Document Details

Generated Narrative: Bundle TEST PURPOSES ONLY - vyxeos

Document Subject

Generated Narrative: MedicinalProductDefinition mp691dd468387a7314644483dde7be004c

identifier: http://ema.europa.eu/identifier/EU/1/18/1308/001 1 vial

type: Medicinal Product

domain: Human use

status: active

legalStatusOfSupply: Medicinal product subject to medical prescription

name

productName: Vyxeos liposomal 44 mg/100 mg powder for concentrate for solution for infusion.

type: Full name

part

part: nan

type: Invented name part

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part: nan

type: Scientific name part

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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-691dd468387a7314644483dde7be004c

identifier: http://ema.europa.eu/identifier/EU/1/18/1308/001 1 vial

status: Final

type: Package Leaflet

category: Raw

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

author: Organization ACME industry

title: TEST PURPOSES ONLY - vyxeos

Attesters

What is in this leaflet

1. What Vyxeos liposomal is and what it is used for
2. What you need to know before you are given Vyxeos liposomal
3. How you are given Vyxeos liposomal
4. Possible side effects
5. How to store Vyxeos liposomal
6. Contents of the pack and other information

What Vyxeos liposomal is Vyxeos liposomal belongs to a group of medicines called antineoplastics used in cancer. It contains two active substances, called daunorubicin and cytarabine , in the form of tiny particles known as liposomes . These active substances act in different ways to kill cancer cells by stopping them from growing and dividing. Packaging them in liposomes prolongs their action in the body and helps them to enter and kill the cancer cells.

What Vyxeos liposomal is used for Vyxeos liposomal is used to treat patients with newly diagnosed acute myeloid leukaemia (a cancer of the white blood cells). It is given when the leukaemia was caused by previous treatments (known as therapy related acute myeloid leukaemia) or when there are certain changes in the bone marrow (known as acute myeloid leukaemia with myelodysplasia-related changes ).

You must not be given Vyxeos liposomal

• if you are allergic to the active substances (daunorubicin or cytarabine) or any of the other ingredients of this medicine (listed in section 6).

Warnings and precautions Your doctor will monitor you during treatment. Talk to your doctor or nurse before you are given Vyxeos liposomal:

• if you have low numbers of platelets, red or white blood cells in your blood (you will have a blood test before starting treatment). If this applies to you:

• your doctor may also give you a medicine to help stop you getting an infection.
• your doctor will also check you for infections during treatment.

• if you have ever had a heart problem or heart attack, or you have previously taken anthracycline cancer medicines. If this applies to you, your doctor may check your heart before starting, and during treatment.
• if you think you might be pregnant. You should use an effective method of contraception to avoid getting (you or your partner) pregnant during the treatment, and for the next 6 months after your last dose.
• if you have any allergic (hypersensitivity) reactions. Your doctor may pause or stop treatment, or slow the rate of your drip, if any hypersensitivity occurs.
• if you have had problems with your kidneys or liver. Your doctor will monitor you during treatment.
• if you have ever had a condition known as Wilson s disease or other copper-related disorder, as Vyxeos liposomal contains an ingredient known as 'copper gluconate'.
• if you are to be given a vaccine.

Your doctor will monitor you with regards to your general health during treatment and may also give you other medicines to support your treatment, either before or with Vyxeos liposomal. If any of the above apply to you (or you are not sure), talk to your doctor, pharmacist, or nurse before you are given Vyxeos liposomal.

Children and adolescents Vyxeos liposomal is not recommended for use in children and adolescents under 18 years.

Other medicines and Vyxeos liposomal Tell your doctor or nurse if you are using, have recently used or might use any other medicines. This is because Vyxeos liposomal may affect the way some other medicines work. Also, some other medicines may affect the way Vyxeos liposomal works.

In particular, tell your doctor or nurse if you are taking any of the following medicines:

• cancer medicines that can affect your heart, such as doxorubicin.
• medicines that can affect your liver.

Pregnancy and breast-feeding You should not use Vyxeos liposomal during pregnancy as it may be harmful to the baby. Use an effective method of contraception during and for 6 months after treatment. Tell your doctor straight away if you become pregnant during treatment.

You should not breast-feed while you are receiving treatment with Vyxeos liposomal as it may be harmful to the baby.

If you are pregnant or breast-feeding, think you may be pregnant, or are planning to have a baby, ask your doctor for advice before you are given this medicine.

Contraception in males Use an effective method of contraception during and for 6 months after treatment with Vyxeos liposomal.

Driving and using machines You may feel sleepy or dizzy after having Vyxeos liposomal. If this happens, do not drive or use any tools or machines.

Vyxeos liposomal must be given to you by a doctor or nurse with experience in treating AML.

• It is given to you as a drip (infusion) into a vein.
• The infusion is given over one and a half hours (90 minutes).

