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Eribulin: Drug information

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

For abbreviations, symbols, and age group definitions used in Lexicomp (show table)
Brand Names: US
  • Halaven
Brand Names: Canada
  • Halaven
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: Hepatic 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 Equivalent Available: US

No

Pricing: US

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]

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 2016 [group 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 2016; 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:

This medication is in a class the Institute for Safe Medication Practices (ISMP) includes among its list of drug classes which have a heightened risk of causing significant patient harm when used in error.

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 Lexicomp drug interactions program by clicking on the “Launch drug interactions program” link above.

5-Aminosalicylic Acid Derivatives: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

Abrocitinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

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

Baricitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Baricitinib. Risk X: Avoid combination

BCG (Intravesical): Myelosuppressive Agents may diminish the therapeutic effect of BCG (Intravesical). Risk X: Avoid combination

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

Brincidofovir: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Brincidofovir. Risk C: Monitor therapy

Brivudine: May enhance the adverse/toxic effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

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

Chloramphenicol (Ophthalmic): May enhance the adverse/toxic effect of Myelosuppressive Agents. Risk C: Monitor therapy

Chloramphenicol (Systemic): Myelosuppressive Agents may enhance the myelosuppressive effect of Chloramphenicol (Systemic). Risk X: Avoid combination

Cladribine: May enhance the myelosuppressive effect of Myelosuppressive Agents. Risk X: Avoid combination

Cladribine: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Cladribine. Risk X: Avoid combination

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

Coccidioides immitis Skin Test: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the diagnostic effect of Coccidioides immitis Skin Test. 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 (Adenovirus Vector): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Adenovirus Vector). Management: Administer a 2nd dose using an mRNA COVID-19 vaccine (at least 4 weeks after the primary vaccine dose) and a bivalent booster dose (at least 2 months after the additional mRNA dose or any other boosters). Risk D: Consider therapy modification

COVID-19 Vaccine (Inactivated Virus): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Inactivated Virus). Risk C: Monitor therapy

COVID-19 Vaccine (mRNA): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 diminish the therapeutic effect of COVID-19 Vaccine (Subunit). Risk C: Monitor therapy

COVID-19 Vaccine (Virus-like Particles): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of COVID-19 Vaccine (Virus-like Particles). Risk C: Monitor therapy

Deferiprone: Myelosuppressive Agents may enhance the neutropenic effect 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 enhance the adverse/toxic effect of Dengue Tetravalent Vaccine (Live). Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Dengue Tetravalent Vaccine (Live). Risk X: Avoid combination

Denosumab: May enhance the immunosuppressive effect 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 enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Dipyrone: May enhance the adverse/toxic effect of Myelosuppressive Agents. Specifically, the risk for agranulocytosis and pancytopenia may be increased Risk X: Avoid combination

Etrasimod: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Fexinidazole: Myelosuppressive Agents may enhance the myelosuppressive effect of Fexinidazole. Risk X: Avoid combination

Filgotinib: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Haloperidol: QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect of Haloperidol. Risk C: Monitor therapy

Inebilizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Inebilizumab. Risk C: Monitor therapy

Influenza Virus Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 enhance the immunosuppressive effect 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 diminish the therapeutic effect 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

Lipegfilgrastim: Antineoplastic Agents may diminish the therapeutic effect 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 enhance the adverse/toxic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Specifically, the risk of vaccine-associated infection may be increased. Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Mumps- Rubella- or Varicella-Containing Live Vaccines. Risk X: Avoid combination

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

Natalizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Natalizumab. Risk X: Avoid combination

Ocrelizumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ocrelizumab. Risk C: Monitor therapy

Ofatumumab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ofatumumab. Risk C: Monitor therapy

Olaparib: Myelosuppressive Agents may enhance the myelosuppressive effect of Olaparib. Risk C: Monitor therapy

Palifermin: May enhance the adverse/toxic effect 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 diminish the therapeutic effect of Pidotimod. Risk C: Monitor therapy

Pimecrolimus: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk X: Avoid combination

Pneumococcal Vaccines: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Pneumococcal Vaccines. Risk C: Monitor therapy

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

Polymethylmethacrylate: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the potential for allergic or hypersensitivity reactions to 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 enhance the myelosuppressive effect of Myelosuppressive Agents. Risk C: Monitor therapy

QT-prolonging Agents (Highest Risk): QT-prolonging Agents (Indeterminate Risk - Caution) may enhance the QTc-prolonging effect 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 therapy

Rabies Vaccine: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 enhance the immunosuppressive effect of Ritlecitinib. Risk X: Avoid combination

Ropeginterferon Alfa-2b: Myelosuppressive Agents may enhance the myelosuppressive effect 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 enhance the immunosuppressive effect of Ruxolitinib (Topical). Risk X: Avoid combination

Sipuleucel-T: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect 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 Modulator: May enhance the immunosuppressive effect of Immunosuppressants (Cytotoxic Chemotherapy). Risk C: Monitor therapy

Tacrolimus (Topical): Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tacrolimus (Topical). Risk X: Avoid combination

Talimogene Laherparepvec: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the adverse/toxic effect 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 combination

Tertomotide: Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Tertomotide. Risk X: Avoid combination

Tofacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Tofacitinib. Risk X: Avoid combination

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

Ublituximab: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Ublituximab. Risk C: Monitor therapy

Upadacitinib: Immunosuppressants (Cytotoxic Chemotherapy) may enhance the immunosuppressive effect of Upadacitinib. Risk X: Avoid combination

Vaccines (Inactivated/Non-Replicating): Immunosuppressants (Cytotoxic Chemotherapy) may diminish the therapeutic effect of Vaccines (Inactivated/Non-Replicating). Management: Give inactivated vaccines at least 2 weeks prior to initiation of chemotherapy when possible. Patients vaccinated less than 14 days before initiating or during chemotherapy should be revaccinated at least 3 months after therapy is complete. Risk D: Consider therapy modification

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

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

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 | 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: 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
  1. <800> Hazardous Drugs—Handling in Healthcare Settings. United States Pharmacopeia and National Formulary (USP 43-NF 38). Rockville, MD: United States Pharmacopeia Convention; 2020:74-92.
  2. Cortes J, O'Shaughnessy J, Loesch D, et al; EMBRACE (Eisai Metastatic Breast Cancer Study Assessing Physician's Choice Versus E7389) Investigators. Eribulin monotherapy versus treatment of physician's choice in patients with metastatic breast cancer (EMBRACE): a phase 3 open-label randomised study. Lancet. 2011;377(9769):914-923. doi:10.1016/S0140-6736(11)60070-6 [PubMed 21376385]
  3. 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]
  4. Griggs JJ, Mangu PB, Anderson H, et al; American Society of Clinical Oncology. Appropriate chemotherapy dosing for obese adult patients with cancer: American Society of Clinical Oncology clinical practice guideline. J Clin Oncol. 2012;30(13):1553-1561. doi:10.1200/JCO.2011.39.9436 [PubMed 22473167]
  5. Griggs JJ, Bohlke K, Balaban EP, et al. Appropriate systemic therapy dosing for obese adult patients with cancer: ASCO guideline update. J Clin Oncol. 2021;39(18):2037-2048. doi:10.1200/JCO.21.00471 [PubMed 33939491]
  6. Halaven (eribulin) [prescribing information]. Nutley, NJ: Eisai Inc; September 2022.
  7. Halaven (eribulin) [product monograph]. Mississauga, Ontaria, Canada: Eisai Limited; August 2017.
  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. 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]
  11. 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.
Topic 16096 Version 204.0

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