Eribulin Advanz Pharma

PACKAGE LEAFLET

Package leaflet: information for the user

Eribulina Advanz Pharma 0.44 mg/mL solution for injection

Eribulina
Generic medicine
Please read this leaflet carefully before using this medicine because it contains important information for you.

• Keep this leaflet. You may need to read it again.
• If you have any questions, ask your doctor or nurse.
• If you experience any side effects, including those not listed in this leaflet, tell your doctor or nurse. See section 4.

Contents of this leaflet:

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

1. What Eribulina Advanz Pharma is and what it is used for

Eribulina Advanz Pharma contains the active substance eribulina and is an antitumour medicine that
works by stopping the growth and spread of cancer cells.
It is used in adults for metastatic or locally advanced breast cancer (breast cancer that has spread
beyond the original tumour) when at least one other therapy has been tried but was not effective.
It is also used in adults for advanced or metastatic liposarcoma (a type of tumour originating from
fatty tissue) when a previous therapy has been tried but was not effective.

2. What you need to know before using Eribulina Advanz Pharma

Do not use Eribulina Advanz Pharma

• 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 using Eribulina Advanz Pharma:

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

If any of these apply to you, inform your doctor, who may decide to stop treatment or reduce the dose.

Children and adolescents
Do not administer this medicine to children and adolescents aged between 0 and 18 years, as it is not effective.

Other medicines and Eribulina Advanz Pharma
Inform your doctor if you are currently taking, have recently taken, or might take any other medicines.

Pregnancy, breastfeeding and fertility
This medicine may cause severe congenital malformations and must not be used during pregnancy unless strictly necessary and only after careful consideration of all risks to you and the unborn child. It may also cause permanent fertility problems in men undergoing treatment; therefore, this issue should be discussed with your doctor before starting treatment. Women of childbearing potential must use effective contraception during treatment and for up to 3 months after treatment with Eribulina Advanz Pharma.
This medicine must not be used during breastfeeding due to possible risks to the infant.

Driving and using machines
Eribulina Advanz Pharma may cause side effects such as fatigue (very common) and dizziness (common). Do not drive or operate machinery if you experience fatigue or dizziness.

Eribulina Advanz Pharma contains ethanol (alcohol)
This medicine contains 80 mg of alcohol (ethanol) per vial, equivalent to 40 mg/ml (4% w/v). The amount in 2 ml of this medicine is equivalent to less than 2 ml of beer or 0.8 ml of wine.
The small amount of alcohol in this medicine will not produce significant effects.

3. How to use Eribulina Advanz Pharma

This medicine will be administered to you by a qualified healthcare professional, by injection
through an infusion line into a vein over 2 to 5 minutes. The dose is based on body surface area
(expressed in square meters, m²), calculated according to your weight and height. The usual dose of
Eribulina Advanz Pharma is 1.23 mg/m², but your doctor may adjust this dose based on blood test results or other factors. To ensure that the entire dose of this medicine is administered, it is recommended that a saline solution be injected through the same infusion line into the vein after administration of Eribulina Advanz Pharma.
How often will Eribulina Advanz Pharma be administered?
This medicine is usually administered on day 1 and day 8 of each 21-day cycle. Your doctor will determine the number of treatment cycles. Depending on blood test results, your doctor may decide to delay administration of the medicine until values return to normal. Your doctor may also decide to reduce the dose to be administered.
If you have any doubts about how to use this medicine, consult your doctor.

4. Possible side effects

Like all medicines, this medicine can cause side effects, although not everyone gets them.
If you experience any of the following serious symptoms, stop taking Eribulina Advanz Pharma and
contact your doctor immediately:

• fever, with rapid heartbeat, fast shallow breathing, cold, pale, clammy or mottled skin, and/or confusion. These may be signs of a condition called sepsis: a severe and intense reaction to an infection. Sepsis is of uncommon frequency (may affect up to 1 in 100 people) and can be very dangerous 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, which may be signs of a condition called Stevens-Johnson syndrome/toxic epidermal necrolysis. This condition has an unknown frequency but can be life-threatening.

