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Why VYXEOS for sAML treatment?

A variety of factors are considered when determining whether or not VYXEOS (vix-e-ose) is the right treatment. These factors may include your age, your overall health, and whether you have a confirmed diagnosis of secondary acute myeloid leukemia (sAML), specifically therapy-related AML (t-AML) or AML with myelodysplasia-related changes (AML-MRC). Only a healthcare provider can decide if VYXEOS is the best course of treatment.

See the treatment success story of a patient diagnosed with AML-MRC.

Individual results may vary.

Please see Important Safety Information, including Boxed Warning for VYXEOS at the bottom of this page and the full Prescribing Information.

 

How VYXEOS may help

VYXEOS provides a chance to live longer and allows you to spend less time connected to an intravenous (IV) infusion line during treatment compared to the standard chemotherapya treatment

In a clinical trial including older adults with t-AML or AML-MRC in which 153 people received VYXEOS and 156 people received the standard chemotherapya treatment for AML:

In this clinical trial, people with sAML treated with VYXEOS lived longer than those treated with standard chemotherapy.a

Median survival timeb

Estimated survivalc at 1 year after the start of treatment

In this clinical trial, more people with sAML treated with VYXEOS achieved a complete responsed than those treated with standard chemotherapya

Secondary AML patients who achieved a complete responsed

In this clinical trial, more people with sAML treated with VYXEOS received transplant after treatment

Secondary AML patients who received a hematopoietic stem cell transplant (HSCT)

  1. Standard chemotherapy was cytarabine 100 mg/m2 and daunorubicin 60 mg/m2.
  2. Median survival time refers to the time when half of the people in the trial were alive.
  3. Estimated survival was based on Kaplan-Meier-estimated percentages of the people in the trial who were still alive 1 year after the start of treatment.
  4. Complete response, also known as complete remission (CR): when leukemia cells make up less than 5% of cells in your bone marrow and your blood cell counts are back to normal.

VYXEOS may cause serious side effects, including:

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Fever, signs of infection, or bruising or bleeding which can result in serious infection and/or bleeding and possibly lead to death. 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 such as shortness of breath or trouble breathing; swelling or fluid retention, especially in the feet, ankles, or legs; or unusual tiredness.

Skin damage icon

Skin damage which can occur if VYXEOS 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 such as difficulty breathing, severe itching, skin rash and hives, or swelling of the face, lips, mouth, or tongue. Seek immediate medical attention if you develop any of these signs or symptoms.

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.

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

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.