What Halaven is used for and how to use it
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Halaven - Consumer Medicine Information

Manufacture: Eisai Inc.
Country: Canada
Condition: Breast Cancer, Breast Cancer, Metastatic, Liposarcoma, Metastatic Breast Cancer (Breast Cancer, Metastatic)
Class: Antineoplastics, Mitotic inhibitors
Form: Liquid solution, Intravenous (IV)
Ingredients: eribulin mesylate,ethanol, water

(Eribulin Mesylate) Injection

About this Medication

What the Medication is Used For

HALAVEN (HAL-ih-ven) is a prescription cancer medicine.

HALAVEN is used to treat patients with breast cancer that has spread to other parts of the body.

HALAVEN is used for patients who have already received at least two other types of anticancer medicines for the treatment of breast cancer that has spread.

What It Does

HALAVEN is an anti-cancer agent which works by stopping the growth of cancer cells.

When It Should not be Used

Do not use HALAVEN if you are allergic to eribulin mesylate, or halichondrin B, or any drug related to halichondrin B.

What the Medicinal Ingredient Is

Eribulin mesylate

What the Non medicinal Ingredients Are

Alcohol, hydrochloric acid, sodium hydroxide, water for injection.

What Dosage Form It Comes In

HALAVEN contains 1.0 mg eribulin mesylate per vial in 2 mL of solution.

Warnings and Precautions

Serios Warning and Precautions

HALAVEN should be prescribed and managed by a doctor experienced in the use of cancer drugs. Serious side effects with HALAVEN include:

  • Neutropenia (decrease in the number of white blood cells)
  • Abnormal electrical signal of the heart called “prolongation of the QT interval” (changes in heartbeat)
  • HALAVEN has not been studied in patients with severe hepatic (liver) impairment or End Stage Renal Disease (ESRD, a disease of the kidney).

BEFORE you use HALAVEN talk to your doctor or pharmacist about all of your medical conditions, including if you:

  • have low white blood cell counts or low platelet levels
  • have a fever (temperature above 38.1°C) or an infection
  • have heart problems including an abnormal electrical signal of the heart called “prolongation of the QT interval”(changes in heartbeat)
  • experience numbness, tingling or burning in your hands and feet
  • have liver or kidney problems
  • are pregnant or plan to become pregnant. You should not receive HALAVEN during pregnancy because it may harm your unborn baby. Talk with your health professional about how to prevent pregnancy while receiving HALAVEN, as you should use effective contraception during and for at least 3 months after receiving HALAVEN. Tell your health professional right away if you become pregnant or think you are pregnant while receiving HALAVEN
  • are breast feeding. It is not known if HALAVEN passes into breast milk. Breast feeding must be avoided.

HALAVEN may cause drowsiness or tiredness. Do not drive or operate machinery until you know how the medication affects you.

The safety and effectiveness of HALAVEN in patients under 18 years of age have not been established.

Interactions With This Medication

Tell your doctor before taking HALAVEN if you are taking or have recently taken any other medicines, including medicines obtained without a prescription.

HALAVEN may interact with the following medications;

  • drugs know to prolong the QT/QTc interval and/or cause torsade de pointes
  • drugs that decrease electrolyte levels

Proper Use of This Medication

Usual dose

1.4 mg/m2 body surface area given as an injection into the vein over 2 to 5 minutes on Days 1 and 8 of a 21-day treatment cycle.

During treatment with HALAVEN, you may also need to have other tests including blood tests.

Overdose

In case of drug overdose, contact a health professional,hospital department or regional Poison Control Centre immediately, even if there are no symptoms.

Side Effects and What to Do About Them

Possible side effects with the use of HALAVEN include:

Very common side effects (>10%)

  • low white or red blood cell count
  • weakness or tiredness
  • hair loss
  • numbness, tingling, or burning in your hands and feet (neuropathy)
  • nausea, vomiting, and constipation, or diarrhea
  • fever
  • muscle or joint pain, bone pain
  • headache
  • eating disorder (anorexia)
  • lost weight
  • shortness of breath
  • cough

Common side effects (10%)

  • inflammation of the mucosal lining of the mouth
  • dizziness, vertigo
  • swelling of hands and feet or limbs (edema peripheral)
  • skin rash, itchiness
  • abdominal pain
  • high blood pressure
  • anxiety, depression, trouble sleeping
  • changes in heart beat (prolongation of the QT interval)

Uncommon side effects (1%)

  • allergic reaction
  • hepatoxicity (inflammation of the liver)

Rare side effects (0.1%)

  • pancreatitis (inflammation of the pancreas)
  • breathing problems including persistent cough and/or shortness of breath

Tell your health professional about any side effect that bothers you or that does not go away.

These are not all the possible side effects with HALAVEN. For more information, ask your health professional.

Serious Side Effects, how Often They Happen and What to Do About Them

Symptom / effect Talk with your
doctor or
pharmacist
Stop taking
drug and
call your
doctor or
pharmacist
Only if
severe
In all
cases
Very Common (≥ 10%) Tiredness
Hair loss
Nausea,vomiting, constipation
Numbness,tingling,or burning inhands and feett
Diarrhea
Signs ofinfection(fever, chills, cough, burning or pain whenurinating)
Common (<10%) Swelling of hands, feet,or limbs
Abdominal pain
Muscle spasms or weakness
Changed heart beat (prolongation of the QT interval)
Uncommon(<1%) Allergic reaction
Hepatoxicity (inflammation of the liver)
Rare (<0.1%) Pancreatitis (inflammation of the pancreas)
Breathing problems including persistentcough and/or shortness of breath

frequency from postmarketing reports

This is not a complete list of side effects. For any unexpected effects while taking HALAVEN, contact your doctor or pharmacist.

How to Store It

Store up to 25°C.Excursions permitted to 30°C
Do not freeze.

Reporting Suspected Side Effects

You can report any suspected adverse reactions associated with the use of health products to the Canada Vigilance Program by one of the following 3 ways:

  • Report online at www.healthcanada.gc.ca/medeffect
  • Call toll-free at 1-866-234-2345
  • Complete a Canada Vigilance Reporting Form and:
    • Fax toll-free to 1-866-678-6789, or
    • Mail to: Canada Vigilance Program
      Health Canada
      Postal Locator 0701E
      Ottawa, Ontario
      K1A 0K9

Postage paid labels, Canada Vigilance Reporting Form and the adverse reaction reporting guidelines are available on the MedEffect™ Canada Web site at www.healthcanada.gc.ca/medeffect

NOTE: Should you require information related to the management of the side effect, contact your health professional. The Canada Vigilance Program does not provide medical advice.

More Information

This document plus the full product monograph, prepared for health professionals can be found by contacting the sponsor, Eisai Limited, at: 1-877-873-4724.