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Eribulin: Drug information

Eribulin: Drug information
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For additional information see "Eribulin: Patient drug information"

For abbreviations, symbols, and age group definitions show table
Brand Names: US
  • Halaven
Brand Names: Canada
  • Halaven;
  • NAT-Eribulin
Pharmacologic Category
  • Antineoplastic Agent, Antimicrotubular
Dosing: Adult

Note: International Considerations: Some products available internationally may have vial strength and dosing expressed as the base (instead of as the salt). Refer to prescribing information for specific dosing information.

Breast cancer, metastatic

Breast cancer, metastatic: IV: Eribulin mesylate: 1.4 mg/m2 on days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity (Ref).

Liposarcoma, unresectable or metastatic

Liposarcoma, unresectable or metastatic: IV: Eribulin mesylate: 1.4 mg/m2 on days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity (Ref).

Uterine leiomyosarcoma, refractory

Uterine leiomyosarcoma, refractory (off-label use): IV: Eribulin mesylate: 1.4 mg/m2 on days 1 and 8 of a 21-day treatment cycle until disease progression or unacceptable toxicity (Ref). Refer to protocol for dosage modification details.

Dosage adjustment for concomitant therapy: Significant drug interactions exist, requiring dose/frequency adjustment or avoidance. Consult drug interactions database for more information.

Dosing: Kidney Impairment: Adult

Note: International Considerations: Some products available internationally may have vial strength and dosing expressed as the base (instead of as the salt). Refer to prescribing information for specific dosing information.

CrCl ≥50 mL/minute: No initial dosage adjustment necessary.

CrCl 15 to 49 mL/minute: Reduce initial dose to eribulin mesylate 1.1 mg/m2.

ESRD (Canadian labeling): Use is not recommended.

Hemodialysis: May consider administering 80% of the original dose (Ref).

Dosing: Liver Impairment: Adult

Note: International Considerations: Some products available internationally may have vial strength and dosing expressed as the base (instead of as the salt). Refer to prescribing information for specific dosing information.

Mild hepatic impairment (Child-Pugh class A): Reduce initial dose to eribulin mesylate 1.1 mg/m2.

Moderate hepatic impairment (Child-Pugh class B): Reduce initial dose to eribulin mesylate 0.7 mg/m2.

Severe hepatic impairment (Child-Pugh class C): There are no dosage adjustments provided in the manufacturer's US labeling. Use is not recommended (Ref).

Dosing: Obesity: Adult

American Society of Clinical Oncology guidelines for appropriate systemic therapy dosing in adults with cancer with a BMI ≥30 kg/m2: Utilize patient's actual body weight for calculation of BSA- or weight-based dosing; manage regimen-related toxicities in the same manner as for patients with a BMI <30 kg/m2; if a dose reduction is utilized due to toxicity, may consider resumption of full, weight-based dosing (or previously tolerated dose level) with subsequent cycles only if dose escalations are allowed in the prescribing information, if contributing underlying factors (eg, hepatic or kidney impairment) are sufficiently resolved, AND if performance status has markedly improved or is considered adequate (Ref).

Dosing: Adjustment for Toxicity: Adult

Note: International Considerations: Some products available internationally may have vial strength and dosing expressed as the base (instead of as the salt). Refer to prescribing information for specific dosing information.

ANC <1,000/mm3 or platelets <75,000/mm3 or grade 3 or 4 nonhematologic toxicity on day 1 or 8: Withhold dose; may delay day 8 dose up to 1 week. If toxicity resolves to ≤ grade 2 by day 15, administer a reduced dose and wait at least 2 weeks before beginning the next cycle. Omit dose if not resolved to ≤ grade 2 by day 15. Do not re-escalate dose after reduction.

Permanently reduce dose from eribulin mesylate 1.4 mg/m2 to 1.1 mg/m2 for the following:

ANC <500/mm3 for >7 days

ANC <1000/mm3 with fever or infection

Platelets <25,000/mm3

Platelets <50,000/mm3 requiring transfusion

Nonhematologic toxicity of grade 3 or 4

Dose omission or delay due to toxicity on day 8 of prior cycle

Permanently reduce dose from eribulin mesylate 1.1 mg/m2 to 0.7 mg/m2 for occurrence of any of the above events; discontinue treatment if the above toxicities occur at the 0.7 mg/m2 dose level.

