Halaven

Do not take it if

Quoted from the official label, section “Contraindications”.

How to take it

These directions are for this exact strength and form. Another one is different.

• Administer 1.4 mg/m2 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 )
• 2.1 Recommended Dose The recommended dose of HALAVEN 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 HALAVEN 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 HALAVEN 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 HALAVEN 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) ] .
• 2.2 Dose Modification Assess for peripheral neuropathy and obtain complete blood cell counts prior to each dose.
• Recommended dose delays Do not administer HALAVEN on Day 1 or Day 8 for any of the following:
• ANC < 1,000/mm 3 - Platelets < 75,000/mm 3 - Grade 3 or 4 non-hematological toxicities.
• The Day 8 dose may be delayed for a maximum of 1 week. - If toxicities do not resolve or improve to ≤ Grade 2 severity by Day 15, omit the dose. - If toxicities resolve or improve to ≤ Grade 2 severity by Day 15, administer HALAVEN 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 HALAVEN at a reduced dose as set out in Table 1.
• Do not re-escalate HALAVEN dose after it has been reduced.
• Table 1:
• Recommended Dose Reductions Event Description Recommended HALAVEN Dose Permanently reduce the 1.4 mg/m 2 HALAVEN dos e 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 HALAVEN 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 HALAVEN ANC = absolute neutrophil count.
• Toxicities graded in accordance with National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 3.0.
• 2.3 Instructions for Preparation and Administration Aseptically withdraw the required amount of HALAVEN 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 HALAVEN 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 HALAVEN 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.

Quoted from the official label, section “Dosage & Administration”.

Other warnings

Quoted from the official label, section “Warnings”.

Pregnancy and breastfeeding

Quoted from the official label, section “OTC — Pregnancy or Breast Feeding”.

Other medicines

Quoted from the official label, section “Drug Interactions”.

If you take too much

In an emergency, call your local emergency number or a poison control centre.

Quoted from the official label, section “Overdosage”.

Use in children

• The safety and effectiveness of HALAVEN in pediatric patients have not been established.
• The safety and effectiveness of HALAVEN 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.

Quoted from the official label, section “Pediatric Use”.

Use in older people

• 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 HALAVEN 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 HALAVEN 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.

Quoted from the official label, section “Geriatric Use”.

