Eribulin Glenmark

Package leaflet: Information for the user

Eribulina Glenmark 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, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. See section 4.

Contents of this leaflet:

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

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

Eribulina Glenmark contains the active substance eribulin 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 treatment 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 treatment has been tried but was not effective.

2. What you need to know before using Eribulina Glenmark

Do not use Eribulina Glenmark

• 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 Glenmark:

• if you have liver problems
• if you have fever or an infection
• if you develop pain, numbness, tingling, 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 0 to 18 years, as it is not effective.

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

Pregnancy, breastfeeding and fertility
Women of childbearing age must use effective contraception during treatment and for at least 7 months after treatment with Eribulina Glenmark. Men must not father a child during treatment with Eribulina Glenmark. Men must use an effective method of contraception during treatment with Eribulina Glenmark and for at least 4 months after treatment.
Eribulina Glenmark may cause severe congenital malformations and must not be used during pregnancy unless absolutely necessary and after careful consideration of all risks to you and the unborn child.
Eribulina Glenmark must not be used during breastfeeding due to the potential risks to the infant.
It may also cause long-term permanent fertility problems in men undergoing treatment; therefore, this issue should be discussed with your doctor before starting treatment.

Driving and using machines
Eribulina Glenmark 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 Glenmark contains ethanol (alcohol)
This medicine contains 79 mg of alcohol (ethanol) per vial, equivalent to 40 mg/ml.
The amount in each vial 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 any significant effects.

3. How to use Eribulina Glenmark

Eribulina Glenmark 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 from your weight and height. The usual dose of
Eribulina Glenmark 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 Glenmark is administered, it is recommended that a saline solution be injected into the vein through the same infusion line immediately after administration of Eribulina Glenmark.
How often will Eribulina Glenmark be administered?
Eribulina Glenmark 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 questions about the use of this medicine, 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 Glenmark 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 overwhelming response to infection. Sepsis is of uncommon frequency (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 may 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, feeling of dizziness
• 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 or 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 sensation
• skin rash, itching, nail problems, dry or red skin
• excessive sweating (including night sweats)
• ringing in the ears
• blood clots in the lungs
• shingles (herpes zoster)
• 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 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 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 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 Glenmark

Keep this medicine out of the sight and reach of children.
Do not use this medicine after the expiry date 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 Glenmark 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 48 hours.
If undiluted Eribulina Glenmark solution has been transferred into a syringe, it should be stored at a temperature of 25 °C for a maximum of 24 hours or at 2-8 °C for a maximum of 96 hours.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately, the storage times and conditions during use are the responsibility of the user and should normally not exceed 24 hours at a temperature of 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 Glenmark contains

• The active substance is eribulin. One ml contains eribulin mesylate equivalent to 0.44 mg of eribulin. Each 2 ml vial contains eribulin mesylate equivalent to 0.88 mg of eribulin.
• The other components are ethanol and water for injections, with hydrochloric acid and sodium hydroxide.

Description of the appearance of Eribulina Glenmark and contents of the pack
Eribulina Glenmark is a clear, colourless aqueous injectable solution supplied in glass vials containing 2 ml of solution. Each carton contains 1 or 6 vials.
Not all pack sizes may be marketed.

Marketing Authorisation Holder and Manufacturer
Marketing Authorisation Holder
Glenmark Pharmaceuticals s.r.o.
Hvezdova 1716/2b
140 78 - Prague
Czech Republic

Manufacturer
AqVida GmbH
Kaiser-Wilhelm-Str. 89
20355 Hamburg
Germany

This medicinal product is authorised in the European Economic Area countries under the following names:
Italy: Eribulina Glenmark
Sweden: Eribulin Glenmark 0.44 mg/ml solution for injection
Denmark: Eribulin Glenmark
Norway: Eribulin Glenmark 0.44 mg/ml solution for injection
Finland: Eribulin Glenmark 0.44 mg/ml solution for injection
Spain: Eribulina Glenmark 0.44 mg/ml solución inyectable EFG