Your doctor or nurse will work out your dose of the medicine based on your weight and height. Your treatment will be given in courses . Each course is given as a separate infusion and can be given weeks apart.
You will receive a first course of treatment and your doctor will decide if you will receive further courses of treatment depending on how you respond to treatment and any side effects you get. Your doctor will assess how you respond to treatment after each course.

• During your first course - you will have an infusion on days 1, 3, and 5. * On further courses - you will have an infusion on days 1 and 3. This can be repeated if necessary.

While you are receiving treatment with Vyxeos liposomal your doctor will perform regular blood tests to assess how you respond to the treatment and to check it is well tolerated. Your doctor may also check your heart as Vyxeos liposomal may affect it.

If you are given too much Vyxeos liposomal This medicine will be given to you in a hospital by a doctor or nurse. It is unlikely that you will be given too much, however, tell your doctor or nurse if you have any concerns.

If you miss an appointment Contact your doctor or nurse as soon as possible.

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

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

Serious side effects which may affect more than 1 in 10 people (very common) Vyxeos liposomal may reduce the number of white blood cells, which fight infection, and also the blood cells which help the blood to clot (platelets) leading to bleeding disorders such as nosebleeds and bruising. Vyxeos liposomal may also cause heart problems and damage to the heart muscle.

Therefore you must tell your doctor immediately if you experience:

• fever, chills, sore throat, cough, mouth ulcers or any other symptoms of infection
• bleeding or bruising without injury
• chest pain or leg pain
• feeling short of breath.

Tell your doctor immediately if you get any of the side effects listed above.

Other side effects

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

• a fall in the number of platelets (cells that help blood to clot) which may cause bruising or bleeding
• fever, often with other signs of infection, due to very low white blood cells (febrile neutropenia)
• slow, fast, or irregular heartbeat, chest pain (which may be a sign of infection)
• problems with your sight, blurred vision
• pain or swelling of the tissue lining the digestive system (mucositis), or pain in the abdomen (belly), constipation, loss of appetite, diarrhoea, nausea (feeling sick) or vomiting
• redness of skin, rashes, muscle aches, headache, bone pain, joint pain, tiredness, generalised swelling including swelling of your arms and legs
• headache, dizziness, confusion, difficulty sleeping, anxiety
• kidney failure
• shortness of breath, cough, fluid in the lungs
• itching
• bleeding
• increased blood pressure or a fall in blood pressure
• chills, low body temperature, or high body temperature
• increased sweating

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

• a fall in the number of red blood cells (anaemia) leading to tiredness and weakness
• kidney failure and abnormal blood tests due to massive death of cancer cells (Tumour lysis syndrome).
• stomach cramps or excessive gas
• excessive sweating at night
• hair loss

Uncommon side effects (may affect up to 1 in 100 people):

• numbness and rash in the hands and feet (palmar-plantar erythrodysaesthesia syndrome).

Reporting of side effects If you get any side effects, talk to your doctor, pharmacist 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.
• Store in a refrigerator (2 C to 8 C).
• Keep the vial in the outer carton in order to protect from light.
• Store in an upright position.
• After reconstitution, the vials should be stored in a refrigerator (2 C to 8 C) for up to 4 hours in an upright position.
• After dilution, the solution in infusion bags should be stored in a refrigerator (2 C to 8 C) for up to 4 hours. The maximum combined storage time, for reconstituted product in the vial kept in an upright position and reconstituted product after dilution into an infusion bag, should not exceed 4 hours. The 90-minute infusion time is in addition to the up to 4 hours storage time.
• Do not use this medicine if you notice any particles in the diluted solution.
• Do not throw away any medicines via wastewater. Ask your pharmacist how to throw away medicines you no longer use. These measures will help protect the environment.

What Vyxeos liposomal contains

• The active substances are daunorubicin and cytarabine. Each 50 mL vial contains 44 mg of daunorubicin and 100 mg of cytarabine.
• After reconstitution the solution contains 2.2 mg/mL daunorubicin and 5 mg/mL cytarabine encapsulated in liposomes.
• The other ingredients are distearoylphosphatidylcholine, distearoylphosphatidylglycerol, cholesterol, copper gluconate, trolamine and sucrose.

What Vyxeos liposomal looks like and contents of the pack Vyxeos liposomal is a purple powder for concentrate for solution for infusion supplied in a glass vial.
Each pack contains 1 vial, 2 vials or 5 vials. Not all pack sizes may be marketed. Marketing Authorisation Holder and Manufacturer

Jazz Pharmaceuticals Ireland Ltd
5th Floor Waterloo Exchange Waterloo Road Dublin D04 E5W7 Ireland Tel: +353 1 968 1Email: medinfo-int@jazzpharma.com

This leaflet was last revised in

Other sources of information

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