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How effective is HALAVEN® in the treatment of advanced liposarcoma?

When used alone after a certain type of anticancer treatment, HALAVEN is the first and only chemotherapy that is proven to help some patients with advanced liposarcoma live longer.

HALAVEN was compared to dacarbazine, another chemotherapy commonly used to treat advanced liposarcoma. Among the 143 patients with advanced liposarcoma in the trial, some patients lived longer and some did not live as long. Patients with advanced liposarcoma who were treated with HALAVEN lived an average of 15.6 months compared with patients treated with the other chemotherapy, who lived an average of 8.4 months.

This means that patients who received HALAVEN lived 86% longer than patients who received the other chemotherapy.

HALAVEN was studied in patients with 3 types of advanced liposarcoma intermediate to high tumor grade. This included patients with dedifferentiated, myxoid/round cell, and pleomorphic liposarcoma.

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Who is HALAVEN® (eribulin mesylate) Injection for?

HALAVEN is a prescription medicine used to treat adults with liposarcoma that cannot be treated with surgery or that has spread to other parts of the body, and who have received treatment with a certain type of anticancer medicine.

What safety information do I need to know about HALAVEN?

HALAVEN can cause serious side effects, including

  • Low white blood cell count (neutropenia). This can lead to serious infections that could lead to death. Your health care provider will check your blood cell counts. Call your health care provider right away if you develop fever (temperature above 100.5°F), chills, cough, or burning or pain when you urinate, as any of these can be symptoms of infection

  • Numbness, tingling, or pain in your hands or feet (peripheral neuropathy). Peripheral neuropathy is common with HALAVEN and sometimes can be severe. Tell your health care provider if you have new or worsening symptoms of peripheral neuropathy

  • Your health care provider may delay or decrease your dose or stop treatment with HALAVEN if you have side effects

Before you receive HALAVEN, tell your health care provider about all of your medical conditions, including if you

  • have liver or kidney problems

  • have heart problems, including a problem called congenital long QT syndrome

  • have low potassium or low magnesium in your blood

  • are pregnant or plan to become pregnant. HALAVEN can harm your unborn baby. Tell your health care provider right away if you become pregnant or think you are pregnant during treatment with HALAVEN. Females who are able to become pregnant should use an effective form of birth control during treatment with HALAVEN and for at least 2 weeks after the final dose of HALAVEN and males should use an effective form of birth control when having sex with female partners who are able to become pregnant during treatment with HALAVEN and for 3½ months (14 weeks) after the final dose of HALAVEN

  • are breastfeeding or plan to breastfeed. It is not known if HALAVEN passes into your breast milk. Do not breastfeed during treatment with HALAVEN and for 2 weeks after the final dose of HALAVEN

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of HALAVEN?

HALAVEN can cause changes in your heartbeat (called QT prolongation). This can cause irregular heartbeats. Your health care provider may do heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with HALAVEN to check for heart problems.

The most common side effects of HALAVEN in adults with liposarcoma include tiredness, nausea, hair loss (alopecia), constipation, stomach pain, and fever.

Your health care provider will do blood tests before and during treatment while you are taking HALAVEN.The most common changes to blood tests in adults with liposarcoma include low white blood cell count (neutropenia) and decreased blood levels of potassium or calcium.

For more information about HALAVEN, please see full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

Who is HALAVEN® (eribulin mesylate) Injection for?

HALAVEN is a prescription medicine used to treat adults with breast cancer that has spread to other parts of the body, and who have already received other types of anticancer medicines after the cancer has spread.

HALAVEN is a prescription medicine used to treat adults with liposarcoma that cannot be treated with surgery or that has spread to other parts of the body, and who have received treatment with a certain type of anticancer medicine.

What safety information do I need to know about HALAVEN?

HALAVEN can cause serious side effects, including

  • Low white blood cell count (neutropenia). This can lead to serious infections that could lead to death. Your health care provider will check your blood cell counts. Call your health care provider right away if you develop fever (temperature above 100.5°F), chills, cough, or burning or pain when you urinate, as any of these can be symptoms of infection
  • Numbness, tingling, or pain in your hands or feet (peripheral neuropathy). Peripheral neuropathy is common with HALAVEN and sometimes can be severe. Tell your health care provider if you have new or worsening symptoms of peripheral neuropathy
  • Your health care provider may delay or decrease your dose or stop treatment with HALAVEN if you have side effects

Before you receive HALAVEN, tell your health care provider about all of your medical conditions, including if you

  • have liver or kidney problems
  • have heart problems, including a problem called congenital long QT syndrome
  • have low potassium or low magnesium in your blood
  • are pregnant or plan to become pregnant. HALAVEN can harm your unborn baby. Tell your health care provider right away if you become pregnant or think you are pregnant during treatment with HALAVEN. Females who are able to become pregnant should use an effective form of birth control during treatment with HALAVEN and for at least 2 weeks after the final dose of HALAVEN and males should use an effective form of birth control when having sex with female partners who are able to become pregnant during treatment with HALAVEN and for 3½ months (14 weeks) after the final dose of HALAVEN
  • are breastfeeding or plan to breastfeed. It is not known if HALAVEN passes into your breast milk. Do not breastfeed during treatment with HALAVEN and for 2 weeks after the final dose of HALAVEN

Tell your health care provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

What are the possible side effects of HALAVEN?

HALAVEN can cause changes in your heartbeat (called QT prolongation). This can cause irregular heartbeats. Your health care provider may do heart monitoring (electrocardiogram or ECG) or blood tests during your treatment with HALAVEN to check for heart problems.

The most common side effects of HALAVEN in adults with breast cancer include low white blood cell count (neutropenia), low red blood cell count (anemia), weakness or tiredness, hair loss (alopecia), nausea, and constipation.

The most common side effects of HALAVEN in adults with liposarcoma include tiredness, nausea, hair loss (alopecia), constipation, stomach pain, and fever.

Your health care provider will do blood tests before and during treatment while you are taking HALAVEN. The most common changes to blood tests in adults with liposarcoma include low white blood cell count (neutropenia) and decreased blood levels of potassium or calcium.

For more information about HALAVEN, please see full Prescribing Information.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

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 your, or your loved ones', personal medical needs. Individual responses to treatment may vary.

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