Secondary AML Treatment | VYXEOS® (daunorubicin and cytarabine)_Shopping

You are using an outdated browser. Please upgrade your browser to improve your experience and security.Skip to contentCOVID-19 Update: Questions about Coronavirus? Click hereThis site is intended for US healthcare professionals only.Contact a RepresentativeFull Prescribing InformationImportant Safety InformationVisit Patient SiteVisit Patient SiteContact a RepresentativeSubtypes of sAMLMechanism of DeliveryClinical DataEfficacySafety ProfileMortalityStudy DesignDosing & OrderingDosing ScheduleOutpatient AdministrationPreparation & AdministrationOrdering InformationNCCN RecommendationsResources & SupportReimbursement & SupportDownloads & ResourcesA Strong Start ForSuperior Survival1,25-Year OS Data AvailableVYXEOS demonstrated superior efficacy with longer overall survival and higher CR and CR+CRi rates compared to traditional chemotherapya and provided an improved opportunity for transplant1,2 Median overall survivalb (primary endpoint) of 9.6 months with VYXEOS vs 5.9 months with 7+3 (HR=0.69 [95% CI: 0.52, 0.90], P=0.005c).1 Rate of CR was 38% with VYXEOS vs 26% with 7+3; rate of CR+CRi was 48% with VYXEOS vs 33% with 7+3.1,2 Overall rate of HSCTd was 35% with VYXEOS vs 25% with 7+33,e In a Phase 3, randomized, multicenter, open-label, active-controlled superiority study of VYXEOS vs 7+3 (cytarabine and daunorubicin) in 309 patients (aged 60-75) with newly-diagnosed t-AML or AML-MRC1See full study design See VYXEOS long-term estimated survival dataVYXEOS LONG-TERM OS DATAOverall survival is more than double at 5 years with VYXEOS (18%) vs 7+3 (8%) based on KM estimates1,3View dataNational Comprehensive Cancer Network® (NCCN®) recommendationsLiposomal daunorubicin and cytarabine (VYXEOS) is the ONLY treatment recommended by NCCN forinduction in sAML patients ≥60years4Learn moreOutpatient administrationInpatient and outpatient administration options for appropriatepatientsExploreJazzCaresVYXEOS financial assistance andcoverageDiscoverGroup purchasing organizationVYXEOS is now partnering with certain group purchasingorganizationsSee partnersExplore NCCN recommendationsLearn about an outpatient administration possibility for some patientsFind financial assistance and coverage with JazzCaresVYXEOS is now partnering with certain group purchasing organizations7+3: cytarabine 100 mg/m2 and daunorubicin 60 mg/m2.1Overall survival was defined as date of randomization to death from any cause.1P value is 2-sided.1First CR, induction failure, or as salvage after relapse.1In the primary analysis of the Phase 3trial, the overall rate of HSCT (first CR, induction failure, or as salvage after relapse) was 34% (52/153) in the VYXEOS arm and 25% (39/156) in the control arm.1NCCN makes no warranties of any kind whatsoever regarding their content, use or application and disclaims any responsibility for their application or use in any way.INDICATIONVYXEOS 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 1year and older.IMPORTANT SAFETY INFORMATIONWARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTSVYXEOS 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.ContraindicationsVYXEOS is contraindicated in patients with a history of serious hypersensitivity reactions to cytarabine, daunorubicin, or any component of the formulation.Warnings and PrecautionsHemorrhageSerious or fatal hemorrhage events, including fatal CNS hemorrhages, associated with prolonged thrombocytopenia, have occurred with VYXEOS. The overall incidence (grade 1-5) of hemorrhagic events was 74% in the VYXEOS arm and 56% in the control arm. The most frequently reported hemorrhagic event was epistaxis (36% in VYXEOS arm and 18% in control arm). Grade 3 or greater events occurred in 12% of VYXEOS-treated patients and in 8% of patients in the control arm. Fatal treatment-emergent CNS hemorrhage not in the setting of progressive disease occurred in 2% of patients in the VYXEOS arm and in 0.7% of patients in the control arm. Monitor blood counts regularly and administer platelet transfusion support as required.CardiotoxicityVYXEOS contains daunorubicin, which has a known risk of cardiotoxicity. This risk may be increased in