THERAPEUTIC CLASS
Antimicrotubule agent
ADULT DOSAGE & INDICATIONS
Metastatic Breast Cancer
Treatment of Patients Who Have Previously Received at Least 2 Chemotherapeutic Regimens (Anthracycline and a Taxane in Adjuvant/Metastatic Setting) for the Treatment of Metastatic Disease:
1.4mg/m2
Administer IV over 2-5 min on Days 1 and 8 of a 21-day cycle
DOSING CONSIDERATIONS
Renal Impairment
Moderate or Severe (CrCl 15-49mL/min):
1.1mg/m2
Hepatic Impairment
Mild (Child-Pugh A):
1.1mg/m2
Moderate (Child-Pugh B):
0.7mg/m2
Adverse Reactions
Do Not Administer on Day 1 or Day 8 for any of the Following:
ANC < 1000/mm3
Platelets <75000/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 improve to <Grade 2 severity by Day 15, administer at a reduced dose and initiate the next cycle no sooner than 2 weeks later
Permanently Reduce to 1.1mg/m2 for Any of The Following:
ANC <500/mm3 for >7 days
ANC <1000/mm3 w/ 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
Reduce to 0.7mg/m2 if:
Occurrence of any event requiring permanent dose reduction while receiving 1.1mg/m2
D/C w/ occurrence of any event requiring permanent dose reduction while receiving 0.7mg/m2
If a dose has been delayed for toxicity and toxicities have recovered to <Grade 2, resume at a reduced dose
Do not re-escalate dose after it has been reduced
ADMINISTRATION
IV route
Aseptically withdraw required amount of eribulin from the single use vial and administer undiluted or diluted in 100mL of 0.9% NaCl Inj.
Do not dilute in or administer through an IV line containing sol w/ dextrose.
Do not administer in the same IV line concurrent w/ other medicinal products.
Store undiluted eribulin in the syringe for up to 4 hrs at room temperature or for up to 24 hrs under refrigeration (4°C [40°F]).
Store diluted sol of eribulin for up to 4 hrs at room temperature or up to 24 hrs under refrigeration.
HOW SUPPLIED
Inj: 0.5mg/mL [2mL]
WARNINGS/PRECAUTIONS
Severe neutropenia (ANC <500/mm3) reported; higher incidence in patients w/ ALT/AST >3X ULN or bilirubin >1.5X ULN. Peripheral neuropathy reported. May cause fetal harm during pregnancy. QT prolongation reported; monitor ECG in patients w/ CHF, bradyarrhythmias, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to therapy. Avoid w/ congenital long QT syndrome.
ADVERSE REACTIONS
Neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, constipation.
DRUG INTERACTIONS
Monitor ECG w/ drugs known to prolong the QT interval (eg, Class IA and III antiarrhythmics).
PREGNANCY AND LACTATION
Pregnancy: Category D.
Lactation: It is not known whether eribulin is excreted into human milk; not for use in nursing.
MECHANISM OF ACTION
Antimicrotubule agent; inhibits the growth phase of microtubules via a tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and, ultimately, apoptotic cell death after prolonged mitotic blockage.
PHARMACOKINETICS
Distribution: Vd=43-114L/m2; plasma protein binding (49-65%). Elimination: Urine (9%, 91% unchanged), feces (82%, 88% unchanged); T1/2=40 hrs.
ASSESSMENT
Assess for renal/hepatic impairment, CHF, bradyarrhythmias, congenital long QT syndrome, electrolyte abnormalities, pregnancy/nursing status, and possible drug interactions. Correct hypokalemia or hypomagnesemia prior to initiating therapy. Assess for peripheral neuropathy and obtain CBC prior to each dose.
MONITORING
Monitor for severe neutropenia, peripheral motor and sensory neuropathy, and other adverse reactions. Monitor ECG in patients w/ CHF, bradyarrhythmias, and electrolyte abnormalities. Monitor K+ and Mg2+ levels periodically. Increase frequency of CBC monitoring if Grade 3 or 4 cytopenias develop.
PATIENT COUNSELING
Advise to contact physician for a fever ≥38.1°C (100.5°F) or other signs/symptoms of infection (eg, chills, cough, burning/pain on urination). Advise women of childbearing potential to avoid pregnancy and to use effective contraception during treatment.
STORAGE
25°C (77°F); excursions permitted to 15-30°C (59-86°F). Do not freeze. Undiluted Sol in Syringe/Diluted Sol: Up to 4 hrs at room temperature or up to 24 hrs under refrigeration (4°C [40°F]).
