A treatment option for certain patients with metastatic breast cancer

Although some women lived longer and some women did not live as long, women who were treated with HALAVEN in a clinical trial lived an average of 13.2 months compared with women treated with other chemotherapy or hormone therapy, who lived an average of 10.6 months.

An advantage of living longer: beating her at her own game
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Who is HALAVEN® (eribulin mesylate) Injection for?

HALAVEN is a prescription medicine used to treat patients with metastatic breast cancer. HALAVEN is for patients who have already received at least 2 other types of anticancer medicines for their breast cancer once it has spread to other parts of the body. Previous therapy should have included an anthracycline and a taxane for either early or advanced breast cancer.

What safety information do I need to know about HALAVEN®?

Neutropenia (Decreased White Blood Cells)

  • Your health care provider should do a blood test to monitor your blood cells before you receive each dose of HALAVEN, and should monitor you more often if you develop lower white blood cells
  • If you develop severe neutropenia lasting longer than 7 days or neutropenia with a fever, your next dose of HALAVEN should be delayed and reduced. In a clinical trial, severe neutropenia occurred in 57% of patients who received HALAVEN and lasted more than 1 week in 12% of patients
  • Neutropenia with a fever occurred in 5% of patients; 2 patients died from complications of neutropenia with a fever
  • Neutropenia with a fever can result in serious infections that could lead to hospitalization or death. Call your health care provider immediately if you have any of the following symptoms: fever (temperature above 100.5°F), chills, coughing, and burning or pain when you urinate

Peripheral Neuropathy (Nerve Problems)

  • HALAVEN can cause numbness, tingling, or burning in your hands and feet (peripheral neuropathy). You should be monitored closely for signs of neuropathy. If you develop severe neuropathy, treatment with HALAVEN should be delayed until the neuropathy improves and the next dose of HALAVEN should be reduced
  • Severe peripheral neuropathy occurred in 8% of patients who received HALAVEN. Neuropathy lasting more than 1 year occurred in 5% of patients. Twenty-two percent of patients developed a new or worsening neuropathy that had not recovered after an average of 269 days
  • Peripheral neuropathy was the most common side effect that caused patients to stop taking HALAVEN

Pregnancy and Nursing

  • HALAVEN may harm your unborn baby. Avoid becoming pregnant while you are receiving HALAVEN. Tell your health care provider right away if you become pregnant or think you are pregnant while you are receiving HALAVEN
  • It is not known if HALAVEN passes into your breast milk. You and your health care provider should decide if you will take HALAVEN or breast-feed. You should not do both

QT Prolongation (Heartbeat Changes)

  • HALAVEN can cause changes in your heartbeat. This can cause irregular heartbeats that may lead to death
  • Before you receive HALAVEN, tell your health care provider if you have heart problems, including a problem called “congenital long QT syndrome”
  • Your health care provider will decide if you need heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with HALAVEN to watch for this problem

Pre-existing Liver and/or Kidney Problems

  • Before you receive HALAVEN, tell your health care provider if you have liver or kidney problems. A lower starting dose of HALAVEN is recommended in patients with mild or moderate liver problems, and/or moderate or severe kidney problems

Most Common Side Effects

  • The most common side effects reported in ≥25% of patients receiving HALAVEN were low white blood cells; low red blood cells; weakness/tiredness; hair loss; numbness, tingling, or burning in the hands and feet; nausea; and constipation
  • The most common serious side effects reported in patients receiving HALAVEN were neutropenia with or without a fever

Please see HALAVEN full Prescribing Information.

The health information contained herein is provided for educational purposes only and is not intended to replace discussions with a health care provider.

All decisions regarding patient care must be made with a health care professional, considering the unique characteristics of the patient.

This site is intended for residents of the United States only. The products discussed herein may have different product labeling in different countries.

To report suspected adverse reactions, contact Eisai Inc. at 1-888-274-2378 or the FDA at 1-800-FDA-1088 or www.FDA.gov/medwatch.

This Web site contains information relating to various medical conditions and treatment. Such information is provided for educational purposes only and is not meant to be a substitute for the advice of a physician or other health care professionals. You should not use this information for diagnosing a health problem or disease. In order for you to make intelligent health care decisions, you should always consult with a physician or other health care provider for you, or your loved ones, personal medical needs. Individual responses to treatment may vary.

HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
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