Eribulin Baxter 0.44 mg/ml solution for injection EFG

Package leaflet: Information for the user

Introduction

Package leaflet: information for the user

Eribulina Baxter 0.44 mg/ml solution for injection EFG

eribulin

Read all of this leaflet carefully before you start using this medicine, because it contains important information for you.

• Keep this leaflet, as you may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, talk to your doctor or nurse, even if it is a side effect not listed in this leaflet. See section 4.

Contents of this leaflet

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

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

Eribulina Baxter 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) 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 using Eribulina Baxter

Do not use Eribulina Baxter

• if you are allergic to eribulin mesilate 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 Baxter:

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

If any of the above conditions affect you, inform your doctor, as they may wish to discontinue 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 in this population.

Other medicines and Eribulina Baxter

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

Pregnancy, breastfeeding and fertility

Eribulina Baxter 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 the baby. It may also cause permanent fertility problems in men who take it, and they should discuss this with their doctor before starting treatment. Women of childbearing age must use highly effective contraceptive methods during treatment with Eribulina Baxter and for up to 7 months after completion of treatment.

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

Men with partners of childbearing potential must not make them pregnant while receiving Eribulina Baxter. They must use effective contraception during treatment with Eribulina Baxter and for up to 4 months after completion of treatment.

Driving and use of machines

Eribulina Baxter 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 Baxter contains anhydrous ethanol

This medicine contains 78.9 mg (0.1 ml) of ethanol (alcohol) per vial. The amount in 2 ml of this medicine is equivalent to 2 ml of beer or less than 1 ml of wine. The small amount of alcohol contained in this medicine does not produce any noticeable effect.

Eribulina Baxter contains sodium

This medicine contains less than 1 mmol of sodium (23 mg) per vial; i.e., essentially “sodium-free”.

3. How to use Eribulina Baxter

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

Frequency of administration of Eribulina Baxter

Eribulina Baxter 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 values. At that point, your doctor may also decide to reduce the dose administered to you.

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 experiences them.

If you experience any of the following serious symptoms, stop taking Eribulina Baxter 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 blistering of 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 fatal.

Other adverse effects:

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

• Decrease in white 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 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 burning of the eye surface), nosebleeds
• Dehydration, dry mouth, cold sores, mouth ulcers, indigestion, heartburn, 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, irritated or runny nose, increased nasal secretion, 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 (herpes zoster)
• Skin swelling and numbness in hands and feet

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

• 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 adverse effects (may affect up to 1 in 1000 people) are:

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

Reporting of adverse effects

If you experience any adverse effects, consult your doctor or nurse, even if they are adverse effects not listed in this leaflet. You may also report them directly via the Spanish Pharmacovigilance System for Human Medicines: www.notificaRAM.es. By reporting adverse effects, you can help provide more information on the safety of this medicine.

5. Storage of Eribulina Baxter

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.

Store below 30 °C.

If Eribulina Baxter is diluted for infusion:

Chemical and physical in-use stability has been demonstrated for the diluted solution for 24 hours between 15 °C and 25 °C and for 72 hours between 2 °C and 8 °C.

From a microbiological standpoint, the product should be used immediately. If not used immediately, the in-use storage times and conditions prior to use are the responsibility of the user and normally should not exceed 24 hours between 2 °C and 8 °C, unless dilution has taken place under controlled and validated aseptic conditions.

If undiluted Eribulina Baxter solution has been transferred into a syringe:

Chemical and physical in-use stability has been demonstrated for the undiluted solution in a syringe for 4 hours between 15 °C and 25 °C and for 24 hours between 2 °C and 8 °C.

Eribulina Baxter vials are for single use only. Any unused medicinal product should be discarded.

Medicines should not be disposed of via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer required. These measures will help protect the environment.

6. Contents of the pack and other information

Composition of Eribulina Baxter

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

Appearance of Eribulina Baxter and contents of the pack

Eribulina Baxter is a clear, colourless, aqueous, injectable solution essentially free from visible particles, supplied in a glass vial containing 2 ml of solution. Each carton contains 1 vial.

Marketing Authorization Holder

Baxter Holding B.V.

Kobaltweg 49

3542 CE, Utrecht

The Netherlands

Manufacturer

Baxter Oncology GmbH

Kantstraße 2

33790 Halle/Westfalen

Germany

Further information on this medicinal product is available upon request by contacting the local representative of the Marketing Authorization Holder:

Baxter is a registered trademark of Baxter International Inc.

Date of the most recent review of this leaflet:

Detailed information on this medicine is available on the website of the European Medicines Agency: https://www.ema.europa.eu.