Vyxeos (daunorubicin and cytarabine (liposomal))
An approved treatment for Acute Myeloid Leukemia.
The same compound appears under different names depending on the context. Here is how to identify Daunorubicin and cytarabine (liposomal) wherever you encounter it, plus the key facts at a glance.
- Generic name
- Daunorubicin and cytarabine (liposomal)
- Brand name
- Vyxeos
- Development code
- CPX-351
- Drug class
- Liposomal cytotoxic chemotherapy (anthracycline plus nucleoside analog)
- Manufacturer
- Jazz Pharmaceuticals
- How it's taken
- IV infusion over 90 minutes on days 1, 3 and 5 of induction
An IV infusion that packages the 2 standard 7+3 chemotherapy drugs inside tiny fat bubbles, approved for newly diagnosed therapy-related AML or AML with myelodysplasia-related changes in adults and children 1 year and older. Approved August 3, 2017 after it lengthened survival compared with conventional 7+3 in adults 60 to 75.
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Where Daunorubicin and cytarabine (liposomal) fits
The intensive-chemotherapy choice for secondary AML in fit patients, in place of conventional 7+3. People who are not fit for intensive treatment are usually offered venetoclax with a hypomethylating agent instead.
How Daunorubicin and cytarabine (liposomal) works
Daunorubicin and cytarabine kill dividing leukemia cells in different ways, and in the laboratory they work best together at a 5 to 1 ratio of cytarabine to daunorubicin. Vyxeos locks that ratio inside a liposome so the 2 drugs reach the bone marrow together and stay there longer than when they are infused separately[1].
Mechanism: Liposome carrying daunorubicin and cytarabine in a fixed 1:5 molar ratio that holds the 2 drugs together in the marrow longer than separate infusions
Side effects and safety
- Hemorrhage. Serious or fatal bleeding with prolonged low platelets; counts are followed until recovery.
- Cardiotoxicity. Heart function by echocardiogram or MUGA before starting and before consolidation; not recommended when heart function is below normal; total lifetime anthracycline dose is tracked.
- Hypersensitivity. Severe reactions require stopping the drug.
- Tissue necrosis. Daunorubicin leaking from a vein damages tissue; IV access is confirmed before each infusion.
- Embryo-fetal toxicity. Can harm an unborn baby; contraception during treatment and for 6 months after (women) or 3 months after (men).
- Blood counts daily in hospital until recovery
- ECG and heart function before induction and consolidation
- Cumulative anthracycline dose before each cycle
- Pregnancy test before starting
Vyxeos carries a boxed warning not to interchange it with other daunorubicin or cytarabine products, because its doses are different and mix-ups can cause serious dosing errors[1]. Its warnings are serious or fatal bleeding from prolonged low platelets, heart damage from the anthracycline (heart function is checked before treatment and before consolidation), hypersensitivity reactions, copper overload in people with Wilson disease, tissue damage if the drug leaks from the vein, and harm to an unborn baby[1].
The most common side effects (25% or more) were bleeding, febrile neutropenia, rash, swelling, nausea, mouth sores, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, shortness of breath, headache, cough, decreased appetite, irregular heart rhythm, pneumonia, bloodstream infection, chills, sleep problems and vomiting[1].
This is not a complete list of side effects. Talk to your doctor or pharmacist about what to expect and when to seek medical attention.
Taking Daunorubicin and cytarabine (liposomal)
Given as a 90-minute IV infusion in hospital. First induction is daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 (liposomal) on days 1, 3 and 5; a second induction, if needed, uses the same dose on days 1 and 3; up to 2 consolidation cycles use daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 on days 1 and 3[1]. Anti-nausea medicine is given before each dose. A stem cell transplant may follow instead of or after consolidation.
Availability and cost
Only available as the brand-name product.
Help paying for Vyxeos
Pick your insurance to see which help fits. Drugmaker copay cards can't be used with Medicare, Medicaid or TRICARE; charity funds are the usual route there.
- Copay help
JazzCares Savings Card: eligible commercially insured patients may pay as little as $0 per prescription, subject to an annual maximum that the page does not state.
For: private insurance · source - Free medicine program
Patient Assistance Program: uninsured or underinsured patients who meet financial and residency criteria may receive Vyxeos at no cost.
For: no insurance, underinsured · source - Insurance and case manager help
Help understanding insurance coverage, other cost and coverage questions, and referrals to other financial assistance. Call 1-833-533-JAZZ, Monday to Friday, 8 AM to 8 PM ET; enrollment starts with a signed patient consent form.
For: private insurance, Medicare, Medicaid, TRICARE, no insurance, underinsured · source
Good to know: Phone is 1-833-533-JAZZ (5299).
Access and eligibility
For newly diagnosed therapy-related AML (after earlier chemotherapy or radiation) or AML with myelodysplasia-related changes, in adults and children 1 year and older who are fit for intensive chemotherapy. It is not approved for de novo AML without those features or for relapsed disease in adults.
Access program details are provided for informational purposes and may vary based on insurance coverage, geographic location, and individual circumstances. Confirm current eligibility directly with the manufacturer or your specialty pharmacy.
Clinical trial results
Study 1 (NCT01696084) randomized 309 adults aged 60 to 75 with newly diagnosed therapy-related AML or AML with myelodysplasia-related changes to Vyxeos or conventional 7+3. Median overall survival was 9.6 months with Vyxeos against 5.9 months with 7+3 (hazard ratio 0.69, 95% CI 0.52 to 0.90, p=0.005), and complete remission was 38% against 26%[1]. The pediatric indication (March 2021) rests on a Children's Oncology Group study of relapsed AML described in the label[1][2].
Development history
Explore Acute Myeloid Leukemia trials
Other Acute Myeloid Leukemia treatments
Common questions about Daunorubicin and cytarabine (liposomal)
▸What is Daunorubicin and cytarabine (liposomal) (Vyxeos)?
An IV infusion that packages the 2 standard 7+3 chemotherapy drugs inside tiny fat bubbles, approved for newly diagnosed therapy-related AML or AML with myelodysplasia-related changes in adults and children 1 year and older. Approved August 3, 2017 after it lengthened survival compared with conventional 7+3 in adults 60 to 75.
▸How does Daunorubicin and cytarabine (liposomal) work?
Daunorubicin and cytarabine kill dividing leukemia cells in different ways, and in the laboratory they work best together at a 5 to 1 ratio of cytarabine to daunorubicin. Vyxeos locks that ratio inside a liposome so the 2 drugs reach the bone marrow together and stay there longer than when they are infused separately[1].
▸What are the side effects of Daunorubicin and cytarabine (liposomal)?
Vyxeos carries a boxed warning not to interchange it with other daunorubicin or cytarabine products, because its doses are different and mix-ups can cause serious dosing errors[1]. Its warnings are serious or fatal bleeding from prolonged low platelets, heart damage from the anthracycline (heart function is checked before treatment and before consolidation), hypersensitivity reactions, copper overload in people with Wilson disease, tissue damage if the drug leaks from the vein, and harm to an unborn baby[1]. The most common side effects (25% or more) were bleeding, febrile neutropenia, rash, swelling, nausea, mouth sores, diarrhea, constipation, musculoskeletal pain, fatigue, abdominal pain, shortness of breath, headache, cough, decreased appetite, irregular heart rhythm, pneumonia, bloodstream infection, chills, sleep problems and vomiting[1].
▸How is Daunorubicin and cytarabine (liposomal) taken?
Given as a 90-minute IV infusion in hospital. First induction is daunorubicin 44 mg/m2 and cytarabine 100 mg/m2 (liposomal) on days 1, 3 and 5; a second induction, if needed, uses the same dose on days 1 and 3; up to 2 consolidation cycles use daunorubicin 29 mg/m2 and cytarabine 65 mg/m2 on days 1 and 3[1]. Anti-nausea medicine is given before each dose. A stem cell transplant may follow instead of or after consolidation.
▸Is Daunorubicin and cytarabine (liposomal) FDA approved?
Yes, Daunorubicin and cytarabine (liposomal) (Vyxeos) is FDA approved (2017) for the treatment of Acute Myeloid Leukemia.
Sources and references
Every factual claim on this page is drawn from the public sources listed below. Click any reference to open the original document.
- Jazz Pharmaceuticals via openFDA · 2026-01-30. Vyxeos (daunorubicin and cytarabine) liposome for injection prescribing information. https://api.fda.gov/drug/label.json?search=set_id:%227ea701ce-e7d3-4349-a9c2-642a501d45c8%22
- FDA. Vyxeos approval history. https://www.accessdata.fda.gov/scripts/cder/daf/index.cfm?event=overview.process&ApplNo=209401
- Jazz Pharmaceuticals. JazzCares for Vyxeos patients. https://www.jazzcares.com/patients/vyxeos