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It is not known if HALAVEN is safe and effective in children under 18 years of age.
Before you receive HALAVEN, tell your healthcare 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 healthcare 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 birth control during treatment with HALAVEN and for at least 2 weeks after the final dose of HALAVEN.
° 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 3 1/2 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 healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
How will I receive HALAVEN?
HALAVEN is given by intravenous (IV) injection in your vein.
HALAVEN is given in “cycles” of treatment, with each cycle lasting 21 days.
HALAVEN is usually given on day 1 and day 8 of a treatment cycle.
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 QT prolongation). This can cause irregular heartbeats. Your healthcare 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 people with breast cancer include:
low white blood cell count (neutropenia)
low red blood cell count (anemia)
weakness or tiredness
hair loss (alopecia)
nausea
constipation
The most common side effects of HALAVEN in people with liposarcoma include:
tiredness
nausea
hair loss (alopecia)
constipation
stomach pain
fever
Your healthcare provider will do blood tests before and during treatment while you are taking HALAVEN. The most common changes to blood tests in people with liposarcoma include:
low white blood cell count (neutropenia)
decreased blood levels of potassium or calcium
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. 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. 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
Inactive Ingredients: ethanol, water
HALAVEN® is a registered trademark used by Eisai Inc. under license from Eisai R&D Management Co., Ltd.
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