ERIBULINA ADVANZ PHARMA 0.44 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Eribulin Advanz Pharma 0.44 mg/ml Solution for Injection EFG

eribulin

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.

Contents of the pack

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

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

Eribulin Advanz Pharma contains the active substance eribulin and is a cancer medicine that works by slowing down or stopping 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 tumor) when at least one other treatment has been used and is no longer effective.

It is also used to treat adult patients with advanced or metastatic liposarcoma (a type of cancer that occurs in fat tissue) when another treatment has been used previously and is no longer effective.

2. What you need to know before you use Eribulin Advanz Pharma

Do not use Eribulin Advanz Pharma:

• if you are allergic to eribulin mesylate 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 you start using eribulin

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

If you are affected by any of these, tell your doctor as they may want to stop your treatment or reduce your dose.

Children and adolescents

Do not give this medicine to children from 0 to 18 years old as it is not effective in them.

Other medicines and Eribulin Advanz Pharma

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

Pregnancy, breast-feeding, and fertility

This medicine may cause severe birth defects and should not be used during pregnancy unless clearly necessary after careful consideration of all risks to you and your baby. It may also cause permanent fertility problems in men if taken, and they should discuss this with their doctor before starting treatment. Women of childbearing age should use effective contraceptive methods during and up to 3 months after finishing treatment with eribulin.

This medicine should not be used during breast-feeding due to the potential risk to the baby.

Driving and using machines

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

Eribulin Advanz Pharma contains ethanol (alcohol)

This medicine contains 80 mg of alcohol (ethanol) in each vial, which is equivalent to 40 mg/ml (4% p/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 in this medicine does not have any noticeable effect.

3. How to use Eribulin Advanz Pharma

A healthcare professional will give you this medicine as an injection into a vein over a period of 2 to 5 minutes. The dose you receive will be 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, but your doctor may adjust it based on blood test results or other factors. After administration of this medicine, it is recommended to flush the vein with a saline solution to ensure that the full dose of this medicine is administered.

Frequency of administration of Eribulin Advanz Pharma

This medicine is usually given on days 1 and 8 of each 21-day cycle. Your doctor will decide how many cycles of treatment 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. At that time, your doctor may also decide to reduce the dose you receive.

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

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 serious symptoms, stop taking eribulin and see a doctor immediately:

• Fever, with a very fast heartbeat, rapid and shallow breathing, cool, pale, moist, or mottled skin, and/or confusion. These may be signs of a condition called septicemia, a severe and life-threatening reaction to an infection. Septicemia 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 a rare allergic reaction (may affect up to 1 in 100 people).
• Severe skin rash 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 not known, but it can be potentially fatal.

Other side effects:

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

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

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

• Decrease in the number of platelets (which can lead to bruising or prolonged bleeding)
• Infection with fever, pneumonia, chills
• Fast heartbeat, hot flushes
• Dizziness, dizziness when standing up
• Increased tear production, conjunctivitis (redness and irritation of the eye surface), nosebleeds
• Dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling
• Swelling of soft tissues, pain (including chest, back, and bone pain), muscle spasms or weakness
• Infections of the mouth, respiratory tract, and urinary tract, pain when urinating
• Sore throat, nose pain, increased nasal secretion, flu-like symptoms, pharyngitis
• Abnormalities in liver function tests, altered levels of sugar, bilirubin, phosphates, potassium, magnesium, or calcium in the blood
• Insomnia, depression, altered sense of taste
• Rash, itching, nail problems, dryness or redness of the skin
• Excessive sweating (including night sweats)
• Ringing in the ears
• Blood clots in the lungs
• Shingles
• Swelling of the skin and numbness in hands and feet

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

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

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

• A severe blood clotting disorder that can lead to widespread blood clot formation and internal bleeding.

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. You can also report side effects directly through the Spanish Pharmacovigilance System for Human Use Medicines: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eribulin Advanz Pharma

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 is the last day of the month shown.

This medicine does not require any special storage conditions.

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

If Eribulin Advanz Pharma as an undiluted solution has been transferred to a syringe, it should be stored at 25°C and ambient light for no more than 48 hours or 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eribulin Advanz Pharma

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

Appearance and pack contents

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

Marketing authorisation 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

You can request more information about this medicine from the local representative of the marketing authorisation 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 medicine is authorised in the Member States of the European Economic Area 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 last revision of this leaflet 06/2025