Eribulin Advanz Pharma 0.44 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eribulina Advanz Pharma 0.44 mg/ml injection solution EFG

eribulina

Read the 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, consult your doctor or nurse.
• If you experience any adverse reactions, consult your doctor or nurse, even if they are adverse reactions not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Eribulina Advanz Pharma is and what it is used for

Eribulina Advanz Pharma contains the active substance eribulina and is an anticancer medicine that works by slowing 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) when at least one other treatment 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) when a previous treatment has stopped being effective.

2. What you need to know before starting to use Eribulina Advanz Pharma

Do not use Eribulina Advanz Pharma:

• 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

Consult your doctor or nurse before starting eribulin treatment

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

If any of the above conditions affect you, inform your doctor, as they may wish to discontinue your treatment or reduce your dose.

Children and adolescents

Do not administer this medicine to children aged between 0 and 18 years, as its effects have not been established in this population.

Other medicines and Eribulina Advanz Pharma

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

Pregnancy, breastfeeding, and fertility

This medicine 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 who take it, and this should be discussed with your doctor before starting treatment. Women of childbearing potential must use effective contraception during treatment and for up to 3 months after completion of eribulin therapy.

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

Driving and using machines

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

Eribulina Advanz Pharma contains ethanol (alcohol)

This medicine contains 80 mg of alcohol (ethanol) per vial, equivalent to 40 mg/ml (4% w/v). The amount in 2 ml of this medicine is equivalent to less than 2 ml of beer or 0.8 ml of wine.

The small amount of alcohol contained in this medicine does not produce any noticeable effect.

3. How to use Eribulina Advanz Pharma

A qualified healthcare professional will administer this medicine 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 this medicine is 1.23 mg/m², although your doctor may adjust it depending on the results of blood tests or other factors. After administration of this medicine, it is recommended to flush the vein with a saline solution to ensure the complete dose is delivered.

Frequency of administration of Eribulina Advanz Pharma

This medicine 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 blood test results, your doctor may need to delay administration of the medicine until blood test results return to normal values. At that time, 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 experiences them.

If you experience any of the following serious symptoms, stop taking eribulin 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):

• Decrease in 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):

• Decrease in platelets (which may lead to bruising or longer time to stop bleeding)
• Infection with fever, pneumonia, chills
• Rapid heartbeat, hot flushes
• Dizziness, lightheadedness
• Increased tear production, conjunctivitis (redness and burning of the eye surface), nosebleeds
• Dehydration, dry mouth, cold sores, mouth fungal infections, indigestion, heartburn, abdominal pain or bloating
• 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 sugar, bilirubin, phosphates, potassium, magnesium, or calcium in the blood
• Difficulty sleeping, 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):

• Blood clots
• Abnormalities in liver function tests (hepatotoxicity)
• Kidney failure, blood or protein in urine
• Extensive lung inflammation that may lead to scarring
• Pancreatitis
• Mouth ulcers

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

• 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 it is a possible adverse effect 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 Eribulina Advanz Pharma

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 refers to the last day of the month indicated.

This medicine does not require any special storage conditions.

If Eribulina Advanz Pharma has been diluted for infusion, the diluted solution should be used immediately. If not used immediately, the diluted solution may be stored for no more than 48 hours at 25°C under ambient light, or for no more than 72 hours if stored between 2°C and 8°C.

If undiluted Eribulina Advanz Pharma solution has been transferred into a syringe, it should be stored at 25°C under ambient light for no more than 48 hours, or for no more than 72 hours at 2°C–8°C.

Medicines should 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 Eribulina Advanz Pharma

• The active substance is eribulina. One ml of solution contains eribulina mesylate equivalent to 0.44 mg of eribulina. Each 2 ml vial contains eribulina mesylate equivalent to 0.88 mg of eribulina.
• The other components are ethanol and water for injections, with possible presence in very small amounts of hydrochloric acid and sodium hydroxide.

Appearance of the product and contents of the pack

Eribulina Advanz Pharma is a clear, colourless solution free from visible particles, supplied in glass vials containing 2 ml of solution. Each carton contains 1 vial.

Marketing Authorization Holder

ADVANZ PHARMA Limited
Unit 17, Northwood House,
Northwood Crescent,
Dublin 9, D09 V504,
Ireland

Manufacturer

KeVaRo Group Ltd
9, Tsaritsa Eleonora str., office 23,
Sofia 1618,
Bulgaria

Or

Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000
Malta

For further information about this medicinal product, please contact the local representative of the Marketing Authorization Holder:

Advanz Pharma Spain S.L.U.
Paseo de la Castellana 135, 7th floor
Madrid – 28046 – Spain
Tel. +34 900 834 889
[email protected]

This medicinal product is authorized in the European Economic Area member states under the following names:

Austria: Eribulina Advanz Pharma 0.44 mg/ml Injektionslösung
Belgium: Eribulina Advanz Pharma 0.44 mg/ml Injektionslösung/ solution injectable/ oplossing voor injectie
Spain: Eribulina Advanz Pharma 0.44 mg/ml solución inyectable EFG
Finland: Eribulina Advanz Pharma 0.44 mg/ml injektioneste, liuos
France: Eribulina Advanz Pharma 0.44 mg/mL solution injectable
Ireland: Eribulina Advanz Pharma 0.44 mg/ml solution for injection
Iceland: Eribulina Advanz Pharma 0.44 mg/ml stungulyf, lausn
Italy: Eribulina Advanz Pharma
Norway: Eribulina Advanz Pharma
Portugal: Eribulina Advanz Pharma
Sweden: Eribulina Advanz Pharma 0.44 mg/ml injektionsvätska, lösning

Date of the most recent review of this leaflet: 06/2025