Eribulin Glenmark 0.44 mg/ml solution for injection EFG

Patient Information Leaflet

Introduction

Patient Information Leaflet

Eribulin Glenmark 0.44 mg/ml injection solution EFG

Read the entire leaflet carefully before you start using this medicine, as it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, consult your doctor or nurse.
• If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. See section 4.

Package leaflet contents

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

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

Eribulina Glenmark contains the active substance eribulina and is an anticancer medicine that works by slowing 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) after 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 that arises in fatty tissue) after a previous treatment has ceased to be effective.

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

Do not use Eribulina Glenmark

• 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

Consult your doctor or nurse before starting to use eribulin.

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

If any of the above affect you, inform your doctor, as they may wish to stop your treatment or reduce your dose.

Children and adolescents

Do not administer this medicine to children aged between 0 and 18 years, as it has no effect on them.

Other medicines and Eribulina Glenmark

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

The input is empty. Please provide text for translation.

Pregnancy, breastfeeding and fertility

Eribulin may cause severe congenital malformations and must not be used during pregnancy unless clearly necessary after careful consideration of all risks to both you and the baby. It may also cause permanent fertility problems in men who take it, and men should discuss this with their doctor before starting treatment.

Women of childbearing potential must use highly effective methods of contraception during treatment with eribulin and for up to 7 months after completion of

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

Men with partners of childbearing potential must not impregnate them while receiving eribulin. They must use effective contraceptive methods during treatment with eribulin and for up to 4 months after completion of treatment.

Driving and use of machines

Eribulin 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 Glenmark contains ethanol (alcohol)

This medicine contains 79 mg of alcohol (ethanol) in each vial, equivalent to 40 mg/mL. The amount in each vial of this medicine is equivalent to less than 2 mL of beer or 1 mL of wine.

The small amount of alcohol contained in this medicine does not produce any perceptible effect.

Eribulina Glenmark contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per mL; therefore, it is essentially "sodium-free".

3. How to use Eribulina Glenmark

A qualified healthcare professional will administer eribulin 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), which is calculated from your weight and height. The usual dose of eribulin is 1.23 mg/m², although your doctor may adjust this depending on the results of blood tests or other factors. After administration of eribulin, it is recommended to flush the vein with a saline solution to ensure the complete dose of eribulin is delivered.

Eribulin Glenmark Administration Schedule

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 your blood test results, your doctor may need to delay administering the medicine until your blood test results return to normal levels. At that time, 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 may cause side effects, although not everyone gets 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), can be life-threatening, and may 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 side effects:

Very common side effects (may affect more than 1 in 10 people):

• 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 side effects (may affect up to 1 in 10 people):

• Decrease in platelets (which may lead to bruising or prolonged bleeding)
• Infection with fever, pneumonia, chills
• Rapid heartbeat, hot flushes
• Dizziness, lightheadedness
• 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 swelling
• Swelling of soft tissues, pain (particularly chest, back, and bone pain), muscle spasms or muscle weakness
• Mouth, respiratory tract, and urinary tract infections, pain when urinating
• Sore throat, nasal pain, increased nasal discharge, flu-like symptoms, pharyngitis
• Abnormal 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
• Shingles
• Skin swelling and numbness in hands and feet

Uncommon side effects (may affect up to 1 in 100 people):

• Blood clots
• Abnormal 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 side effects (may affect up to 1 in 1,000 people):

• A serious blood clotting disorder that may lead to widespread blood clot formation and internal bleeding

Reporting of Adverse Reactions

If you experience any type of adverse reaction, consult your doctor or nurse, even if it is a possible adverse reaction not listed in this leaflet. You may also report them directly through the Spanish Pharmacovigilance System for Human Medicinal Products: www.notificaRAM.es. By reporting adverse reactions, you can help provide more information on the safety of this medicine.

5. Storage of Eribulina Glenmark

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 Eribulina Glenmark has been diluted for infusion, the diluted solution should be used immediately. If not used immediately, the diluted solution should be stored between 2 °C and 8 °C for no longer than 48 hours.

If undiluted Eribulina Glenmark 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.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and should normally not exceed 24 hours between 2 °C and 8 °C.

Medicines must not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines and packaging when they are no longer needed. This will help protect the environment.

6. Contents of the pack and other information

Composition of Eribulin Glenmark

• The active substance is eribulin. Each ml contains eribulin mesylate equivalent to 0.44 mg of eribulin. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg of eribulin.
• The other components are ethanol and water for injections, with hydrochloric acid and sodium hydroxide.

Appearance of the product and contents of the container

Eribulina Glenmark is a clear, colourless, aqueous 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 Manufacturing Responsibility

Marketing Authorization Holder:

Glenmark Arzneimittel GmbH

Industriestr. 31

82194 Gröbenzell

Germany

Manufacturer:

AqVida GmbH

Kaiser-Wilhelm-Str. 89

20355 Hamburg

Germany

For further information about this medicinal product, please contact the local representative of the marketing authorization holder:

Glenmark Pharmaceuticals, S.L.U.

C/ Retama 7, 7th floor

28045 Madrid

Spain

This medicinal product is authorized in the European Economic Area member states under the following names:

Date of last review of this leaflet: April 2025.

Other sources of information

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