Improving outcomes in patients with newly-diagnosed secondary AML
Jazz Pharmaceuticals Webinar
Originally presented Tuesday, April 30, 2019
Listen to this 1-hour webinar to gain a better understanding of therapy-related acute myeloid leukemia (t-AML) or AML with myelodysplasia-related changes (AML-MRC), and treatment with VYXEOS® (daunorubicin and cytarabine).
- Understand the overall prognosis of AML, specifically t-AML or AML-MRC
- Discuss the proposed mechanism of action of VYXEOS for injection
- Examine the phase 3 trial which evaluated the efficacy and safety of VYXEOS
- Review VYXEOS dosing and administration
Kathryn A. Culos, PharmD BCOP
Stem Cell Transplant Clinical Pharmacist
Vanderbilt University Medical Center
Judith G. Alberto, RPh BCOP
Oncology Pharmacy Manager
Thomas Jefferson University Hospital
- This free event is hosted by the Hematology/Oncology Pharmacy Association (HOPA) and is open to HOPA members and nonmembers.
- Please note: There are no certified continuing education credits approved for this program.
VYXEOS is indicated for the treatment of adults with newly-diagnosed t-AML or AML-MRC.
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.
- 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.
- 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 click here to see the full Prescribing Information, including BOXED Warning, for VYXEOS.