ASH Clinical News ACN_4.14_Full Issue_web | Page 35

Learn more at vyxeos.com
Safety and effectiveness of VYXEOS in
pediatric patients have not been established.
IMPORTANT SAFETY
INFORMATION, continued
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. 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%)
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 following pages for Brief Summary of
full Prescribing Information, including Boxed Warning.
a
Cytarabine and daunorubicin.
AML=acute myeloid leukemia; AML-MRC=acute myeloid leukemia
with myelodysplasia-related changes; HR=hazard ratio;
MDS=myelodysplastic syndromes; t-AML=therapy-related
acute myeloid leukemia.
Reference: 1. VYXEOS [package insert]. Palo Alto, CA: Jazz Pharmaceuticals.
©2018 Jazz Pharmaceuticals
VYX-0036(3) Rev0118