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sAML and VYXEOS frequently asked questions

Explore our most frequently asked questions and learn more about VYXEOS (vix-e-ose).

What is t-AML?

Therapy-related acute myeloid leukemia, also known as t-AML, is a type of secondary AML (sAML) that may occur in those who have previously been treated for cancer or non-cancer with chemotherapy, radiation therapy, or immunotherapy.

Learn more about t-AML.

What is AML-MRC?

Acute myeloid leukemia with myelodysplasia-related changes, also known as AML-MRC, is a type of secondary AML (sAML) that may be present in those who have previously had certain types of blood disorders, have a specific genetic mutation, or have certain abnormal blood cells.

Learn more about AML-MRC.

How does VYXEOS work?

VYXEOS is an advancement in chemotherapy that combines 2 currently used chemotherapies, daunorubicin and cytarabine, into tiny, bubble-like carriers called liposomes. The liposomes are taken up by leukemia cells (blasts) to a greater extent than by normal cells. Once inside, the liposomes release the drugs to help kill the blasts.

Learn more about VYXEOS.

How is VYXEOS administered?

VYXEOS is given as an intravenous (IV) infusion using a central IV line or peripherally inserted central catheter. VYXEOS is given in steps known as induction and consolidation, and your doctor will determine how many cycles of treatment are needed based on your response. You may receive up to two cycles of induction and up to two cycles of consolidation.

Learn more about the dosing and administration of VYXEOS.

What makes me eligible to receive VYXEOS treatment?

There are a variety of factors your healthcare team will consider when determining if you are a candidate for VYXEOS, such as your age, your overall health, and whether or not you have a confirmed diagnosis of t-AML or AML-MRC.

Will I receive my treatment in the hospital or in an outpatient setting?

Your healthcare team may decide to administer VYXEOS in an outpatient setting depending on your overall health before and during therapy, your ability to travel to see your providers in the outpatient setting and several other factors. Your healthcare team will discuss options with you to help determine what is best.

How long will I be on treatment?

Although induction and consolidation phases only require 2 to 3 days of treatment per cycle, you will most likely be in the hospital for several weeks to monitor your response and manage any potential side effects.

Can I do anything that will increase my positivity during treatment?

It is important to remain positive during treatment. Keep participating in hobbies, like puzzles or journaling, and physical activities you are deemed capable of by your doctor, such as walking.

See more tips for treatment.

What should I tell my doctor before treatment with VYXEOS?

Before treatment, you should tell your doctor of any known or suspected pregnancy, history of heart disease, history of copper-processing disorder, additional medications you may be taking, or history of treatment with an anthracycline.

See what to discuss with your healthcare team.

What should I tell my doctor during treatment with VYXEOS?

During treatment, you should tell your doctor if you are experiencing fever; signs of infection; bruising; bleeding; signs of heart failure such as shortness of breath or trouble breathing and swelling or fluid retention; skin damage; signs of hypersensitivity reactions; or signs of anaphylaxis such as difficulty breathing, severe itching, skin rash, hives, or swelling of the face, lips, mouth, or tongue.

See what to discuss with your healthcare team.

What are the possible side effects of VYXEOS?

The most common side effects of 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.

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 the difference between 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 any remaining blasts.

See more on induction and consolidation.

Why might I need a second induction or consolidation?

Your VYXEOS dosing schedule is designed specifically for you by your healthcare team based on your response at certain benchmarks (like bone marrow assessments) during treatment.

Learn more about multiple cycles of induction and consolidation.

Will my insurance cover VYXEOS?

Ask your healthcare team about your insurance coverage for VYXEOS. You can also contact our dedicated reimbursement specialists at JazzCares, our patient support hotline. Call 1-833-533-JAZZ (5299) Monday through Friday from 8 AM to 8 PM ET.

Learn more about our reimbursement support program.

Are there any financial assistance programs available to me?

Our patient support program, JazzCares, has dedicated specialists who are available to assist you with financial coverage options for VYXEOS. Contact our team at 1-833-533-JAZZ (5299) Monday through Friday from 8 AM to 8 PM ET for all questions regarding financial assistance options.

Learn more about our patient assistance program.

Who can answer specific questions I have regarding my treatment and insurance coverage?

Your healthcare team is the best source of information about treatment and insurance coverage 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.