Package leaflet: Information for the user

Eribulin EVER Pharma, 0.44 mg/mL, concentrate for solution for infusion
Eribulinum
Please read all of this leaflet carefully before this medicine is given to you 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 get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. See section 4.

Contents of the leaflet

What Eribulin EVER Pharma is and what it is used for
What you need to know before you are given Eribulin EVER Pharma
How Eribulin EVER Pharma is given
Possible side effects
How to store Eribulin EVER Pharma
Contents of the pack and other information

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

Eribulin EVER Pharma contains a substance called eribulin and is a cancer medicine that works by
inhibiting the growth and spread of cancer cells.
It is used in adults to treat advanced breast cancer or metastatic breast cancer (breast cancer that has
spread beyond the original tumour), when at least one other therapy has been tried but is no longer effective.
It is also used in adults to treat advanced liposarcoma or metastatic liposar游戏副本

2. Important information before using Eribulin EVER Pharma

When not to use Eribulin EVER Pharma:

if the patient is allergic to eribulin mesylate or any of the other ingredients of this medicine (listed in section 6)
if the patient is breastfeeding.

Warnings and precautions
Before starting treatment with Eribulin EVER Pharma, discuss this with your doctor or
nurse:

if the patient has liver disease
if the patient has fever or infection
if the patient has previously experienced numbness, tingling, skin prickling sensation, touch sensitivity, or muscle weakness
if the patient has heart disease

If any of the above symptoms occur, inform the doctor, who may suspend treatment or reduce the dose.
Children and adolescents
This medicine should not be given to children and adolescents aged 0 to 18 years due to lack of efficacy.
Eribulin EVER Pharma and other medicines
Inform your doctor about all medicines the patient is currently taking or has recently taken, as well as any medicines the patient plans to take.
Pregnancy, breastfeeding and effects on fertility
Eribulin EVER Pharma may cause severe birth defects and should not be used in pregnant women unless clearly necessary, after careful consideration of the risks to both mother and child. The medicine may also cause permanent fertility problems in men who take it. Men should discuss this thoroughly with their doctor before starting treatment. Women of childbearing potential must use an effective method of contraception during treatment and for at least 3 months after completion of treatment with Eribulin EVER Pharma. Eribulin EVER Pharma must not be used during breastfeeding due to the potential risk to the infant.
Driving and operating machinery
Eribulin EVER Pharma may cause adverse effects such as fatigue (very common) and dizziness (common). Patients should not drive or operate machinery if they experience fatigue or dizziness.
Eribulin EVER Pharma contains ethanol (alcohol)
2 mL vial
This medicine contains 79 mg of alcohol (ethanol) per vial. The amount of alcohol 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 of alcohol 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 cause noticeable effects.
Eribulin EVER Pharma contains less than 1 mmol (23 mg) of sodium per mL, meaning the medicine is considered "sodium-free".

3. How to use Eribulin EVER Pharma

Eribulin EVER Pharma will be administered to the patient by qualified medical personnel as an intravenous injection lasting from 2 to 5 minutes. The dose the patient receives depends on their body surface area (BSA), expressed in square meters (m²), which is calculated based on body weight and height. The usual dose of Eribulin EVER Pharma is 1.23 mg/m² BSA, but the physician may adjust the dose individually depending on blood test results or other factors. To ensure the entire dose of Eribulin EVER Pharma is delivered, after administration of the drug, a flush with sodium chloride solution should be given through the intravenous infusion set.

How often will Eribulin EVER Pharma be administered to the patient?
Eribulin EVER Pharma is usually administered on Day 1 and Day 8 of each 21-day treatment cycle. The treating physician will determine the number of treatment cycles the patient should receive. Depending on the patient's blood test results, the physician may temporarily withhold administration of the drug until blood test values return to normal. The physician may also decide to reduce the dose administered to the patient.

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

4. Possible adverse reactions

Like all medicines, this medicine can cause adverse reactions, although not everyone experiences them.
If any of the following severe symptoms occur in the patient, they should
discontinue taking Eribulin EVER Pharma and contact their doctor immediately:

Fever with rapid heartbeat, sudden shallow breathing, feeling cold, paleness, moist skin or skin spots, and/or confusion. These may be symptoms of a condition called sepsis – a severe and serious reaction to infection. Sepsis occurs uncommonly (may occur in no more than 1 in 100 people), can be life-threatening, and may result in death.
Any difficulty breathing or swelling of the face, lips, tongue or throat. These may be symptoms of an uncommon allergic reaction (may occur in no more than 1 in 100 people).
Severe cases of skin rash with blisters on the skin, mouth, eyes, and genital organs. These may be symptoms of a disease called Stevens-Johnson syndrome/toxic epidermal necrolysis. The frequency of this condition is unknown, but it may be life-threatening.

Other adverse reactions:
Very common adverse reactions (may occur in more than 1 in 10 people) are:

Decreased number of white or red blood cells
Fatigue or weakness
Nausea, vomiting, constipation, diarrhoea
Numbness, tingling and prickling sensations
Fever
Loss of appetite, weight loss
Difficulty breathing, cough
Joint, muscle and back pain
Headache
Hair loss

Common adverse reactions (may occur in no more than 1 in 10 people) are:

