Halaven

Package leaflet: Information for the user

HALAVEN 0.44 mg/mL injection solution

eribulin
Please read this leaflet carefully before using this medicine because it contains important information for you.

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

Contents of this leaflet:

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

1. What HALAVEN is and what it is used for

HALAVEN contains the active substance eribulin and is an anticancer medicine that works by
inhibiting the growth and spread of cancer cells.
It is used in adults for metastatic or locally advanced breast cancer (breast cancer
that has spread beyond the original tumour) when at least one other therapy has been attempted but has not
been effective.
It is also used in adults for advanced or metastatic liposarcoma (a type of tumour originating in fatty
tissue) when a prior therapy has been attempted but has not been effective.

2. What you need to know before using HALAVEN

Do not use HALAVEN

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

Warnings and precautions
Talk to your doctor or nurse before using HALAVEN:

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

If any of these apply to you, inform your doctor, who may decide to discontinue treatment or
reduce the dose.
Children and adolescents
Do not administer this medicine to children aged between 0 and 18 years because it is not effective.
Other medicines and HALAVEN
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
HALAVEN may cause severe congenital malformations and must not be used during pregnancy,
except in cases of absolute necessity and after careful consideration of all risks to you and the
baby. It may also cause permanent fertility problems in men undergoing treatment; therefore, this aspect should be discussed with your doctor before starting
treatment. Women of childbearing age must use highly effective contraceptive methods during
treatment with HALAVEN and for 7 months after treatment ends.
HALAVEN must not be used during breastfeeding due to possible risks to the infant.
Men with partners of childbearing age must not father a child while receiving treatment with
HALAVEN. Men must use an effective contraceptive method while taking
HALAVEN and for 4 months after treatment ends.
Driving and using machines
HALAVEN may cause side effects such as fatigue (very common) and dizziness (common).
Do not drive or operate machinery if you experience fatigue or dizziness.
HALAVEN contains ethanol (alcohol)
This medicine contains small amounts of ethanol (alcohol), less than 100 mg per vial.

3. How to use HALAVEN

HALAVEN will be administered to you by a qualified healthcare professional through an intravenous infusion over 2 to 5 minutes. The dose is based on body surface area (expressed in square meters, m²), calculated according to your height and weight. The usual dose of HALAVEN is 1.23 mg/m², but your doctor may adjust this dose based on blood test results or other factors. To ensure the entire dose of HALAVEN is delivered, it is recommended that a saline solution be flushed through the same infusion line into the vein after administration of HALAVEN.

How often will HALAVEN be administered?
HALAVEN is usually administered on day 1 and day 8 of each 21-day cycle. Your doctor will determine the number of treatment cycles. Depending on blood test results, your doctor may decide to delay administration of the medicine until values return to normal. Your doctor may also decide to reduce the dose to be administered.

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

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone experiences them.
If you experience any of the following serious symptoms, stop taking HALAVEN and contact your doctor immediately:

• fever, with rapid heartbeat, fast shallow breathing, cold, pale, moist or mottled skin, and/or confusion. These may be signs of a condition called sepsis: a severe and overwhelming response to infection. Sepsis is uncommon (may affect up to 1 in 100 people) and can be life-threatening and lead to death
• difficulty breathing or swelling of the face, mouth, tongue or throat. These may be signs of an uncommon allergic reaction (may affect up to 1 in 100 people)
• severe skin rashes with blistering of the skin, mouth, eyes and genitals, which may be signs of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. This condition has an unknown frequency but can be life-threatening.

Other side effects:
Very common side effects (may affect more than 1 in 10 people) are:

• decreased number of white blood cells or red blood cells
• fatigue or weakness
• nausea, vomiting, constipation, diarrhoea
• sensations of numbness, tingling or prickling
• fever
• loss of appetite, weight loss
• difficulty breathing, cough
• joint, muscle and back pain
• headache
• hair loss

Common side effects (may affect up to 1 in 10 people) are:

• reduced number of platelets (which may cause bruising or increased time needed to stop bleeding)
• infection with fever, pneumonia, chills
• rapid heartbeat, hot flushes
• dizziness, vertigo
• increased tear production, conjunctivitis (redness and pain on the surface of the eye), nosebleeds
• dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling
• swelling of soft tissues, pain (particularly in the chest, back and bones), muscle spasms or weakness
• infections of the mouth, respiratory tract and urinary tract, painful urination
• sore throat, irritated or runny nose, flu-like symptoms, throat pain
• abnormalities in liver function tests, altered levels of glucose, bilirubin, phosphates, potassium, magnesium or calcium in the blood
• inability to sleep, depression, altered sense of taste
• skin rash, itching, nail problems, dry or red skin
• excessive sweating (including night sweats)
• ringing in the ears
• blood clots in the lungs
• herpes zoster (shingles)
• skin swelling and numbness of hands and feet

