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What is VYXEOS?

VYXEOS (vix-e-ose) is an intravenous (IV) chemotherapy used for the treatment of adults and pediatric patients 1 year and older with certain types of newly-diagnosed secondary acute myeloid leukemia (sAML): therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

You can learn more about VYXEOS by watching this video.

See more facts about VYXEOS.
 

How is VYXEOS different?

VYXEOS is an advancement in chemotherapy used for the treatment of adults and pediatric patients 1 year and older with certain types of newly-diagnosed sAML: t-AML or AML-MRC. For these types of AML, VYXEOS is the only chemotherapy that combines 2 currently used, effective chemotherapies into tiny, bubble-like carriers called liposomes, which carry the drugs to the bone marrow. The liposomes are taken up by the blasts to a greater extent than by normal cells. Once inside, the liposomes release the drugs to help kill the blasts.a This type of technology, combining 2 drugs in this way, is the first of its kind in sAML treatment.

 
IV Bag icon

Chemotherapy solutions can be various colors. The VYXEOS solution is purple.

Chemotherapy may help patients get to remission and the opportunity to receive a stem cell transplant, if appropriate. Stem cell transplant may be used to replace blood-forming cells in the bone marrow that have been destroyed by treatment with chemotherapy or radiation. With a stem cell transplant, a person receives new cells from a donor’s blood or bone marrow that grow into healthy blood cells to replace the ones that were lost.

  1. Results based on early studies in animals.

WHAT IS VYXEOS?

VYXEOS is an intravenous (IV) chemotherapy used for the treatment of adults and pediatric patients 1 year and older with certain types of newly-diagnosed secondary acute myeloid leukemia (sAML): therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC).

IMPORTANT SAFETY INFORMATION

WARNING: VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products.

VYXEOS should not be given to patients who have a history of serious allergic reaction to daunorubicin, cytarabine, or any of its ingredients.

VYXEOS can cause a severe decrease in blood cells (red and white blood cells and cells that prevent bleeding, called platelets) which can result in serious infection or bleeding and possibly lead to death. Your doctor will monitor your blood counts during treatment with VYXEOS. Patients should tell the doctor about new onset fever or symptoms of infection or if they notice signs of bruising or bleeding.

VYXEOS can cause heart-related side effects. Tell your doctor about any history of heart disease, radiation to the chest, or previous chemotherapy. Inform your doctor if you develop symptoms of heart failure such as:

  • shortness of breath or trouble breathing
  • swelling or fluid retention, especially in the feet, ankles, or legs
  • unusual tiredness

VYXEOS may cause allergic reactions including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis such as:

  • trouble breathing
  • severe itching
  • skin rash or hives
  • swelling of the face, lips, mouth, or tongue

VYXEOS contains copper and may cause copper overload in patients with Wilson’s disease or other copper-processing disorders.

VYXEOS can damage the skin if it leaks out of the vein. Tell your doctor right away if you experience symptoms of burning, stinging, or blisters and skin sores at the injection site.

VYXEOS can harm your unborn baby. Inform your doctor if you are pregnant, planning to become pregnant, or nursing. Do not breastfeed while receiving VYXEOS. Females and males of reproductive potential should use effective contraception during treatment and for 6 months following the last dose of VYXEOS.

The most common side effects were bleeding events, fever, rash, swelling, nausea, sores in the mouth or throat, diarrhea, constipation, muscle pain, tiredness, stomach pain, difficulty breathing, headache, cough, decreased appetite, irregular heartbeat, pneumonia, blood infection, chills, sleep disorders, and vomiting.

Call your doctor for medical advice about side effects. You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088. You may also report side effects to Jazz Pharmaceuticals at 1-800-520-5568.

Please see full Prescribing Information, including BOXED Warning, and discuss with your doctor.

Important Safety Information

VYXEOS has different dosage recommendations from other medications that contain daunorubicin and/or cytarabine. Do not substitute VYXEOS for other daunorubicin and/or cytarabine-containing products.