Decreased number of platelets (which may lead to bruising and prolonged bleeding time)
Infection with fever, pneumonia, chills
Rapid heartbeat, hot flushes
Dizziness
Watery eyes, conjunctivitis (redness and pain in the surface of the eye), nosebleeds
Dehydration, dry mouth, rash, oral thrush, indigestion, heartburn, abdominal pain or swelling
Soft tissue swelling, aches (particularly in the chest, spine and bones), muscle cramps or weakness
Infections of the mouth, respiratory tract and urinary tract, pain during urination
Sore throat, nasal inflammation or rhinitis, flu-like symptoms, throat pain
Abnormal liver function test results, changes in blood levels of sugar (glucose), bilirubin, phosphates, potassium, magnesium or calcium
Insomnia, depression, altered taste sensation
Difficulty breathing, cough, sore throat
Rash, itching, nail changes, dry or red skin
Excessive sweating (including night sweats)
Ringing in the ears
Blood clots in the lungs
Shingles
Skin swelling and numbness in hands and feet

Uncommon adverse reactions (may occur in no more than 1 in 100 people) are:

Blood clots
Abnormal liver function test results (hepatotoxicity)
Kidney failure, presence of blood or protein in urine
Extensive lung inflammation which may lead to scarring
Pancreatitis
Mouth ulcers

Rare adverse reactions (may occur in no more than 1 in 1,000 people) are:

Severe disorders of blood coagulation, leading to formation of clots throughout the body and internal bleeding.

Reporting of adverse reactions
If any adverse reactions occur, including any not listed in this leaflet, inform your doctor or nurse. Adverse reactions can be reported directly to the Department of Monitoring Adverse Drug Reactions of the Office for Registration of Medicinal Products, Medical Devices and Biocidal Products, Al. Jerozolimskie 181 C, 02-222 Warsaw, tel.: +48 22 49 21 301, fax: +48 22 49 21 309, website: https://smz.ezdrowie.gov.pl
Adverse reactions can also be reported to the marketing authorization holder.
Reporting adverse reactions helps provide more information on the safety of this medicine.

5. How to store Eribulin 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 stated month.
Do not store above 30°C.
Chemical and physical stability of the undiluted solution in the syringe has been demonstrated for up to 8 hours at a temperature of 15 to 25°C under indoor light, or for up to 32 hours at a temperature of 2 to 8°C.
Chemical and physical stability of the diluted solution [from 0.012 mg/mL to 0.18 mg/mL eribulin in 9 mg/mL (0.9%) sodium chloride injection solution] has been demonstrated for 8 hours at a temperature of 15 to 25°C under indoor light and for up to 48 hours at a temperature of 2 to 8°C, provided that dilution was carried out under controlled and validated aseptic conditions.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the responsibility for storage conditions and duration prior to use lies with the user. Usually, this period should not exceed 24 hours at a temperature of 2 to 8°C, provided that dilution was 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 no longer required. Such measures will help protect the environment.

6. Contents of the package and other information

What Eribulin EVER Pharma contains

The active substance is eribulin. Each 2 mL vial of solution contains eribulin mesylate equivalent to 0.88 mg of eribulin. Each 3 mL vial of solution contains eribulin mesylate equivalent to 1.32 mg of eribulin.
The other components are: anhydrous ethanol and water for injections, and possibly hydrochloric acid, concentrated and sodium hydroxide in very small amounts, to adjust pH.

What Eribulin EVER Pharma looks like and contents of the pack
Eribulin EVER Pharma is a clear, colourless, aqueous solution for injection, practically free from visible solid particles, available in glass vials closed with a rubber stopper and an aluminium cap with a plastic flip-off cap. The vials contain 2 mL or 3 mL of solution and are placed in cardboard boxes.
Each cardboard box contains 1 or 6 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder
EVER Valinject GmbH
Oberburgau 3
4866 Unterach am Attersee
Austria

Manufacturer
Oncomed Manufacturing a.s.
Karasek 2229/1b
621 00 Brno Rechkovice
Czech Republic
EVER Pharma Jena GmbH
Brüsseler Str. 18
07747 Jena
Germany

For further information about this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
EVER Pharma Poland Sp. z o.o.
e-mail: [email protected]

This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Austria: Eribulin EVER Pharma 0.44 mg/mL Injektionslösung
Belgium: Eribulin EVER Pharma 0.44 mg/mL oplossing voor injectie / solution injectable / Injektionslösung
Bulgaria: Ерибулин EVER Pharma 0.44 mg/mL инжекционен разтвор
Croatia: Eribulin EVER Pharma 0.44 mg/mL otopina za injekciju
Denmark: Eribulin EVER Pharma
Finland: Eribulin EVER Pharma
France: ERIBULINE EVER PHARMA 0.44 mg/mL, solution injectable
Greece: Eribulin/EVER Pharma
Spain: Eribulin EVER Pharma 0.44 mg/mL solución inyectable EFG
Netherlands: Eribulin EVER Pharma 0.44 mg/mL oplossing voor injectie
Ireland: Eribulin EVER Pharma 0.44 mg/mL solution for injection
Lithuania: Eribulin EVER Pharma 0.44 mg/mL injekcinis tirpalas
Germany: Eribulin EVER Pharma 0.44 mg/mL Injektionslösung
Norway: Eribulin EVER Pharma
Poland: Eribulin EVER Pharma
Portugal: Eribulina Ever Pharma
Czech Republic: Eribulin EVER Pharma
Romania: Eribulin EVER Pharma 0.44 mg/mL soluție injectabilă
Slovenia: Eribulin EVER Pharma 0.44 mg/mL raztopina za injiciranje
Slovakia: Eribulin EVER Pharma 0.44 mg/mL injekčný roztok
Sweden: Eribulin EVER Pharma
Hungary: Eribulin EVER Pharma 0.44 mg/mL oldatos injekció
Italy: Eribulina EVER Pharma

The following information is intended for healthcare professionals only:

For detailed information, please refer to the Summary of Product Characteristics.