patients with prior anthracycline therapy, preexisting cardiac disease, previous radiotherapy to the mediastinum, or concomitant use of cardiotoxic drugs. Assess cardiac function prior to VYXEOS treatment and repeat prior to consolidation and as clinically required. Discontinue VYXEOS in patients with impaired cardiac function unless the benefit of initiating or continuing treatment outweighs the risk. VYXEOS is not recommended in patients with cardiac function that is less than normal.Total cumulative doses of non-liposomal daunorubicin greater than 550 mg/m2 have been associated with an increased incidence of drug-induced congestive heart failure. The tolerable limit appears lower (400 mg/m2) in patients who received radiation therapy to the mediastinum. Calculate the lifetime cumulative anthracycline exposure prior to each cycle of VYXEOS. VYXEOS is not recommended in patients whose lifetime anthracycline exposure has reached the maximum cumulative limit.Hypersensitivity ReactionsSerious or fatal hypersensitivity reactions, including anaphylactic reactions, have been reported with daunorubicin and cytarabine. Monitor patients for hypersensitivity reactions. If a mild or moderate hypersensitivity reaction occurs, interrupt or slow the rate of infusion with VYXEOS and manage symptoms. If a severe or life-threatening hypersensitivity reaction occurs, discontinue VYXEOS permanently, treat the symptoms, and monitor until symptoms resolve.Copper OverloadVYXEOS contains copper. Consult with a hepatologist and nephrologist with expertise in managing acute copper toxicity in patients with Wilson’s disease treated with VYXEOS. Monitor total serum copper, serum non-ceruloplasmin-bound copper, 24-hour urine copper levels, and serial neuropsychological examinations during VYXEOS treatment in patients with Wilson’s disease or other copper-related metabolic disorders. Use only if the benefits outweigh the risks. Discontinue in patients with signs or symptoms of acute copper toxicity.Tissue NecrosisDaunorubicin 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. Do not administer by intramuscular or subcutaneous route.Embryo-Fetal ToxicityVYXEOS can cause embryo-fetal harm when administered to a pregnant woman. Patients should avoid becoming pregnant while taking VYXEOS. If VYXEOS is used during pregnancy or if the patient becomes pregnant while taking VYXEOS, apprise the patient of the potential risk to a fetus. Advise females and males of reproductive potential to use effective contraception during treatment and for 6 months following the last dose of VYXEOS.MOST COMMON ADVERSE REACTIONSThe 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.AML=acute myeloid leukemia; AML-MRC=AML with myelodysplasia-related changes; CR=complete remission; CRi=complete remission with incomplete recovery; HR=hazard ratio; HSCT=hematopoietic stem cell transplant; KM=Kaplan-Meier; OS=overall survival; sAML=secondary AML; t-AML=therapy-related AML.References: 1. VYXEOS [package insert]. Palo Alto, CA: Jazz Pharmaceuticals. 2.Lancet JE, Uy GL, Cortes JE, et al. CPX-351 (cytarabine and daunorubicin) liposome for injection versus conventional cytarabine plus daunorubicin in older patients with newly diagnosed secondary acute myeloid leukemia. J Clin Oncol. 2018;36(26):2684-2692. 3.Lancet JE, Uy GL, Newell LF, et al. CPX-351 versus 7+3 cytarabine and daunorubicin chemotherapy in older adults with newly diagnosed high-risk or secondary acute myeloid leukaemia: 5-year results of a randomised, open-label, multicentre, phase 3 trial. Lancet Haematol. 2021;8(7):e481-e491. 4.Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.3.2021. ©National Comprehensive Cancer Network, Inc. 2021. All rights reserved. Accessed March 2, 2021. To view the most recent and complete version of the guideline, go online to NCCN.org. Contact UsTerms of UsePrivacy StatementSite Map©2021 Jazz Pharmaceuticals VYX-2000216 Rev1021INDICATIONVYXEOS 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 1year and older.Important Safety InformationWARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTSVYXEOS 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. 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