ERIBULINA BAXTER 0.44 mg/mL Injectable Solution

Introduction

Package Leaflet: Information for the User

Eribulin 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, you may need to read it again.
• If you have any further 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 pack

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

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

Eribulin Baxter 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 another treatment has been used previously and is no longer effective.

2. What you need to know before you use Eribulin Baxter

Do not use Eribulin Baxter

• 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

Tell your doctor or nurse before you start using Eribulin Baxter:

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

If you are affected by any of these, tell your doctor as they may want to stop your treatment or reduce your dose.

Children and adolescents

Do not give this medicine to children from 0 to 18 years as it is not effective in this age group.

Other medicines and Eribulin Baxter

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

Pregnancy, breast-feeding and fertility

Eribulin Baxter may cause serious birth defects and should not be used during pregnancy unless clearly necessary after careful consideration of the risks to you and your baby. It may also cause permanent fertility problems in men in the future if taken, and men should discuss this with their doctor before starting treatment. Women of childbearing age should use highly effective contraceptive methods during treatment with Eribulin Baxter and for 7 months after the end of treatment.

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

Men with female partners of childbearing age should not father a child while receiving Eribulin Baxter. They should use effective contraceptive methods during treatment with Eribulin Baxter and for 4 months after the end of treatment.

Driving and using machines

Eribulin Baxter 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 Baxter contains ethanol

This medicine contains 78.9 mg (0.1 ml) of ethanol (alcohol) in each 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 in this medicine does not have any noticeable effect.

Eribulin Baxter contains sodium

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

3. How to use Eribulin Baxter

A qualified healthcare professional will give you Eribulin Baxter as an injection into a vein over a period of 2 to 5 minutes. 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 Baxter is 1.23 mg/m2, but your doctor may adjust it based on the results of blood tests or other factors. After administration of Eribulin Baxter, it is recommended to flush the vein with a saline solution to ensure that the full dose of Eribulin Baxter is administered.

Frequency of administration of Eribulin Baxter

Eribulin Baxter is usually given on days 1 and 8 of each 21-day cycle. Your doctor will decide how many cycles of treatment you should receive. Depending on the results of blood tests, it may be necessary for your doctor to delay the administration of the medicine until the blood test results return to normal. At that time, your doctor may also decide to reduce the dose that is given to you.

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 Baxter and go to your doctor immediately:

• Fever, with a very fast heart rate, rapid and shallow breathing, cool, 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 cause 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 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 not known, but it can be fatal.

Other side effects:

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

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

• Decrease in the number of platelets (which can lead to bruising or bleeding)
• Infection with fever, pneumonia, chills
• Fast heart rate, hot flushes
• Dizziness, dizziness
• Increased tear production, conjunctivitis (redness and irritation of the eye surface), nosebleeds
• Dehydration, dry mouth, cold sores, mouth ulcers, 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 and urinary tract, pain when urinating
• Sore throat, irritated nose or runny nose, increased nasal secretion, flu-like symptoms, pharyngitis
• Abnormal liver function tests, altered blood sugar, bilirubin, phosphate, potassium, magnesium or calcium levels
• 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

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

• Blood clots
• Abnormal liver function tests (hepatotoxicity)
• Kidney failure, blood or protein in the urine
• Widespread lung inflammation that can lead to scarring
• Pancreatitis
• Mouth ulcers

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

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

Reporting of side effects

If you experience any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the Spanish Medicines Agency's website for the reporting of adverse reactions: www.notificaRAM.es. By reporting side effects, you can help provide more information on the safety of this medicine.

5. Storage of Eribulin Baxter

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 stated.

Store below 30°C.

If Eribulin Baxter is diluted for infusion:

Chemical and physical stability of the diluted solution has been demonstrated for 24 hours at 15°C to 25°C and 72 hours at 2°C to 8°C.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions are the responsibility of the user and would normally not be longer than 24 hours at 2°C to 8°C, unless dilution has taken place in controlled and validated aseptic conditions.

If Eribulin Baxter as an undiluted solution has been transferred to a syringe:

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

The vials of Eribulin Baxter are for single use only. Discard any unused medicine.

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 Baxter contains

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

Appearance and pack of Eribulin Baxter

Eribulin Baxter is a clear and colorless aqueous solution for injection, essentially free from visible particles, in a glass vial containing 2 ml of solution. Each carton contains 1 vial.

Marketing authorisation holder

Baxter Holding B.V.

Kobaltweg 49

3542 CE, Utrecht

Netherlands

Manufacturer

Baxter Oncology GmbH

Kantstraße 2

33790 Halle/Westfalen

Germany

For further information about this medicine, contact the local representative of the marketing authorisation holder:

Baxter is a registered trademark of Baxter International Inc.

Date of last revision of this leaflet:

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