ERIBULIN ZENTIVA 0.44 MG/ML SOLUTION FOR INJECTION EFG

Package leaflet: Information for the user

Introduction

Package leaflet: Information for the user

Eribulina Zentiva 0.44 mg/ml solution for injection EFG

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 questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if they are side effects not listed in this leaflet. See section 4.

Leaflet contents

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

1. What Eribulina Zentiva is and what it is used for

Eribulina Zentiva contains the active substance eribulin, and is an anticancer medicine that works by slowing the growth and spread of cancer cells.

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

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

2. What you need to know before using Eribulina Zentiva

Do not use Eribulina Zentiva

• 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 Eribulina Zentiva if:

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

If any of the above 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 it is not effective in this population.

Other medicines and Eribulina Zentiva

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

Pregnancy and breastfeeding

Eribulina Zentiva may cause severe congenital malformations and must not be used during pregnancy unless clearly necessary after careful consideration of all 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 the doctor before starting treatment. Women of childbearing age must use highly effective methods of contraception during treatment with eribulin and for up to 7 months after completion of treatment.

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

Men with partners of childbearing age must not make their partners pregnant while receiving eribulin. They must use effective contraception during treatment with eribulin and for up to 4 months after completion of treatment.

Driving and using machines

Eribulina Zentiva 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 Zentiva contains ethanol (alcohol)

This medicine contains 80 mg of alcohol (ethanol) per vial. The amount in one vial of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine.

3. How to use Eribulina Zentiva

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

How often will Eribulina Zentiva be administered?

Eribulina Zentiva 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. At that point, your doctor may also decide to reduce the dose administered.

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

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicology Information Service at telephone number 91 562 04 20, stating the medicine and the amount ingested.

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 Eribulina Zentiva and see a 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 septicemia, a severe and serious reaction to 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 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 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
• Pain in joints, muscles, and back
• Headache
• Hair loss

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

• 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 (specifically 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, sore throat
• Abnormal liver function test results, altered levels of blood sugar, bilirubin, phosphates, potassium, magnesium, or calcium
• 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
• Herpes zoster
• Skin swelling and numbness in hands and feet

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

• Blood clots
• Abnormal 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 1,000 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 an effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eribulina Zentiva

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

Do not use this medicine after the expiry date stated on the packaging after EXP. The expiry date refers to the last day of the month indicated.

This medicine requires no special storage conditions.

In-use stability

Chemical and physical in-use stability has been demonstrated for the undiluted solution in a syringe for 24 hours at 20 to 25 °C and for 96 hours at 2 to 8 °C.

Chemical and physical in-use stability has been demonstrated for the diluted solution (0.018 mg/ml to 0.18 mg/ml eribulina in sodium chloride (0.9%)) for 48 hours at a temperature of 2 to 8 °C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the responsibility for the storage times and conditions prior to use lies with the user and normally should not exceed 24 hours at 2 to 8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.

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

6. Contents of the container and other information

Composition of Eribulina Zentiva

• The active substance is eribulin. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg of eribulin.
• The other components are: anhydrous ethanol and water for injections, with hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment).

Appearance of the product and contents of the container

Eribulina Zentiva is a clear, colourless aqueous solution for injection with a pH of 6.0 to 9.0, supplied in glass vials containing 2 ml of solution. Each carton contains 1 or 6 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder

Zentiva, k.s.

U Kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer responsible for production

AqVida GmbH

Kaiser-Wilhelm-Str. 89

20355 Hamburg

Germany

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

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1

28224 Pozuelo de Alarcón, Madrid

Spain

This medicinal product is authorized in the European Economic Area Member States under the following names:

Czech Republic, Denmark, Germany, Lithuania, Norway, Sweden: Eribulin Zentiva

Bulgaria: ???????? ???????

France: Eribuline Zentiva

Italy, Spain: Eribulina Zentiva

Date of the most recent review of this leaflet: February 2025

Detailed information on this medicine is available on the website of the Spanish Agency for Medicines and Health Products (AEMPS) http://www.aemps.gob.es/