Leaflet: Information for the user

Eribulina Zentiva 0.44 mg/ml injectable solution EFG

Read this leaflet carefully before you start taking 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 side effects, consult your doctor or nurse, even if they are not listed in this leaflet. See section 4.

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. Storage of Eribulina Zentiva

6. Contents of the pack and additional information

Eribulina Zentiva contains the active ingredient eribulina, and is a cancer medication that works by slowing down 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 tumor) when at least one other treatment has stopped working.

It is also used for the treatment of adult patients with advanced or metastatic liposarcoma (a type of cancer that appears in fatty tissue) when a previous treatment has stopped working.

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

Consult your doctor or nurse before starting to use Eribulina Zentiva if:

• you have liver problems,
• you have a fever or an infection,
• you experience numbness, tingling, pins and needles, sensitivity to touch, or muscle weakness,
• you have heart problems.

If you are affected by any of the above points, inform your doctor as they may want to stop or reduce your treatment.

Children and adolescents

Do not administer this medicine to children aged 0 to 18 years as it has no effect on them.

Other medicines and Eribulina Zentiva

Inform your doctor if you are using, have used recently, or may have to use any other medicine.

Pregnancy and breastfeeding

Eribulina Zentiva may cause severe congenital malformations and should not be used during pregnancy, unless it is clearly necessary after carefully considering all the risks for you and the baby. It may also cause permanent fertility problems in the future for men who take it, and you should consult your doctor before starting treatment. Women of childbearing age should use highly effective contraceptive methods during treatment with eribulina and for up to 7 months after treatment is completed.

Eribulina Zentiva should not be used during breastfeeding due to the possible risk to the child.

Men with fertile partners should not leave them pregnant while receiving eribulina. They should use effective contraceptive methods during treatment with eribulina and for up to 4 months after treatment is completed.

Driving and operating machines

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

Eribulina Zentiva contains ethanol (alcohol)

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

A qualified healthcare professional will administer Eribulina Zentiva as an injection into a vein 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 based on blood test results or other factors. After administration of Eribulina Zentiva, it is recommended to irrigate the vein with a saline solution to ensure the complete administration of Eribulina Zentiva.

How often will you be administered Eribulina Zentiva?

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 blood test results, it may be necessary for your doctor to delay administration of the medication until blood test results return to normal. At that time, your doctor may also decide to reduce the dose administered.

If you have any other questions about the use of this medication, ask your doctor.

In case of overdose or accidental ingestion, consult your doctor or pharmacist immediately or call the Toxicological Information Service. Phone 91 562 04 20, indicating the medication and the amount ingested.

Like all medicines, this medicine may cause side effects, although not everyone will experience them.

If you experience any of the following severe symptoms, stop taking Eribulina Zentiva and seek medical attention immediately:

• Fever, with very rapid 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 rare (may affect up to 1 in 100 people) and can be life-threatening and fatal.
• 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 eruptions 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 side effects:

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

• Decreased white blood cell or red blood cell count
• Fatigue or weakness
• Nausea, vomiting, constipation, diarrhea
• Numbness, tingling, or pins and needles
• 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 platelet count (which may lead to bruising or delayed bleeding)
• Infection with fever, pneumonia, chills
• Rapid heart rate, palpitations
• Dizziness, vertigo
• Increased tear production, conjunctivitis (redness and itching of the eye surface), nasal bleeding
• Dehydration, dry mouth, herpes labialis, oral thrush, indigestion, stomach pain or swelling
• Swelling of soft tissues, pain (specifically chest, back, and bone pain), muscle spasms or weakness
• Infections in the mouth, respiratory tract, and urinary tract, painful urination
• Irritation of the throat, nasal pain, increased nasal secretion, flu-like symptoms, throat pain
• Abnormal liver function test results, altered blood sugar, bilirubin, phosphate, potassium, magnesium, or calcium levels
• Inability to sleep, depression, altered sense of taste
• Rash, itching, nail problems, dry or red skin
• Excessive sweating (including nocturnal sweating)
• Tinnitus in the ears
• Pulmonary embolism
• Herpes zoster
• Swelling of the skin and numbness in the hands and feet

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

• Clotting in the blood
• Abnormal liver function test results (hepatotoxicity)
• Renal failure, blood or protein in the urine
• Pancreatitis
• Mouth ulcers

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

• A severe blood clotting disorder that can lead to extensive blood clots and internal bleeding

Reporting side effects

If you experience any type of side effect, consult your doctor or nurse, even if it is not listed in this prospectus. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use: https://www.notificaram.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

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

Do not use this medication after the expiration date that appears on the packaging after CAD. The expiration date is the last day of the month indicated.

This medication does not require special storage conditions.

Period of validity in use

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

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

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

Medicines should not be disposed of through the drains or in the trash. Ask your pharmacist how to dispose of the packaging and the medication that you no longer need. This will help to protect the environment.

Composition ofEribulina Zentiva

• The active ingredient is eribulina. Each vial of 2 ml contains mesylate of eribulina equivalent to 0.88 mg of eribulina.
• The other components are: anhydrous ethanol and water for injection, 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 transparent and colorless aqueous solution for injection with a pH of 6.0 to 9.0 that is presented in glass vials containing 2 ml of solution. Each box contains 1 or 6 vials.

Only some container sizes may be commercially marketed.

Holder of the marketing authorization

Zentiva, k.s.

U Kabelovny 130

Dolní Mecholupy

102 37 Prague 10

Czech Republic

Responsible for manufacturing

AqVida GmbH

Kaiser-Wilhelm-Str. 89

20355 Hamburg

Germany

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Zentiva Spain S.L.U.

Avenida de Europa, 19, Building 3, 1st floor.

28224 Pozuelo de Alarcón, Madrid

Spain

This medication is authorized in the member states of the European Economic Area with the following names:

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

Bulgaria:Eribulina Zentiva

France: Eribuline Zentiva

Italy, Spain: Eribulina Zentiva

Last review date of this leaflet: February 2025

Detailed information about this medication is available on the website of the Spanish Agency for Medicines and Medical Devices (AEMPS) http://www.aemps.gob.es/