Side effects

• 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 Eisai Inc. at (1-877-873-4724) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
• 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, 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, HALAVEN has been administered to 1963 patients including 467 patients exposed to HALAVEN 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 HALAVEN were neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, and constipation.
• The most common serious adverse reactions reported in patients receiving HALAVEN were febrile neutropenia (4%) and neutropenia (2%).
• The most common adverse reaction resulting in discontinuation of HALAVEN was peripheral neuropathy (5%).
• The adverse reactions described in Table 2 were identified in 750 patients treated in Study 1 [ see Clinical Studies (14.1) ] .
• In Study 1, patients were randomized (2:1) to receive either HALAVEN (1.4 mg/m 2 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 HALAVEN 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 HALAVEN 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 a with a Per-Patient Incidence of at Least 10% in Study 1 Adverse Reactions HALAVEN n=503 Control Group n=247 All Grades ≥ Grade 3 All Grades ≥ Grade 3 Blood and l ymphatic s ystem d isorders b Neutropenia 82% 57% 53% 23% Anemia 58% 2% 55% 4% Nervous system disorders Peripheral neuropathy c 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 and nutrition disorders Decreased weight 21% 1% 14% <1% Anorexia 20% 1% 13% 1% Respiratory, thoracic, and mediastinal disorders Dyspnea 16% 4% 13% 4% Cough 14% 0 9% 0 Skin and subcutaneous tissue disorders Alopecia 45% NA d 10% NA d Infections Urinary Tract Infection 10% 1% 5% 0 a adverse reactions were graded per National Cancer Institute Criteria for Adverse Events version 4.0. b based upon laboratory data. c includes peripheral neuropathy, peripheral sensorimotor neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. d not applicable;
• (grading system does not specify > Grade 2 for alopecia).
• Cytopenias :
• Grade 3 neutropenia occurred in 28% (143/503) of patients who received HALAVEN in Study 1, and 29% (144/503) of patients experienced Grade 4 neutropenia.
• Febrile neutropenia occurred in 5% (23/503) of patients; two patients (0.4%) died from complications of febrile neutropenia.
• Dose reduction due to neutropenia was required in 12% (62/503) of patients and discontinuation was required in <1% of patients.
• The mean time to nadir was 13 days and the mean time to recovery from severe neutropenia (<500/mm 3 ) was 8 days.
• Grade 3 or greater thrombocytopenia occurred in 1% (7/503) of patients.
• G-CSF (granulocyte colony-stimulating factor) or GM-CSF (granulocyte–macrophage colony-stimulating factor) was used in 19% of patients who received HALAVEN.
• Peripheral Neuropathy :
• In Study 1, 17% of enrolled patients had Grade 1 peripheral neuropathy and 3% of patients had Grade 2 peripheral neuropathy at baseline.
• Dose reduction due to peripheral neuropathy was required by 3% (14/503) of patients who received HALAVEN.
• Four percent (20/503) of patients experienced peripheral motor neuropathy of any grade and 2% (8/503) of patients developed Grade 3 peripheral motor neuropathy.
• Liver Function Test Abnormalities :
• Among patients with Grade 0 or 1 ALT levels at baseline, 18% of HALAVEN-treated patients experienced Grade 2 or greater ALT elevation.
• One HALAVEN-treated patient without documented liver metastases had concomitant Grade 2 elevations in bilirubin and ALT; these abnormalities resolved and did not recur with re-exposure to HALAVEN.
• Less Common Adverse Reactions :
• The following additional adverse reactions were reported in ≥5% to <10% of the HALAVEN-treated group:
• Eye Disorders:
• increased lacrimation Gastrointestinal Disorders:
• dyspepsia, abdominal pain, stomatitis, dry mouth General Disorders and Administration Site Conditions:
• peripheral edema Infections and Infestations:
• upper respiratory tract infection Metabolism and Nutrition Disorders:
• hypokalemia Musculoskeletal and Connective Tissue Disorders:
• muscle spasms, muscular weakness Nervous System Disorders:
• dysgeusia, dizziness Psychiatric Disorders:
• insomnia, depression Skin and Subcutaneous Tissue Disorders:
• rash Liposarcoma The safety of HALAVEN was evaluated in Study 2, an open-label, randomized, multicenter, active-controlled trial, in which patients were randomized (1:1) to receive either HALAVEN 1.4 mg/m 2 on Days 1 and 8 of a 21-day cycle or dacarbazine at doses of 850 mg/m 2 (20%), 1000 mg/m 2 (64%), or 1200 mg/m 2 (16%) every 3 weeks.
• A total of 223 patients received HALAVEN and 221 patients received dacarbazine.
• Patients were required to have received at least two prior systemic chemotherapy regimens.
• The trial excluded patients with pre-existing ≥ Grade 3 peripheral neuropathy, known central nervous system metastasis, elevated serum bilirubin or significant chronic liver disease, history of myocardial infarction within 6 months, history of New York Heart Association Class II or IV heart failure, or cardiac arrhythmia requiring treatment.
• The median age of the safety population in Study 2 was 56 years (range:
