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The product codes for this leaflet are: EU/1/11/678/002, EU/1/11/678/001

 

Halaven 0.44 mg/ml solution for injection

Company Details

Eisai Ltd


European Knowledge CentreMosquito WayHatfieldHertfordshireAL10 9SN
Telephone:
Fax:
Medical Information e-mail:Lmedinfo@eisai.net
Out of Hours Telephone:
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Package leaflet: Information for the user

HALAVEN 0.44 mg/ml solution for injection

Eribulin

▼ This medicine is subject to additional monitoring. This will allow quick identification of new safety information. You can help by reporting any side effects you may get. See the end of section 4 for how to report side effects.

Read all of this leaflet carefully before you start using this medicine because it contains important information for you.

  • Keep this leaflet. You may need to read it again.
  • If you have any further questions, ask your doctor or nurse.
  • If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

What is in this leaflet

1. What HALAVEN is and what it is used for
2. What you need to know before you use HALAVEN
3. How to use HALAVEN
4. Possible side effects
5. How to store HALAVEN
6. Contents of the pack and other information

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1. What HALAVEN is and what it is used for

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

It is used for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) when at least one other therapy has been tried but has lost its effect.

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2. What you need to know before you use HALAVEN

Do not use HALAVEN:

  • if you are allergic to eribulin mesilate or any of the other ingredients of this medicine (listed in section 6)
  • if you are breast-feeding

Warnings and precautions

Talk to your doctor or nurse before using HALAVEN:

  • if you have liver problems
  • if you have a fever or an infection
  • if you experience numbness, tingling, prickling sensations, sensitivity to touch or muscle weakness
  • if you have heart problems

If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.

Other medicines and HALAVEN

Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility

HALAVEN may cause serious birth defects and should not be used if you are pregnant unless it is thought clearly necessary after carefully considering all the risk to you and the baby. It may also cause future permanent fertility problems in men if they take it and they should discuss this with their doctor before starting treatment. Women of childbearing age should use effective contraception during and up to 3 months after treatment with HALAVEN.

HALAVEN should not be used during breast-feeding because of the possibility of risk to the child.

Driving and using machines

HALAVEN may cause side effects such as tiredness (very common) and dizziness (common). Do not drive or use machines if you feel tired or dizzy.

HALAVEN contains small amounts of ethanol (alcohol)

This medicine contains small amounts of ethanol (alcohol), less than 100 mg in a vial.

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3. How to use HALAVEN

HALAVEN will be given to you by a doctor or nurse as an injection into a vein, over a period of 2 to 5 minutes. The dose you will receive is based on your body surface area (expressed in squared metres, or m2) which is calculated from your weight and height. The usual dose of HALAVEN is 1.23 mg/m2, but this may be adjusted by your doctor based on your blood test results or other factors.

How often will you be given HALAVEN?

HALAVEN is usually given on Days 1 and 8 of every 21-day cycle. Your doctor will determine how many cycles of treatment you should receive. Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal. The doctor may also then decide to reduce the dose you are given.

If you have any further questions about the use of this medicine, ask your doctor.

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4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following rare but serious symptoms, stop taking HALAVEN and seek medical attention straightaway:

  • Any difficulty breathing, or swelling of your face, mouth, tongue or throat. These are signs of an allergic reaction.

Other side effects:

Very common side effects (reported in at least 1 out of 10 patients) are:

  • Decrease in the number of white blood cells or red blood cells
  • Tiredness or weakness
  • Nausea, vomiting, constipation, diarrhoea
  • Numbness, tingling or prickling sensations
  • Fever
  • Loss of appetite, weight loss
  • Difficulty breathing, cough
  • Pain in the joints and muscles and back
  • Headache
  • Hair loss

Common side effects (reported in at least 1 out of 100 patients) are:

  • Decrease in the number of platelets (which may result in bruising or taking longer to stop bleeding)
  • Infection with fever, pneumonia, chills
  • Fast heart rate, flushing
  • Vertigo, dizziness
  • Increased production of tears, conjunctivitis (redness and soreness of the surface of the eye), nosebleed
  • Dehydration, dry mouth, mouth ulcers, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling
  • Swelling of soft tissues, pains (in particular chest, back and bone pain), muscle spasm or weakness
  • Mouth, respiratory and urinary tract infections, painful urination
  • Sore throat, sore or runny nose, flu-like symptoms, throat pain
  • Liver function test abnormalities, altered level of sugar, bilirubin, phosphates, potassium or magnesium in the blood
  • Inability to sleep, depression, changed sense of taste
  • Rash, itching, nail problems, dry or red skin
  • Excessive sweating (including night sweats)

Uncommon side effects (reported in less than 1 out of 100 patients) are:

  • Severe infections with blood poisoning (sepsis), shingles
  • Ringing in the ears
  • Blood clots
  • Abnormal liver function tests (hepatoxicity)
  • Swelling of the skin and numbness of the hands and feet
  • Kidney failure, blood or protein in the urine

Rare side effects (reported in less than 1 out of 1000 patients) are:

  • Inflammation of the pancreas
  • Widespread inflammation of the lungs which may lead to scarring
  • Widespread development of blood clots in the very tiny blood vessels with associated inability for the blood to clot in the bigger blood vessels leading to internal bleeding throughout the body

Reporting of side effects

If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Yellow Card Scheme Website: www.mhra.gov.uk/yellowcard

By reporting side effects you can help provide more information on the safety of this medicine.

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5. How to store HALAVEN

Keep this medicine out of the sight and reach of children.

Do not use this medicine after the expiry date which is stated on the carton and the vial after EXP. The expiry date refers to the last day of that month.

This medicine does not require any special storage conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

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6. Contents of the pack and other information

What HALAVEN contains

  • The active substance is eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg eribulin.
  • The other ingredients are ethanol and water for injections, with hydrochloric acid and sodium hydroxide possibly present in very small amounts.

What HALAVEN looks like and contents of the pack

HALAVEN is a clear, colourless aqueous solution for injection provided in glass vials containing 2 ml of solution. Each carton contains either 1 or 6 vials.

Marketing Authorisation Holder and Manufacturer

Eisai Europe Limited
European Knowledge Centre
Mosquito Way
Hatfield
Hertfordshire
AL10 9SN
United Kingdom
Tel:+44 (0) 845 676 1400

For any information about this medicine, please contact the local representative of the Marketing Authorisation Holder:

United Kingdom
Eisai Ltd.
Tel:+ 44 (0) 845 676 1400
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This leaflet was last revised in June 2014.

Detailed information on this medicine is available on the European Medicines Agency web site: http://www.ema.europa.eu


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