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National Comprehensive Cancer Network® (NCCN®) recommendations

Liposomal daunorubicin and cytarabine (VYXEOS) is the ONLY treatment recommended in the NCCN Clinical Guidelines in Oncology (NCCN Guidelines®) for induction in patients ≥60 years of age with therapy-related AML or antecedent MDS/CMML or AML-MRC (Category 1)1

Liposomal daunorubicin and cytarabine (VYXEOS) is recommended for the following patients1:

≥60 years Treatment
Category 1
recommendation		 Induction
therapy		 Therapy-related AML or antecedent MDS/CMML or AML-MRC
Category 2A
recommendation		 Reinduction Patients with residual disease (preferred only if given in induction)a
Consolidation Postremission therapy in patients with complete response (preferred only if given in induction)
<60 years Treatment
Category 2B
recommendation		 Induction
therapy		 Therapy-related AML other than CBF/AML or antecedent MDS/CMML or cytogenetic changes consistent with MDS (AML-MRC)
Category 2A
recommendation		 Reinduction Patients with significant residual disease without a hypocellular bone marrow (preferred only if given in induction; bone marrow aspirate and biopsy 14-21 days after start of therapy)b
Consolidation Postremission therapy in treatment-related disease other than CBF and/or unfavorable cytogenetics and/or molecular abnormalities (preferred only if given in induction)c
≥60 years
Category 1 recommendation
Induction therapy: Therapy-related AML or antecedent MDS/CMML or AML-MRC
Category 2A recommendation

Reinduction: Patients with residual disease (preferred only if given in induction)a

Consolidation: Postremission therapy in patients with complete response (preferred only if given in induction)
<60 years
Category 2B recommendation
Induction therapy: Therapy-related AML other than CBF/AML or antecedent MDS/CMML or cytogenetic changes consistent with MDS (AML-MRC)
Category 2A recommendation

Reinduction: Patients with significant residual disease without a hypocellular bone marrow (preferred only if given in induction; bone marrow aspirate and biopsy 14-21 days after start of therapy)b

Consolidation: Postremission therapy in treatment-related disease other than CBF and/or unfavorable cytogenetics and/or molecular abnormalities (preferred only if given in induction)c
Category 1: Based upon high-level evidence, there is uniform NCCN consensus that the intervention is appropriate.1
Category 2A: Based upon lower-level evidence, there is uniform NCCN consensus that the intervention is appropriate.1
Category 2B: Based upon lower-level evidence, there is NCCN consensus that the intervention is appropriate.1
NCCN 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.
With therapy-related AML or antecedent MDS/CMML or AML-MRC.1
With therapy-related AML other than CBF-AML/APL or antecedent MDS/CMML or AML-MRC.1
In patients with therapy-related AML or antecedent MDS/CMML or AML-MRC.1

INDICATION

VYXEOS 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.

IMPORTANT SAFETY INFORMATION

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

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.

Contraindications

VYXEOS is contraindicated in patients with a history of serious hypersensitivity reactions to cytarabine, daunorubicin, or any component of the formulation.

Warnings and Precautions

Hemorrhage

Serious 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.

Cardiotoxicity

VYXEOS 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 Reactions

Serious 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 Overload

VYXEOS 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 Necrosis

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. Do not administer by intramuscular or subcutaneous route.

Embryo-Fetal Toxicity

VYXEOS 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 REACTIONS

The most common adverse reactions (incidence ≥25%) are 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; APL=acute promyelocytic leukemia; CBF=core binding factor; CMML=chronic myelomonocytic leukemia; MDS=myelodysplastic syndromes; NCCN=National Comprehensive Cancer Network.

Reference: 1. Referenced with permission from the NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) for Acute Myeloid Leukemia V.2.2022. © National Comprehensive Cancer Network, Inc. 2022. All rights reserved. Accessed June 14, 2022. To view the most recent and complete version of the guideline, 
go online to NCCN.org.

INDICATION

VYXEOS 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.

Important Safety Information

WARNING: DO NOT INTERCHANGE WITH OTHER DAUNORUBICIN AND/OR CYTARABINE-CONTAINING PRODUCTS

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.