Halaven is a cancer medicine that interferes with the growth and spread of cancer cells in the body.

Halaven is used to treat breast cancer that has spread to other parts of the body (metastatic).

Halaven is also used to treat liposarcoma, a rare type of cancer that develops in fatty tissue anywhere in the body. It is used for liposarcoma that cannot be treated with surgery, or has spread throughout the body.

Halaven is usually given after at least two other cancer treatments did not work or have stopped working.

Do not use Halaven if you are pregnant. It could harm the unborn baby.

Before you receive Halaven, tell your doctor if you have liver or kidney disease, congestive heart failure, a heart rhythm disorder, a personal or family history of Long QT syndrome, or an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Halaven can weaken (suppress) your immune system, and you may get an infection or bleed more easily. Call your doctor if you have unusual bruising or bleeding, or signs of infection (fever, chills, cough, or painful urination).

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Call your doctor at once if you have a serious side effect while taking Halaven such as fever, chills, body aches, flu symptoms, mouth sores, pain or burning when you urinate, pale skin, feeling light-headed or short of breath, fast or uneven heart rate, severe numbness or tingling in your hands and feet, extreme thirst, increased urination, leg discomfort, muscle weakness or limp feeling.

Halaven is given as an infusion into a vein. A healthcare provider will give you this injection.

Halaven is given in a 21-day treatment cycle. You may need to use the medicine only during the first 1 to 2 weeks of each cycle. Your doctor will determine how long to treat you with this medicine.

Halaven can weaken (suppress) your immune system, and you may get an infection or bleed more easily. Your blood will need to be tested often. Your cancer treatments may be delayed based on the results.

Your heart function may also need to be checked using an electrocardiograph or ECG (sometimes called an EKG).

Usual Adult Dose for Breast Cancer:

1.4 mg/m2 IV over 2 to 5 minutes on days 1 and 8 of a 21-day cycle

Comments:
-This drug should be administered under the supervision of a qualified physician experienced in the appropriate use of cytotoxic medicinal products.
-Patients may experience nausea or vomiting. Antiemetic prophylaxis including corticosteroids should be considered.
-Peripheral neuropathy should be assessed and complete blood cell counts should be obtained prior to each dose.

Use: For the treatment of patients with metastatic breast cancer who have previously received at least 2 chemotherapeutic regimens for the treatment of metastatic disease. Prior therapy should have included an anthracycline and a taxane in either the adjuvant or metastatic setting.

You should not use Halaven if you are allergic to eribulin.

To make sure Halaven is safe for you, tell your doctor if you have ever had:

• liver disease;

• kidney disease;

• heart problems;

• long QT syndrome (in you or a family member); or

• an electrolyte imbalance (such as low levels of potassium or magnesium in your blood).

Eribulin can harm an unborn baby if the mother or the father is using this medicine.

• If you are a woman, do not use Halaven if you are pregnant. Use effective birth control to prevent pregnancy while you are using this medicine and for at least 2 weeks after your last dose.

• If you are a man, use effective birth control if your sex partner is able to get pregnant. Keep using birth control for at least 3.5 months (14 weeks )after your last dose.

• Tell your doctor right away if a pregnancy occurs while either the mother or the father is using Halaven.

This medicine may affect fertility (ability to have children) in both men and women. However, it is important to use birth control to prevent pregnancy because eribulin can harm an unborn baby.

Do not breastfeed while using this medicine, and for at least 2 weeks after your last dose.

Call your doctor for instructions if you miss an appointment for your Halaven injection.

Seek emergency medical attention or call the Poison Help line at 1-800-222-1222.

Overdose symptoms may include signs of infection such as fever or chills.

Avoid being near people who are sick or have infections. Tell your doctor at once if you develop signs of infection.

Get emergency medical help if you have signs of an allergic reaction to Halaven (hives, difficult breathing, swelling in your face or throat) or a severe skin reaction (fever, sore throat, burning eyes, skin pain, red or purple skin rash with blistering and peeling).

Call your doctor at once if you have:

• chest pain, severe dizziness, fast or pounding heartbeats;

• numbness, tingling, or burning pain in your hands or feet;

• pain or burning when you urinate;

• low calcium level - muscle spasms or contractions, numbness or tingly feeling (around your mouth, or in your fingers and toes);

• low potassium level - leg cramps, constipation, irregular heartbeats, fluttering in your chest, increased thirst or urination, numbness or tingling, muscle weakness or limp feeling; or

• low blood cell counts - fever, chills, tiredness, mouth sores, skin sores, easy bruising, unusual bleeding, pale skin, cold hands and feet, feeling light-headed or short of breath.

Your cancer treatments may be delayed or permanently discontinued if you have certain side effects.

Common Halaven side effects may include:

• low blood cell counts;

• low calcium or potassium levels;

• nausea, constipation;

• hair loss; or

• feeling tired or weak.

This is not a complete list of side effects and others may occur. Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.

Other drugs may interact with eribulin, including prescription and over-the-counter medicines, vitamins, and herbal products. Tell your doctor about all your current medicines and any medicine you start or stop using.