Product Information for the User

Eribulina Advanz Pharma 0.44 mg/ml injectable solution EFG

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

• Keep this product information, 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 not listed in this product information. See section 4

1. What is Eribulina Advanz Pharma and how is it used

2. What you need to know before starting to use Eribulina Advanz Pharma

3. How to use Eribulina Advanz Pharma

4. Possible adverse effects

5. Storage of Eribulina Advanz Pharma

6. Contents of the package and additional information

Eribulina Advanz Pharma contains the active ingredient eribulina and is a cancer medication that works by slowing down 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 Advanz Pharma:

-if you are allergic to eribulin mesylate or to any of the other ingredients of this medication (listed in section6).

-if you are breastfeeding.

Warnings and precautions

Consult your doctor or nurse before starting to use eribulina

-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 stop or reduce your treatment.

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 Advanz Pharma

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

Pregnancy, breastfeeding, and fertility

This medication may cause severe congenital malformations 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 in men who take it, and you should consult your doctor before starting treatment. Women of childbearing age should use effective contraceptive methods during and up to 3months after completing eribulina treatment.

This medication should not be used during breastfeeding due to the possible risk to the child.

Driving and operating machinery

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

Eribulina Advanz Pharma contains ethanol (alcohol)

This medication contains small amounts of ethanol (alcohol), less than 100mg per vial.

A qualified healthcare professional will administer this medication, as an injection into a vein over a period of 2 to 5minutes. 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 this medication is 1.23mg/m2, although your doctor may adjust it based on the results of blood tests or other factors. After administration of this medication, it is recommended to irrigate the vein with a saline solution to ensure that the complete dose of this medication is administered.

Administration Frequency of Eribulina Advanz Pharma

This medication is usually administered on days1 and8 of each 21-day cycle. Your doctor will determine how many treatment cycles you should receive. Depending on the results of blood tests, 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 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 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:

The 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

The 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, hot flashes

-Dizziness, vertigo

-Increased tear production, conjunctivitis (redness and itching of the eye surface), nasal bleeding

-Dehydration, dry mouth, herpes labialis, oral thrush, indigestion, heartburn, 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

-Sore throat, nasal congestion, 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 nocturnal sweating)

-Tinnitus in the ears

-Pulmonary embolism

-Herpes zoster

-Swelling of the skin and numbness in the hands and feet

The uncommon 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

-Pulmonary inflammation that can lead to scarring

-Pancreatitis

-Mouth ulcers

The rare side effects (may affect up to 1 in 10,000 people):

-A severe blood clotting disorder that can lead to extensive blood clots and internal bleeding.

Reporting of side effects:

If you experience any type of side effect, consult your doctor or nurse, even if it is a possible side effect that does not appear in this leaflet. You can also report them directly through the Spanish System for Pharmacovigilance of Medicines for Human Use:www.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.

This medication does not require special conservation conditions.

If Eribulina Advanz Pharma is diluted for infusion, the diluted solution must be used immediately. If not used immediately, the diluted solution must be conserved for no more than 48 hours at 25 °C and ambient light or for no more than 72 hours if conserved between 2 °C and 8 °C.

If Eribulina Advanz Pharma as undiluted solution has been transferred to a syringe, it must be conserved at 25 °C and ambient light for no more than 48 hours or 72 hours at 2 °C-8 °C.

Medicines should not be thrown down the 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 Advanz Pharma

-The active ingredient is eribulina. One milliliter of solution contains eribulina mesilate equivalent to 0.44 mg of eribulina. Each vial of 2 ml contains eribulina mesilate equivalent to 0.88 mg of eribulina.

-The other components are ethanol and water for injectable preparations, with possible presence in very small quantities of hydrochloric acid and sodium hydroxide.

Appearance of the product and contents of the package

Eribulina Advanz Pharma is a transparent and colorless solution, free of visible particles that comes in glass vials containing 2 ml of solution. Each box contains 1 vial.

Marketing Authorization Holder

ADVANZ PHARMA Limited

Unit 17, Northwood House,

Northwood Crescent,

Dublín 9, D09 V504,

Irlanda

Responsible for manufacturing

KeVaRo Group Ltd

9, Tsaritsa Eleonora str., office 23,

Sofia 1618,

Bulgaria

O

Pharmadox Healthcare Limited

KW20A Kordin Industrial Park

Paola PLA 3000

Malta

You can request more information about this medication by contacting the local representative of the marketing authorization holder:

Advanz Pharma Spain S.L.U.

Paseo de la Castellana 135, 7ª Planta

Madrid – 28046 – España

Tel. +34 900 834 889

[email protected]

This medication is authorized in the member states of the European Economic Area with the following names:

Austria:Eribulina Advanz Pharma 0.44 mg/ml Injektionslösung

Bélgica:Eribulina Advanz Pharma 0.44 mg/ml Injektionslösung/ solution injectable/ oplossing voor injectie

España: Eribulina Advanz Pharma 0.44 mg/ml solución inyectable EFG

Finlandia: Eribulina Advanz Pharma 0.44 mg/ml injektioneste, liuos

Francia: Eribulina Advanz Pharma 0.44 mg/mL solution injectable

Irlanda:Eribulina Advanz Pharma 0.44 mg/ml solution for injection

Islandia:Eribulina Advanz Pharma 0.44 mg/ml stungulyf, lausn

Italia: Eribulina Advanz Pharma

Noruega: Eribulina Advanz Pharma

Portugal:Eribulina Advanz Pharma

Suecia:Eribulina Advanz Pharma 0.44 mg/ml injektionsvätska, lösning

Last review date of this leaflet 06/2023