• 24 to 83 years); 67% female; 73% White, 3% Black or African American, 8% Asian/Pacific Islander, and 15% unknown; 99% received prior anthracycline-containing regimen; and 99% received ≥ 2 prior regimens.
• The median duration of exposure was 2.3 months (range:
• 21 days to 26 months) for patients receiving HALAVEN [ see Clinical Studies (14.2) ] .
• The most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue, nausea, alopecia, constipation, peripheral neuropathy, abdominal pain, and pyrexia.
• The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia, hypokalemia, and hypocalcemia.
• The most common serious adverse reactions reported in patients receiving HALAVEN were neutropenia (4.9%) and pyrexia (4.5%).
• Permanent discontinuation of HALAVEN for adverse reactions occurred in 8% of patients.
• The most common adverse reactions resulting in discontinuation of HALAVEN were fatigue and thrombocytopenia (0.9% each).
• Twenty-six percent of patients required at least one dose reduction.
• The most frequent adverse reactions that led to dose reduction were neutropenia (18%) and peripheral neuropathy (4.0%).
• Table 3 summarizes the incidence of adverse reactions occurring in at least 10% of patients in the HALAVEN-treated arm in Study 2.
• Table 3:
• Adverse Reactions a Occurring in ≥10% (all Grades) of Patients Treated on the HALAVEN arm and at a Higher Incidence than in the Dacarbazine Arm (Between Arm Difference of ≥5% for All Grades or ≥2% for Grades 3 and 4) (Study 2) b Adverse Reaction HALAVEN n =22 3 Dacarbazine n =22 1 All Grades Grades 3-4 All Grades Grades 3-4 Nervous s ystem d isorders Peripheral Neuropathy c 29% 3.1% 8% 0.5% Headache 18% 0% 10% 0% General d isorders Pyrexia 28% 0.9% 14% 0.5% G astrointestinal d isorders Constipation 32% 0.9% 26% 0.5% Abdominal pain d 29% 1.8% 23% 4.1% Stomatitis 14% 0.9% 5% 0.5% Skin and s ubcutaneous t issue d isorders Alopecia 35% NA e 2.7% NA e Infections Urinary tract infection 11% 2.2% 5% 0.5% a Adverse reactions were graded per National Cancer Institute Criteria for Adverse Events version 4.03 (NCI CTCAE v4.03). b Safety data from one study site enrolling six patients were excluded. c Includes peripheral neuropathy, peripheral sensorimotor neuropathy, peripheral motor neuropathy, polyneuropathy, peripheral sensory neuropathy, and paraesthesia. d Includes abdominal pain, upper abdominal pain, lower abdominal pain, abdominal discomfort. e Not applicable;
• (grading system does not specify > Grade 2 for alopecia).
• Other clinically important adverse reactions occurring in ≥10% of the HALAVEN-treated patients were:
• Gastrointestinal Disorders:
• nausea (41%); vomiting (19%), diarrhea (17%) General Disorders:
• asthenia/fatigue (62%); peripheral edema (12%) Metabolism and Nutrition Disorders:
• decreased appetite (19%) Musculoskeletal and Connective Tissue Disorders:
• arthralgia/myalgia (16%); back pain (16%) Respiratory Disorders:
• cough (18%) Less Common Adverse Reactions :
• The following additional clinically important adverse reactions were reported in ≥5% to <10% of the HALAVEN-treated group:
• Blood and Lymphatic System Disorders:
• thrombocytopenia Eye Disorders:
• increased lacrimation Gastrointestinal Disorders:
• dyspepsia Metabolism and Nutrition Disorders:
• hyperglycemia Musculoskeletal and Connective Tissue Disorders:
• muscle spasms, musculoskeletal pain Nervous System Disorders:
• dizziness, dysgeusia Psychiatric Disorders:
• insomnia, anxiety Respiratory, Thoracic, and Mediastinal Disorders:
• oropharyngeal pain Vascular Disorders:
• hypotension Table 4:
• Laboratory Abnormalities Occurring in ≥10% (all Grades) of Patients Treated on the HALAVEN arm and at a Higher Incidence than in the Dacarbazine Arm (Between Arm Difference of ≥5% for All Grades or ≥2% for Grades 3 and 4) a (Study 2) † Laboratory Abnormality H alaven Dacarbazine All Grades Grades 3 - 4 All Grades Grades 3 – 4 Hematology Anemia 70% 4.1% 52% 6% Neutropenia 63% 32% 30% 8.9% Chemistry Increased alanine aminotransferase (ALT) 43% 2.3% 28% 2.3% Increased aspartate aminotransferase (AST) 36% 0.9% 16% 0.5% Hypokalemia 30% 5.4% 14% 2.8% Hypocalcemia 28% 5% 18% 1.4% Hypophosphatemia 20% 3.2% 11% 1.4% a Each test incidence is based on the number of patients who had both baseline and at least one on-study measurement and at least 1 grade increase from baseline.
• Halaven group (range 221-222) and dacarbazine group (range 214-215). † Laboratory results were graded per NCI CTCAE v4.03. 6. 2 Post ma rketing Experience The following adverse drug reactions have been identified during post-approval of HALAVEN.
• Because these reactions are reported voluntarily from a population of uncertain size, it is not always possible to reliably estimate their frequency or establish a causal relationship to drug exposure.
• Blood and Lymphatic System Disorders:
• lymphopenia Gastrointestinal Disorders:
• pancreatitis Hepatobiliary Disorders:
• hepatotoxicity Immune System Disorders:
• drug hypersensitivity Infections and Infestations:
• pneumonia, sepsis/neutropenic sepsis Metabolism and Nutrition Disorders:
• hypomagnesemia, dehydration Respiratory, thoracic and mediastinal disorders:
• interstitial lung disease Skin and Subcutaneous Tissue Disorders:
• pruritus, Stevens-Johnson syndrome, toxic epidermal necrolysis

