Halaven 0.44 mg/ml solution for injection

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

HALAVEN 0.44 mg/ml injection solution

eribulin

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

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience side effects, consult your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

Contents of the container and additional 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 slowing down the growth and spread of cancer cells.

It is used to treat adult patients with locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) after at least one prior therapy has stopped being effective.

It is also used to treat adult patients with advanced or metastatic liposarcoma (a type of cancer that arises in fatty tissue) after prior therapy has stopped being effective.

2. What you need to know before using HALAVEN

Do not use HALAVEN:

• if you are allergic to eribulin mesylate 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 starting HALAVEN

• if you have liver problems
• if you have 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 the above apply to you, inform your doctor, as they may wish to stop your treatment or reduce your dose.

Children and adolescents

Do not give this medicine to children aged between 0 and 18 years, as it is not effective in this population.

Other medicines and HALAVEN

Tell your doctor if you are taking, have recently taken, or might need to take any other medicines.

Pregnancy, breastfeeding and fertility

HALAVEN may cause severe congenital malformations and must not be used during pregnancy unless clearly necessary after careful consideration of the risks to both you and the baby. It may also cause permanent fertility problems in men; therefore, men should discuss this with their doctor before starting treatment. Women of childbearing age must use highly effective contraception during treatment with HALAVEN and for 7 months after treatment ends.

HALAVEN must not be used during breastfeeding due to the potential risk to the infant.

Men with partners of childbearing age must not make them pregnant while receiving HALAVEN. They must use effective contraception during treatment with HALAVEN and for 4 months after treatment ends.

Driving and using machines

HALAVEN may cause adverse effects such as fatigue (very common) and dizziness (common). Do not drive or operate machinery if you feel tired or dizzy.

HALAVEN contains ethanol (alcohol)

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

3. How to use HALAVEN

A qualified healthcare professional will administer HALAVEN to you as an intravenous injection over a period of 2 to 5 minutes. The dose you receive is based on your body surface area (expressed in square meters, or m2), calculated from your weight and height. The usual dose of HALAVEN is 1.23 mg/m2, although your doctor may adjust it depending on the results of blood tests or other factors. After administration of HALAVEN, the vein should be flushed with saline solution to ensure the complete dose of HALAVEN is delivered.

Frequency of HALAVEN administration

HALAVEN is usually administered on days 1 and 8 of each 21-day cycle. Your doctor will determine how many treatment cycles you should receive. Depending on the results of blood tests, your doctor may need to delay administration of the medicine until blood test results return to normal values. At that point, your doctor may also decide to reduce the dose administered to you.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone will experience them.

If you experience any of the following serious symptoms, stop taking HALAVEN and contact your doctor immediately:

• Fever, with very rapid heartbeat, fast and shallow breathing, cold, pale, moist or mottled skin, and/or confusion. These may be signs of a condition called sepsis, a severe and serious reaction 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 blisters on the skin, mouth, eyes, and genitals. These may be signs of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. The frequency of this condition is unknown, but it can be potentially fatal.

Other adverse effects:

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

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

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

• Decrease in the number of platelets (which may lead to bruising or prolonged bleeding)
• Infection with fever, pneumonia, chills
• Rapid heartbeat, hot flushes
• Dizziness, vertigo
• Increased tear production, conjunctivitis (redness and irritation of the eye surface), nosebleeds
• Dehydration, dry mouth, cold sores, mouth fungal infections, indigestion, stomach burning, abdominal pain or swelling
• Swelling of soft tissues, pain (particularly chest, back, and bone pain), muscle spasms or weakness
• Infections in the mouth, respiratory tract, or urinary tract, pain when urinating
• Sore throat, nasal pain, increased nasal discharge, flu-like symptoms, pharyngitis
• Abnormalities in liver function tests, altered levels of blood sugar, bilirubin, phosphates, potassium, magnesium, or calcium in the blood
• Inability to sleep, depression, altered sense of taste
• Rash, itching, nail problems, dry or red skin
• Excessive sweating (including night sweats)
• Ringing in the ears
• Blood clots in the lungs
• Shingles (herpes zoster)
• Skin swelling and numbness in hands and feet

Uncommon adverse 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
• Extensive lung inflammation that may lead to scarring
• Pancreatitis
• Mouth ulcers

Rare adverse effects (may affect up to 1 in 1000 people) are:

• A serious blood clotting disorder that may lead to widespread blood clot formation and internal bleeding

Reporting of adverse effects

If you experience any type of adverse effect, consult your doctor or nurse, even if they are possible adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of HALAVEN

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

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

No special storage conditions are required.

If HALAVEN is diluted for infusion, the diluted solution should be used immediately. If not used immediately, the diluted solution should be stored between 2 °C and 8 °C for no more than 72 hours.

If undiluted HALAVEN solution has been transferred into a syringe, it should be stored between 15 °C and 25 °C under ambient light for no more than 4 hours, or between 2 °C and 8 °C for no more than 24 hours.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of HALAVEN

• 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, with possible trace amounts of hydrochloric acid and sodium hydroxide.

Appearance of the product and contents of the pack

HALAVEN is an aqueous, clear, colorless injectable solution supplied in glass vials containing 2 ml of solution. Each carton contains 1 or 6 vials.

Marketing Authorization 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

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Date of the most recent review of this leaflet:

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