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What to expect with VYXEOS

VYXEOS (vix-e-ose) is administered as an intravenous (IV) infusion using a central IV line or peripherally inserted central catheter.

VYXEOS is given in phases known as induction and consolidation. Induction is the first phase of treatment, used to control the disease and reduce the number of blasts to achieve remission (a decrease in or disappearance of signs and symptoms of cancer). Consolidation is the next phase of treatment, used to maintain remission and decrease the number of remaining blasts.

A full VYXEOS treatment course can consist of up to 2 cycles of induction and up to 2 cycles of consolidation. Your doctor will determine what is needed based on your progress.

See more information about this dosing schedule.
 

Why you might need multiple cycles of induction and consolidation during your treatment with VYXEOS

Your VYXEOS dosing schedule is designed specifically for you by your healthcare team based on your progress at certain time points during treatment.

Doctors may complete a bone marrow assessment 2 to 3 weeks after first induction to determine if VYXEOS is working. If your results show you are in remission, your doctors may decide to move you directly to first consolidation.

Some patients may receive a second induction to help further reduce blast count. You may receive another bone marrow assessment to check blast count 2 to 3 weeks after this round. Depending on the results of this, your doctors may decide that you should begin first consolidation.

Second consolidation cycles may be administered to ensure the disease remains controlled.

 

What to tell your healthcare team before treatment with VYXEOS

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History of heart disease

VYXEOS can cause heart-related side effects. Tell your healthcare team about any history of heart disease, radiation to the chest, or previous chemotherapy.

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History of copper-processing disorder

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

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Additional medications you may be taking

It is important to tell your healthcare team about all medications you may be taking, including any vitamins or supplements, to determine what you may need to discontinue during treatment. Some medications may affect treatment with VYXEOS.

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Previous chemotherapy treatment

Tell your healthcare team about any prior treatment with an anthracycline such as daunorubicin, doxorubicin, epirubicin, or idarubicin.

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Known or suspected pregnancy

VYXEOS can harm your unborn baby and should not be received during pregnancy. Females and males of reproductive age should use effective contraception during treatment and for 6 months following the last dose of VYXEOS. Additionally, you should not breastfeed during treatment with VYXEOS and for at least 2 weeks after the last dose.

 

What to tell your healthcare team during treatment with VYXEOS

You should immediately contact a member of your healthcare team if you experience any of the following:

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Fever, signs of infection, or bruising or bleeding

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

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Signs of heart failure

VYXEOS can cause heart-related side effects such as shortness of breath or trouble breathing; swelling or fluid retention, especially in the feet, ankles, or legs; or unusual tiredness.

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Skin damage

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.

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Signs of hypersensitivity reactions, including anaphylaxis

VYXEOS may cause allergic reactions, including anaphylaxis. Seek immediate medical attention if you develop signs and symptoms of anaphylaxis, such as difficulty breathing, severe itching, skin rash or hives, or swelling of the face, lips, mouth, or tongue.

These are not all of the possible side effects of VYXEOS. Be sure to speak to your healthcare team about any side effects you have. You will also have blood tests done to check for side effects during treatment with VYXEOS.

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.