Eribulin

Generic name: eribulin
Brand name: Halaven
Dosage form: intravenous solution (1 mg/2 mL)
Drug class: Mitotic inhibitors

What is eribulin?

Eribulin is a prescription medicine that is used to treat breast cancer. It is used to treat soft tissue sarcoma.

Before taking eribulin, tell your doctor:

• If you are allergic to eribulin; any part of this medicine; or any other drugs, foods, or substances. Tell your doctor about the allergy and what signs you had.
• If you have any of these health problems: Long QT on ECG, low magnesium levels, or low potassium levels.
• If you are breast-feeding. Do not breast-feed while you take eribulin and for 2 weeks after your last dose.

This is not a list of all drugs or health problems that interact with eribulin.

Tell your doctor and pharmacist about all of your drugs (prescription or OTC, natural products, vitamins) and health problems. You must check to make sure that it is safe for you to take eribulin with all of your drugs and health problems. Do not start, stop, or change the dose of any drug without checking with your doctor.

What are some things I need to know or do while I take eribulin?

• Tell all of your health care providers that you take eribulin. This includes your doctors, nurses, pharmacists, and dentists.
• You may have more of a chance of getting an infection. Wash hands often. Stay away from people with infections, colds, or flu. Some infections have been very bad and even deadly.
• You may bleed more easily. Be careful and avoid injury. Use a soft toothbrush and an electric razor.
• If you have upset stomach, throwing up, diarrhea, or are not hungry, talk with your doctor. There may be ways to lower these side effects.
• Have blood work checked as you have been told by the doctor. Talk with the doctor.
• This medicine may affect being able to father a child. It is not known how long this effect lasts. Talk with the doctor.
• Men with a partner who may get pregnant must use birth control while taking eribulin and for some time after the last dose. Ask your doctor how long to use birth control. If your partner gets pregnant, call the doctor right away.
• This medicine may cause harm to the unborn baby if you take it while you are pregnant.
• Women must use birth control while taking eribulin and for some time after the last dose. Ask your doctor how long to use birth control. If you get pregnant, call your doctor right away.

How is eribulin best taken?

Use eribulin as ordered by your doctor. Read all information given to you. Follow all instructions closely.

• It is given into a vein for a period of time.

What do I do if I miss a dose?

• Call your doctor to find out what to do.

What are the side effects of eribulin that I need to call my doctor about immediately?

WARNING/CAUTION: Even though it may be rare, some people may have very bad and sometimes deadly side effects when taking a drug. Tell your doctor or get medical help right away if you have any of the following signs or symptoms that may be related to a very bad side effect:

• Signs of an allergic reaction, like rash; hives; itching; red, swollen, blistered, or peeling skin with or without fever; wheezing; tightness in the chest or throat; trouble breathing, swallowing, or talking; unusual hoarseness; or swelling of the mouth, face, lips, tongue, or throat.
• Signs of infection like fever, chills, very bad sore throat, ear or sinus pain, cough, more sputum or change in color of sputum, pain with passing urine, mouth sores, or wound that will not heal.
• Signs of electrolyte problems like mood changes, confusion, muscle pain or weakness, a heartbeat that does not feel normal, seizures, not hungry, or very bad upset stomach or throwing up.
• Signs of high blood sugar like confusion, feeling sleepy, more thirst, more hungry, passing urine more often, flushing, fast breathing, or breath that smells like fruit.
• A burning, numbness, or tingling feeling that is not normal.
• Very bad dizziness or passing out.
• Shortness of breath.
• Swelling in the arms or legs.
• Any unexplained bruising or bleeding.
• Feeling very tired or weak.
• Low mood (depression).
• A type of abnormal heartbeat (prolonged QT interval) can happen with eribulin. Call your doctor right away if you have a fast heartbeat, a heartbeat that does not feel normal, or if you pass out.

What are some other side effects of eribulin?

All drugs may cause side effects. However, many people have no side effects or only have minor side effects. Call your doctor or get medical help if any of these side effects or any other side effects bother you or do not go away:

• Feeling dizzy, tired, or weak.
• Headache.
• Hair loss.
• Constipation, diarrhea, stomach pain, upset stomach, throwing up, or feeling less hungry.
• Mouth irritation or mouth sores.
• Weight loss.
• Back, bone, joint, or muscle pain.
• Pain in arms or legs.
• Muscle spasm.
• More tears.
• Dry mouth.
• Change in taste.
• Signs of a common cold.
• Trouble sleeping.
• Anxiety.

These are not all of the side effects that may occur. If you have questions about side effects, call your doctor. Call your doctor for medical advice about side effects.

You may report side effects to the FDA at 1-800-332-1088. You may also report side effects at https://www.fda.gov/medwatch.

If overdose is suspected:

If you think there has been an overdose, call your poison control center or get medical care right away. Be ready to tell or show what was taken, how much, and when it happened.

How do I store and/or throw out eribulin?

• If you need to store eribulin at home, talk with your doctor, nurse, or pharmacist about how to store it.

Label

PRINCIPAL DISPLAY PANEL – SHIPPER LABEL