylate Injection if you have side effects.

See “ What are possible side effects of Eribulin Mesylate Injection?” for more information about side effects . What is Eribulin Mesylate Injection? Eribulin Mesylate Injection is a prescription medicine used to treat people with: • Breast cancer o that has spread to other parts of the body, and o who have already received certain types of anticancer medicines after the cancer has spread • Liposarcoma o that cannot be treated with surgery or has spread to other parts of the body, and o who have received treatment with a certain type of anticancer medicine It is not known if Eribulin Mesylate Injection is safe and effective in children under 18 years of age.

Before you receive Eribulin Mesylate Injection, tell your healthcare provider about all of your medical conditions, including if you: • have liver or kidney problems • have heart problems, including a problem called congenital long QT syndrome • have low potassium or low magnesium in your blood • are pregnant or plan to become pregnant. Eribulin Mesylate Injection can harm your unborn baby. Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with Eribulin Mesylate Injection. o Females who are able to become pregnant should use an effective birth control during treatment with Eribulin Mesylate Injection and for at least 2 weeks after the final dose of Eribulin Mesylate Injection. o Males should use an effective form… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacokinetics ~3 min read ▾

12.3Pharmacokinetics The pharmacokinetics (PK) of eribulin is linear with a mean elimination half-life of approximately 40 hours, a mean volume of distribution of 43 L/m 2 to 114 L/m 2 and mean clearance of

1.16 L/hr/m 2 to

2.42L/hr/m 2 over the dose range of 0.25 mg/m 2 to 4.0 mg/m 2 . The human plasma protein binding of eribulin at concentrations of 100 ng/mL to 1,000 ng/mL ranges from 49% to 65%. Eribulin exposure after multiple dosing is comparable to that following a single dose.

No accumulation of eribulin is observed with weekly administration. Elimination Metabolism Unchanged eribulin was the major circulating species in plasma following administration of 14 C-eribulin to patients. Metabolite concentrations represented <0.6% of parent compound, confirming that there are no major human metabolites of eribulin.

Cytochrome P450 3A4 (CYP3A4) negligibly metabolizes eribulin in vitro. Excretion Eribulin is eliminated primarily in feces unchanged. After administration of 14 C-eribulin to patients, approximately 82% of the dose was eliminated in feces and 9% in urine.

Unchanged eribulin accounted for approximately 88% and 91% of total eribulin in feces and urine, respectively. Specific Populations Age, Sex, and Race/Ethnicity : Based on a population pharmacokinetic analysis, no clinically meaningful differences in the pharmacokinetics of eribulin were observed based on age, sex, or race. Hepatic Impairment In a study evaluating the effect of hepatic impairment on the PK of eribulin, eribulin exposures increased by 1.8-fold in patients with mild hepatic impairment (Child-Pugh A; n=7) and by 2.5-fold in patients with moderate (Child-Pugh B; n=5) hepatic impairment as compared to patients with normal hepatic function (n=6).

Administration of Eribulin Mesylate Injection at a dose of 1.1 mg/m 2 to patients with mild hepatic impairment and 0.7 mg/m 2 to patients with moderate hepatic impairment resulted in similar exposure to eribulin at a dose of 1.4 mg/m 2 to patients with normal hepatic function [ see Dosage and Administration (2.1) , Use in Specific Populations (8.6) ] . Renal Impairment In a study evaluating the effect of renal impairment on the PK of eribulin, patients with moderate (CLcr 30-49 mL/min; n=7) and severe renal impairment (CLcr 15-29 mL/min; n=6) had 1.5-fold higher eribulin dose-normalized exposures compared to that in patients with normal renal function (CLcr ≥ 80 mL/min; n=6).

