Mevlyq

Package leaflet: Information for the user

Mevlyq 0.44 mg/mL injectable solution

eribulin
Please read all of this leaflet carefully before you use 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 Mevlyq is and what it is used for
2. What you need to know before you use Mevlyq
3. How to use Mevlyq
4. Possible side effects
5. How to store Mevlyq
6. Contents of the pack and other information

1. What Mevlyq is and what it is used for

Mevlyq 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 therapy has been tried but has not
been 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 has not been effective.

2. What you should know before using Mevlyq

Do not use Mevlyq

• if you are allergic to eribulin 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 Mevlyq:

• if you have liver problems
• if you have fever or an infection
• if you experience muscle 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 stop treatment or
reduce the dose.
Children and adolescents
Mevlyq is not recommended in children and adolescents under 18 years of age with
pediatric sarcomas, as its effects in this age group are not yet known.
Other medicines and Mevlyq
Inform your doctor if you are currently using, have recently used, or might use any other medicines.
Pregnancy, breastfeeding, and fertility
Mevlyq can cause severe congenital malformations 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 age must use highly
effective contraceptive measures during treatment with Mevlyq and for 7 months after treatment.
Mevlyq 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 Mevlyq treatment.
Men must use an effective contraceptive method while taking Mevlyq and for 4 months after treatment.
Driving and using machines
Mevlyq may cause side effects such as fatigue (very common) and dizziness (common).
Do not drive or operate machinery if you experience fatigue or dizziness.
Mevlyq contains alcohol (ethanol) and sodium
This medicine contains 80 mg of alcohol (ethanol) in each 2 mL vial. The amount per dose (5 mL) of this
medicine is equivalent to less than 5 mL of beer or 2 mL of wine.
The small amount of alcohol in this medicine will not produce significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium per 2 mL vial, i.e. essentially ‘sodium-free’.

3. How to use Mevlyq

Mevlyq will be administered to you by a qualified healthcare professional, as an intravenous injection through an infusion line, over a period of 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 Mevlyq 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 Mevlyq is delivered, it is recommended that a saline solution be injected through the same infusion line into the vein after administration of Mevlyq.

How often will Mevlyq be administered?
Mevlyq 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 everybody gets them.
If you experience any of the following serious symptoms, you must stop taking Mevlyq and consult 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 intense reaction to an infection. Sepsis is uncommon in 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 disease called Stevens-Johnson syndrome/toxic epidermal necrolysis. This condition has a frequency that is not known 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
• fatigue 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)

• reduction in the number of platelets (which may cause bruising or increased time needed to stop bleeding)
• infection with fever, pneumonia, chills
• rapid heartbeat, hot flushes
• dizziness, vertigo
• 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 (particularly in the chest, back and bones), muscle spasms or 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
• 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)

• 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 get any side effects, including ones not listed in this leaflet, talk to your doctor or nurse. You can also report side effects directly through 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 Mevlyq

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 requires no special storage conditions.
If Mevlyq is diluted for infusion, it must be stored at a temperature between 2 °C and
8 °C for up to 72 hours.
If undiluted Mevlyq solution has been transferred into a syringe, it must be stored at
25 °C for up to 4 hours or at a temperature between 2 °C and 8 °C for up to
24 hours.
From a microbiological standpoint, the medicine should be used immediately. If not used immediately,
the storage times during use and the conditions prior to use are the responsibility of the user and should
normally not exceed 24 hours at a temperature between 2 °C and 8 °C, unless the dilution has been carried out under controlled and validated aseptic conditions.
Do not dispose of any medicine via wastewater or household waste. Ask your pharmacist how to dispose of medicines no longer in use. This will help protect the environment.

6. Package contents and other information

What Mevlyq contains

• The active substance is eribulin. Each vial contains eribulin mesylate equivalent to 0.88 mg of eribulin in 2 mL of solution.
• The other components are anhydrous ethanol, water for injections, hydrochloric acid (for pH adjustment), and sodium hydroxide (for pH adjustment). See section 2 “Mevlyq contains alcohol (ethanol) and sodium”.

Description of the appearance of Mevlyq and contents of the pack
Mevlyq is a clear, colourless aqueous solution supplied in glass vials containing 2 mL of injectable solution. Each carton contains 1 vial.
Marketing Authorisation Holder
YES Pharmaceutical Development Services GmbH
Basler Strasse 7
61352 Bad Homburg
Germany
Manufacturer
A & O Pharma GmbH
Am Sattel 17
79588 Efringen-Kirchen
Germany
Other sources of information
More detailed information on this medicinal product is available on the website of the European Medicines Agency: http://www.ema.europa.eu/.
This leaflet is available in all languages of the European Union/European Economic Area on the website of the European Medicines Agency.