Dosing: Older Adult

Refer to adult dosing.

Adverse Reactions

The following adverse drug reactions and incidences are derived from product labeling unless otherwise specified. Adverse reactions reported in adolescents and adults.

>10%:

Cardiovascular: Peripheral edema (≥5% to 12%)

Dermatologic: Alopecia (35% to 45%)

Endocrine & metabolic: Hypocalcemia (28%), hypokalemia (5% to 30%), hypophosphatemia (20%), weight loss (21%)

Gastrointestinal: Abdominal pain (5% to 29%), anorexia (20%), constipation (25% to 32%), decreased appetite (19%), diarrhea (17% to 18%), nausea (35% to 41%; grades ≥3: 1%), stomatitis (5% to 14%; grades 3/4: <1%), vomiting (18% to 19%; grades ≥3: 1%)

Genitourinary: Urinary tract infection (10% to 11%)

Hematologic & oncologic: Anemia (58% to 70%; grades ≥3: 2% to 4%), neutropenia (63% to 82%; grades ≥3: 12% to 57%)

Hepatic: Increased serum alanine aminotransferase (43%), increased serum aspartate aminotransferase (36%)

Nervous system: Asthenia (≤62%), fatigue (≤62%), headache (18% to 19%), peripheral neuropathy (29% to 35%; grade ≥3: ≤8%; including paresthesia, peripheral motor neuropathy [4%], polyneuropathy, sensorimotor neuropathy)

Neuromuscular & skeletal: Arthralgia (≤22%), back pain (16%), limb pain (11%), myalgia (≤22%), ostealgia (12%)

Respiratory: Cough (14% to 18%), dyspnea (16%)

Miscellaneous: Fever (21% to 28%)

1% to 10%:

Cardiovascular: Hypotension (5% to 10%)

Dermatologic: Skin rash (5% to 10%)

Endocrine & metabolic: Hyperglycemia (5% to 10%)

Gastrointestinal: Dysgeusia (5% to 10%), dyspepsia (5% to 10%), mucosal swelling (9%), xerostomia (5% to 10%)

Hematologic & oncologic: Febrile neutropenia (≤5%), thrombocytopenia (5% to 10%; grades ≥3: 1%)

Nervous system: Anxiety (5% to 10%), depression (5% to 10%), dizziness (5% to 10%), insomnia (5% to 10%), myasthenia (5% to 10%)

Neuromuscular & skeletal: Muscle spasm (5% to 10%), musculoskeletal pain (5% to 10%)

Ophthalmic: Increased lacrimation (5% to 10%)

Respiratory: Oropharyngeal pain (5% to 10%), upper respiratory tract infection (5% to 10%)

Postmarketing:

Cardiovascular: Prolonged QT interval on ECG (Lesimple 2013)

Dermatologic: Pruritus, skin abnormalities related to radiation recall (Tran 2020), Stevens-Johnson syndrome, toxic epidermal necrolysis

Endocrine & metabolic: Dehydration, hypomagnesemia

Gastrointestinal: Pancreatitis

Hematologic & oncologic: Leukopenia (Watanabe 2017), lymphocytopenia (Watanabe 2017), tumor lysis syndrome (Pabon 2018, Tsuchie 2021)

Hepatic: Hepatotoxicity

Hypersensitivity: Hypersensitivity reaction

Infection: Neutropenic sepsis (Lim 2021), sepsis

Nervous system: Encephalopathy (Sheikh 2020)

Respiratory: Hypersensitivity pneumonitis (Murakami 2020), interstitial pulmonary disease (including interstitial pneumonitis) (Murakami 2020, Nakamura 2017), pneumonia, pneumothorax (Takada 2019)

Contraindications

There are no contraindications listed in the manufacturer’s US labeling.

Canadian labeling (not in the US labeling): Hypersensitivity to eribulin mesylate, halichondrin B, or its chemical derivatives.

