Eribulin Viatriss

Package leaflet: Information for the user

Eribulina Viatris 0.44 mg/ml injection solution

eribulin
Generic medicine
Please 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 questions, ask your doctor or nurse.
• If you get 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 Viatris is and what it is used for
2. What you need to know before using 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 Eribulina Viatris is and what it is used for

Eribulina Viatris contains the active substance eribulina and is an anticancer 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 in fatty tissue) when a previous therapy has been tried but was not effective.

2. What you need to know before using Eribulina Viatris

Do not use Eribulina Viatris

• 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 Viatris:

• 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 Viatris
Inform your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Eribulina Viatris can cause severe birth defects and must not be used during pregnancy unless absolutely necessary and only after careful consideration of all risks to you and your baby. 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 3 months after treatment with Eribulina Viatris.
Eribulina Viatris must not be used during breastfeeding due to possible risks to the infant.
Driving and using machines
Eribulina Viatris may cause side effects such as fatigue (very common) and dizziness (common). Do not drive or operate machinery if you feel fatigued 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 one 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 produce significant effects.

3. How to use Eribulina Viatris

Eribulina Viatris will be administered to you by a qualified healthcare professional, by injection, 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 Viatris is 1.23 mg/m², but your doctor may adjust this dose based on blood test results or other factors. To ensure the entire dose of Eribulina Viatris is administered, it is recommended that a saline solution be injected into the vein after administration of Eribulina Viatris.

How often will Eribulina Viatris be administered?
Eribulina Viatris 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 the use of 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 Viatris and contact your
doctor immediately:

• fever, with rapid heartbeat, fast shallow breathing, cold, pale, moist or mottled skin and/or confusion. These may be signs of a condition called sepsis: a severe and widespread reaction to infection. Sepsis is uncommon (may affect up to 1 in 100 people) and can be life-threatening 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. The frequency of this condition is unknown but it can be life-threatening.

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

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

• 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), nosebleed
• dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling
• swelling of soft tissues, pain (particularly in the chest, back and bones), muscle cramps or muscle weakness
• infections of the mouth, respiratory tract and urinary tract, pain when urinating
• irritated throat, irritated or runny nose, flu-like symptoms, sore throat
• abnormalities in liver function tests, altered levels of sugar, bilirubin, phosphates, potassium, magnesium or calcium in the blood
• inability to sleep, depression, altered 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 and numbness of the skin, 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 may 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, causing widespread blood clots and internal bleeding.

Reporting of side effects
If you get any side effects, including ones not listed in this leaflet, talk to your doctor or nurse. You can
also report side effects directly via 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 carton and vial after
Exp. The expiry date refers to the last day of that month.
This medicine does not require any special storage conditions.
If Eribulina Viatris is diluted for infusion, the diluted solution must be used immediately.
If not used immediately, the diluted solution should be stored at 2-8 °C for a maximum of 72 hours.
If undiluted Eribulina Viatris solution has been transferred into a syringe, it should be stored at
15-25 °C under ambient light conditions for a maximum of 4 hours or at 2-8 °C for a maximum of 24 hours.
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 Viatris contains

• The active substance is eribulin. Each 2 ml vial contains eribulin mesilate equivalent to 0.88 mg of eribulin.
• The other components 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, colourless injectable solution supplied in a glass vial with a rubber stopper and an aluminium flip-off cap, containing 2 ml of solution. Each pack contains 1 or 6 vials.
Marketing Authorization 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 European Economic Area countries under the
following names:
Norway: Eribulin Viatris
Belgium: Eribuline Viatris 0,44 mg/ml oplossing voor injectie
Germany: Eribulin Viatris 0,44 mg/ml Injektionslösung
Denmark: Eribulin Viatris
Spain: Eribulina Viatris 0,44 mg/ ml solución inyectable EFG
France: Eribuline Viatris 0,44 mg/mL, solution injectable
Iceland: Eribulin Viatris
Italy: Eribulina Viatris
Luxembourg: Eribuline Viatris 0,44 mg/mL solution injectable