ASH Clinical News September 2017 New | Page 65

FEATURE
Training for a Career You Love:
What Can the ASH Trainee Council Do For You?
Jennifer Saultz, DO, immediate-past chair of the
Trainee Council, speaks about the obstacles facing
trainees today – from securing funding in a competitive
environment to finding positions that support
protected research time – and how the Trainee Council
Learn more at vyxeos.com
is helping them overcome those challenges.
Dr. Saultz is a fellow in hematology and medical
oncology at The Ohio State University Wexner Medical
Center in Columbus.
Safety and eff ectiveness 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. 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.
a
Embryo-Fetal Toxicity
VYXEOS can cause embryo-fetal harm when administered
to a pregnant woman. Patients should avoid becoming
pregnant while taking VYXEOS. Advise females and males
of reproductive potential to use eff ective 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, febrile neutropenia, rash, edema,
nausea, mucositis, diarrhea, constipation, musculoskeletal
pain, fatigue, abdominal pain, dyspnea, headache, cough,
decreased appetite, arrhythmia, pneumonia, bacteremia,
chills, sleep disorders, and vomiting.
Please see following pages for Brief Summary of
full Prescribing Information, including BOXED Warning.
Reference: 1. VYXEOS [package insert]. Palo Alto, CA: Jazz Pharmaceuticals.
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.
©2017 Jazz Pharmaceuticals
VYX-0036(1)a Rev0817
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