Warnings/Precautions

Concerns related to adverse effects:

• Bone marrow suppression: Hematologic toxicity, including severe neutropenia and neutropenic fever, has occurred. Neutropenic sepsis (fatal) has also been reported (case reports). A higher incidence of grade 4 neutropenia and neutropenic fever occurred in patients with ALT or AST >3 × ULN or bilirubin >1.5 × ULN. Hematologic toxicity may require treatment delay and dosage reduction.

• Peripheral neuropathy: Peripheral neuropathy commonly occurs. Peripheral neuropathy may be prolonged (>1 year in 5% of metastatic breast cancer patients and >60 days in close to 60% of liposarcoma patients); over 60% of liposarcoma patients with peripheral neuropathy had not recovered within a median follow-up of ~6 months in one clinical trial. The median time to the first occurrence of peripheral neuropathy (any severity) in liposarcoma patients was 5 months (range: 3.5 to 9 months). Peripheral neuropathy may require treatment delay or discontinuation.

• QT prolongation: QT prolongation was observed on day 8 of eribulin therapy (in an uncontrolled study). Monitor ECG in patients with heart failure, bradyarrhythmia, with concomitant medication known to prolong the QT interval, or with electrolyte imbalance. Correct hypokalemia and hypomagnesemia prior to treatment; monitor electrolytes periodically during treatment. Avoid use in patients with congenital long QT syndrome.

Other warnings/precautions:

• International issues: Some products available internationally may have vial strength and dosing expressed as the base (instead of as the salt). Refer to prescribing information for specific dosing information.

Dosage Forms: US

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as mesylate:

Halaven: 1 mg/2 mL (2 mL) [contains alcohol, usp]

Generic: 1 mg/2 mL (2 mL)

Generic Equivalent Available: US

Yes

Pricing: US

Solution (eriBULin Mesylate Intravenous)

1 mg/2 mL (per mL): $510.00 - $803.70

Solution (Halaven Intravenous)

1 mg/2 mL (per mL): $846.00

Disclaimer: A representative AWP (Average Wholesale Price) price or price range is provided as reference price only. A range is provided when more than one manufacturer's AWP price is available and uses the low and high price reported by the manufacturers to determine the range. The pricing data should be used for benchmarking purposes only, and as such should not be used alone to set or adjudicate any prices for reimbursement or purchasing functions or considered to be an exact price for a single product and/or manufacturer. Medi-Span expressly disclaims all warranties of any kind or nature, whether express or implied, and assumes no liability with respect to accuracy of price or price range data published in its solutions. In no event shall Medi-Span be liable for special, indirect, incidental, or consequential damages arising from use of price or price range data. Pricing data is updated monthly.

Dosage Forms: Canada

Excipient information presented when available (limited, particularly for generics); consult specific product labeling.

Solution, Intravenous, as mesylate:

Halaven: 1 mg/2 mL (2 mL) [contains alcohol, usp]

Generic: 1 mg/2 mL (2 mL)

Administration: Adult

IV: Infuse over 2 to 5 minutes. May be administered undiluted or diluted. Do not administer other medications through the same IV line, or through a line containing dextrose.

Hazardous Drugs Handling Considerations

Hazardous agent (NIOSH 2024 [table 1]).

Use appropriate precautions for receiving, handling, storage, preparation, dispensing, transporting, administration, and disposal. Follow NIOSH and USP 800 recommendations and institution-specific policies/procedures for appropriate containment strategy (NIOSH 2023; NIOSH 2024; USP-NF 2020).

Use: Labeled Indications

Breast cancer, metastatic: Treatment of metastatic breast cancer in patients who have received at least 2 prior chemotherapy regimens for the treatment of metastatic disease (prior treatment should have included an anthracycline and a taxane in either the adjuvant or metastatic setting).

Liposarcoma, unresectable or metastatic: Treatment of unresectable or metastatic liposarcoma in patients who have received a prior anthracycline-containing regimen.

Use: Off-Label: Adult

Uterine leiomyosarcoma, refractory

Medication Safety Issues
Sound-alike/look-alike issues:

EriBULin may be confused with epiRUBicin, erdafitinib, erlotinib, tirbanibulin

High alert medication:

The Institute for Safe Medication Practices (ISMP) includes this medication among its list of drug classes (chemotherapeutic agent, parenteral and oral) which have a heightened risk of causing significant patient harm when used in error (High-Alert Medications in Acute Care, Community/Ambulatory Care, and Long-Term Care Settings).

