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eribulin (Rx)Brand and Other Names:Halaven

 
 
 

Dosing & Uses

AdultPediatricGeriatric

Dosage Forms & Strengths

intravenous solution

  • 1mg/2mL (0.5mg/mL)
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Breast Cancer, Metastatic

Indicated for metastatic breast cancer in patients who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic disease; prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting

1.4 mg/m² IV infused over 2-5 min on days 1 and 8 of 21-day cycle 

Liposarcoma

Indicated for unresectable or metastatic liposarcoma in patients who have received a prior anthracycline-containing regimen

1.4 mg/m² IV infused over 2-5 min on days 1 and 8 of 21-day cycle 

Dosage Modifications

Assess for peripheral neuropathy and obtain CBC counts prior to each dose

Recommended dose delays

  • Do not administer on Day 1 or Day 8 for any of the following
    • ANC <1,000/mm³
    • Platelets <75,000/mm³
    • Grade 3 or 4 nonhematological 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 improved to ≤Grade 2 severity by Day 15, administer 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 then recovered to ≤Grade 2 severity, resume at reduced doses (see below)
  • Do not re-escalate once dose has been reduced
  • Permanently reduce the 1.4 mg/m² dose to 1.1 mg/m² for any of the following:
    • ANC <500/mm³ for >7 days
    • ANC <1,000/mm³ with fever or infection
    • Platelets <25,000/mm³
    • Platelets <50,000/mm³ requiring transfusion
    • Nonhematologic Grade 3 or 4 toxicities
    • Omission or delay of Day 8 dose in previous cycle for toxicity
  • Permanently reduce dose to 0.7 mg/m² for any of the following:
    • Occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m²
  • Discontinue
    • Occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m²

Renal impairment

  • Moderate-to-severe (CrCl 15-49 mL/min): 1.1 mg/m² IV

Hepatic impairment

  • Mild (Child-Pugh A): 1.1 mg/m² IV
  • Moderate (Child-Pugh B): 0.7 mg/m² IV

Safety and efficacy not established

No overall differences in safety were observed between elderly and younger patients

See Adult Dosing section

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Interactions

Interaction Checker

eribulin and

No Results

     
     activity indicator 
    No Interactions Found
    Interactions Found

    Contraindicated

      Serious - Use Alternative

        Significant - Monitor Closely

          Minor

            Sort by :  
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            Adverse Effects

            >10%

            Neutropenia (82%)

            Anemia (58%)

            Asthenia/fatigue (54%)

            Alopecia (45%)

            Peripheral neuropathy (35%)

            Nausea (35%)

            Constipation (25%)

            Arthralgia/myalgia (22%)

            Pyrexia (21%)

            Weight loss (21%)

            Anorexia (20%)

            Headache (19%)

            Vomiting (18%)

            Diarrhea (18%)

            Back pain (16%)

            Dyspnea (16%)

            Cough (14%)

            Bone pain (12%)

            Extremity pain (11%)

            Urinary tract infection (10%)

            1-10%

            Increased lacrimation

            Dyspepsia

            Abdominal pain

            Stomatitis

            Xerostomia

            URI

            Hypokalemia

            Muscle spasm/weakness

            Dysgeusia

            Dizziness

            Insomnia

            Depression

            Rash

            Postmarketing Reports

            Gastrointestinal disorders: Pancreatitis

            Blood and lymphatic system disorders: Lymphopenia

            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

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            Warnings

            Contraindications

            None known

            Cautions

            Monitor for peripheral neuropathy before each dose (see Dosage Modifications)

            Severe neutropenia reported; monitor complete blood counts prior to each dose (see Dosage Modifications); increase frequency of monitoring in patients who develop Grade 3 or 4 cytopenias; delay therapy and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days

            Delay administration and/or reduce dose if ANC <1,000/m³, platelets <75,000/m³, or for grade 3-4 nonhematological toxicities (see Dosage Modifications)

            Caution with CHF, bradyarrhythmias, and congenital long QT syndrome (monitor for QT prolongation); correct hypokalemia or hypomagnesemia before administering drug

            May cause additive effects when coadministration with other drugs that prolong QT interval (eg, class Ia or III antiarrhythmics, thioridazine, erythromycin)

            Based on animal studies and its mechanism of action, can cause fetal harm when administered to pregnant women or males with female partners of reproductive potential

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            Pregnancy & Lactation

