Vyxeos liposomal – Daunorubicin and cytarabine uses, dose and side effects


44 mg/100 mg powder for concentrate for infusion solution, solution
daunorubicin and cytarabine

What Vyxeos liposomal is and what it is used for

What Vyxeos liposomal is

Vyxeos liposomal belongs to a group of medicines called antineoplastic and are used in cancer. It contains two active substances called daunorubicin and cytarabine, in the form of very small particles called liposomes. These active substances work in different ways to kill cancer cells by preventing them from growing and dividing. By packing them in liposomes, their effect on the body is extended and makes it easier to penetrate and kill cancer cells.

What Vyxeos liposomal is used for

Vyxeos liposomal is used to treat patients with newly diagnosed acute myeloid leukemia (a cancer of the white blood cells ). It is given when the leukemia was caused by previous treatment (called therapy-related acute myeloid leukemia ) or when there are special changes in the bone marrow (called acute myeloid leukemia with myelodysplasia-related changes).

What you need to know before you are given Vyxeos liposomal

You should not be given Vyxeos liposomal

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

Warnings and precautions

The doctor will monitor you during treatment. Talk to your doctor or nurse before you are given Vyxeos liposomal:

  • If you have a low number of platelets ( thrombocytes ), and red or white blood cells in your blood (you must submit a blood sample before you can start the treatment). If this applies to you:
    • The doctor may also give you medicine to prevent you from getting an infection.
    • the doctor will also check you for infection during treatment.
  • If you have ever had heart problems or a heart attack, or if you have previously taken anthracyclines (cancer medicines). If any of these apply to you, your doctor may check your heart before and during treatment.
  • If you think you may be pregnant. You must use an effective method of contraception so that (you or your partner) do not become pregnant during treatment and for 6 months after the last dose.
  • If you get allergic (hypersensitivity) reactions. The doctor can pause or stop the treatment or give the drop more slowly if hypersensitivity occurs.
  • If you have had problems with your kidneys or liver. The doctor will monitor you during the treatment.
  • If you have ever had a condition called Wilson’s disease or other copper-related diseases because Vyxeos liposomal contains a substance called copper gluconate.
  • If you are to be given a vaccine.

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

Children and young people

Vyxeos liposomal is not recommended for children and adolescents under 18 years of age.

Other medicines and Vyxeos liposomal

Tell the doctor or nurse if you are using, have recently used, or might be using other medicines. This is because Vyxeos liposomal can affect how other medicines work. Other medicines can also affect how Vyxeos liposomal works.

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

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

Pregnancy and breastfeeding

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

You should not breastfeed while receiving treatment with Vyxeos liposomal as it may be harmful to the baby.

If you are pregnant or breastfeeding, think you may be pregnant, or are planning to have a baby, consult your doctor before receiving this medicine.

Driving ability and use of machinery

You may feel tired or dizzy after receiving Vyxeos liposomal. If this happens, do not drive or use tools or machines.

How you are given Vyxeos liposomal

Vyxeos liposomal must be given by a doctor or nurse experienced in the treatment of AML.

  • It is given as a drip ( infusion ) into a vein.
  • Infusion one is given over 1½ hours (90 minutes).

The doctor or nurse calculates the drug dose based on your weight and height. You receive the treatment in courses. Each course is given as a separate infusion and given weeks apart.

You receive an initial course of treatment and then the doctor decides whether you should receive further courses of treatment depending on how you react to the treatment and any side effects you experience. The doctor will assess how you react to the treatment after each course.

  • During the first course, you will receive an infusion on days 1, 3, and 5.
  • In subsequent courses, you receive an infusion on days 1 and 3. This can be repeated if necessary.

When you receive treatment with Vyxeos liposomal, your doctor will regularly take blood samples to assess how you respond to the treatment and check how well you are tolerating it. The doctor may also check the heart as it may be affected by Vyxeos liposomal.

If you are given too much Vyxeos liposomal

You will be given this medicine in a hospital by a doctor or nurse. It is unlikely that you will be given too much, but tell the doctor or nurse if you are worried.

