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Quick facts about treatment with VYXEOS for sAML

Learn key facts, statistics, and benefits of treatment with VYXEOS (vix-e-ose).

About VYXEOS

sAML

VYXEOS is used to treat 2 types of secondary acute myeloid leukemia (sAML): therapy-related AML (t-AML) and AML with myelodysplasia-related changes (AML-MRC).

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VYXEOS is a combination of 2 chemotherapies, daunorubicin and cytarabine, into tiny, bubble-like carriers called liposomes.

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The VYXEOS solution is purple. It is given as an intravenous (IV) injection.

 

Induction and consolidation with VYXEOS

90 min

For first induction therapy, VYXEOS is given as an infusion for 90 minutes on Days 1, 3, and 5 of treatment.

A second induction may be given if you do not reach remission after the first treatment cycle. Second induction is given 2-5 weeks after the first cycle as an infusion for 90 minutes on Days 1 and 3 of treatment.

90 min

For consolidation therapy, VYXEOS is given as an infusion for 90 minutes on Days 1 and 3 of treatment.

cycles

You may receive up to 2 cycles of induction and up to 2 cycles of consolidation.

 

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 sAML

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Approximately half of the patients treated with VYXEOS were alive at 9.6 months compared to 5.9 months for those treated with standard chemotherapy.a

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Estimated survival at 1 year after the start of treatment was 42% for patients treated with VYXEOS compared to 28% for patients treated with standard chemotherapy.a

38% vs 26%

38% of patients treated with VYXEOS (58 out of 153 people) achieved a complete response compared to 26% of patients treated with standard chemotherapya (41 out of 156 people)

34% vs 25%

34% of patients treated with VYXEOS (52 out of 153 people) received a hematopoietic stem cell transplant (HSCT) after treatment compared to 25% of patients treated with standard chemotherapya (39 out of 156 people)

  1. Standard chemotherapy was cytarabine 100 mg/m2 and daunorubicin 60 mg/m2.
  2. Complete remission is the disappearance of all signs of cancer in response to treatment. This does not always mean the cancer has been cured.

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.