ERIBULINA ZENTIVA 0.44 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Eribulin Zentiva 0.44 mg/ml solution for injection EFG

Read all of this leaflet carefully before you start taking 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 experience any side effects, talk to your doctor or nurse, even if they are not listed in this leaflet. See section 4.

Contents of the pack

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

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

Eribulin Zentiva contains the active substance eribulin, and is a cancer 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 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 previous treatment has been used and is no longer effective.

2. What you need to know before you use Eribulin Zentiva

Do not use Eribulin Zentiva

• 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 Zentiva if:

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

If you are affected by any of the above, 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 aged 0 to 18 years as it has no effect on them.

Other medicines and Eribulin Zentiva

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

Pregnancy and breast-feeding

Eribulin Zentiva may cause serious 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 in the future if they take it, and they should discuss this with their doctor before starting treatment. Women of childbearing age should use highly effective contraceptive methods during treatment with eribulin and for 7 months after finishing treatment.

Eribulin Zentiva should not be used during breast-feeding due to the potential risk to the baby.

Men with female partners of childbearing age should not get them pregnant while receiving eribulin. They should use effective contraceptive methods during treatment with eribulin and for 4 months after finishing treatment.

Driving and using machines

Eribulin Zentiva 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 Zentiva contains ethanol (alcohol)

This medicine contains 80 mg of alcohol (ethanol) in each 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 Eribulin Zentiva

A qualified healthcare professional will give you Eribulin Zentiva 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 Eribulin Zentiva is 1.23 mg/m2, although your doctor may adjust it based on blood test results or other factors. After administration of Eribulin Zentiva, it is recommended to flush the vein with a saline solution to ensure that the full dose of Eribulin Zentiva is administered.

How often will you be given Eribulin Zentiva?

Eribulin Zentiva is usually given on days 1 and 8 of each 21-day cycle. Your doctor will determine how many cycles of treatment you should receive. Depending on blood test results, it may be necessary for your doctor 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 are given.

If you have any further questions on 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. Phone 91 562 04 20, indicating the medicine and the amount ingested.

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 Zentiva and go to your doctor immediately:

• Fever, with a very fast heart rate, rapid and shallow breathing, cold, 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 (affects 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 (affects 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):

• Decreased 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):

• Decreased number of platelets (which can lead to bruising or prolonged bleeding)
• Infection with fever, pneumonia, chills
• Fast heart rate, hot flushes
• Dizziness, dizziness
• 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 (especially chest, back and bone pain), muscle spasms or weakness
• Infections of the mouth, respiratory and urinary tract, pain when urinating
• Sore throat, nose pain, increased nasal secretion, flu-like symptoms, sore throat
• 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
• Ulcers in the mouth

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

• A serious 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 them directly to the Spanish Medicines Agency's online platform: https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eribulin Zentiva

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 after EXP. The expiry date is the last day of the month stated.

This medicine does not require any special storage conditions.

Shelf life

The chemical and physical stability of the undiluted solution in a syringe has been demonstrated for 24 hours between 20 and 25°C and 96 hours between 2 and 8°C.

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

From a microbiological point of view, the product should be used immediately. If not used immediately, the in-use storage times and conditions are the responsibility of the user and would normally not exceed 24 hours between 2 and 8°C, unless the dilution has been made in controlled and validated aseptic conditions.

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

What Eribulin Zentiva contains

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

Appearance and packaging

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

Not all pack sizes may be marketed.

Marketing authorisation holder

Zentiva, k.s.

U Kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Manufacturer

AqVida GmbH

Kaiser-Wilhelm-Str. 89

20355 Hamburg

Germany

You can request more information about this medicine from the local representative of the marketing authorisation holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Edificio 3, Planta 1.

28224 Pozuelo de Alarcón, Madrid

Spain

This medicine is authorised in the Member States of the European Economic Area under the following names:

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

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

France: Eribuline Zentiva

Italy, Spain: Eribulina Zentiva

Date of last revision 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/