- Orders can be placed Monday-Thursday, 7 AM-6:30 PM CT; Friday, 7 AM-6 PM CT
-
For emergency orders after hours of
service, call
1-800-746-6273
Ordering
VYXEOS reimbursement
information and patient support
J code issued for VYXEOS
Permanent, product-specific HCPCS J code for VYXEOS
| Dosage | Billing | |
|---|---|---|
| J9153 | Injection, liposomal, 1 mg daunorubicin and 2.27 mg cytarabine | Units per dose: 1 Units per vial: 44 |
Permanent, product-specific
HCPCS J code for VYXEOS
HCPCS J code for VYXEOS
J9153
Dosage
Injection, liposomal, 1 mg daunorubicin
and 2.27 mg cytarabine
Billing
Units per dose: 1
Units per vial: 44
HCPCS=Healthcare Common Procedure Coding System.
Ordering Information
Order VYXEOS through our distribution partners
Specialty Distributors
Verify that your facility has an account with their Specialty Distributor before ordering. If not, they should contact their Specialty Distributor. The facility should also contact their Specialty Distributor with questions regarding product returns.
-
AmerisourceBergen
-
ASD Healthcare
-
Oncology SupplyOnline: https://www.oncologysupply.comPhone: 1-800-633-7555Fax: 1-800-248-8205Email: custserv@oncologysupply.com
- Orders can be placed Monday-Friday, 9 AM-8 PM CT
- If orders are placed after hours via Oncology Supply's email address, they will be managed on the morning of the next business day
-
-
Cardinal Health
-
Cardinal Specialty Pharmaceutical DistributionOnline:
Order Express (hospitals)
https://orderexpress.cardinalhealth.com
Specialty Online (clinics)
https://specialtyonline.cardinalhealth.comPhone: 1-800-746-6273Fax: 1-800-547-9413- Orders can be placed Monday-Friday, 8 AM-7 PM CT
-
For emergency orders after hours of
service, call
1-877-453-3972
-
-
McKesson
-
McKesson Plasma and BiologicsOnline: https://connect.mckesson.comPhone: 1-877-625-2566Fax: 1-888-752-7626Email: MPBOrders@mckesson.com
- Orders can be placed Monday-Friday, 9 AM-7:30 PM ET
-
Email for all other information
requests:
MPB@mckesson.com -
For emergency orders after hours of
service, call
1-877-625-2566
-
McKesson Specialty Health
- Orders can be placed Monday-Friday, 8 AM-8 PM ET
- If orders are placed after hours via MSH’s email address, they will be managed on the morning of the next business day
-
VYXEOS is now partnering with certain group
purchasing organizations (GPOs)
- VON (Vizient Oncology Network)
- Intersectta
- ION (Cencora)
- Unity GPO (McKesson Specialty Health)
- VitalSource (Cardinal Health)
- ON Solutions (AmerisourceBergen)
Please contact your GPO representative to learn more about purchasing VYXEOS.
Efficacy
VYXEOS is the only FDA-approved intensive chemotherapy that delivers on key treatment milestones needed to beat sAML better than 7+3.1,2 Learn more about lasting remission, increased chance of HSCT, and prolonged survival.
More
Resources & Support
Find VYXEOS publications and check out our downloadable resources for you, your office staff, and your patients.
More
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.
References: 1. VYXEOS [package insert]. Palo Alto, CA: Jazz Pharmaceuticals. 2. 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.
