HALAVEN® resources to help support you and your patients

Downloadable resources

Download resources or check boxes to add to your Resource Suite ZIP file.

Physician resources

HALAVEN Brochure

HALAVEN Brochure

Key information about HALAVEN for physicians.

HALAVEN Mechanism of Action Brochure

HALAVEN Mechanism of Action Brochure

Information about the dual action of HALAVEN.

L.H. Patient Profile

L.H. Patient Profile

Profile of a 58-year-old woman with ER/PR-positive metastatic breast cancer.

N.S. Patient Profile

N.S. Patient Profile

Profile of a 62-year-old woman with triple-negative metastatic breast cancer.

S.T. Patient Profile

S.T. Patient Profile

Profile of a 45-year-old woman with triple-negative metastatic breast cancer.

Nurse resources

HALAVEN Nurse Brochure

HALAVEN Nurse Brochure

Key information about HALAVEN for nurses.

HALAVEN Pocket Dosing Guide

HALAVEN Pocket Dosing Guide

Information about recommended dosing and dose adjustments.

Adverse Reaction Grading Flashcard

Adverse Reaction Grading Flashcard

Information about grading select adverse reactions.

Additional resources

HALAVEN Patient Brochure

HALAVEN Patient Brochure

Important information about HALAVEN for your patients.

HALAVEN Full Prescribing Information (PI)

HALAVEN Full Prescribing Information (PI) Updated

A PDF of the full PI.

Interactive resources

Halaven patient selection tool

HALAVEN Patient Selection Tool

Identify whether HALAVEN could be the right option for your patients by choosing from preselected patient profiles or creating a profile of a patient you may consider treating with HALAVEN.

 FAQs page

HALAVEN FAQs

Find quick answers to frequently asked questions about HALAVEN for health care professionals.

Dosing Calculator

HALAVEN Dosing Calculator

Calculates body surface area and determines the appropriate HALAVEN dose and number of vials needed. Found within the Recommended Starting Dose section.

For questions about HALAVEN, e-mail Eisai Medical Information at medinfo@eisai.com or call 1.888.274.2378

Indications

Metastatic Breast Cancer

HALAVEN (eribulin mesylate) Injection is indicated for the treatment of patients with metastatic breast cancer (mBC) who have previously received at least 2 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.

Liposarcoma

HALAVEN is indicated for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.

Important Safety Information

Warnings and Precautions

Neutropenia: Severe neutropenia (ANC <500/mm3) lasting >1 week occurred in 12% of patients with mBC and liposarcoma or leiomyosarcoma. Febrile neutropenia occurred in 5% of patients with mBC and 2 patients (0.4%) died from complications. Febrile neutropenia occurred in 0.9% of patients with liposarcoma or leiomyosarcoma, and fatal neutropenic sepsis occurred in 0.9% of patients. Patients with mBC with elevated liver enzymes >3 × ULN and bilirubin >1.5 × ULN experienced a higher incidence of Grade 4 neutropenia and febrile neutropenia than patients with normal levels. Monitor complete blood cell counts prior to each dose, and increase the frequency of monitoring in patients who develop Grade 3 or 4 cytopenias. Delay administration and reduce subsequent doses in patients who experience febrile neutropenia or Grade 4 neutropenia lasting >7 days.

Peripheral Neuropathy: Grade 3 peripheral neuropathy occurred in 8% of patients with mBC (Grade 4=0.4%) and 22% developed a new or worsening neuropathy that had not recovered within a median follow-up duration of 269 days (range 25-662 days). Neuropathy lasting >1 year occurred in 5% of patients with mBC. Grade 3 peripheral neuropathy occurred in 3.1% of patients with liposarcoma and leiomyosarcoma receiving HALAVEN and neuropathy lasting more than 60 days occurred in 58% (38/65) of patients who had neuropathy at the last treatment visit. Patients should be monitored for signs of peripheral motor and sensory neuropathy. Withhold HALAVEN in patients who experience Grade 3 or 4 peripheral neuropathy until resolution to Grade 2 or less.

Embryo-Fetal Toxicity: HALAVEN can cause fetal harm when administered to a pregnant woman. Advise females of reproductive potential to use effective contraception during treatment with HALAVEN and for at least 2 weeks following the final dose. Advise males with female partners of reproductive potential to use effective contraception during treatment with HALAVEN and for 3.5 months following the final dose.

QT Prolongation: Monitor for prolonged QT intervals in patients with congestive heart failure, bradyarrhythmias, drugs known to prolong the QT interval, and electrolyte abnormalities. Correct hypokalemia or hypomagnesemia prior to initiating HALAVEN and monitor these electrolytes periodically during therapy. Avoid in patients with congenital long QT syndrome.

Adverse Reactions

In patients with mBC receiving HALAVEN, the most common adverse reactions (≥25%) were neutropenia (82%), anemia (58%), asthenia/fatigue (54%), alopecia (45%), peripheral neuropathy (35%), nausea (35%), and constipation (25%). Febrile neutropenia (4%) and neutropenia (2%) were the most common serious adverse reactions. The most common adverse reaction resulting in discontinuation was peripheral neuropathy (5%).

In patients with liposarcoma and leiomyosarcoma receiving HALAVEN, the most common adverse reactions (≥25%) reported in patients receiving HALAVEN were fatigue (62%), nausea (41%), alopecia (35%), constipation (32%), peripheral neuropathy (29%), abdominal pain (29%), and pyrexia (28%). The most common (≥5%) Grade 3-4 laboratory abnormalities reported in patients receiving HALAVEN were neutropenia (32%), hypokalemia (5.4%), and hypocalcemia (5%). Neutropenia (4.9%) and pyrexia (4.5%) were the most common serious adverse reactions. The most common adverse reactions resulting in discontinuation were fatigue and thrombocytopenia (0.9% each).

Use in Specific Populations

Lactation: Because of the potential for serious adverse reactions in breastfed infants from eribulin mesylate, advise women not to breastfeed during treatment with HALAVEN and for 2 weeks after the final dose.

Hepatic and Renal Impairment: A reduction in starting dose is recommended for patients with mild or moderate hepatic impairment and/or moderate or severe renal impairment.

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