Eribulin Ever Pharma

Package Leaflet: Information for the User

Eribulin EVER Pharma, 0.44 mg/mL, Solution for Injection

Eribulin

Read the package leaflet carefully before using the medicine, as it contains important information for the patient.

• Keep this package 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, including those not listed in this package leaflet, tell your doctor or nurse. See section 4.

Table of Contents of the Package Leaflet

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

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

Eribulin EVER Pharma contains the active substance eribulin and is a medicine used to treat cancer by stopping the growth and spread of cancer cells. It is used in adults to treat advanced breast cancer or breast cancer that has spread (metastatic breast cancer) when at least one other therapy has been tried but has stopped working. It is also used in adults to treat advanced liposarcoma or liposarcoma that has spread (a type of cancer that originates from fat tissue) when other therapies have been tried but have stopped working.

2. Important information before using Eribulin EVER Pharma

When not to 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 breastfeeding.

Warnings and precautions

Before starting treatment with Eribulin EVER Pharma, discuss with your doctor or nurse:

• if you have liver disease
• if you have a fever or infection
• if you have experienced numbness, tingling, prickling sensation, sensitivity to touch, or muscle weakness
• if you have heart disease

If you experience any of the above symptoms, tell your doctor, who may stop treatment or reduce the dose.

Children and adolescents

This medicine should not be given to children and adolescents from 0 to 18 years due to lack of efficacy.

Eribulin EVER Pharma and other medicines

Tell your doctor about all medicines you are taking or have recently taken, as well as any medicines you plan to take.

Pregnancy, breastfeeding, and 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 risk to the mother and the child. The medicine may also cause long-term fertility problems in men who take it. Men should discuss this with their doctor before starting treatment. Women of childbearing age must use effective contraception during and up to 3 months after treatment with Eribulin EVER Pharma. During breastfeeding, do not use Eribulin EVER Pharma due to possible risk to the child.

Driving and using machines

Eribulin EVER Pharma may cause side effects such as fatigue (very common) and dizziness (common). Do not drive or operate machinery if you feel tired or dizzy.

Eribulin EVER Pharma contains ethanol (alcohol)

Vial of 2 mL This medicine contains 79 mg of alcohol (ethanol) in each 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. Vial of 3 mL This medicine contains 118.5 mg of alcohol (ethanol) in each 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 have noticeable effects. Eribulin EVER Pharma contains less than 1 mmol (23 mg) of sodium per mL, which means the medicine is considered "sodium-free".

3. How to use Eribulin EVER Pharma

Eribulin EVER Pharma will be given to you by a qualified healthcare professional as an injection into a vein, lasting from 2 to 5 minutes. The dose you receive depends on your body surface area (BSA) (expressed in square meters or m^2), which is calculated based on your weight and height. The usual dose of Eribulin EVER Pharma is 1.23 mg/m^2 BSA, but your doctor may adjust the dose individually based on blood test results or other factors. To ensure that the entire dose of Eribulin EVER Pharma is administered, after injection of the medicine, a saline solution should be injected through the intravenous access site.

How often will Eribulin EVER Pharma be given to you?

Eribulin EVER Pharma is usually given on day 1 and day 8 of each 21-day treatment cycle. Your doctor will determine the number of treatment cycles you should receive. Depending on your blood test results, your doctor may stop treatment or reduce the dose. If you have any further questions about using 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 contact your doctor immediately:

• Fever with rapid heart rate, sudden shortness of breath, feeling of coldness, paleness, moist skin, or spots on the skin and (or) feeling of confusion. These may be symptoms of a condition called sepsis - a severe and life-threatening reaction to infection. Sepsis occurs uncommonly (in less than 1 in 100 people), may 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 (occurring in less than 1 in 100 people).
• Severe skin rash with blisters on the skin, mouth, eyes, and genitals. These may be symptoms of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. The frequency of this condition is unknown, but it may be life-threatening.

