Eribulin Stada 0.44 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eribulina 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 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

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

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

This medicine 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 prior treatment has stopped being effective.

2. What you need to know before starting to use Eribulina Stada

DO NOT USE Eribulina Stada

• if you are allergic to eribulin mesylate or to any of the other ingredients 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 if:

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

If any of the above apply to you, 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 and adolescents aged between 0 and 18 years, as it is not effective in this population.

Other medicines and Eribulina Stada

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

Pregnancy, breastfeeding and fertility

Eribulina may cause severe birth defects and must not be used during pregnancy unless clearly necessary after careful consideration of the risks to both you and your baby. It may also cause permanent fertility problems in men, and men should discuss this with their doctor before starting treatment. Women of childbearing age must use effective contraception during treatment and for at least 3 months after stopping eribulina.

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

Driving and using machines

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

Eribulina contains ethanol (alcohol)

This medicine contains 40 mg of ethanol per ml of injectable solution. 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 produce any noticeable effect.

3. How to use Eribulina Stada

Method of administration

A qualified healthcare professional will administer eribulin to you as an intravenous injection over a period of 2 to 5 minutes.

Dosage

Your dose is 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 depending on the results of blood tests or other factors. After administration of eribulin, saline flush is recommended to ensure the complete dose of eribulin is delivered.

Frequency of eribulin administration

Eribulin 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 the results of blood tests, your doctor may need to delay administration of the medicine until blood test results return to normal levels. At that point, your doctor may also decide to reduce your dose.

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 will experience them.

If you experience any of the following serious symptoms, stop taking eribulin and contact your doctor 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 sepsis, a severe and serious reaction to infection. Sepsis 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 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 platelet count (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 burning of the eye surface), nosebleeds
• dehydration, dry mouth, cold sores, oral fungal infections, indigestion, stomach burning, abdominal pain or bloating
• swelling of soft tissues, pain (particularly chest, back, and bone pain), muscle spasms or muscle weakness
• infections in the mouth, respiratory tract, or urinary tract, pain when urinating
• 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
• inability to sleep, 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
• shingles (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 urine
• extensive lung inflammation that may lead to scarring
• inflammation of the pancreas
• mouth ulcers

Rare adverse effects (may affect up to 1 in 1000 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 adverse effect, talk to your doctor or nurse, even if it is a possible adverse effect not listed in this leaflet. You can also report them directly via the Spanish Pharmacovigilance System for Human Medicines: https://www.notificaram.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eribulina Stada

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.

This medicine does not require any special storage conditions.

If eribulin has been diluted for infusion, the diluted solution should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and normally the solution should not be stored for more than 24 hours at 2 °C to 8 °C, unless the dilution has taken place under controlled and validated aseptic conditions.

If undiluted eribulin solution has been transferred into 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 and containers you no longer need. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eribulina Stada

• The active substance is eribulina. Each 2 ml vial contains eribulina mesilate equivalent to 0.88 mg of eribulina.
• The other components are ethanol and water for injections, with possible trace amounts of hydrochloric acid (diluted) and sodium hydroxide.

Appearance of the product and contents of the container

Eribulina is an aqueous, clear, colorless injectable solution supplied in glass vials containing 2 ml of solution. Each carton contains 1 or 6 vials.

Only certain pack sizes may be marketed.

Marketing Authorization Holder and Manufacturer

Marketing Authorization Holder

Laboratorio STADA, S.L.

Frederic Mompou, 5

08960 Sant Just Desvern (Barcelona)

Spain

[email protected]

Manufacturer Responsible

STADA Arzneimittel AG

Stadastrasse 2 – 18

61118 Bad Vilbel

Germany

or

AqVida GmbH

Kaiser-Wilhelm-Str. 89

20355 Hamburg

Germany

This medicinal product is authorized in the Member States of the European Economic Area under the following names:

Date of the most recent review of this leaflet: September 2023

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