Quoted from the official label, section “Adverse Reactions”.

What to discuss with your doctor

• 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 HALAVEN 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 HALAVEN 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 HALAVEN and for 2 weeks after the final dose [see Use in Specific Populations (8.2) ] .
• Distributed by: Eisai Inc.
• Nutley, NJ 07110 © 2010-2022 Eisai Inc.

Quoted from the official label, section “Patient Counseling Information”.

Strengths and forms

• 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 )

Quoted from the official label, section “Dosage Forms & Strengths”.

What it looks like and how it is packed

• NDC 62856-389-01 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.
• HALAVEN injection is a cytotoxic drug.
• Follow applicable special handling and disposal procedures.¹

Quoted from the official label, section “How Supplied”.

What is in it

• HALAVEN contains eribulin mesylate, a microtubule dynamics inhibitor. Eribulin mesylate is a synthetic analogue of halichondrin B, a product isolated from the marine sponge Halichondria okad ai . 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:
• HALAVEN 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. 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-9H,15H-furo[3,2-i]furo[2',3':5,6]pyrano[4,3-b][1,4]dioxacyclopentacosin-5(4H)-one, 2-[(2S)-3-amino-2-hydroxypropyl]hexacosahydro-3-methoxy-26-methyl-20,27-bis(methylene)-, (2R,3R,3aS,7R,8aS,9S,10aR,11S,12R,13aR,13bS,15S,18S,21S,24S,26R,28R,29aS)-, methanesulfonate (salt). It has a molecular weight of 826.0 (729.9 for free base). The empirical formula is C40H59NO11
• CH4O3S. Eribulin mesylate has the following structural formula:

Quoted from the official label, section “Description”.

Ingredients people check for

Lactose, gluten, dyes, sugars and other ingredients that matter with an allergy, intolerance or diet — as this product’s FDA label lists them.

Same active substance, strength and form in other countries

Matched on active substance, strength and kind of form only. This is not a statement that the products are equivalent or interchangeable: other ingredients, release and approved uses can differ — ask a pharmacist before swapping.

Medicine passport: one printable page to show a pharmacist abroad

Details

Source: NDC Directory · 2026-09-13 · not reviewed by a clinician

Source: US Food and Drug Administration, NDC Directory. Reuse terms: US government work (FDA).

Report wrong or outdated information on this page

Other strengths and forms

2 products are sold under this name. Grouped by form; a number on a strength means several companies make it.

Same active substance

These contain the same substance. That does not mean one can replace another — ask a pharmacist.

See every product with Eribulin Mesylate