Other side effects: Very common side effects (occurring in more than 1 in 10 people) include:

• Decreased white or red blood cell count
• Fatigue or weakness
• Nausea, vomiting, constipation, diarrhea
• Numbness, tingling, or prickling sensation
• Fever
• Loss of appetite, weight loss
• Breathing difficulties, cough
• Joint, muscle, or back pain
• Headache
• Hair loss

Common side effects (occurring in less than 1 in 10 people) include:

• Decreased platelet count (which may lead to bruising and prolonged bleeding time)
• Infection with fever, pneumonia, chills
• Rapid heart rate, hot flashes
• Dizziness
• Tearing, conjunctivitis (redness and pain of the eye surface), nosebleeds
• Dehydration, dry mouth, thrush, oral candidiasis, indigestion, heartburn, abdominal pain or swelling
• Soft tissue swelling, pain (especially chest, spine, and bone), muscle spasms, or weakness
• Oral, respiratory, or urinary tract infections, painful urination
• Pharyngitis, rhinitis, or sinusitis, flu-like symptoms, sore throat
• Abnormal liver function tests, changes in blood sugar (glucose), bilirubin, phosphate, potassium, magnesium, or calcium levels
• Insomnia, depression, change in taste
• Breathing difficulties, cough, sore throat
• Rash, itching, nail changes, dryness, or redness of the skin
• Excessive sweating (including night sweats)
• Ringing in the ears
• Blood clots in the lungs
• Shingles
• Skin swelling and numbness of hands and feet

Uncommon side effects (occurring in less than 1 in 100 people) include:

• The following side effects have been reported:
• Blood clots
• Abnormal liver function tests (hepatotoxicity)
• Kidney failure, presence of blood or protein in the urine
• Widespread pneumonia, which may lead to scarring
• Pancreatitis
• Mouth ulcers

Rare side effects (occurring in less than 1 in 1,000 people) include:

• Severe blood clotting disorders, leading to blood clots and internal bleeding throughout the body.

Reporting side effects

If you experience any side effects, including those not listed in this package leaflet, tell your doctor or nurse. You can also report side effects directly to the national reporting system via the contact details listed below. By reporting side effects, you can help 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: Expiry date (EXP). The expiry date refers to the last day of the month. Do not store above 30°C. The chemical and physical stability of the undiluted solution in a syringe has been demonstrated for up to 8 hours at a temperature of 15°C to 25°C in indoor lighting and up to 32 hours at a temperature of 2°C to 8°C. The 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] has been demonstrated for up to 8 hours at a temperature of 15°C to 25°C in indoor lighting and up to 48 hours at a temperature of 2°C to 8°C, provided that the dilution was performed under 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. Normally, the storage time should not exceed 24 hours at 2°C to 8°C, provided that the dilution was performed 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 no longer required. This will help protect the environment.

6. Contents of the pack and other information

What Eribulin EVER Pharma contains

• The active substance is eribulin. Each 2 mL vial contains eribulin mesylate equivalent to 0.88 mg eribulin. Each 3 mL vial contains eribulin mesylate equivalent to 1.32 mg eribulin.
• The other ingredients are anhydrous ethanol and water for injection, and may include hydrochloric acid and sodium hydroxide in very small amounts to adjust the pH.

What Eribulin EVER Pharma looks like and contents of the pack

Eribulin EVER Pharma is a clear, colorless, aqueous solution for injection, practically free from visible particles, available in glass vials closed with a rubber stopper and an aluminum cap with a plastic flip-off cap. The vials contain 2 mL or 3 mL of solution and are packed in a cardboard box. Each cardboard box 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 621 00 Brno Rechkovice Czech Republic EVER Pharma Jena GmbH Brüsseler Str. 18 07747 Jena Germany For further information, contact your local representative of the marketing authorization holder: EVER Pharma Poland Sp. z o.o. e-mail: office.pl@everpharma.com

This medicine is authorized 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 Germany: Eribulin EVER Pharma 0.44 mg/mL Injektionslösung 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 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

Date of last revision of the package leaflet: ---------------------------------------------------------------------------------------------------------------------------

The following information is intended for healthcare professionals only: For further information, refer to the Summary of Product Characteristics.