Eribulin: Difference between revisions

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{{DrugProjectFormSinglePage
|authorTag={{AP}}
|genericName=Eribulin
|aOrAn=an
|drugClass=[[antineoplastic agent]] and [[mitotic Inhibitor]]
|indicationType=treatment
|indication=patients with [[metastatic breast cancer]] who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease.  Prior therapy should have included an [[anthracycline]] and a [[taxane]] in either the adjuvant or metastatic setting.
|blackBoxWarningTitle=<b><span style="color:#FF0000;">TITLE</span></b>
|blackBoxWarningBody=<i><span style="color:#FF0000;">Condition Name:</span></i> (Content)
|fdaLIADAdult=====Recommended Dose====
The recommended dose of HALAVEN is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.
====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/mm3
**[[Platelets]] < 75,000/mm3
**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.
[[file:Dose modification Eribulin.png|none|400px]]
====Instructions for Preparation and Administration====
*Aseptically withdraw the required amount of HALAVEN from the single-use 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 (40°F or/ 4°C).  Store diluted solutions of HALAVEN for up to 4 hours at room temperature or up to 24 hours under refrigeration.
*Discard unused portions of the vial.
|offLabelAdultGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Eribulin in adult patients.
|offLabelAdultNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Eribulin in adult patients.
|offLabelPedGuideSupport=There is limited information regarding <i>Off-Label Guideline-Supported Use</i> of Eribulin in pediatric patients.
|offLabelPedNoGuideSupport=There is limited information regarding <i>Off-Label Non–Guideline-Supported Use</i> of Eribulin in pediatric patients.
|alcohol=Alcohol-Eribulin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
}}
__NOTOC__
__NOTOC__
{{Drugbox
{{Drugbox

Revision as of 16:30, 28 January 2015

Eribulin
Adult Indications & Dosage
Pediatric Indications & Dosage
Contraindications
Warnings & Precautions
Adverse Reactions
Drug Interactions
Use in Specific Populations
Administration & Monitoring
Overdosage
Pharmacology
Clinical Studies
How Supplied
Images
Patient Counseling Information
Precautions with Alcohol
Brand Names
Look-Alike Names

Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Alberto Plate [2]

Disclaimer

WikiDoc MAKES NO GUARANTEE OF VALIDITY. WikiDoc is not a professional health care provider, nor is it a suitable replacement for a licensed healthcare provider. WikiDoc is intended to be an educational tool, not a tool for any form of healthcare delivery. The educational content on WikiDoc drug pages is based upon the FDA package insert, National Library of Medicine content and practice guidelines / consensus statements. WikiDoc does not promote the administration of any medication or device that is not consistent with its labeling. Please read our full disclaimer here.

Overview

Eribulin is an antineoplastic agent and mitotic Inhibitor that is FDA approved for the treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.. Common adverse reactions include {{{adverseReactions}}}.

Adult Indications and Dosage

FDA-Labeled Indications and Dosage (Adult)

Recommended Dose

The recommended dose of HALAVEN is 1.4 mg/m2 administered intravenously over 2 to 5 minutes on Days 1 and 8 of a 21-day cycle.

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/mm3
    • Platelets < 75,000/mm3
    • 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.

Instructions for Preparation and Administration

  • Aseptically withdraw the required amount of HALAVEN from the single-use 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 (40°F or/ 4°C). Store diluted solutions of HALAVEN for up to 4 hours at room temperature or up to 24 hours under refrigeration.
  • Discard unused portions of the vial.

Off-Label Use and Dosage (Adult)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Eribulin in adult patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Eribulin in adult patients.

Pediatric Indications and Dosage

FDA-Labeled Indications and Dosage (Pediatric)

There is limited information regarding Eribulin FDA-Labeled Indications and Dosage (Pediatric) in the drug label.

Off-Label Use and Dosage (Pediatric)

Guideline-Supported Use

There is limited information regarding Off-Label Guideline-Supported Use of Eribulin in pediatric patients.

Non–Guideline-Supported Use

There is limited information regarding Off-Label Non–Guideline-Supported Use of Eribulin in pediatric patients.

Contraindications

There is limited information regarding Eribulin Contraindications in the drug label.

Warnings

There is limited information regarding Eribulin Warnings' in the drug label.

Adverse Reactions

Clinical Trials Experience

There is limited information regarding Eribulin Clinical Trials Experience in the drug label.

Postmarketing Experience

There is limited information regarding Eribulin Postmarketing Experience in the drug label.

Drug Interactions

There is limited information regarding Eribulin Drug Interactions in the drug label.

Use in Specific Populations

Pregnancy

Pregnancy Category (FDA): There is no FDA guidance on usage of Eribulin in women who are pregnant.
Pregnancy Category (AUS): There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Eribulin in women who are pregnant.

Labor and Delivery

There is no FDA guidance on use of Eribulin during labor and delivery.