There were no clinically meaningful changes in patients with mild renal impairment (CLcr 50-79 mL/min; n=27) [ see Dosage and Administration (2.1) , Use in Specific Populations (8.7) ] . Drug Interaction Studies Effect of Strong Inhibitors or Inducers of CYP3A4 on Eribulin: The effect of a strong CYP3A4 inhibitor and a P-gp inhibitor, ketoconazole, on the PK of eribulin was studied in a crossover trial of 12 patients with advanced solid tumors. No clinically relevant PK interaction was observed when Eribulin Mesylate Injection was administered with or without ketoconazole (the geometric mean ratio of the AUC: 0.97; 90% CI: 0.83, 1.12).

The effect of a CYP3A4 inducer, rifampin, on the PK of eribulin was studied in a crossover trial of 14 patients with advanced solid tumors. No clinically relevant PK interaction was observed when Eribulin Mesylate Injection was administered with or without rifampin (the geometric mean ratio of the AUC: 1.10; 90 CI%: 0.91, 1.34). Effect of Eribulin on CYP Substrates: Eribulin shows no induction potential for CYP1A, CYP2B6, CYP2C9, CYP2C19, and CYP3A in primary human hepatocytes.

Eribulin inhibits CYP3A4 activity in human liver microsomes, but it is unlikely that eribulin will substantially increase the plasma levels of CYP3A4 substrates. No significant inhibition of CYP1A2, CYP2C9, CYP2C19, CYP2D6, or CYP2E1 was detected with eribulin concentrations up to 5 μM in pooled human liver microsomes. In vitro drug interaction studies indicate that eribulin does not inhibit drugs that are substrates of these enzym… [Excerpted — this section continues on DailyMed.]

🧬 Pharmacodynamics 81 words ▾

12.2Pharmacodynamics Cardiac Electrophysiology The effect of Eribulin Mesylate Injection on the QTc interval was assessed in an open-label, uncontrolled, multicenter, single-arm dedicated QT trial. A total of 26 patients with solid tumors received 1.4 mg/m 2 of Eribulin Mesylate Injection on Days 1 and 8 of a 21-day cycle. A delayed QTc prolongation was observed on Day 8, with no prolongation observed on Day 1.

The maximum mean QTcF change from baseline (95% upper confidence interval) was 11.4 (19.5) ms.

🔬 Clinical Studies ~3 min read ▾

14 CLINICAL STUDIES

14.1Metastatic Breast Cancer Study 1 was an open-label, randomized, multicenter trial of 762 patients with metastatic breast cancer who received at least two chemotherapeutic regimens for the treatment of metastatic disease and experienced disease progression within 6 months of their last chemotherapeutic regimen. Patients were required to receive prior anthracycline- and taxane-based chemotherapy for adjuvant or metastatic disease. Patients were randomized (2:1) to receive Eribulin Mesylate Injection (n=508) or a single agent therapy selected prior to randomization (control arm, n=254).

Randomization was stratified by geographic region, HER2/ neu status, and prior capecitabine exposure. Eribulin Mesylate Injection was administered at a dose of 1.4 mg/m 2 on Days 1 and 8 of a 21-day cycle. Eribulin Mesylate Injection-treated patients received a median of 5 cycles (range: 1 to 23 cycles) of therapy.

Control arm therapy consisted of 97% chemotherapy (26% vinorelbine, 18% gemcitabine, 18% capecitabine, 16% taxane, 9% anthracycline, 10% other chemotherapy), and 3% hormonal therapy. The main efficacy outcome was overall survival. Patient demographic and baseline characteristics were comparable between the treatment arms.

The median age was 55 (range: 27 to 85 years) and 92% were White. Sixty-four percent of patients were enrolled in North America/Western Europe/Australia, 25% in Eastern Europe/Russia, and 11% in Latin America/South Africa. Ninety-one percent of patients had a baseline ECOG performance status of 0 or 1.

