ERIBULINA EVER PHARMA 0.44 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

Eribulin EVER Pharma 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 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 package leaflet

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

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

Eribulin EVER Pharma 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 start using Eribulin EVER Pharma

Do not use Eribulin EVER 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 EVER Pharma

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

If you are affected by any of the above, inform 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 has no effect on them.

Other medicines and Eribulin EVER Pharma

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

Pregnancy, breast-feeding, and fertility

Eribulin EVER Pharma 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 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 EVER Pharma.

Eribulin EVER Pharma should not be used during breast-feeding due to the possible risk to the baby.

Driving and using machines

Eribulin EVER Pharma 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 EVER Pharma contains ethanol (alcohol)

2 ml vial

This medicine contains 79 mg of alcohol (ethanol) in each vial. The amount in 2 ml of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine.

3 ml vial

This medicine contains 118.5 mg of alcohol (ethanol) in each vial. The amount in 3 ml of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.

The reduced amount of alcohol in this medicine will not produce noticeable effects.

Eribulin EVER Pharma containsless than 23 mg of sodium (1mmol) per ml; it is essentially "sodium-free".

3. How to use Eribulin EVER Pharma

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

Frequency of administration of Eribulin EVER Pharma

Eribulin EVER Pharma 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 the doctor to delay administration of the medicine until blood test results return to normal. At that time, the doctor may also decide to reduce the dose administered.

If you use more Eribulin EVER Pharma than you should

In case of overdose, call the Toxicology Information Service, phone: 91 562 04 20, indicating the medicine and the amount taken.

If you have any other questions about 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 EVER Pharma and go to your doctor immediately:

• Fever, with a very fast heart rate, rapid and shallow breathing, cold, pale, damp, 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) are:

• 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) are:

• Decreased number of platelets (which can lead to bruising or prolonged bleeding)
• Infection with fever, pneumonia, chills
• Fast heart rate, hot flashes
• Dizziness, dizziness
• Increased tear production, conjunctivitis (redness and irritation of the eye surface), nosebleeds
• Dehydration, dry mouth, cold sores, mouth fungus, 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) are:

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

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

• A serious blood clotting disorder that can lead to extensive 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 through the Spanish Medicines Agency's website: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eribulin EVER 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.

Do not store above 30°C.

Chemical and physical stability has been demonstrated for the use as an undiluted solution in a syringe for up to 8 hours between 15°C and 25°C and with natural or artificial light, and up to 32 hours between 2°C and 8°C.

Chemical and physical stability has been demonstrated for the use as a diluted solution (0.012 mg/ml to 0.18 mg/ml of eribulin in sodium chloride 9 mg/ml [0.9%] injection solution) for up to 8 hours between 15-25°C and natural light, and up to 48 hours between 2-8°C, unless the dilution has taken place in controlled and validated aseptic conditions.

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 normally should not be longer than 24 hours between 2°C and 8°C, unless the dilution has taken place 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 further information

Composition of Eribulin EVER Pharma

• The active substance is eribulin. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg of eribulin. Each 3 ml vial contains eribulin mesylate equivalent to 1.32 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, for pH adjustment.

Appearance and pack contents

Eribulin EVER Pharma is a clear and colorless aqueous solution for injection, practically free from visible particles, presented in glass vials closed with a rubber stopper and an aluminum cap with a plastic flip-off disk. The vials contain 2 ml or 3 ml of solution and are placed in a carton.

Each carton contains 1 or 6 vials.

Not all pack sizes may be marketed.

Marketing authorization holder

EVER Valinject GmbH

Oberburgau 3

4866 Unterach am Attersee,

Austria

Manufacturer

Oncomed Manufacturing a.s

Karasek 2229/1b

Brno Rechcovice

62100 Czech Republic

EVER Pharma Jena GmbH

Brüsseler Str. 18,

07747 Jena,

Germany

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

EVER Pharma Therapeutics Spain, S.L.

C/ Toledo 170

28005 Madrid

Spain

Date of last revision of this leaflet: 03/2024

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/)

This information is intended only for healthcare professionals.

For more information, consult the Summary of Product Characteristics.