e-RIB-yoo-lin

Therapeutic Classification: antineoplastics

Pharmacologic Classification:

• Metastatic breast cancer that has progressed despite 2 previous regimens which included an anthracycline and a taxane in either the adjuvant or metastatic setting.
• Unresectable or metastatic liposarcoma in patients who have received a prior regimen that included an anthracycline.

• Inhibits intracellular microtubule growth phase, causing G₂/M cell-cycle block resulting in apoptotic cell death.

• Death of rapidly replicating cells, particularly malignant ones.
• Improved survival in patients with breast cancer or liposarcoma.

Absorption: IV administration results in complete bioavailability.

Distribution: Unknown.

Metabolism/Excretion: Minimal metabolism, mostly excreted unchanged in feces (82%) and less in urine (9%).

Half-life: 40 hr.

(effects on blood counts)

Contraindicated in:

• Severe hepatic impairment
• Severe renal impairment (CCr <15 mL/min)
• Congenital long QT syndrome
• OB: Pregnancy; may cause fetal harm
• Lactation: Avoid breast feeding.

Use Cautiously in:

• HF, bradyarrhythmias, concurrent use of drugs known to prolong the QT interval (including Class Ia and III antiarrhythmics), electrolyte abnormalities (↑ risk of arrhythmias)
• Moderate renal impairment; lower initial dose recommended for CCr 30–50 mL/min
• Mild to moderate hepatic impairment; lower initial dose recommended
• Rep: Women of reproductive potential and men with female partners of reproductive potential (use effective contraception)
• Pedi: Safety and effectiveness not established.

CNS: fatigue, weakness, depression, dizziness, headache, insomnia.

EENT: ↑lacrimation.

CV: QT INTERVAL PROLONGATION, peripheral edema.

Resp: cough, dyspnea, upper respiratory tract infection.

GI: PANCREATITIS, anorexia, constipation, nausea, abdominal pain, abnormal taste, dry mouth, dyspepsia, mucositis, diarrhea, vomiting.

Derm: stevens-johnson syndrome, toxic epidermal necrolysis, alopecia, rash.

F and E: hypokalemia.

Hemat: anemia, neutropenia.

MS: arthralgia, myalgia.

Neuro: peripheral neuropathy.

Misc: fever, urinary tract infection.

Drug-Drug:

• ↑risk of bone marrow depression with other antineoplastics or radiation therapy.
• ↓antibody response and ↑ risk of adverse reactions with live virus vaccines.

• IV (Adults): 1.4 mg/m² on days 1 and 8 of a 21-day cycle; dose modifications required for neutropenia, thrombocytopenia, or peripheral neuropathy.

• Solution for IV administration: 0.5 mg/mL;

• Assess for peripheral motor and sensory neuropathy (numbness, tingling, burning in hands or feet). Withhold eribulin in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.
• Monitor ECG periodically as indicated.

• Monitor CBC prior to each dose; ↑ frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who develop febrile neutropenia or Grade 4 neutropenia lasting longer than 7 days.
  • Monitor electrolytes periodically during therapy.

• Do not confuse eribulin with epirubicin.
• Correct hypokalemia or hypomagnesemia prior to initiating therapy.

IV Administration:

• Do not administer on Day 1 or Day 8 if: ANC <1000/mm³, platelets <75,000/mm³, or Grade 3 or 4 nonhematological toxicities occur.
• Day 8 dose may be delayed for a maximum of 1 wk: If toxicities do not resolve or improve to Grade 2 severity by Day 15, omit dose.
  • If toxicities resolve or improve to Grade 2 by Day 15, administer eribulin at a reduced dose and initiate next cycle no sooner than 2 wk later.
  • If a dose has been delayed for toxicity and toxicities have recovered to Grade 2 severity or less, resume eribulin at a reduced dose of 1.1 mg/m².
  • Permanently reduce 1.4 mg/m² eribulin dose to 1.1 mg/m² if: ANC <500/mm³ for >7 days, ANC <1000/mm³ either fever or infection, platelets <25,000/mm³, platelets <50,000/mm³ requiring transfusion, nonhematologic Grade 3 or 4 toxicities, or omission or delay of Day 8 eribulin dose in previous cycle for toxicity.
  • Permanently reduce 1.4 mg/m² eribulin dose to 0.7 mg/m² if: occurrence of any event requiring permanent dose reduction while receiving 1.1 mg/m² dose.
  • If occurrence of any event requiring permanent dose reduction while receiving 0.7 mg/m²: discontinue eribulin.
• IV Push:
  Diluent: Administer undiluted or dilute in 100 mL of 0.9% NaCl. Store undiluted in syringe or diluted eribulin for up to 4 hr at room temperature or for up to 24 hr under refrigeration. Discard unused portion of vial.
• Rate: Infuse over 2–5 minutes on Days 1 and 8 of a 21-day cycle.
• Y-Site Incompatibility: Do not dilute in or administer through an IV line containing solutions with dextrose or other medications.

• Advise patient to notify health care professional if fever of 100.5° F or other signs or symptoms of infection (chills, cough, burning or pain on urination) or rash occur.
• Instruct patient to notify health care professional of all Rx or OTC medications, vitamins, or herbal products being taken and consult health care professional before taking any new medications.
• Advise patient not to receive vaccinations without consulting health care professional.
• Rep: Advise female patient to use effective contraception during and for at least 2 wk after last dose of therapy and to notify health care professional immediately if pregnancy is planned or suspected or if breast feeding. Advise males with female partners of reproductive potential to use effective contraception for 3.5 mo after final dose. May cause male infertility.

• ↓spread of breast cancer.

Halaven

• Activity intolerance

NDC Code^*

• 62856- Eisai Inc.
  • 62856-389- Halaven
    • 62856-389-01- 1 VIAL in 1 CARTON (62856-389-01) > 2 mL in 1 VIAL