Tumor prognostic characteristics, including estrogen receptor status (positive: 67%, negative: 28%), progesterone receptor status (positive: 49%, negative: 39%), HER2/neu receptor status (positive: 16%, negative: 74%), triple negative status (ER - , PR - , HER2/ neu - : 19%), presence of visceral disease (82%, including 60% liver and 38% lung) and bone disease (61%), and number of sites of metastases (greater than two: 50%), were also similar in the Eribulin Mesylate Injection and control arms. Patients received a median of four prior chemotherapy regimens in both arms.

In Study 1, a statistically significant improvement in overall survival was observed in patients randomized to the Eribulin Mesylate Injection arm compared to the control arm (see ). An updated, unplanned survival analysis, conducted when 77% of events had been observed (see ), was consistent with the primary analysis. In patients randomized to Eribulin Mesylate Injection, the objective response rate by the RECIST criteria was 11% (95% CI: 8.6%, 14.3%) and the median response duration was 4.2 months (95% CI: 3.8, 5.0 months).

Table 5: Comparison of Overall Survival in Eribulin Mesylate Injection and Control Arm - Study 1 Overall Survival Eribulin Mesylate Injection (n=508) Control Arm (n=254) Primary survival analysis Number of deaths 274 148 Median, months (95% CI) 13.1 (11.8, 14.3) 10.6 (9.3, 12.5) Hazard Ratio (95% CI) Based on Cox proportional hazards model stratified by geographic region, HER2 status, and prior capecitabine therapy. 0.81 (0.66, 0.99) P value Based on a log-rank test stratified by geographic region, HER2 status, and prior capecitabine therapy.

0.041 Updated survival analysis Number of deaths 386 203 Median, months (95% CI) 13.2 (12.1, 14.4) 10.6 (9.2, 12.0) CI = confidence interval Figure 1: Updated Overall Survival Analysis for Study 1 EriBULin Figure 1

14.2Liposarcoma The efficacy and safety of Eribulin Mesylate Injection were evaluated in Study 2, an open-label, randomized (1:1), multicenter, active-controlled trial. Eligible patients were required to have unresectable, locally advanced or metastatic liposarcoma or leiomyosarcoma, at least two prior systemic chemotherapies (one of which must have included an anthracycline), and disease progression within 6 months of the most recent chemotherapy regimen. Patients were randomized to Eribulin Mesylate Injection 1.4 mg/m 2 administered intravenously on Days 1… [Excerpted — this section continues on DailyMed.]

🧪 Nonclinical Toxicology 181 words ▾

13 NONCLINICAL TOXICOLOGY

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with eribulin mesylate. Eribulin mesylate was not mutagenic in in vitro bacterial reverse mutation assays (Ames test). Eribulin mesylate was positive in mouse lymphoma mutagenesis assays, and was clastogenic in an in vivo rat bone marrow micronucleus assay.

Fertility studies have not been conducted with eribulin mesylate in humans or animals; however, nonclinical findings in repeat-dose dog and rat toxicology studies suggest that male fertility may be compromised by treatment with eribulin mesylate. Rats exhibited testicular toxicity (hypocellularity of seminiferous epithelium with hypospermia/aspermia) following dosing with eribulin mesylate at or above 0.43 times the recommended human dose (based on body surface area) given once weekly for 3 weeks, or at or above 0.21 times the recommended human dose (based on body surface area) given once weekly for 3 out of 5 weeks, repeated for 6 cycles.

Testicular toxicity was also observed in dogs given 0.64 times the recommended human dose (based on body surface area) weekly for 3 out of 5 weeks, repeated for 6 cycles.

📄 Carcinogenesis, Mutagenesis, Impairment of Fertility 178 words ▾

13.1Carcinogenesis, Mutagenesis, Impairment of Fertility Carcinogenicity studies have not been conducted with eribulin mesylate. Eribulin mesylate was not mutagenic in in vitro bacterial reverse mutation assays (Ames test). Eribulin mesylate was positive in mouse lymphoma mutagenesis assays, and was clastogenic in an in vivo rat bone marrow micronucleus assay.