Uncommon side effects (may affect up to 1 in 100 people) are:

• blood clots
• abnormalities in liver function tests (hepatotoxicity)
• kidney failure, blood or protein in the urine
• widespread inflammation of the lungs, which may lead to scarring
• inflammation of the pancreas
• mouth ulcers

Rare side effects (may affect up to 1 in 1,000 people) are:

• severe disorder of blood clotting, causing widespread blood clots and internal bleeding.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly via the national reporting system listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

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 vial after "Exp". The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
If HALAVEN is diluted for infusion, the diluted solution must be used immediately. If not used immediately, the diluted solution should be stored at 2–8 °C for a maximum of 72 hours.
If undiluted HALAVEN solution has been transferred into a syringe, it should be stored at 15–25 °C under normal light conditions for a maximum of 4 hours, or at 2–8 °C for a maximum of 24 hours.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. This will help protect the environment.

6. Package contents and other information

What HALAVEN contains

• The active substance is eribulin. Each 2 mL vial contains eribulin mesilate equivalent to 0.88 mg of eribulin.
• The other components are ethanol and water for injections; hydrochloric acid and sodium hydroxide may be present in very small quantities.

Description of the appearance of HALAVEN and contents of the pack
HALAVEN is a clear, colourless aqueous injectable solution supplied in glass vials containing 2 mL of solution. Each cardboard pack contains 1 or 6 vials.
Marketing Authorisation Holder
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
e-mail: [email protected]
Manufacturer
Eisai GmbH
Edmund-Rumpler-Straße 3
60549 Frankfurt am Main
Germany
For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Eisai SA/NV Ewopharma AG
Tél/Tel: +32 (0)800 158 58 Tel: +370 5 248 73 50
България Luxembourg/Luxemburg
Ewopharma AG Eisai SA/NV
Teл: +359 2 962 12 00 Tél/Tel: + 32 (0)800 158 58
(Belgique/Belgien)
Česká republika Magyarország
Eisai GesmbH organizační složka Ewopharma Hungary Ltd.
Tel: + 420 242 485 839 Tel.: +36 1 200 46 50
Danmark Malta
Eisai AB Cherubino LTD
Tlf.: + 46 (0) 8 501 01 600 Tel: +356 21343270
(Sverige)
Deutschland Nederland
Eisai GmbH Eisai B.V.
Tel: + 49 (0) 69 66 58 50 Tel: + 31 (0) 900 575 3340
Eesti Norge
Ewopharma AG Eisai AB
Tel: +370 5 248 73 50 Tlf: + 46 (0) 8 501 01 600
(Sverige)
Ελλάδα Österreich
Eisai Ltd. Eisai GesmbH
Τηλ: + 44 (0)208 600 1400 Tel: + 43 (0) 1 535 1980-0
(Ηνωµένο Βασίλειο)
España Polska
Eisai Farmacéutica, S.A. Ewopharma AG Sp. z o.o.
Tel: + (34) 91 455 94 55 Tel.: +48 (22) 620 11 71
France Portugal
Eisai SAS Eisai Farmacêutica, Unipessoal Lda
Tél: + (33) 1 47 67 00 05 Tel: + 351 214 875 540
Hrvatska România
Ewopharma d.o.o. Ewopharma AG
Tel: +385 (0) 1 6646 563 Tel: +40 21 260 13 44
Ireland Slovenija
Eisai GmbH Ewopharma d.o.o.
Tel: + 49 (0) 69 66 58 50 Tel: +386 590 848 40
(Germany)
Ísland Slovenská republika
Eisai AB Eisai GesmbH organizační složka
Sími: + 46 (0)8 501 01 600 Tel: + 420 242 485 839
(Svíþjóð) (Česká republika)
Italia Suomi/Finland
Eisai S.r.l. Eisai AB
Tel: + 39 02 5181401 Puh/Tel: + 46 (0) 8 501 01 600
(Ruotsi)
Κύπρος Sverige
Eisai Ltd. Eisai AB
Τηλ: +44 (0)208 600 1400 Tel: + 46 (0) 8 501 01 600
(Ηνωµένο Βασίλειο)
Latvija United Kingdom (Northern Ireland)
Ewopharma AG Eisai GmbH
Tel: +371 677 04000 Tel: + 49 (0) 69 66 58 50
(Germany)
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu/.