            Pregnancy

            Based on findings from an animal reproduction study and its mechanism of action, can cause fetal harm when administered to a pregnant woman

            There are no available data on the use during pregnancy

            Animal studies

            • In an animal reproduction study, eribulin mesylate caused embryo-fetal toxicity when administered to pregnant rats during organogenesis at doses below the recommended human

            Contraception

            • Females: Advise females of reproductive potential to use effective contraception during treatment and for at least 2 weeks following the final dose
            • Males: Advise males with female partners of reproductive potential to use effective contraception during treatment and for 3.5 months following the final dose

            Infertility

            • Based on animal data, may result in damage to male reproductive tissues leading to impaired fertility of unknown duration

            Lactation

            Unknown whether distributed in breast milk, caution advised; because of the potential for serious adverse reactions in human milk fed infants, a decision should be made whether to discontinue nursing or to discontinue eribulin, taking into account the importance of the drug to the mother

            Pregnancy Categories

            A:Generally acceptable. Controlled studies in pregnant women show no evidence of fetal risk.

            B:May be acceptable. Either animal studies show no risk but human studies not available or animal studies showed minor risks and human studies done and showed no risk.

            C:Use with caution if benefits outweigh risks. Animal studies show risk and human studies not available or neither animal nor human studies done.

            D:Use in LIFE-THREATENING emergencies when no safer drug available. Positive evidence of human fetal risk.

            X:Do not use in pregnancy. Risks involved outweigh potential benefits. Safer alternatives exist.

            NA:Information not available.

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            Pharmacology

            Mechanism of Action

            Microtubule inhibitor; inhibits growth phase of microtubules, leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death

            Pharmacokinetics

            Half-life elimination: 40 hr

            Vd: 43-115 L/m²

            Protein Bound: 49-65%  

            Metabolism: Negligible

            Clearance: 1.16-2.42 L/hr

            Excretion: Mostly unchanged in feces (82%), urine (9%)  

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            Administration

            IV Incompatibilities

            Additive: Dextrose

            Y-site: Dextrose

            IV Compatibilities

            Solution: 0.9% NaCl

            IV Preparation

            Clear, colorless, sterile solution for IV administration

            Each vial contains 1 mg of eribulin mesylate as a 0.5 mg/mL solution in ethanol:water (5:95)

            IV infusion: Aseptically withdraw dose; may be administered undiluted or diluted (in 0.9% NaCl 100 mL)

            Discard unused portion of vial

            IV Administration

            May be administered undiluted or diluted (in 0.9% NaCl 100 mL)

            Administer over 2-5 minutes

            Do not dilute in or administer through IV line contain solutions with dextrose

            Do not administer in same IV line concurrent with other medical products

            Storage

            Store undiluted eribulin in syringe for up to 4 hr at room temperature or for up to 24 hr under refrigeration (40°F or/ 4°C)

            Store diluted solutions of eribulin for up to 4 hr at room temperature or up to 24 hr under refrigeration (40°F or/ 4°C)

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            Images

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            Formulary

            FormularyPatient Discounts

            To view formulary information first create a list of plans. Your list will be saved and can be edited at any time.

            Adding plans allows you to:

            • View the formulary and any restrictions for each plan.
            • Manage and view all your plans together – even plans in different states.
            • Compare formulary status to other drugs in the same class.
            • Access your plan list on any device – mobile or desktop.

            The above information is provided for general informational and educational purposes only. Individual plans may vary and formulary information changes. Contact the applicable plan provider for the most current information.

            Tier Description
            1 This drug is available at the lowest co-pay. Most commonly, these are generic drugs.
            2 This drug is available at a middle level co-pay. Most commonly, these are "preferred" (on formulary) brand drugs.
            3 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs.
            4 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            5 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            6 This drug is available at a higher level co-pay. Most commonly, these are "non-preferred" brand drugs or specialty prescription products.
            NC NOT COVERED – Drugs that are not covered by the plan.
            Code Definition
            PA Prior Authorization
            Drugs that require prior authorization. This restriction requires that specific clinical criteria be met prior to the approval of the prescription.
            QL Quantity Limits
            Drugs that have quantity limits associated with each prescription. This restriction typically limits the quantity of the drug that will be covered.
            ST Step Therapy
            Drugs that have step therapy associated with each prescription. This restriction typically requires that certain criteria be met prior to approval for the prescription.
            OR Other Restrictions
            Drugs that have restrictions other than prior authorization, quantity limits, and step therapy associated with each prescription.
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