MEVLYQ 0.44 mg/ml Инъекционный раствор

Содержание инструкции

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

Mevlyq 0.44 mg/mL injectable solution

eribulina

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, tell your doctor or nurse. 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 is Mevlyq and what is it used for

Mevlyq contains the active substance eribuline and is an antineoplastic medicinal product 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 using Mevlyq

Do not use Mevlyq

• if you are allergic to eribulin 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 Mevlyq:

• 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
Mevlyq is not recommended in children and adolescents under 18 years of age with pediatric sarcomas
because it is not yet known how it works in this age group.

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

Pregnancy, breastfeeding and fertility
Mevlyq can cause serious birth defects and should 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 who use this
medicine; 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 Mevlyq.
Mevlyq should not be used during breastfeeding, due to the potential risks to
the baby.

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

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 have any significant effects.
This medicine contains less than 1 mmol (23 mg) of sodium in each 2 mL vial, that is to say
essentially ‘sodium-free’.

3. How to use Mevlyq

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

How often will you be administered Mevlyq?
Mevlyq 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, you must stop taking Mevlyq and consult
your doctor immediately:

• fever, with a rapid heartbeat, shallow rapid breathing, cold, pale, damp or mottled skin and/or confusion. These may be signs of a condition called sepsis: a severe 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 condition has an unknown frequency but can be life-threatening.

Other side effects:

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

• 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)

• reduction in the number of platelets (which may cause bruising or an 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, oral herpes, 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)

• 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)

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

Reporting of side effects
If you get any side effects, talk to your doctor or nurse. This includes any side effects not listed in this leaflet. 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 which is stated on the package 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 Mevlyq is diluted for infusion, it must be stored at a temperature between 2 °C and
8 °C for a maximum of 72 hours.
If Mevlyq as an undiluted solution has been transferred into a syringe, it must be stored at a
temperature of 25 °C for a maximum of 4 hours or at a temperature between 2 °C and 8 °C for a maximum
of 24 hours.
From a microbiological point of view, the medicine must be used immediately. If not
used immediately, the storage times in use and the conditions prior to use are the
responsibility of the user and should generally not exceed 24 hours at a temperature
between 2 °C and 8 °C, unless the dilution has taken place under controlled and validated aseptic conditions.
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 Mevlyq contains

• The active substance is eribuline. Each vial contains eribuline mesylate equivalent to 0.88 mg of eribuline 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 and colourless aqueous solution, supplied in glass vials containing 2 mL of
injectable solution. Each pack 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 medicine is available on the European Medicines Agency website, http://www.ema.europa.eu/.
This leaflet is available in all languages of the European Union/European Economic Area on the
European Medicines Agency website.