International Issues:

Some products available internationally may have vial strength and dosing expressed as the base (instead of as the salt). Refer to prescribing information for specific strength and dosing information.

Metabolism/Transport Effects

Substrate of CYP3A4 (Minor); Note: Assignment of Major/Minor substrate status based on clinically relevant drug interaction potential;

Drug Interactions

Note: Interacting drugs may not be individually listed below if they are part of a group interaction (eg, individual drugs within “CYP3A4 Inducers [Strong]” are NOT listed). For a complete list of drug interactions by individual drug name and detailed management recommendations, use the drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Abrocitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Antithymocyte Globulin (Equine): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Antithymocyte Globulin (Equine). Specifically, these effects may be unmasked if the dose of cytotoxic chemotherapy is reduced. Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Antithymocyte Globulin (Equine). Specifically, infections may occur with greater severity and/or atypical presentations. Risk C: Monitor

Antithyroid Agents: Myelosuppressive Agents may increase neutropenic effects of Antithyroid Agents. Risk C: Monitor

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Baricitinib. Risk X: Avoid

BCG Products: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of BCG Products. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of BCG Products. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Brincidofovir. Risk C: Monitor

Brivudine: May increase adverse/toxic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Chikungunya Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Chikungunya Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Chikungunya Vaccine (Live). Risk X: Avoid

Chloramphenicol (Ophthalmic): May increase adverse/toxic effects of Myelosuppressive Agents. Risk C: Monitor

Chloramphenicol (Systemic): Myelosuppressive Agents may increase myelosuppressive effects of Chloramphenicol (Systemic). Risk X: Avoid

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Cladribine. Risk X: Avoid

CloZAPine: Myelosuppressive Agents may increase adverse/toxic effects of CloZAPine. Specifically, the risk for neutropenia may be increased. Risk C: Monitor

Coccidioides immitis Skin Test: Coadministration of Immunosuppressants (Cytotoxic Chemotherapy) and Coccidioides immitis Skin Test may alter diagnostic results. Management: Consider discontinuing cytotoxic chemotherapy several weeks prior to coccidioides immitis skin antigen testing to increase the likelihood of accurate diagnostic results. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (mRNA). Management: Give a 3-dose primary series for all patients aged 6 months and older taking immunosuppressive medications or therapies. Booster doses are recommended for certain age groups. See CDC guidance for details. Risk D: Consider Therapy Modification

COVID-19 Vaccine (Subunit): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of COVID-19 Vaccine (Subunit). Risk C: Monitor

Deferiprone: Myelosuppressive Agents may increase neutropenic effects of Deferiprone. Management: Avoid the concomitant use of deferiprone and myelosuppressive agents whenever possible. If this combination cannot be avoided, monitor the absolute neutrophil count more closely. Risk D: Consider Therapy Modification

Dengue Tetravalent Vaccine (Live): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Dengue Tetravalent Vaccine (Live). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Denosumab: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Management: Consider the risk of serious infections versus the potential benefits of coadministration of denosumab and cytotoxic chemotherapy. If combined, monitor patients for signs/symptoms of serious infections. Risk D: Consider Therapy Modification

Deucravacitinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Etrasimod: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Fexinidazole: Myelosuppressive Agents may increase myelosuppressive effects of Fexinidazole. Risk X: Avoid

Filgotinib: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of Haloperidol. Risk C: Monitor

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Inebilizumab. Risk C: Monitor

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Influenza Virus Vaccines. Management: Administer influenza vaccines at least 2 weeks prior to initiating chemotherapy if possible. If vaccination occurs less than 2 weeks prior to or during chemotherapy, revaccinate at least 3 months after therapy discontinued if immune competence restored. Risk D: Consider Therapy Modification

Leflunomide: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Leflunomide. Management: Increase the frequency of chronic monitoring of platelet, white blood cell count, and hemoglobin or hematocrit to monthly, instead of every 6 to 8 weeks, if leflunomide is coadministered with immunosuppressive agents, such as cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Lenograstim: Antineoplastic Agents may decrease therapeutic effects of Lenograstim. Management: Avoid the use of lenograstim 24 hours before until 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Linezolid: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

