Adult Dosing

Metastatic breast cancer

• Give by IV injection over 2-5 minutes. 1.4 mg/m² on Days 1 and 8 of a 21-day cycle
• Note: Refer PI for dose modifications and for recommended dose reductions

Pediatric Dosing

• Safety and effectiveness in pediatric patients have not been established

[Outline]

• Adult Dosing
• Pediatric Dosing

• Treatment of metastatic breast cancer in patients who have previously received =>2 chemotherapeutic regimens (should have included anthracycline and taxane) for the treatment of metastatic disease

• Hypersensitivity to any component of the drug
• Hypokalemia
• Hypomagnesemia
• Congenital QT prolongation

• N/A

Renal Dose Adjustment

• CrCl 50-80 mL/min: No dose adjustments
• CrCl 30-50mL/min: 1.1 mg/m² on days 1 and 8 of a 21-day cycle
• CrCl <30 mL/min: Dose adjustments not defined

Hepatic Dose Adjustment

• Mild hepatic impairment (Child-Pugh A): 1.1 mg/m² on days 1 and 8 of a 21-day cycle
• Moderate hepatic impairment (Child-Pugh B): 0.7 mg/m² on Days 1 and 8 of a 21-day cycle
• Severe hepatic impairment (Child-Pugh C): Dose adjustments not defined

See Supplemental Patient Information

• Severe neutropenia (ANC <500/mm³) may occur; monitor CBCs; increase frequency of monitoring if grade 3 or 4 cytopenias develop, delay and reduce subsequent doses if febrile neutropenia or grade 4 neutropenia lasting >7 days develops
• Peripheral neuropathy reported. Monitor for peripheral motor and sensory neuropathy; withhold dose if grade 3 or 4 peripheral neuropathy develops until resolution to grade 2 or less
• Monitor ECG in patients with CHF, bradyarrhythmias and electrolyte abnormalities
• Correct hypokalemia or hypomagnesemia prior to therapy and monitor periodically
• As eribulin is microtubule inhibitor; it may cause fetal harm when administered to a pregnant woman
• Avoid with congenital long QT syndrome

Cautions: Use cautiously in

• Severe hepatic impairment
• Severe renal impairment
• Congenital long QT syndrome
• CHF
• Bradyarrhythmias
• Electrolyte abnormalities

Supplemental Patient Information

• Advise women of childbearing potential to avoid pregnancy and use effective contraception during treatment
• Advise patients to contact healthcare provider for a fever (temperature above 100.5°F) or other signs/symptoms of infection (eg, chills, cough, or burning or pain on urination)

Pregnancy Category:D

Breastfeeding: Safety unknown; due to the potential for serious adverse reactions in nursing infants, manufacturer recommends discontinuation of nursing or discontinuation of drug, taking into account the importance of the drug to the mother.

• HEMA: Neutropenia, febrile neutropenia, anemia
• CNS: Asthenia/fatigue, headache
• CV: QT prolongation
• DERM: Alopecia
• NEURO: Peripheral neuropathy
• GI: Nausea, constipation, vomiting, diarrhea
• LABTESTS: LFTs elevated
• RESP: Dyspnea, cough
• MUSC: Arthralgia/myalgia, back pain, extremity pain, bone pain, mucosal inflammation
• METABOLIC: Weight loss, anorexia
• GU: Urinary tract infection
• MISC: Pyrexia

• Antimicrotubule agent; inhibits growth phase of microtubules via tubulin-based antimitotic mechanism leading to G2/M cell-cycle block, disruption of mitotic spindles, and apoptotic cell death after prolonged mitotic blockage
• Metabolized in liver via CYP3A4 (negligible)
• Mostly unchanged in feces (82%), urine (9%)
• Half-life: 40 hrs

US Trade Name(s)

• Halaven

US Availability

Halaven

• INJ: 1 mg/2 mL (0.5 mg/mL)

Canadian Trade Name(s)

• N/A

Canadian Availability

• N/A

UK Trade Name(s)

• Halaven

UK Availability

Halaven

• INJ: 0.44 mg/mL (1 mL vial)

Australian Trade Name(s)

• N/A

Australian Availability

• N/A

[Outline]

Hematology/Oncology

Antineoplastics

Mitotic Inhibitors

Pricing data from www.DrugStore.com in U.S.A.

• Halaven 1 MG/2ML SOLN [Vial] (EISAI)
  2 2ml = $1047.1
  4 2ml = $2056.99

Warning: This pricing information is subject to change at the sole discretion of DS Pharmacy. For the most current and up-to-date pricing information, please visit drugstore.com.