Fertility studies have not been conducted with eribulin mesylate in humans or animals; however, nonclinical findings in repeat-dose dog and rat toxicology studies suggest that male fertility may be compromised by treatment with eribulin mesylate. Rats exhibited testicular toxicity (hypocellularity of seminiferous epithelium with hypospermia/aspermia) following dosing with eribulin mesylate at or above 0.43 times the recommended human dose (based on body surface area) given once weekly for 3 weeks, or at or above 0.21 times the recommended human dose (based on body surface area) given once weekly for 3 out of 5 weeks, repeated for 6 cycles.

Testicular toxicity was also observed in dogs given 0.64 times the recommended human dose (based on body surface area) weekly for 3 out of 5 weeks, repeated for 6 cycles.

📚 References 8 words ▾

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

📄 Package Label / Principal Display Panel ~1 min read ▾

PACKAGE/LABEL PRINCIPAL DISPLAY PANEL Container Label Lot/Exp NDC 10019-080-01 Rx only Eribulin Mesylate Injection 1 mg/2 mL (0.5 mg/mL) For Intravenous Use STERILE SOLUTION CAUTION: Cytotoxic Agent Bar Code 3 10019 08001 7 SINGLE DOSE VIAL - discard unused portion. Store at 25ºC (77ºF); excursions permitted to 15º-30ºC (59º-86ºF). Do not freeze or refrigerate.

DOSAGE AND USE See accompanying prescribing information. Distributed by: Baxter Healthcare Corporation, Deerfield IL 60015 USA. 2D Barcode USA HA-65-01-988 C 544 Carton Label GTIN: SN: LOT: EXP: YYY-MM NDC 10019-080-01 Eribulin Mesylate Injection 1 mg/2 mL (0.5 mg/ mL) For Intravenous Use STERILE SOLUTION CAUTION: Cytotoxic Agent SINGLE-DOSE VIAL-discard unused portion.

DOSAGE AND USE See accompanying prescribing information. Baxter logo HA-80-03-187 USA Each single-dose vial contains 1 mg of eribulin mesylate in 2 mL of solution. Each mL of solution contains 0.5 mg of eribulin mesylate (equivalent to 0.44 mg eribulin) in dehydrated alcohol (5% v/v) and water for injection (95% v/v).

Sodium hydroxide or hydrochloric acid may be used for pH adjustment. Store at 25°C (77°F); excursions permitted to 15°-30°C (59°-86°F). Do not freeze or refrigerate.

C 309 NDC 10019-080-01 Rx only Eribulin Mesylate Injection 1 mg/2 mL (0.5 mg/mL) For Intravenous Use STERILE SOLUTION CAUTION: Cytotoxix Agent SINGLE-DOSE VIAL-discard unused portion. Baxter logo 2206B0012 Barcode Barcode (01)20310019080011 Baxter is a registered trademark of Baxter International Inc. Distributed by: Baxter Healthcare Corporation, Deerfield, IL 60015 USA.

Product of Germany Eriibulin Representative Container Label - NDC 10119-080-01 Eribulin Representative Carton Label - NDC 10119-080-01 -1 of 2 Eribulin Representative Carton Label - NDC 10119-080-01 -2 of 2

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 Eribulin Mesylate — the program that covers self-administered drugs. 2 manufacturers.
⚠️ 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 Eribulin Mesylate. 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
$154.9K
Claims incl. refills
31
Beneficiaries
—
Spend / beneficiary
—
Spend / claim
$4,995.54
💵 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.

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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 Baxter Healthcare Company. Listing status can change — the directory data on this page refreshes weekly.
Who lists this product with the FDA?
Baxter Healthcare Company 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.
Does this product have a billing J-code?
Yes — this NDC cross-references HCPCS code J9179 for medical-claim billing (typically used when a product is administered in a clinical setting rather than dispensed at a retail pharmacy). See the Billing section on this page.
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.
← 10019-0079-01 · Baxter 10019-0115-01 · Baxter →
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.