Lipegfilgrastim: Antineoplastic Agents may decrease therapeutic effects of Lipegfilgrastim. Management: Avoid concomitant use of lipegfilgrastim and myelosuppressive cytotoxic chemotherapy. Lipegfilgrastim should be administered at least 24 hours after the completion of myelosuppressive cytotoxic chemotherapy. Risk D: Consider Therapy Modification

Mumps- Rubella- or Varicella-Containing Live Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Nadofaragene Firadenovec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Nadofaragene Firadenovec. Specifically, the risk of disseminated adenovirus infection may be increased. Risk X: Avoid

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Natalizumab. Risk X: Avoid

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ocrelizumab. Risk C: Monitor

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ofatumumab. Risk C: Monitor

Olaparib: Myelosuppressive Agents may increase myelosuppressive effects of Olaparib. Risk C: Monitor

Palifermin: May increase adverse/toxic effects of Antineoplastic Agents. Specifically, the duration and severity of oral mucositis may be increased. Management: Do not administer palifermin within 24 hours before, during infusion of, or within 24 hours after administration of myelotoxic chemotherapy. Risk D: Consider Therapy Modification

Pidotimod: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pidotimod. Risk C: Monitor

Pimecrolimus: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Piperacillin: May increase hypokalemic effects of Antineoplastic Agents. Risk C: Monitor

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Pneumococcal Vaccines. Risk C: Monitor

Poliovirus Vaccine (Live/Trivalent/Oral): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Poliovirus Vaccine (Live/Trivalent/Oral). Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may increase hypersensitivity effects of Polymethylmethacrylate. Management: Use caution when considering use of bovine collagen-containing implants such as the polymethylmethacrylate-based Bellafill brand implant in patients who are receiving immunosuppressants. Consider use of additional skin tests prior to administration. Risk D: Consider Therapy Modification

Promazine: May increase myelosuppressive effects of Myelosuppressive Agents. Risk C: Monitor

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may increase QTc-prolonging effects of QT-prolonging Agents (Highest Risk). Management: Monitor for QTc interval prolongation and ventricular arrhythmias when these agents are combined. Patients with additional risk factors for QTc prolongation may be at even higher risk. Risk C: Monitor

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Rabies Vaccine. Management: Complete rabies vaccination at least 2 weeks before initiation of immunosuppressant therapy if possible. If combined, check for rabies antibody titers, and if vaccination is for post exposure prophylaxis, administer a 5th dose of the vaccine. Risk D: Consider Therapy Modification

Ritlecitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ritlecitinib. Risk X: Avoid

Ropeginterferon Alfa-2b: Myelosuppressive Agents may increase myelosuppressive effects of Ropeginterferon Alfa-2b. Management: Avoid coadministration of ropeginterferon alfa-2b and other myelosuppressive agents. If this combination cannot be avoided, monitor patients for excessive myelosuppressive effects. Risk D: Consider Therapy Modification

Ruxolitinib (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ruxolitinib (Topical). Risk X: Avoid

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Sipuleucel-T. Management: Consider reducing the dose or discontinuing the use of immunosuppressants, such as cytotoxic chemotherapy, prior to initiating sipuleucel-T therapy. Risk D: Consider Therapy Modification

Sphingosine 1-Phosphate (S1P) Receptor Modulators: May increase immunosuppressive effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tacrolimus (Topical). Risk X: Avoid

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Talimogene Laherparepvec. Specifically, the risk of infection from the live, attenuated herpes simplex virus contained in talimogene laherparepvec may be increased. Risk X: Avoid

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Tertomotide. Risk X: Avoid

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Tofacitinib. Risk X: Avoid

Typhoid Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Typhoid Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Typhoid Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Ublituximab. Risk C: Monitor

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may increase immunosuppressive effects of Upadacitinib. Risk X: Avoid

Vaccines (Live): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Vaccines (Live). Specifically, the risk of vaccine-associated infection may be increased. Vaccines (Live) may decrease therapeutic effects of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid

