Package Insert: Information for the User

Eribulina Baxter 0.44 mg/mL Injectable Solution EFG

eribulina

Read this entire package insert carefully before starting to use this medication, as it contains important information for you.

• Keep this package insert, as you may need to refer to 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 not listed in this package insert. See section 4.

Eribulina Baxter contains the active ingredient eribulina and is a cancer medication that works by slowing the growth and spread of cancer cells.

It is used for the treatment of 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 stopped working.

It is also used for the treatment of adult patients with advanced or metastatic liposarcoma (a type of cancer that appears in fatty tissue) when a previous treatment has stopped working.

Do not use Eribulina Baxter

• if you are allergic to eribulin mesylate or any of the other components of this medication (listed in section 6).
• if you are breastfeeding.

Warnings and precautions

Consult your doctor or nurse before starting to use Eribulina Baxter:

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

If you are affected by any of the above points, inform your doctor as they may want to suspend your treatment or reduce your dose.

Children and adolescents

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

Other medications and Eribulina Baxter

Inform your doctor if you are using, have used recently, or may need to use any other medication.

Pregnancy, breastfeeding, and fertility

Eribulina Baxter may cause severe birth defects and should not be used during pregnancy, unless it is clearly necessary after carefully considering all the risks for you and the baby. It may also cause permanent fertility problems in the future for men who take it, and you should consult your doctor before starting treatment. Women of childbearing age should use highly effective contraceptive methods during treatment with Eribulina Baxter and for up to 7 months after completing treatment.

Eribulina Baxter should not be used during breastfeeding due to the possible risk to the child.

Men with fertile partners should not leave them pregnant while receiving Eribulina Baxter. They should use effective contraceptive methods during treatment with Eribulina Baxter and for up to 4 months after completing treatment.

Driving and operating machines

Eribulina Baxter may cause side effects such as fatigue (very common) and dizziness (common). Do not drive or use machines if you are tired or dizzy.

Eribulina Baxter contains anhydrous ethanol

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

Eribulina Baxter contains sodium

This medication contains less than 1 mmol of sodium (23 mg) per vial; it is essentially "sodium-free".

A qualified healthcare professional will administer Eribulina Baxter as an injection into a vein 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 based on blood test results or other factors. After administration of Eribulina Baxter, it is recommended to irrigate the vein with a saline solution to ensure the complete administration of Eribulina Baxter.

Administration Frequency 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 blood test results, it may be necessary for your doctor to delay administration of the medication until blood test results return to normal values. At that time, your doctor may also decide to reduce the dose administered.

If you have any other questions about the use of this medication, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everyone will experience them.

If you experience any of the following severe symptoms,stop taking Eribulina Baxter and seek medical attention immediately:

• Fever, with very rapid 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 rare (may affect up to 1 in 100 people) and can be life-threatening and fatal.
• 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 eruptions with blister formation 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 fatal.

Other side effects:

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

• Decreased white blood cell or red blood cell count
• Fatigue or weakness
• Nausea, vomiting, constipation, diarrhea
• Numbness, tingling, or pins and needles
• 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:

• Decreased platelet count (which may lead to bruising or delayed bleeding)
• Infection with fever, pneumonia, chills
• Rapid heart rate, palpitations
• Dizziness, vertigo
• Increased tear production, conjunctivitis (redness and itching of the eye surface), nasal bleeding
• Dehydration, dry mouth, herpes labialis, mouth ulcers, indigestion, stomach burning, abdominal pain or swelling
• Swelling of soft tissues, pain (specifically chest, back, and bone pain), muscle spasms or weakness
• Infections in the mouth, respiratory tract, and urinary tract, painful urination
• Throat pain, irritated nose or runny nose, increased nasal secretion, flu-like symptoms, pharyngitis
• Abnormal liver function test results, altered blood sugar, bilirubin, phosphate, potassium, magnesium, or calcium levels
• Inability to sleep, depression, altered sense of taste
• Rash, itching, nail problems, dry or red skin
• Excessive sweating (including night sweats)
• Tinnitus in the ears
• Pulmonary embolism
• Herpes zoster
• Swelling of the skin and numbness in hands and feet

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

• Clots in the blood
• Abnormal liver function test results (hepatotoxicity)
• Renal failure, blood or protein in the urine
• Extensive pulmonary inflammation that may lead to scarring
• Pancreatitis
• Mouth ulcers

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

• A severe blood clotting disorder that may lead to extensive blood clots and internal bleeding.

Reporting side effects

If you experience side effects, consult your doctor or nurse, even if they are not listed in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Usewww.notificaRAM.es. By reporting side effects, you can contribute to providing more information on the safety of this medicine.

Keep this medication out of the sight and reach of children.

Do not use this medication after the expiration date that appears on the box and vial after CAD. The expiration date is the last day of the month indicated.

Store below 30 °C.

If Eribulina Baxter is diluted for infusion:

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

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

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

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

Eribulina Baxter vials are for single use only. Dispose of unused medication.

Medications should not be thrown away through drains or in the trash. Ask your pharmacist how to dispose of the containers and medications that you no longer need. This will help protect the environment.

Composition of Eribulina Baxter

• The active ingredient is eribulina. Each vial of 2 ml contains mesylate of eribulina equivalent to 0.88 mg of eribulina.
• The other components are anhydrous ethanol and water for injectable preparations, with possible presence in very small quantities of concentrated hydrochloric acid (to adjust the pH) and sodium hydroxide (to adjust the pH).

Appearance of Eribulina Baxter and contents of the package

Eribulina Baxter is a transparent and colorless aqueous injectable solution, essentially free of visible particles, which comes in a glass vial containing 2 ml of solution. Each box contains 1 vial.

Marketing Authorization Holder

Baxter Holding B.V.

Kobaltweg 49

3542 CE, Utrecht

Netherlands

Manufacturer

Baxter Oncology GmbH

Kantstraße 2

33790 Halle/Westfalen

Germany

For more information about this medication, please contact the local representative of the marketing authorization holder:

Baxter is a registered trademark of Baxter International Inc.

Last review date of this leaflet:

The detailed information about this medication is available on the website of the European Medicines Agency:https://www.ema.europa.eu.