Generic Name and Formulations:
Eribulin mesylate 0.5mg/mL, soln for IV inj.

Company:
Eisai Pharmaceuticals

Indications for HALAVEN:
Treatment of metastatic breast cancer in patients who have previously received at least two chemotherapeutic regimens for metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

Adult Dose for HALAVEN:
Give by IV injection over 2–5 minutes. 1.4mg/m² on Days 1 and 8 of a 21-day cycle. Mild hepatic impairment (Child-Pugh A) or moderate renal impairment (CrCl 30–50mL/min): 1.1mg/m² on days 1 and 8 of a 21-day cycle. Moderate hepatic impairment (Child-Pugh B): 0.7mg/m² on Days 1 and 8 of a 21-day cycle. Hold dose for ANC <1000/mm³, platelets <75000/mm³, or grade 3 or 4 non-hematological toxicities. Delay or reduce dose according to toxicities; see literature. Do not re-escalate dose after it is reduced.

Children's Dose for HALAVEN:
<18yrs: not recommended.

Pharmacological Class:
Non-taxane microtubule dynamics inhibitor.

Warnings/Precautions:
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. Monitor for peripheral neuropathy; withhold dose if grade 3 or 4 peripheral neuropathy develops until resolution to grade 2 or less. Congenital long QT syndrome: avoid. CHF, bradyarrhythmias, electrolyte abnormalities: monitor ECG for prolonged QT interval. Correct electrolyte abnormalities (K+, Mg+) before treatment; monitor. Severe hepatic impairment (Child-Pugh C) or severe renal impairment (CrCl<30mL/min): insufficient data. Pregnancy (Cat. D), nursing mothers: not recommended.

Interactions:
Caution with other drugs that prolong QT interval (eg, Class IA and III antiarrhythmics); monitor.

Adverse Reactions:
Neutropenia, anemia, asthenia/fatigue, alopecia, peripheral neuropathy, nausea, constipation, febrile neutropenia; possible QT prolongation, elevated liver enzymes.

Note:
Do not mix with dextrose-containing solutions. Do not administer in same line as other drugs or fluids.

How Supplied:
Single-use vial (2mL)—1

Halaven approved for late-stage breast cancer
HALAVEN (eribulin mesylate) 1mg/2mL injection by Eisai The FDA has approved Halaven (eribulin mesylate, from Eisai) for the treatment of patients with metastatic breast cancer who have received at least two prior chemotherapy regimens for late-stage disease. This approval was based on a single study in 762 women with metastatic breast cancer who had received at least two prior chemotherapy regimens for late-stage disease. The study measured the length of time from when treatment was started until a patient's death (overall survival). The median overall survival for patients receiving Halaven was 13.1 months compared with 10.6 months for those who received a single agent therapy.
Halaven is a synthetic form of a chemotherapeutically active compound derived from the sea sponge Halichondria okadai. This injectable therapy is a microtubule inhibitor, believed to work by inhibiting cancer cell growth. Before receiving Halaven, patients should have received prior anthracycline- and taxane-based chemotherapy for early or late-stage breast cancer.