HALAVEN 0.44 mg/ml solution for injection

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 two other therapies have been tried but have lost their effect.

Do not use HALAVEN

• if you are allergic (hypersensitive) to eribulin mesylate or any of the other ingredients of HALAVEN
• if you are breastfeeding

Take special care with 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.

Taking other medicines

Please tell your doctor if you are taking or have recently taken any other medicines, including herbal supplements and medicines obtained without a prescription.

Pregnancy and breastfeeding

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 breastfeeding 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.

Important information about some of the ingredients of HALAVEN

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

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 m 2) which is calculated from your weight and height. The usual dose of HALAVEN is 1.23 mg/m 2, 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 product 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 product, ask your doctor.

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

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
• Pain in the joints and muscles
• 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, 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, 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
• Sore throat, red, sore or runny nose, flu-like symptoms
• Liver function test abnormalities, altered level of sugar, phosphates, potassium or magnesium in the blood
• Weight loss
• Inability to sleep, depression, changed sense of taste
• Difficulty breathing, cough, throat pain
• Rash, itching, swelling and numbness of the hands and feet, 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), cold sores, shingles
• Ringing in the ears
• Blood clots
• Pneumonia
• High levels of bilirubin in the blood
• Local swelling of the skin
• Kidney failure, blood or protein in the urine, painful urination

If any of the side effects gets serious, or if you notice any side effects not listed in this leaflet, please tell your doctor.

Keep out of the reach and sight of children.

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

This medicinal product does not require any special storage conditions.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help to protect the environment.

What HALAVEN contains

• The active substance is eribulin. Each 2 ml vial contains 0.88 mg of eribulin (as mesylate).
• 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

+44 (0) 20 7538 7075
+44 (0) 800 001 4612

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

BelgiëBelgiqueBelgien Eisai Europe Ltd. TélTel 32 0 2 735 45 34 LuxembourgLuxemburg Eisai Europe Ltd. TélTel 32 0 2 735 45 34 BelgiqueBelgien

Eisai Ltd. Te. 359 2 810 39 96 Magyarország Eisai GesmbH Tel. 36 1 230 43 20

eská republika Eisai GesmbH organizaní sloka Tel. 420 242 485 839 Malta Associated Drug Company Ltd. Tel 356 2124 2751

Nederland Eisai B.V. TélTel 31 0 900 575 3340 Danmark Eisai AB Tlf 46 0 8 501 01 600 Sverige

Deutschland Eisai GmbH Tel 49 0 69 66 58 50 Norge Eisai AB Tlf 46 0 8 501 01 600 Sverige

Österreich Eisai GesmbH Tel 43 0 1 535 1980-0 Eesti Eisai Ltd. Tel 44 020 7538 7075 Ühendkuningriik

Arriani Pharmaceuticals S.A. 30 210 668 3000 Polska Eisai Ltd. Tel. 44 020 7538 7075 Wielka Brytania

España Eisai Farmacéutica, S.A. Tel 34 91 455 94 55 Portugal Eisai Farmacêutica, Unipessoal Lda Tel 351 214 875 540

France Eisai SAS Tél 33 1 47 67 00 05 România Eisai Ltd. Tel 40 21 301 7469

Slovenija Eisai Ltd. Tel 386 0 1 426 7015 Ireland Eisai Ltd. Tel 44 0 208 600 1400 United Kingdom

Ísland Eisai AB Sími 46 08 501 01 600 Svíjóð Slovenská republika Eisai GesmbH organizaní sloka Tel. 420 242 485 839 eská republika

Italia Eisai S.r.l. Tel 39 02 5181401 SuomiFinland Eisai AB PuhTel 46 0 8 501 01 600 Ruotsi

Sverige Eisai AB Tel 46 0 8 501 01 600 Eisai Ltd. 44 020 7538 7075

United Kingdom Eisai Ltd. Tel 44 0 845 676 1400 Latvija Eisai Ltd. Tel 44 020 7538 7075 Anglija

Lietuva
Eisai Ltd.
Tel. +44 (0)20 7538 7075
(Jungtin- Karalyst-)

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