ERIBULINA 0.44 MG/ML Injectable solution

Зміст інструкції

1. Eribulina Viatris 0.44 mg/ml injectable solution
   1. What is Eribulina Viatris and what is it used for
   2. What you need to know before you use Eribulina Viatris
   3. How to use Eribulina Viatris
   4. Possible side effects
   5. How to store Eribulina Viatris
   6. Contents of the pack and other information

Eribulina Viatris 0.44 mg/ml injectable solution

eribulina

Equivalent medicine

Read this leaflet carefully before using this medicine as 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 any side effects occur, including those not listed in this leaflet, ask your doctor or nurse. See section 4.

Contents of this leaflet

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

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

Eribulina Viatris contains the active substance eribulina and is an antineoplastic 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 tumor) when at least one other therapy has been attempted, but has not
been effective.
It is also used in adults for advanced or metastatic liposarcoma (a type of tumor that
originates from fatty tissue) when a previous therapy has been attempted, but has not been effective.

2. What you need to know before you use Eribulina Viatris

Do not use Eribulina Viatris

• if you are allergic to eribulin mesylate or 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 Viatris:

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

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

Children and adolescents
Do not give this medicine to children aged between 0 and 18 years because it is not effective.

Other medicines and Eribulina Viatris
Tell your doctor if you are taking, have recently taken or might take any other
medicines.

Pregnancy, breastfeeding and fertility
Eribulina Viatris can cause serious birth defects and must not be used during
pregnancy unless absolutely necessary and after careful consideration of all the risks to you
and to the baby. It can also cause future permanent fertility problems in men undergoing
treatment; therefore, you need to discuss this with your doctor before starting
treatment. Women of childbearing potential must use effective contraception during and for up to 3 months
after treatment with Eribulina Viatris.
Eribulina Viatris must not be used during breastfeeding, due to the possible
risks to the baby.

Driving and using machines
Eribulina Viatris can cause side effects, such as fatigue (very common) and dizziness
(common). Do not drive vehicles or use machines if you feel tired or dizzy.

Eribulina Viatris contains ethanol (alcohol)
This medicine contains small amounts of ethanol (alcohol), 79 mg in each 2 ml vial. The
amount in a vial of this medicine is equivalent to less than 2 ml of beer or 1 ml of wine. The
small amount of alcohol in this medicine will not have any significant effects.

3. How to use Eribulina Viatris

Eribulina Viatris will be administered to you by a qualified healthcare professional, via injection, , into
a vein over 2-5 minutes. The dose is based on body surface area (expressed in square meters,
or m²), calculated on the basis of weight and height. The usual dose of Eribulina Viatris is 1.23 mg/m²,
but this dose may be adjusted by the doctor based on blood test results or other
factors. To ensure that the entire dose of Eribulina Viatris is administered, it is recommended that a
saline solution be injected into the vein after the administration of Eribulina Viatris.

How often will Eribulina Viatris be administered to you?
Eribulina Viatris is usually administered on day 1 and day 8 of each 21-day cycle. The
doctor will determine the number of treatment cycles. Depending on the results of blood tests, the
doctor may decide to postpone the administration of the medicine until the values return
to normal. The doctor may also decide to reduce the dose to be administered.
If you have any doubts about the use of this medicine, please consult 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 Eribulina Viatris and consult
your doctor immediately:

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

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

• decreased number of white blood cells or red blood cells
• fatigue or weakness
• nausea, vomiting, constipation, diarrhea
• 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) are:

• reduction in the number of platelets (which can cause bruising or increased time 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, thrush, indigestion, heartburn, pain or swelling in the abdomen
• swelling of soft tissues, pain (especially in the chest, back and bones), muscle spasm or weakness
• infections of the mouth, respiratory tract and urinary tract, pain when urinating
• sore throat, irritated or runny nose, flu-like symptoms, sore throat
• abnormalities in liver function tests, altered levels of sugars, bilirubin, phosphates, potassium, magnesium or calcium in the blood
• difficulty sleeping, 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) are:

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

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

• severe blood clotting disorder, which causes widespread formation of blood clots and internal bleeding.

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. You can also report side effects directly through the national reporting system at 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 Viatris

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 pack and vial after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any particular storage conditions.
If Eribulina Viatris is diluted for infusion, the diluted solution must be used
immediately. If not used immediately, the diluted solution must be stored at a
temperature of 2-8 °C for a maximum of 72 hours.
If Eribulina Viatris as an undiluted solution has been transferred into a syringe, it must be stored
at a temperature of 15-25 °C and in ambient light conditions for a maximum of 4 hours or at a temperature
of 2-8 °C for a maximum of 24 hours.
Do not dispose of any medicine in wastewater or household waste. Ask your pharmacist how to
dispose of medicines you no longer use. This will help protect the environment.

6. Contents of the pack and other information

What Eribulina Viatris contains

• The active substance is eribulin. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg of eribulin.
• The other ingredients are ethanol and water for injections; hydrochloric acid (for pH adjustment) and sodium hydroxide (for pH adjustment) may be present in very small quantities.

Description of the appearance of Eribulina Viatris and contents of the pack
Eribulina Viatris is a clear and colourless injectable solution, supplied in a glass vial, with
rubber stopper and tear-off aluminium cap, containing 2 ml of solution. Each pack
contains 1 or 6 vials.

Marketing Authorisation Holder
Mylan S.p.A.
Via Vittor Pisani, 20
20124 Milano
Italy

Manufacturers
Pharmadox Healthcare Ltd.,
KW20A Kordin Industrial Park,
Paola PLA 3000
Malta
Mylan Germany GmbH,
Benzstrasse 1, 61352 Bad Homburg v. d. Hohe,
Germany
Viatris Santé
1 Rue de Turin
69007 Lyon
France

This medicinal product is authorised in the Member States of the European Economic Area with the
following denominations:
Norway: Eribulin Viatris
Belgium: Eribuline Viatris 0.44 mg/ml solution for injection
Germany: Eribulin Viatris 0.44 mg/ml injection solution
Denmark: Eribulin Viatris
Spain: Eribulina Viatris 0.44 mg/ ml injectable solution EFG
France: Eribuline Viatris 0.44 mg/mL, injectable solution
Iceland: Eribulin Viatris
Italy: Eribulina Viatris
Luxembourg: Eribuline Viatris 0.44 mg/mL injectable solution