Eribulin Baxter

Package leaflet: Information for the user

Eribulin Baxter 0.44 mg/mL injection solution

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

1. What Eribulin Baxter is and what it is used for

Eribulin Baxter contains the active substance eribulin and is an antineoplastic medicinal product that works
by inhibiting the growth and spread of cancer cells.
It is used in adults for locally advanced or metastatic breast cancer (breast cancer that has spread beyond the original tumour) 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 tumour originating from fatty tissue) when a previous therapy has been attempted but has not been effective.

2. What you need to know before using Eribulin Baxter

Do not use Eribulin Baxter

• if you are allergic to eribulin mesylate 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 Eribulin Baxter:

• if you have liver problems
• if you have fever or an infection
• if you develop pain, 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 discontinue treatment or
reduce the dose.
Children and adolescents
Do not administer this medicine to children aged between 0 and 18 years because it is not effective.
Other medicines and Eribulin Baxter
Tell your doctor if you are taking, have recently taken, or might take any other medicines.
Pregnancy, breastfeeding and fertility
Eribulin Baxter may cause severe birth defects and must not be used during
pregnancy unless absolutely necessary and after careful consideration of all risks to you
and the unborn child. It may also cause permanent fertility problems in men receiving
treatment; therefore, this issue should be discussed with your doctor before starting
treatment. Women of childbearing age must use highly effective contraceptive measures during
treatment with Eribulin Baxter and for 7 months after treatment with Eribulin Baxter.
Eribulin Baxter must not be used during breastfeeding due to possible risks to the infant.
Men with partners of childbearing potential must not father a child while receiving
treatment with Eribulin Baxter. Men must use an effective contraceptive method while taking Eribulin Baxter
and for 4 months after treatment.
Driving and using machines
Eribulin Baxter may cause side effects such as fatigue (very common) and dizziness (common). Do not drive or
use machinery if you experience fatigue or dizziness.
Eribulin Baxter contains anhydrous ethanol
This medicine contains 78.9 mg (0.1 mL) of anhydrous ethanol in each vial. The amount in
2 mL of this medicine is equivalent to 2 mL of beer or less than 1 mL of wine. The small amount
of alcohol in this medicine will not produce significant effects.
Eribulin Baxter contains sodium
This medicine contains less than 1 mmol (23 mg) of sodium per vial, i.e. essentially
'sodium-free'.

3. How to use Eribulin Baxter

Eribulin Baxter will be administered to you by a qualified healthcare professional, by injection into a vein, over a period of 2 to 5 minutes. The dose you will receive is based on your body surface area (expressed in square meters, m²), calculated according to your weight and height. The usual dose of Eribulin Baxter 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 Eribulin Baxter is administered, it is recommended that a saline solution be injected through the same infusion line into the vein after administration of Eribulin Baxter.

How often will Eribulin Baxter be administered?
Eribulin Baxter 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 the results of blood tests, 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 Eribulin Baxter 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 not 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 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) 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), nosebleeds
• dehydration, dry mouth, cold sores, oral candidiasis, indigestion, heartburn, abdominal pain or swelling
• swelling of soft tissues, pain (particularly 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 glucose, bilirubin, phosphate, potassium, magnesium or calcium in the blood
• inability to sleep, depression, changes in 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 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 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 listed in Annex V. By reporting side effects, you can help provide more information on the safety of this medicine.

5. How to store Eribulin Baxter

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.
Store below 30 °C.

If Eribulin Baxter is diluted for infusion:
Chemical and physical in-use stability has been demonstrated for 24 hours at
15-25 °C and for 72 hours at 2°C - 8 °C.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately,
the responsibility for storage conditions and duration in use lies with the user and should normally not exceed
24 hours at 2°C - 8 °C, unless dilution has been carried out under controlled and validated aseptic conditions.

If undiluted Eribulin Baxter solution has been transferred into a syringe:
Chemical and physical in-use stability of the undiluted solution in a syringe has been demonstrated
for 4 hours at 15-25 °C and for 24 hours at 2°C - 8 °C.

Eribulin Baxter vials are for single use only. Discard all unused portions of Eribulin Baxter.
Do not dispose of medicines via wastewater or household waste. Ask your pharmacist how to dispose of
medicines no longer required. This will help protect the environment.

6. Package contents and other information

What Eribulin Baxter contains

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

Description of the appearance of Eribulin Baxter and contents of the pack
Eribulin Baxter is a clear, colourless, aqueous injectable solution, essentially free from visible
particulate matter, supplied in glass vials containing 2 mL of solution. Each cardboard pack contains 1 vial.
Marketing Authorisation Holder
Baxter Holding B.V.
Kobaltweg 49
3542 CE, Utrecht
The Netherlands
Manufacturer
Baxter Oncology GmbH
Kantstraße 2
33790 Halle/Westfalen
Germany
For further information on this medicinal product, please contact the local representative of the Marketing Authorisation Holder:
België/Belgique/Belgien Lietuva
Baxter Belgium SPRL/BVBA UAB „Baxter Lithuania“
Tél/Tel: +32 (0)2 386 80 00 Tel: +37052527100
[email protected]
България Luxembourg/Luxemburg
Baxter Holding B.V. Baxter Belgium SPRL/BVBA
Teл.: +31 (0)30 2488 911 Tél/Tel: +32 (0)2 386 80 00
[email protected]
Česká republika Magyarország
BAXTER CZECH spol. s r.o. Baxter Hungary Kft.
Tel: +420 225 774 111 Tel: +36 1 202 1980
Danmark Malta
Baxter A/S Baxter Holding B.V.
Tlf: +45 4816 6400 Tel: +44 (0)1635 206345
Deutschland Nederland
Baxter Deutschland GmbH Baxter B.V.
Tel: +49 (0)89 31701-0 Tel: +31 (0)30 2488 911
[email protected] [email protected]
Eesti Norge
OÜ Baxter Estonia Baxter AS
Tel: +372 651 5120 Tlf: +47 22 58 48 00
Ελλάδα Österreich
Baxter (Hellas) Ε.Π.Ε., Baxter Healthcare GmbH
Τηλ: +30 210 28 80 000 Tel: +43 1 71120 0
[email protected]
España Polska
Baxter S.L. Baxter Polska Sp. z o.o.
Tel: +34 91 678 93 00 Tel: +48 22 488 37 77
France Portugal
Baxter SAS Baxter Médico Farmacêutica, Lda.
Tél: +33 1 34 61 50 50 Tel: +351 21 925 25 00
Hrvatska România
Baxter Healthcare d.o.o. BAXTER HEALTHCARE SRL
Tel: +385 1 6610314 Tel: +40 372 302 053
Ireland Slovenija
Baxter Holding B.V. Baxter d.o.o.
Tel: +44 (0)1635 206345 Tel: +386 1 420 16 80
Ísland Slovenská republika
Baxter Medical AB Baxter Slovakia s.r.o.
Sími: +46 8 632 64 00 Tel: +421 2 32 10 11 50
Italia Suomi/Finland
Baxter S.p.A. Baxter Oy
Tel: +390632491233 Puh/Tel: +358 (09) 862 111
Κύπρος Sverige
Baxter Holding B.V. Baxter Medical AB
Τηλ: +31 (0)30 2488 911 Tel: +46 (0)8 632 64 00
Latvija United Kingdom (Northern Ireland)
Baxter Latvia SIA Baxter Holding B.V.
Tel: +371 677 84784 Tel: +44 (0)1635 206345
Baxter is a registered trademark of Baxter International Inc.
More detailed information on this medicinal product is available on the website of the European Medicines Agency, https://www.ema.europa.eu/ .