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Outpatient Strategies

Gain more flexibility with outpatient administration

Outpatient administration of VYXEOS was used for some patients in the Phase 3 study, and multiple institutions have evaluated its use in real-world practice.1-4,a

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Real-world strategies for outpatient administration of VYXEOS5


  • Designate a team of healthcare professionals, including registered nurses, pharmacists, advanced practice providers, and physicians, to run the outpatient center
  • Train all personnel in managing outpatient care
  • Dedicate a space specifically for outpatient care, if possible

Assess Patient Eligibility

  • Ensure patients are compliant and/or have a suitable caregiver
  • Limit a patient's commute to a treatment center to no more than 60 minutes
  • Evaluate patient's overall health fitness (eg, ECOG PS, risk for complications, comorbidities, etc)

Patient Education

  • Arrange calendar development and medication review
  • Educate patients and caregivers on recognizing and reporting signs and symptoms of serious complications

Patient Monitoring

  • Anticipate 2-3 monitoring visits per week, although frequency should be tailored to each patient
  • Start infusions in the morning to allow time for monitoring
  • Coordinate supportive care (eg, transfusions) to be administered on the same day following treatment/monitoring visits
  • Monitor for any signs and symptoms of toxicity

aMost patients in the Phase 3 study received induction in an inpatient setting.4

Patient Assessment

Patient assessment should happen before, during, and after treatment5

Before Treatment
  • Assess patient’s suitability for outpatient therapy
  • Laboratory tests:
    • CMP
    • CBC with differential
    • Magnesium
    • Uric acid
    • Phosphate
    • LDH levels
During Treatment
  • Patient assessments (Days 2-5)
    • Conduct patient assessment daily to evaluate for signs of disease- or treatment-related toxicities, such as TLS and/or infection
  • Laboratory tests (Days 1-5):
    • CMP
    • CBC with differential
    • Magnesium
    • Uric acid
    • Phosphate
    • LDH levels
  • Hospital admission
    • During Days 1-5, if any complications arise, such as infections, fever, uncontrolled pain, or syncope
    • Planned for Day 6 to carefully monitor patient with laboratory testing until ANCb recovery is achievedc
After Treatment
  • Repeat bone marrow biopsy to evaluate response to therapy (Day 14)
  • After patient is discharged, outpatient patient monitoring visits with laboratory testing should be conducted at least 2x weeklyd
Supportive care

Ensure timely access to supportive care

Supportive care may include5

Blood and platelet transfusion support

  • Patients may require frequent transfusions during outpatient care

Prophylactic antimicrobial implementation

  • Prophylaxis with antibacterials, antifungals, and antivirals may be recommended if a patient is considered at high risk for infection

Wellness support

  • Supportive care, such as hydration, antiemetic support, and correction of electrolyte imbalances, are vital to patient care

Additional considerations for outpatient treatment

  • Inpatient access allows for unplanned admission due to urgent adverse reactions or if a patient requires frequent monitoring and/or transfusion support6
  • Some institutions may prefer preplanned admission to monitor patients more closely2
  • A patient who does not experience any major complications may be able to complete all treatment in an outpatient setting5
Patient Setting

Institutions have evaluated administering VYXEOS
in the outpatient setting2,3

In 2 small, postapproval, single-institution studies, more than half of patients initiated VYXEOS induction in the outpatient setting.

Inpatient Outpatient Inpatient Outpatient

In a small, single-center pilot study by Kubal et al, 22 patients received a full induction course of VYXEOS

  • Patients were evaluated each day with CBC, CMP, and uric acid and phosphorus measures
  • Planned admission occurred on Day 6 for continued care
  • 64% (n=14; median age 69 years) received induction in an IPOP setting, and 93% of those patients (n=13) were admitted for continued care on Day 6, as planned
  • One patient was admitted on Day 2 of induction

In a small, single-center pilot study by Deutsch et al, 12 patients received a full induction course of VYXEOS

  • Patients were monitored at least every other day until count recovery and admitted for continued care if complications occurred
  • 58% (n=7; median age 72 years) received induction in an IPOP setting
  • Of these 7 patients, 86% (n=6) were eventually admitted for continued care; all admissions were due to infection complications
  • One patient was admitted prior to completing the third induction dose

These 2 studies assessed the feasibility of patients receiving VYXEOS induction in the inpatient/outpatient setting2,3

Exclusion criteria for outpatient administration were similar across these 2 studies2,3
Kubal et al Study (n=22)2
Increased risk for tumor lysis including white count >50K
Active cardiopulmonary symptoms
Lacked a caregiver or were unable to reside within 60 minutes of the treating facility
Increased creatinine or uric acid
Deutsch et al Study (n=12)3
At risk for tumor lysis syndrome
Signs or symptoms of active infection or cardiopulmonary disease
Lacked an appropriate caregiver or transportation to the cancer center

Treatment in an IPOP setting enables appropriate patients to receive induction in an outpatient setting, with inpatient admission scheduled as needed for continued monitoring and care or for treatment for adverse reactions.2,3

ANC=absolute neutrophil count; CBC=complete blood count; CMP=comprehensive metabolic panel; ECOG PS=Eastern Cooperative Oncology Group Performance Status; IPOP=inpatient/outpatient; LDH=lactate dehydrogenase; TLS=tumor lysis syndrome.

bANC >0.5 x 109/L.5

cThe admission stay typically lasts an average of 30 days (ranging between 25 and 50 days).5

dFrequency of assessment may be modified based on patient need.5


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 Open Close


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.

Warnings and Precautions

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.


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.


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.

References: 1. Kolitz JE, Strickland SA, Cortes JE, et al. Consolidation outcomes in CPX-351 versus cytarabine/daunorubicin-treated older patients with high-risk/secondary acute myeloid leukemia. Leuk Lymphoma. 2020;61(3):631-640. 2. Kubal TE, Salamanca C, Komrokji RS, et al. Safety and feasibility of outpatient induction chemotherapy with CPX-351 in selected older adult patients with newly diagnosed AML. J Clin Oncol. 2018;36(15)(suppl):e19013. 3. Deutsch YE, Presutto JT, Brahim A, et al. Safety and feasibility of outpatient liposomal daunorubicin and cytarabine (Vyxeos) induction and management in patients with secondary AML. Blood. 2018:132(suppl 1):3559.
4. Kolitz JE, Strickland SA, Cortes JE, et al. Efficacy by consolidation administration site: subgroup analysis of a phase 3 study of CPX-351 versus 7+3 in older adults with newly diagnosed, high-risk acute myeloid leukemia (AML). Presented at: American Society of Clinical Oncology Annual Meeting; June 2-6, 2017; Chicago, IL. Poster 7036. 5. Talati C, Frantz D, Lubas A, et al. How I treat newly diagnosed acute myeloid leukemia in an outpatient setting: a multidisciplinary team perspective. Future Oncol. 2020;16(7):281-291. 6. Aw A, Sabloff M, Sheppard D, et al. Evaluation of an outpatient model for treatment of acute myeloid leukemia. J Hematol. 2016;5(1):1-7. 7. VYXEOS [package insert]. Palo Alto, CA: Jazz Pharmaceuticals.