If you forget a visit

Contact a doctor or nurse as soon as possible.

If you have any further questions about this medicine, ask your doctor or nurse.

Possible side effects

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

Serious side effects that may affect more than 1 in 10 users (very common)

Vyxeos liposomal can reduce the number of white blood cells, which fight infection, and also the blood cells that help the blood to clot ( platelets ) which leads to bleeding disorders such as nosebleeds and bruising. Vyxeos liposomal can also cause heart problems and damage the heart muscle.

Therefore, you must immediately contact a doctor if you experience:

  • fever, chills, sore throat, cough, mouth sores, or other symptoms of infection
  • bleeding or bruising without injury
  • chest pain or leg pain
  • respiratory distress.

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

Other side effects are

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

  • reduced number of platelets (cells that help the blood to clot) which may cause bruising or bleeding
  • fever, often with other signs of infection due to very low white blood cell count (febrile neutropenia )
  • slow, fast or irregular heartbeat, chest pain (which may be a sign of infection )
  • vision problems, blurred vision
  • pain or swelling of the lining of the digestive system ( mucositis ), or abdominal (stomach) pain, constipation, loss of appetite, diarrhea, nausea, or vomiting
  • skin redness, rash, muscle pain, headache, bone pain, joint pain, tiredness, and general swelling including swelling of 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 drop in blood pressure
  • chills, low or high body temperature
  • increased sweating.

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

  • reduced number of red blood cells ( anemia ) and lead to fatigue and weakness
  • kidney failure and abnormal blood tests due to many cancer cells dying (tumor lysis syndrome)
  • stomach cramps or severe gas
  • profuse sweating at night
  • hair loss.

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

  • numbness and rash in the hands and feet (palmoplantar erythrodysesthesia syndrome).

How to store Vyxeos liposomal

  • Keep this medicine out of the sight and reach of children.
  • Use before the expiry date stated on the carton and vial after Utg.dat/EXP. The expiration date is the last day of the specified month.
  • Store in a refrigerator (2°C to 8°C)
  • Store the vial in the outer carton. Light sensitive.
  • Store in an upright position.
  • After dilution, vials of reconstituted Vyxeos liposomal should be stored in a refrigerator (2°C to 8°C) for up to 4 hours in an upright position.
  • After dilution, infusion bags should be stored in a refrigerator (2°C to 8°C) for up to 4 hours. The maximum combined storage time for a reconstituted medicinal product in a vial stored in an upright position and reconstituted medicinal product that has been diluted in an infusion bag should not exceed 4 hours. The infusion time of 90 minutes applies in addition to the storage time of up to 4 hours.
  • Do not use this medicine if you see particles in the diluted solution.
  • Medicines should not be thrown down the drain. Ask the pharmacist how to dispose of medicines that are no longer used. These measures will help to protect the environment.

Contents of the packaging and other information

Contents declaration

  • The active substances are daunorubicin and cytarabine. Each 50 ml vial contains 44 mg daunorubicin and 100 mg cytarabine.
  • After preparation, the solution contains 2.2 mg/ml daunorubicin and 5 mg/ml cytarabine encapsulated in liposomes.
  • Other ingredients are di-stearoyl phosphatidylcholine, di-stearoyl phosphatidylglycerol, cholesterol , copper gluconate, trolamine, and sucrose.

Appearance and package sizes of the medicine

Vyxeos liposomal is a purple powder to concentrate for solution for infusion supplied in a glass vial.

Each pack contains 1, 2, or 5 vials. Not all pack sizes may be marketed.

Marketing authorization holder and manufacturer

Jazz Pharmaceuticals Ireland Ltd

5th Floor

Waterloo Exchange

Waterloo Road


D04 E5W7


Phone: +353 1 968 1631

(local telephone number within the Republic of Ireland)

(outside the Republic of Ireland an international call charge may apply)

email: medinfo-int@jazzpharma.com

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