Vaccines (Non-Live/Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Vaccines (Non-Live/Inactivated/Non-Replicating). Management: Give non-live/inactivated/non-replicating vaccines at least 2 weeks prior to starting chemotherapy when possible. Patients vaccinated less than 14 days before or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider Therapy Modification

Yellow Fever Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Yellow Fever Vaccine. Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Yellow Fever Vaccine. Specifically, the risk of vaccine-associated infection may be increased. Risk X: Avoid

Zoster Vaccine (Live/Attenuated): Immunosuppressants (Cytotoxic Chemotherapy) may increase adverse/toxic effects of Zoster Vaccine (Live/Attenuated). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may decrease therapeutic effects of Zoster Vaccine (Live/Attenuated). Risk X: Avoid

Reproductive Considerations

Patients who may become pregnant should use effective contraception during therapy and for at least 2 weeks after the last eribulin dose. Male patients with partners who may become pregnant should also use effective contraception during therapy and for 3.5 months after the last dose of eribulin.

Pregnancy Considerations

Based on the mechanism of action, and data from animal reproduction studies, in utero exposure to eribulin may cause fetal harm.

Breastfeeding Considerations

It is not known if eribulin is present in breast milk.

Due to the potential for serious adverse reactions in the nursing infant, breastfeeding is not recommended by the manufacturer during eribulin treatment and for 2 weeks after the last dose.

Monitoring Parameters

CBC with differential prior to each dose (increase frequency with grade 3 or 4 cytopenias); renal and liver function tests; serum electrolytes, including potassium and magnesium. Assess for peripheral neuropathy prior to each dose. Monitor ECG in patients with heart failure, bradyarrhythmia, with concomitant medication known to prolong the QT interval, and electrolyte abnormalities (eg, hypokalemia, hypomagnesemia).

The American Society of Clinical Oncology hepatitis B screening and management provisional clinical opinion (ASCO [Hwang 2020]) recommends hepatitis B virus screening with hepatitis B surface antigen, hepatitis B core antibody, total Ig or IgG, and antibody to hepatitis B surface antigen prior to beginning (or at the beginning of) systemic anticancer therapy; do not delay treatment for screening/results. Detection of chronic or past HBV infection requires a risk assessment to determine antiviral prophylaxis requirements, monitoring, and follow-up.

Mechanism of Action

Eribulin is a non-taxane microtubule inhibitor which is a halichondrin B analog. It inhibits the growth phase of the microtubule by inhibiting formation of mitotic spindles causing mitotic blockage and arresting the cell cycle at the G2/M phase; suppresses microtubule polymerization yet does not affect depolymerization.

Pharmacokinetics (Adult Data Unless Noted)

Distribution: Vd: 43 to 114 L/m2.

Protein binding: 49% to 65%.

Metabolism: Negligible.

Half-life, elimination: ~40 hours.

Excretion: Feces (~82%, ~88% as unchanged drug); urine (9%, ~91% as unchanged drug).

Clearance: 1.16 to 2.42 L/hour/m2.

Pharmacokinetics: Additional Considerations (Adult Data Unless Noted)

Altered kidney function: Patients with moderate or severe renal impairment (CrCl 15 to 49 mL/minute) had systemic exposure increased 1.5-fold compared to patients with normal renal function.

Hepatic function impairment: Exposures increased 1.8-fold and 2.5-fold in patients with mild and moderate hepatic impairment, respectively, compared to patients with normal hepatic function.

Brand Names: International
International Brand Names by Country
For country code abbreviations (show table)

