ERIBULINA STADA 0.44 mg/ml INJECTABLE SOLUTION

Introduction

Package Leaflet: Information for the User

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

1. What is Eribulin Stada and what is it used for

This medicine 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 use Eribulin Stada

DO NOT USE Eribulin Stada

• 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 starting treatment with eribulin

• if you have liver problems
• if you have a fever or 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 treatment or reduce the dose.

Children and Adolescents

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

Other Medicines and Eribulin Stada

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

Pregnancy, Breast-feeding, and Fertility

Eribulin may cause serious birth defects and should not be used during pregnancy unless clearly necessary after careful consideration of all risks to you and the 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.

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

Driving and Using Machines

Eribulin 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 Contains Ethanol (Alcohol)

This medicine contains 40 mg of ethanol in each ml of solution for injection. The amount in each ml is equivalent to less than 1 ml of beer or 0.4 ml of wine.

The small amount of alcohol in this medicine does not have any noticeable effect.

3. How to Use Eribulin Stada

Method of Administration

A qualified healthcare professional will give you eribulin as an injection into a vein over a period of 2 to 5 minutes.

Dose

The dose you receive will be based on your body surface area (expressed in square meters, or m2) calculated from your weight and height.

The usual dose of eribulin is 1.23 mg/m2, although your doctor may adjust it based on blood test results or other factors. After administration of eribulin, it is recommended to flush the vein with a saline solution to ensure that the full dose of eribulin is administered.

Frequency of Administration of Eribulin

Eribulin is usually administered on days 1 and 8 of each 21-day cycle. Your doctor will determine how many cycles of treatment 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 have any further questions on 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 and see a doctor immediately:

• Fever, with a very fast 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 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:

The very common side effects(may affect more than 1 in 10 people) are:

• decrease in the 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

The common side 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 heart rate, hot flushes
• dizziness, vertigo
• increased tear production, conjunctivitis (redness and irritation of the eye surface), nosebleeds
• dehydration, dry mouth, cold sores, oral thrush, 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

The uncommon side effects(may affect up to 1 in 100 people) are:

• blood clots
• liver damage (hepatotoxicity)
• kidney failure, blood or protein in the urine
• widespread lung inflammation that can lead to scarring
• pancreatitis
• mouth ulcers

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

• a severe blood clotting disorder that can lead to widespread 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 side effects directly through the Spanish Medicines Agency's website https://www.notificaram.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eribulin Stada

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.

This medicine does not require any special storage conditions.

If eribulin is diluted for infusion, the diluted solution 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 stored for more than 24 hours between 2°C and 8°C, unless the dilution has been made in controlled and validated aseptic conditions.

If eribulin as an undiluted solution has been transferred to a syringe, it should be stored at 25°C for no more than 24 hours, or between 2°C and 8°C for no more than 96 hours.

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 Stada

• The active substance is eribulin. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg of eribulin.
• The other ingredients are ethanol and water for injections, with possible presence in very small amounts of hydrochloric acid (diluted) and sodium hydroxide.

Appearance and Pack Size

Eribulin is a clear and colorless solution for injection, which comes in glass vials containing 2 ml of solution. Each carton contains 1 or 6 vials.

Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer

Marketing Authorisation Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

AqVida GmbH

Kaise-Wilhelm-Str. 89

20355 Hamburg

Germany

This medicine is authorised in the Member States of the European Economic Area under the following names:

Date of Last Revision of this Leaflet: September 2023

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/