Nursing Mothers

There is no FDA guidance on the use of Eribulin in women who are nursing.

Pediatric Use

There is no FDA guidance on the use of Eribulin in pediatric settings.

Geriatic Use

There is no FDA guidance on the use of Eribulin in geriatric settings.

Gender

There is no FDA guidance on the use of Eribulin with respect to specific gender populations.

Race

There is no FDA guidance on the use of Eribulin with respect to specific racial populations.

Renal Impairment

There is no FDA guidance on the use of Eribulin in patients with renal impairment.

Hepatic Impairment

There is no FDA guidance on the use of Eribulin in patients with hepatic impairment.

Females of Reproductive Potential and Males

There is no FDA guidance on the use of Eribulin in women of reproductive potentials and males.

Immunocompromised Patients

There is no FDA guidance one the use of Eribulin in patients who are immunocompromised.

Administration and Monitoring

Administration

There is limited information regarding Eribulin Administration in the drug label.

Monitoring

There is limited information regarding Eribulin Monitoring in the drug label.

IV Compatibility

There is limited information regarding the compatibility of Eribulin and IV administrations.

Overdosage

There is limited information regarding Eribulin overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.

Pharmacology

There is limited information regarding Eribulin Pharmacology in the drug label.

Mechanism of Action

There is limited information regarding Eribulin Mechanism of Action in the drug label.

Structure

There is limited information regarding Eribulin Structure in the drug label.

Pharmacodynamics

There is limited information regarding Eribulin Pharmacodynamics in the drug label.

Pharmacokinetics

There is limited information regarding Eribulin Pharmacokinetics in the drug label.

Nonclinical Toxicology

There is limited information regarding Eribulin Nonclinical Toxicology in the drug label.

Clinical Studies

There is limited information regarding Eribulin Clinical Studies in the drug label.

How Supplied

There is limited information regarding Eribulin How Supplied in the drug label.

Storage

There is limited information regarding Eribulin Storage in the drug label.

Images

Drug Images

{{#ask: Page Name::Eribulin |?Pill Name |?Drug Name |?Pill Ingred |?Pill Imprint |?Pill Dosage |?Pill Color |?Pill Shape |?Pill Size (mm) |?Pill Scoring |?NDC |?Drug Author |format=template |template=DrugPageImages |mainlabel=- |sort=Pill Name }}

Package and Label Display Panel

{{#ask: Label Page::Eribulin |?Label Name |format=template |template=DrugLabelImages |mainlabel=- |sort=Label Page }}

Patient Counseling Information

There is limited information regarding Eribulin Patient Counseling Information in the drug label.

Precautions with Alcohol

Alcohol-Eribulin interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.

Brand Names

There is limited information regarding Eribulin Brand Names in the drug label.

Look-Alike Drug Names

There is limited information regarding Eribulin Look-Alike Drug Names in the drug label.

Drug Shortage Status

Price

References

The contents of this FDA label are provided by the National Library of Medicine.


Eribulin
File:Eribulin.svg
Clinical data
Trade namesHalaven
AHFS/Drugs.comConsumer Drug Information
MedlinePlusa611007
[[Regulation of therapeutic goods |Template:Engvar data]]
Pregnancy
category
  • US: D (Evidence of risk)
Routes of
administration		Intravenous
ATC code
Legal status
Legal status
Identifiers
CAS Number
PubChem CID
ChemSpider
UNII
ChEMBL
E number{{#property:P628}}
ECHA InfoCard{{#property:P2566}}Lua error in Module:EditAtWikidata at line 36: attempt to index field 'wikibase' (a nil value).
Chemical and physical data
FormulaC40H59NO11
Molar mass729.90 g/mol
3D model (JSmol)
 ☒N☑Y (what is this?)  (verify)

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Editor-In-Chief: C. Michael Gibson, M.S., M.D. [3]

Overview

Eribulin is an anticancer drug marketed by Eisai Co. under the trade name Halaven. Eribulin mesylate was approved by the U.S. Food and Drug Administration on November 15, 2010, to treat patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease, including both anthracycline- and taxane-based chemotherapies.[1] It was approved by Health Canada on December 14, 2011 for treatment of patients with metastatic breast cancer who have previously received at least two chemotherapeutic regimens for the treatment of metastatic disease. [2]

Eribulin is also being investigated by Eisai Co. for use in a variety of other solid tumors, including non-small cell lung cancer, prostate cancer and sarcoma.[3]

Eribulin has been previously known as E7389 and ER-086526, and also carries the US NCI designation NSC-707389.

