ERIBULIN EVER PHARMA 0.44 MG/ML SOLUTION FOR INJECTION EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eribulina EVER Pharma 0.44 mg/ml injection solution 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 get any side effects, talk to your doctor or nurse, even if it is not listed in this leaflet. See section 4.

Contents of the leaflet

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

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

Eribulina EVER Pharma contains the active substance eribulina and is an anticancer 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 tumour) when at least one prior treatment has stopped being effective.

It is also used to treat adult patients with advanced or metastatic liposarcoma (a type of cancer arising in fatty tissue) when a previous treatment has stopped being effective.

2. What you need to know before starting to use Eribulina EVER Pharma

Do not use Eribulina EVER Pharma:

• if you are allergic to eribulin mesylate or to any of the other components of this medicine (listed in section 6).
• if you are breastfeeding.

Warnings and precautions

Talk to your doctor or nurse before starting treatment with Eribulina EVER Pharma

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

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

Children and adolescents

Do not give this medicine to children aged between 0 and 18 years, as it is not effective in this population.

Other medicines and Eribulina EVER Pharma

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

Pregnancy, breastfeeding and fertility

Eribulina EVER Pharma may cause severe congenital malformations and must not be used during pregnancy unless clearly necessary after careful consideration of the risks to both you and the baby. It may also cause permanent fertility problems in men, so this should be discussed with your doctor before starting treatment. Women of childbearing age must use effective contraception during treatment and for up to 3 months after completion of treatment with Eribulina EVER Pharma.

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

Driving and using machines

Eribulina EVER Pharma 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 EVER Pharma contains ethanol (alcohol)

2 ml vial

This medicine contains 79 mg of alcohol (ethanol) per 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) per vial. The amount in 3 ml of this medicine is equivalent to less than 3 ml of beer or 1 ml of wine.

The small amount of alcohol in this medicine will not produce any observable effects.

Eribulina EVER Pharma contains less than 23 mg of sodium (1 mmol) per ml; therefore, it is essentially “sodium-free”.

3. How to use Eribulina EVER Pharma

A qualified healthcare professional will administer Eribulina EVER Pharma 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 EVER Pharma 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 EVER Pharma, it is recommended to flush the vein with saline solution to ensure the complete dose of Eribulina EVER Pharma is delivered.

Frequency of administration of Eribulina EVER Pharma

Eribulina 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, your doctor may need to delay administration of the medicine until blood values return to normal. At that point, your doctor may also decide to reduce your dose.

If you use more Eribulina EVER Pharma than you should

In case of overdose, call the Toxicology Information Service at telephone number: 91 562 04 20, indicating the medication and the amount ingested.

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

4. Possible adverse effects

Like all medicines, this medicine can cause adverse effects, although not everyone experiences them.

If you experience any of the following serious symptoms, stop taking Eribulina EVER Pharma and seek medical help 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) are:

• 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
• Joint, muscle, and back pain
• Headache
• Hair loss

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

• 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 bloating
• Swelling of soft tissues, pain (especially chest, back, and bone pain), muscle spasms or muscle weakness
• Infections in the mouth, respiratory tract, or urinary tract, pain during urination
• Sore throat, nasal pain, increased nasal discharge, flu-like symptoms, pharyngitis
• Abnormalities in liver function tests, 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) are:

• Blood clots
• Abnormalities in liver function tests (hepatotoxicity)
• Kidney failure, blood or protein in the urine
• Extensive lung inflammation that may lead to scarring
• Inflammation of the pancreas
• Mouth ulcers

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

• 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 a possible adverse effect not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eribulina EVER Pharma

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

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

Do not store above 30°C.

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

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

From a microbiological standpoint, the product should be used immediately. If not used immediately, the duration and conditions of storage during use are the responsibility of the user and should normally not exceed 24 hours between 2°C and 8°C, unless dilution was carried out under controlled and validated aseptic conditions.

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

6. Contents of the container and additional information

Composition of Eribulina EVER Pharma

• The active substance is eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg of eribulin. Each 3 ml vial contains eribulin mesilate equivalent to 1.32 mg of eribulin.
• The other components are ethanol and water for injections, with possible trace amounts of hydrochloric acid and sodium hydroxide to adjust pH.

Appearance of the product and contents of the pack

Eribulina EVER Pharma is an aqueous, clear, colorless injectable solution, practically free from visible particles, supplied in glass vials closed with a rubber stopper and an aluminum cap with a plastic flip-off disc. The vials contain 2 ml or 3 ml of solution and are placed in a box.

Each carton contains 1 or 6 vials.

Only certain pack sizes may be commercially available.

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

For further information about this medicinal product, contact the local representative of the Marketing Authorization Holder:

EVER Pharma Therapeutics Spain, S.L.
C/ Toledo 170
28005 Madrid
Spain

Date of latest revision of this package leaflet: 03/2024

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

This information is intended for healthcare professionals only.

For further information, consult the Summary of Product Characteristics.