Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - mevlyq

Document Subject

Generated Narrative: MedicinalProductDefinition mp72698f459e623b86f3f80561e5b525b7

identifier: http://ema.europa.eu/identifier/EU/1/23/1789/001

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Mevlyq 0.44 mg/mL solution for injection

type: Full name

part

part: nan

type: Invented name part

part

part: nan

type: Scientific name part

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part: nan

type: Strength part

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type: Pharmaceutical dose form part

Usages

-	Country	Jurisdiction	Language
*	EU	EU	en

Document Content

Generated Narrative: Composition composition-en-72698f459e623b86f3f80561e5b525b7

identifier: http://ema.europa.eu/identifier/EU/1/23/1789/001

status: Final

type: Package Leaflet

category: Raw

date: 2022-02-16 13:28:17+0000

author: Organization ACME industry

title: TEST PURPOSES ONLY - mevlyq

Attesters

What is in 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

Mevlyq contains the active substance eribulin and is an anti-cancer medicine which works by stopping 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 tried but has lost its effect.

It is also used in adults for advanced or metastatic liposarcoma (a type of cancer that arises from fat tissue) when previous therapy has been tried but has lost its effect.

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 breast-feeding

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 numbness, tingling, prickling sensations, sensitivity to touch or muscle weakness
• if you have heart problems

If any of these affects you, tell your doctor who may wish to stop treatment or reduce the dose.

Children and adolescents

Mevlyq is not recommended for children and adolescents aged under 18 years with paediatric sarcomas as it is not yet known how well it works in this age group.

Other medicines and Mevlyq Tell your doctor if you are using, have recently used or might use any other medicines.

Pregnancy, breast-feeding and fertility Mevlyq may cause serious birth defects and should not be used if you are pregnant unless it is thought clearly necessary after carefully considering all the risk to you and the baby. It may also cause future permanent fertility problems in men if they use this medicine and they should discuss this with their doctor before starting treatment. Women of childbearing age should use effective contraception during and up to 3 months after treatment with Mevlyq.

Mevlyq must not be used during breast-feeding because of the possibility of risk to the child.

Driving and using machines Mevlyq may cause side effects such as tiredness (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 medicinal product is equivalent to less than 5 mL beer or 2 mL wine. The small amount of alcohol in this medicine will not have any noticeable effects. This medicine contains less than 1 mmol sodium (23 mg) in each 2 mL vial, that is to say essentially sodium-free .

Mevlyq will be given to you by a qualified healthcare professional as an 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 squared metres, or m2) which is calculated from your weight and height. The usual dose of Mevlyq is 1.23 mg/m2, but this may be adjusted by your doctor based on your blood test results or other factors. To ensure that the whole dose of Mevlyq is given it is recommended that a saline solution is flushed into the vein after Mevlyq is given.

How often will you be given Mevlyq? Mevlyq is usually given on Days 1 and 8 of every 21-day cycle. Your doctor will determine how many cycles of treatment you should receive. Depending on the results of your blood tests, the doctor may need to delay administration of the medicine until the blood tests return to normal. The doctor may also then decide to reduce the dose you are given.

If you have any further questions on the use of this medicine, ask your doctor.

Like all medicines, this medicine can cause side effects, although not everybody gets them.

If you experience any of the following serious symptoms, you should stop taking Mevlyq and seek medical attention straightaway:

• Fever, with a racing heart beat, rapid shallow breathing, cold, pale, clammy or mottled skin and/or confusion. These may be signs of a condition called sepsis a severe and serious reaction to an infection. Sepsis is uncommon (may affect up to 1 in 100 people) and can be life- threatening and may result in death.
• Any difficulty breathing, or swelling of your face, mouth, tongue or throat. These could be signs of an uncommon allergic reaction (may affect up to 1 in 100 people).
• Serious skin rashes with blistering of the skin, mouth, eyes and genitals. These may be signs of a condition called Stevens Johnson syndrome/toxic epidermal necrolysis. The frequency of this condition is not known but it 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

Tiredness or weakness

Nausea, vomiting, constipation, diarrhoea

Numbness, tingling or prickling sensations

Fever

Loss of appetite, weight loss

Difficulty breathing, cough

Pain in the joints, muscles and back

Headache

Hair loss

Common side effects (may affect up to 1 in 10 people)

Decrease in the number of platelets (which may result in bruising or taking longer to stop bleeding)

Infection with fever, pneumonia, chills

Fast heart rate, flushing

Vertigo, dizziness

Increased production of tears, conjunctivitis (redness and soreness of the surface of the eye), nosebleed

Dehydration, dry mouth, cold sores, oral thrush, indigestion, heartburn, abdominal pain or swelling

Swelling of soft tissues, pains (in particular chest, back and bone pain), muscle spasm or weakness

Mouth, respiratory and urinary tract infections, painful urination

Sore throat, sore or runny nose, flu-like symptoms, throat pain

Liver function test abnormalities, altered level of sugar, bilirubin, phosphates, potassium, magnesium or calcium in the blood

Inability to sleep, depression, changed sense of taste

Rash, itching, nail problems, dry or red skin

Excessive sweating (including night sweats)

Ringing in the ears

Blood clots in the lungs

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

Abnormal liver function tests (hepatoxicity)

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 1000 people)

A serious disorder of blood clotting resulting in the widespread formation of blood clots and internal bleeding.

Reporting of side effects If you get any side effects, talk to your doctor or nurse. This includes any possible side effects not listed in this leaflet. You can also report side effects directly via the national reporting system listed in Appendix V. By reporting side effects you can help provide more information on the safety of this medicine.

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 the vial after EXP. The expiry date refers to the last day of that month.

This medicinal product does not require any special storage conditions.

If Mevlyq is diluted for infusion, it should be stored at 2 C - 8 C for no longer than 72 hours.

If Mevlyq as an undiluted solution has been transferred into a syringe, it should be stored at 25 C for no longer than 4 hours, or at 2 C - 8 C for no longer than 24 hours.

From a microbiological point of view, the product should be used immediately. If not used immediately, in-use storage times and conditions prior to use are the responsibility of the user and would normally not be longer than 24 hours at 2 C - 8 , unless dilution has taken place in controlled and validated aseptic conditions.

Do not throw away any medicines via wastewater or household waste. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Mevlyq contains

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

What Mevlyq looks like and contents of the pack

Mevlyq is a clear, colourless aqueous solution provided in glass vials containing 2 mL solution for injection. 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 79588 Efringen-Kirchen Germany

This leaflet was last revised in

Other sources of information

Detailed information on this medicine is available on the European Medicines Agency web site: