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Older adults with newly diagnosed high-risk/secondary AML who achieved remission with CPX-351: phase 3 post hoc analyses.

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This journal article reprint is being provided as a professional courtesy by Jazz Pharmaceuticals, Inc. This scientific publication contains information that may or may not be contained within the accompanying package insert. Providing this reprint should not be construed as a recommendation for use of any Jazz Pharmaceuticals product for nonapproved uses. Prior to prescribing, please refer to the accompanying Prescribing Information, which includes the approved indication and a discussion of the benefits and risks associated with our product.

The opinions expressed in this reprint do not necessarily reflect those of Jazz Pharmaceuticals. Readers are encouraged to contact the primary authors with questions regarding the content of the reprint. Jazz Pharmaceuticals does not assume responsibility for any injury and/or damage to persons or property out of or related to any use of the information contained in this reprint.

Financial Disclosure Statement

D.A.R. served as a consultant for AbbVie, Novartis, Pfizer, Spectrum, and Teva; and served on speaker bureaus for Gilead, Incyte, Jazz Pharmaceuticals, Millennium, and Seattle Genetics. D.H.R. holds stock ownership in AbbVie and patents/royalties with the University of Rochester. G.J.S. received research funding from AbbVie, Agios, Actinium, Amgen, Ariad, Astellas Pharma, Bristol Myers Squibb, Constellation, Cyclacel, Daiichi Sankyo, Deciphera, Delta-Fly, Forma, Fujifilm, Gamida, Genentech-Roche, Geron, Incyte, Jazz Pharmaceuticals, Karyopharm, Kite Pharma, Mateon, MedImmune, Novartis, Onconova, Pfizer, REGiMMUNE, Samus, Sangamo, Tolero, and Trovagene; served as a consultant for Agios, Amgen, AstraZeneca, Incyte, Novartis, and Ono Pharma; served on speakers bureaus for Agios, Amgen, Celgene, Gilead, Incyte, Sanofi, and Stemline; provided expert testimony for Kaiser Permanente; and holds stock in Amgen, Bristol Myers Squibb, Johnson & Johnson, and Pfizer. J.E.K. received honoraria from Gilead, Magellan, and Novartis; served as a consultant for Gilead, Magellan, Novartis, Pharmacyclics, and Seattle Genetics; received research funding from Boehringer Ingelheim, Cantex, Erytech, and Millennium; and received travel support from Gilead, Novartis, and Seattle Genetics. G.L.U. served as a consultant for Jazz Pharmaceuticals and Genentech and received honoraria from Astellas Pharma. M.J.W. received research funding from Amgen, Leadiant, Merck, and Shire; participated in advisory committees for Daiichi Sankyo; and holds stock ownership in Reata Pharmaceuticals. R.J.R. and S.F. are employees of and hold stock ownership/options in Jazz Pharmaceuticals. J.E.C. served as a consultant for Astellas Pharma, Daiichi Sankyo, Jazz Pharmaceuticals, Novartis, and Pfizer; and received research funding from Arog, Astellas Pharma, Daiichi Sankyo, Jazz Pharmaceuticals, Novartis, and Pfizer. J.E.L. served as a consultant for Agios, Daiichi Sankyo, Jazz Pharmaceuticals, and Pfizer. The remaining authors declare no competing financial interests.

Detailed information on funding amounts received by the authors of this publication is available at


VYXEOS® (daunorubicin and cytarabine) liposome for injection 44 mg/100 mg is indicated for the treatment of newly-diagnosed therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC) in adults and pediatric patients 1 year and older.



VYXEOS has different dosage recommendations than daunorubicin hydrochloride injection, cytarabine injection, daunorubicin citrate liposome injection, and cytarabine liposome injection. Verify drug name and dose prior to preparation and administration to avoid dosing errors.

  • VYXEOS is contraindicated in patients with a history of serious hypersensitivity reactions to cytarabine, daunorubicin, or any component of the formulation.
  • Serious or fatal hemorrhage events, including fatal CNS hemorrhages, associated with prolonged severe thrombocytopenia, have occurred in patients treated with VYXEOS. Monitor blood counts regularly and administer platelet transfusion support as required.
  • VYXEOS contains daunorubicin, which has a known risk of cardiotoxicity. Assess cardiac function before, during, and after treatment as clinically indicated. Discontinue in patients with impaired cardiac function unless the benefit of treatment outweighs the risk. VYXEOS treatment is not recommended in patients with cardiac function that is less than normal. Calculate the lifetime cumulative anthracycline exposure prior to each cycle of VYXEOS. VYXEOS is not recommended in patients who have reached the maximum lifetime anthracycline dose limit.
  • If a severe or life-threatening hypersensitivity reaction occurs, discontinue VYXEOS permanently, treat according to the standard of care, and monitor until signs and symptoms resolve.
  • VYXEOS contains copper and has the potential to cause copper overload in patients with Wilson's disease or other copper-related metabolic disorders. Monitor patients and use only if the benefits outweigh the risks. Discontinue in patients with signs or symptoms of acute copper toxicity.
  • Daunorubicin has been associated with severe local tissue necrosis at the site of drug extravasation. Administer VYXEOS by the intravenous route only. Confirm patency of intravenous access before administration.
  • VYXEOS can cause fetal harm. Advise females and males of reproductive potential of the potential risk to a fetus and to use effective contraception.
  • The most common adverse reactions (incidence ≥25%) were hemorrhagic events (74%), febrile neutropenia (70%), rash (56%), edema (55%), nausea (49%), mucositis (48%), diarrhea (48%), constipation (42%), musculoskeletal pain (43%), fatigue (39%), abdominal pain (36%), dyspnea (36%), headache (35%), cough (35%), decreased appetite (33%), arrhythmia (31%), pneumonia (31%), bacteremia (29%), chills (27%), sleep disorders (26%), and vomiting (25%).

Please see full Prescribing Information, including BOXED Warning.

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