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Your secondary AML treatment journey with VYXEOS

This section is designed to help you understand the length of your treatment with VYXEOS (vix-e-ose). Follow along to learn about important benchmarks and key terms that will help you feel more confident about what treatment may entail.

You can also watch this video to see what your treatment journey with VYXEOS might look like.

 

Before treatment

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Your doctor may perform multiple tests to determine what type of acute myeloid leukemia (AML) you have. If you receive a diagnosis of therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC), different treatment options may be discussed to ensure you receive the best care for you.

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If your healthcare team decides you will receive VYXEOS, treatment typically begins as soon as possible.

Make your doctor aware of any important information before beginning treatment.

See what topics you should discuss before treatment with VYXEOS.

 

During treatment

VYXEOS is given in phases known as induction and consolidation, as an intravenous (IV) infusion using a central IV line or peripherally inserted central catheter. 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.

A hospital stay may be required so that blood counts can be monitored and potential side effects can be managed. Your healthcare team will determine what is right for you.

Learn more about why multiple cycles of induction and consolidation may be needed.

1st induction

The first phase of treatment, known as first induction, is 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).

Before you receive your first induction, the doctor will perform a few tests.

Treatment Schedule

  • Given in a 1-week time period
  • Days 1, 3, & 5 for 90 minutes
  • Days 14-21: Doctors may assess your bone marrow to see if VYXEOS is working by looking at how many blasts remain
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The next step will depend on the results of your bone marrow assessment. If there are still too many blasts left, you may begin 2nd induction. If your results show you are in remission, you may go directly to 1st consolidation. Your doctor will perform additional tests to determine if consolidation is the next step. Before consolidation can begin, cardiac function, complete blood counts, and liver and kidney function will be assessed.

 

2nd induction (if needed)

A second induction may be given if you did not reach remission after the first treatment cycle.

Treatment Schedule

  • Begins 2-5 weeks after 1st induction, as determined by your healthcare team
  • Days 1 & 3 for 90 minutes
  • Days 14-21: You may have a bone marrow assessment. Depending on the results of this, you may begin 1st consolidation, as determined by your healthcare team
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1st consolidation

Consolidation is the next phase of treatment, used to maintain remission and decrease the number of remaining blasts. This phase begins after induction for patients who are in remission.

Treatment Schedule

  • Begins 5-8 weeks after start of last induction
  • Days 1 & 3 for 90 minutes
  • Days 14-21: Your doctors may perform follow-up tests to determine whether you need a 2nd consolidation
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2nd consolidation (if needed)

Second consolidation may be given to maintain remission.

Treatment Schedule

  • Begins 5-8 weeks after start of 1st consolidation
  • Days 1 & 3 for 90 minutes
  • Your doctor may perform follow-up tests
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More treatment details

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Although infusions do not occur daily, you will most likely be in the hospital for several weeks to monitor your blood count and manage any potential complications during treatment.

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Second consolidation cycles are administered to ensure the disease remains controlled.

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The administration schedule for VYXEOS also supports the possibility of treatment in an outpatient setting in some patients. Your healthcare team will discuss options with you to help determine the best treatment approach.

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Before consolidation can begin, doctors must assess cardiac function, complete blood counts, and liver and kidney function.

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Absolute neutrophil count (ANC) and platelet count, which are measured with a blood test, will be assessed before consolidation to determine if consolidation is the next appropriate step.

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The most common side effects reported by patients receiving VYXEOS include 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.

 

Helpful tips during sAML treatment

 
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Feelings of sadness, anxiety, and loneliness are normal during treatment

Talk with your doctor about these concerns. Your healthcare team can provide you with sources of information and advice.

 
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Accept support

Reach out to family, friends, and any support groups that may be able to offer advice and comfort for those going through chemotherapy.

 
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Stay positive

Chemotherapy can leave you feeling lonely and worried about the future. Continue your normal hobbies as much as possible. Reading, doing puzzles, journaling, and meditating may help you maintain a positive attitude.

 
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Stay physically active

Take walks and engage in physical activities that are okayed by your doctor. Keeping your body in the best possible shape may help during treatment.

 
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Eat healthy

During chemotherapy, it is important to fuel your body with sources of vitamins and nutrients to keep energy levels steady.

 

Please speak with your doctor before starting any new exercise or nutrition regimens.

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.