Other side effects:

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

• decrease in the number of white blood cells or red blood cells
• tiredness or weakness
• nausea, vomiting, constipation, diarrhoea
• sensations of numbness, tingling or prickling
• 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):

• reduced number of platelets (which may cause bruising or increased time needed to stop bleeding)
• infection with fever, pneumonia, chills
• rapid heartbeat, hot flushes
• dizziness, lightheadedness
• increased tear production, conjunctivitis (redness and pain on the surface of the eye), nosebleeds
• dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling
• swelling of soft tissues, pain (especially in the chest, back and bones), muscle spasms or muscle weakness
• infections of the mouth, respiratory tract and urinary tract, pain when urinating
• sore throat, irritated or runny nose, flu-like symptoms, throat pain
• abnormalities in liver function tests, altered levels of sugars, bilirubin, phosphates, potassium, magnesium or calcium in the blood
• inability to sleep, depression, altered sense of taste
• skin rash, itching, nail problems, dry or red skin
• excessive sweating (including night sweats)
• ringing in the ears
• blood clots in the lungs
• herpes zoster (shingles)
• swelling of the skin and numbness of the hands and feet

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

• blood clots
• abnormalities in liver function tests (hepatotoxicity)
• kidney failure, blood or protein in the urine
• widespread inflammation of the lungs, which may lead to scarring
• inflammation of the pancreas
• mouth ulcers

Rare side effects (may affect up to 1 in 1,000 people):

• severe disorder of blood clotting, causing widespread blood clots and internal bleeding.

Reporting of side effects
If you experience any side effect, including those not listed in this leaflet, talk to your doctor or nurse.
You can also report side effects directly via the national reporting system:
Website:
https://www.aifa.gov.it/content/segnalazioni-reazioni-avverse
By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eribulina Advanz Pharma

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date stated on the carton after "Exp." and on the
vial after "Exp.". The expiry date refers to the last day of that month.
This medicine requires no special storage conditions.
If Eribulina Advanz Pharma is diluted for infusion, the diluted solution must be used immediately.
If not used immediately, the diluted solution must not be stored for longer than 48 hours at 25°C under ambient light, or 72 hours at 2°C–8°C.
If undiluted Eribulina Advanz Pharma solution has been transferred into a syringe, it must be stored at 25°C under ambient light for no more than 48 hours, or for 72 hours at 2°C–8°C.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines you no longer use. This will help protect the environment.

6. Package contents and other information

What Eribulina Advanz Pharma contains

• The active substance is eribulin. One mL of solution contains eribulin mesilate equivalent to 0.44 mg of 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 hydrochloric acid and sodium hydroxide, possibly present in very small quantities.

Description of the appearance of Eribulina Advanz Pharma and contents of the pack
Eribulina Advanz Pharma is a clear, colourless solution free from visible particles and is supplied in
glass vials containing 2 mL of solution. Each cardboard pack contains 1 vial.
Marketing Authorisation Holder
ADVANZ PHARMA Limited
Unit 17, Northwood House,
Northwood Crescent,
Dublin 9, D09 V504,
Ireland
Manufacturer
KeVaRo Group Ltd
9 Tzaritza Elenora str., office 23
Sofia 1618
Bulgaria
or
Pharmadox Healthcare Limited
KW20A Kordin Industrial Park
Paola PLA 3000
Malta
This medicinal product is authorised in the Member States of the European Economic Area under the following names:
Iceland Eribulin Advanz Pharma 0.44 mg/ml stungulyf, lausn
Austria Eribulin Advanz Pharma 0.44 mg/ml Injektionslösung
Belgium Eribulin Advanz Pharma 0.44 mg/ml Injektionslösung/ solution injectable/ oplossing voor injectie
Spain Eribulin Advanz Pharma 0.44 mg/ml solución inyectable EFG
Finland Eribulin Advanz Pharma 0.44 mg/ml injektioneste, liuos
France Eribulin Advanz Pharma 0.44 mg/mL solution injectable
Ireland Eribulin Advanz Pharma 0.44 mg/ml solution for injection
Italy Eribulina Advanz Pharma
Norway Eribulin Advanz Pharma
Portugal Eribulin Advanz Pharma
Sweden Eribulin Advanz Pharma 0.44 mg/ml injektionsvätska, lösning