  • (AE) United Arab Emirates: Halaven;
  • (AR) Argentina: Elefix | Halaven;
  • (AT) Austria: Halaven;
  • (AU) Australia: Halaven;
  • (BE) Belgium: Halaven;
  • (BG) Bulgaria: Halaven;
  • (BR) Brazil: Halaven;
  • (CH) Switzerland: Halaven;
  • (CL) Chile: Halaven;
  • (CO) Colombia: Halaven;
  • (CZ) Czech Republic: Halaven;
  • (DE) Germany: Halaven;
  • (EC) Ecuador: Elefix | Halaven;
  • (EE) Estonia: Halaven;
  • (ES) Spain: Halaven;
  • (FI) Finland: Halaven;
  • (FR) France: Halaven;
  • (GB) United Kingdom: Halaven;
  • (GR) Greece: Halaven;
  • (HK) Hong Kong: Halaven;
  • (HU) Hungary: Halaven;
  • (ID) Indonesia: Halaven;
  • (IE) Ireland: Halaven;
  • (IN) India: Ebunat | Embremma | Evaira | Halaven | Mitobulin | Teceris;
  • (IT) Italy: Halaven;
  • (JP) Japan: Halaven;
  • (KR) Korea, Republic of: Halaven;
  • (KW) Kuwait: Halaven;
  • (LB) Lebanon: Halaven;
  • (LT) Lithuania: Halaven;
  • (LV) Latvia: Halaven;
  • (MA) Morocco: Halaven;
  • (MX) Mexico: Halaven;
  • (MY) Malaysia: Halaven;
  • (NL) Netherlands: Halaven;
  • (NO) Norway: Halaven;
  • (PE) Peru: Halaven;
  • (PH) Philippines: Halaven;
  • (PK) Pakistan: Halaven;
  • (PL) Poland: Halaven;
  • (PT) Portugal: Halaven;
  • (QA) Qatar: Halaven;
  • (RO) Romania: Halaven;
  • (RU) Russian Federation: Eribulin promomed | Halaven;
  • (SA) Saudi Arabia: Halaven;
  • (SE) Sweden: Halaven;
  • (SG) Singapore: Halaven;
  • (SI) Slovenia: Halaven;
  • (SK) Slovakia: Halaven;
  • (TH) Thailand: Halaven;
  • (TN) Tunisia: Halaven;
  • (TW) Taiwan: Halaven;
  • (ZA) South Africa: Halaven
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  2. Cortes J, Vahdat L, Blum JL, et al, “Phase II Study of the Halichondrin B Analog Eribulin Mesylate in Patients With Locally Advanced or Metastatic Breast Cancer Previously Treated With an Anthracycline, a Taxane, and Capecitabine,” J Clin Oncol, 2010, 28(25):3922-8. [PubMed 20679609]
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  5. Halaven (eribulin) [prescribing information]. Nutley, NJ: Eisai Inc; September 2022.
  6. Halaven (eribulin) [product monograph]. Mississauga, Ontaria, Canada: Eisai Limited; August 2017.
  7. Hodson L, Ovesen J, Couch J, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. Managing hazardous drug exposures: information for healthcare settings, 2023. https://doi.org/10.26616/NIOSHPUB2023130. Updated April 2023. Accessed December 27, 2024.
  8. Hwang JP, Feld JJ, Hammond SP, et al. Hepatitis B virus screening and management for patients with cancer prior to therapy: ASCO provisional clinical opinion update. J Clin Oncol. 2020;38(31):3698-3715. doi:10.1200/JCO.20.01757 [PubMed 32716741]
  9. Krens SD, Lassche G, Jansman FGA, et al. Dose recommendations for anticancer drugs in patients with renal or hepatic impairment. Lancet Oncol. 2019;20(4):e200-e207. doi:10.1016/S1470-2045(19)30145-7 [PubMed 30942181]
  10. Ovesen JL, Sammons D, Connor TH, et al; US Centers for Disease Control and Prevention, National Institute for Occupational Safety and Health. NIOSH list of hazardous drugs in healthcare settings, 2024. https://doi.org/10.26616/NIOSHPUB2025103. Updated December 18, 2024. Accessed December 20, 2024.
  11. Schöffski P, Chawla S, Maki RG, et a. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial. Lancet. 2016;387(10028):1629-1637. doi:10.1016/S0140-6736(15)01283-0 [PubMed 26874885]
  12. United States Pharmacopeia. <800> Hazardous Drugs—Handling in Healthcare Settings. In: USP-NF. United States Pharmacopeia; July 1, 2020. Accessed January 16, 2025. doi:10.31003/USPNF_M7808_07_01
  13. US Department of Health and Human Services; Centers for Disease Control and Prevention; National Institute for Occupational Safety and Health. NIOSH list of antineoplastic and other hazardous drugs in healthcare settings 2016. https://www.cdc.gov/niosh/docs/2016-161/default.html. Updated September 2016. Accessed October 5, 2016.
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