What is HALAVEN?
HALAVEN (Eribulin mesylate injection ) is a prescription medicine used to treat people with :
- Breast Cancer
- that has spread to other parts of the body, and
- who have already received certain types of anticancer medicines after the cancer has spread
- Liposarcoma
- that cannot be treated with surgery or has spread to other parts of the body, and
- who have received treatment with a certain type of anticancer medicine
It is not known if HALAVEN is safe and effective in children under 18 years of age.
What is the most important information I should know about HALAVEN?
HALAVEN can cause serious side effects. These serious side effects include:
- 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
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.
- 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.
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.
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Important Safety Information
- Your healthcare provider should do blood tests regularly to check your blood cell counts before you receive each dose of HALAVEN.
- HALAVEN may harm your unborn baby. Talk with your healthcare provider about birth control methods to prevent pregnancy while you receive HALAVEN
- 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
Ask your healthcare provider if you do not know.
What should I tell my healthcare provider before taking 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.
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.
What are the ingredients in HALAVEN?
Active ingredient: Eribulin mesylate
Other ingredient: Ethanol, water