July 28, 2016
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(eribulin mesylate) Injection

Read this leaflet before you start receiving HALAVEN and before each injection. There may be new information. This information does not take the place of talking with your healthcare provider about your medical condition or your treatment.

What is the most important information I should know about HALAVEN?

Your healthcare provider should do blood tests regularly to check your blood cell counts before you receive each dose of HALAVEN.

  • HALAVEN can cause a decrease in white blood cell count (neutropenia). This can make you more likely to get serious infections that could lead to death. You may need treatment in the hospital with antibiotic medicines.
  • Call your healthcare provider right away if you develop any of these symptoms of infection while you are receiving HALAVEN:
    • fever (temperature above 100.5°F)
    • chills
    • cough
    • burning or pain when you urinate.
  • HALAVEN can cause numbness, tingling, or burning in your hands and feet (neuropathy). Tell your healthcare provider if you have any of these symptoms.

See “What are possible side effects of HALAVEN?” for more information about side effects.

What is HALAVEN?

HALAVEN is a prescription medicine used to treat people with breast cancer:

  • that has spread to other parts of their body, and
  • who have already received certain types of anticancer medicines after their breast cancer has spread.

What should I tell my healthcare provider before receiving HALAVEN?

Before you receive HALAVEN, tell your healthcare provider if you:

  • have liver or kidney problems.
  • have heart problems, including a problem called “congenital long QT syndrome.”
  • are pregnant or plan to become pregnant. HALAVEN may harm your unborn baby. Talk with your healthcare provider about birth control methods to prevent pregnancy while you receive HALAVEN. Tell your healthcare provider right away if you become pregnant or think you are pregnant while you are receiving HALAVEN
  • are breastfeeding or planning to breastfeed. It is not known if HALAVEN passes into your breast milk. You and your healthcare provider should decide if you will take HALAVEN or breastfeed. You should not do both.

Tell your healthcare provider about all the medicines you take, including prescription and non-prescription medicines, vitamins and herbal supplements.

Know the medicines you take. Keep a list of your medicines to show to your healthcare provider and pharmacist when you get a new medicine.

How will I receive HALAVEN?

  • HALAVEN is injected directly into your vein.
  • HALAVEN is given in “cycles” of treatment, with each cycle lasting 21 days.
  • You will receive an injection 1 time each week for two weeks in a row (day 1 and day 8 of a treatment cycle).
  • Your healthcare provider may need to decrease your dose of HALAVEN or change how often you receive it, depending on your blood test results.

What are the possible side effects of HALAVEN?

HALAVEN may cause serious side effects, including:

  • See “What is the most important information I should know about HALAVEN?”
  • HALAVEN can cause changes in your heartbeat (called QTc prolongation). This can cause irregular heartbeats that may lead to death. Your healthcare provider will decide if you need heart monitoring (electrocardiogram or ECG), or blood tests during your treatment with HALAVEN to watch for this problem.

The most common side effects of HALAVEN include:

  • weakness or tiredness
  • hair loss
  • nausea
  • constipation

Tell your healthcare provider about any side effect that bothers you or that does not go away.

These are not all the possible side effects of HALAVEN. For more information, ask your healthcare provider or pharmacist.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

General information about HALAVEN

Medicines are sometimes prescribed for purposes other than those listed in a patient information leaflet. This leaflet summarizes the most important information about HALAVEN. If you would like more information, talk with your healthcare provider. You can ask your pharmacist or healthcare provider for information about HALAVEN that is written for health professionals.

For more information, go to www.HALAVEN.com or call Eisai Inc. at 1-877-873-4724.

What are the ingredients in HALAVEN?

Active Ingredients: eribulin mesylate

Inactive Ingredients: ethanol, water

Last reviewed on RxList: 1/15/2016
This monograph has been modified to include the generic and brand name in many instances.

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You are encouraged to report negative side effects of prescription drugs to the FDA. Visit the FDA MedWatch website or call 1-800-FDA-1088.

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