Structure and mechanism

Structurally, eribulin is a fully synthetic macrocyclic ketone analogue of the marine sponge natural product halichondrin B,[4][5] the latter being a potent naturally-occurring mitotic inhibitor with a unique mechanism of action found in the Halichondria genus of sponges.[6][7] Eribulin is a mechanistically-unique inhibitor of microtubule dynamics,[8][9] binding predominantly to a small number of high affinity sites at the plus ends of existing microtubules.[10] Eribulin exerts its anticancer effects by triggering apoptosis of cancer cells following prolonged and irreversible mitotic blockade.[11][12]

A new synthetic route to E7389 was published in 2009.[13]

References

  1. ↑ "FDA approves new treatment option for late-stage breast cancer" (Press release). USFDA. 2010-11-15. Retrieved November 15, 2010.
  2. ↑ Notice of Decision for HALAVEN
  3. ↑ http://www.clinicaltrials.gov/ct2/results?term=eribulin+OR+E7389
  4. ↑ Towle MJ, Salvato KA, Budrow J, Wels BF, Kuznetsov G, Aalfs KK, Welsh S, Zheng W, Seletsky BM, Palme MH, Habgood GJ, Singer LA, Dipietro LV, Wang Y, Chen JJ, Quincy DA, Davis A, Yoshimatsu K, Kishi Y, Yu MJ, Littlefield BA (2001). "In vitro and in vivo anticancer activities of synthetic macrocyclic ketone analogues of halichondrin B". Cancer Res. 61 (3): 1013–21. PMID 11221827. Unknown parameter |month= ignored (help)
  5. ↑ Yu MJ, Kishi Y, Littlefield BA (2005). "Discovery of E7389, a fully synthetic macrocyclic ketone analogue of halichondrin B". In Newman DJ, Kingston DGI, Cragg, GM. Anticancer agents from natural products. Washington, DC: Taylor & Francis. ISBN 0-8493-1863-7.
  6. ↑ Hirata Y, Uemura D (1986). "Halichondrins - antitumor polyether macrolides from a marine sponge". Pure Appl. Chem. 58 (5): 701–710. doi:10.1351/pac198658050701.
  7. ↑ Bai RL, Paull KD, Herald CL, Malspeis L, Pettit GR, Hamel E (1991). "Halichondrin B and homohalichondrin B, marine natural products binding in the vinca domain of tubulin. Discovery of tubulin-based mechanism of action by analysis of differential cytotoxicity data". J. Biol. Chem. 266 (24): 15882–9. PMID 1874739. Unknown parameter |month= ignored (help)
  8. ↑ Jordan MA, Kamath K, Manna T, Okouneva T, Miller HP, Davis C, Littlefield BA, Wilson L (2005). "The primary antimitotic mechanism of action of the synthetic halichondrin E7389 is suppression of microtubule growth". Mol. Cancer Ther. 4 (7): 1086–95. doi:10.1158/1535-7163.MCT-04-0345. PMID 16020666. Unknown parameter |month= ignored (help)
  9. ↑ Okouneva T, Azarenko O, Wilson L, Littlefield BA, Jordan MA (2008). "Inhibition of Centromere Dynamics by Eribulin (E7389) during Mitotic Metaphase". Mol. Cancer Ther. 7 (7): 2003–11. doi:10.1158/1535-7163.MCT-08-0095. PMC 2562299. PMID 18645010. Unknown parameter |month= ignored (help)
  10. ↑ Smith JA, Wilson L, Azarenko O, Zhu X, Lewis BM, Littlefield BA, Jordan MA (2010). "Eribulin Binds at Microtubule Ends to a Single Site on Tubulin to Suppress Dynamic Instability". Biochemistry. 49 (6): 1331–7. doi:10.1021/bi901810u. PMC 2846717. PMID 20030375. Unknown parameter |month= ignored (help)
  11. ↑ Kuznetsov G, Towle MJ, Cheng H, Kawamura T, TenDyke K, Liu D, Kishi Y, Yu MJ, Littlefield BA (2004). "Induction of morphological and biochemical apoptosis following prolonged mitotic blockage by halichondrin B macrocyclic ketone analog E7389". Cancer Res. 64 (16): 5760–6. doi:10.1158/0008-5472.CAN-04-1169. PMID 15313917. Unknown parameter |month= ignored (help)
  12. ↑ Towle MJ, Salvato KA, Wels BF, Aalfs KK, Zheng W, Seletsky BM, Zhu X, Lewis BM, Kishi Y, Yu MJ, Littlefield BA (2011). "Eribulin induces irreversible mitotic blockade: implications of cell-based pharmacodynamics for in vivo efficacy under intermittent dosing conditions". Cancer Res. 71 (2): 496–505. doi:10.1158/0008-5472.CAN-10-1874. PMID 21127197. Unknown parameter |month= ignored (help)
  13. ↑ Kim DS, Dong CG, Kim JT, Guo H, Huang J, Tiseni PS, Kishi Y (2009). "New syntheses of E7389 C14-C35 and halichondrin C14-C38 building blocks: double-inversion approach". J. Am. Chem. Soc. 131 (43): 15636–41. doi:10.1021/ja9058475. PMID 19807076. Unknown parameter |month= ignored (help)

External links

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