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than 12 years were prescribed opioids
during the study period, compared with
between 57 and 87 percent of patients
older than 18 years (p values not pro-
vided).
“Pediatric patients do well, but once
they become adults, they have worse
outcomes,” Dr. Ballas said, “and the
reasons for this are multifactorial.” This
pattern may reflect changes in compli-
ance, adherence, and insurance coverage
as patients age, as well as chronic or ac-
cumulated damage from SCD.
“Opioids are good analgesics, and the
best medications available to treat sickle
cell-related pain,” he concluded, “but we
still need to monitor patients to make
sure [they] are using the drugs appropri-
ately – at least until we have something
better.”
The study’s findings are limited by its
retrospective design.
T:7”
may cause dizziness or confusional state without
adequate medical advice [see Warnings and
Precautions (5.7)].
Neuropathy
Inform patients of the risk of neuropathy and to
report the signs and symptoms associated with
these events to their healthcare provider for further
evaluation [see Warnings and Precautions (5.8)].
Second Primary Malignancies
Inform the patient that the potential risk of developing
acute myelogenous leukemia during treatment with
POMALYST is unknown [see Warnings and
Precautions (5.9)].
Tumor Lysis Syndrome
Inform patients of the potential risk of tumor lysis
syndrome and to report any signs and symptoms
associated with this event to their healthcare
provider for evaluation [see Warnings and
Precautions (5.10)].
Smoking Tobacco
Advise patients that smoking tobacco may reduce
the efficacy of POMALYST.
Dosing Instructions
Inform patients on how to take POMALYST [see
Dosage and Administration (2.1)]
• POMALYST should be taken once daily at about
the same time each day.
• Patients on hemodialysis should take POMALYST
following hemodialysis, on hemodialysis days.
• POMALYST may be taken with or without food.
• The capsules should not be opened, broken, or
chewed. POMALYST should be swallowed whole
with water.
• Instruct patients that if they miss a dose of
POMALYST, they may still take it up to 12 hours
after the time they would normally take it. If
more than 12 hours have elapsed, they should
be instructed to skip the dose for that day. The
next day, they should take POMALYST at the
usual time. Warn patients not to take 2 doses
to make up for the one that they missed.
that ED use among patients in the young-
adult “transition” age group increased. 2
In this study, investigators estimated
EDR among 609 patients with SCD over
a five-year period to examine the effect of
several SCD-related initiatives in the state.
“EDR among the sickle cell popula-
tion is an indicator of quality of care and
access to outpatient settings,” the authors
explained. “In the state of Wisconsin,
more recent efforts to improve patient
care include setting up a sickle cell clinic
for adult patients, creating an electronic
health records–based registry for children
with SCD, and [expanding the] hydroxy-
urea indication to all children ≥1 year of
age with sickle cell anemia.”
“Unfortunately,
there is a
general con-
ception that
patients with
SCD take a lot
of opioids. ... In
a way, they are
innocent victims
of the opioid
epidemic.”
Manufactured for: Celgene Corporation
Summit, NJ 07901
POMALYST ® , REVLIMID ® , THALOMID ® , and
POMALYST REMS ® are registered trademarks of
Celgene Corporation.
Pat. http://www.celgene.com/therapies
© 2005-2016 Celgene Corporation All rights reserved.
POM_HCP_BSv.005 06_2016
Lowering Emergency Department Reliance
in Patients With Sickle Cell Disease
Thanks to initiatives to improve care for
Wisconsinites living with SCD, fewer pa-
tients are visiting the ED to manage pain, ac-
cording to a longitudinal analysis of ED use
among patients with SCD. While children
and young adults had lower-than-expected
ED reliance (EDR), the researchers, led by
Ashima Singh, PhD, MS, from the Medical
College of Wisconsin in Milwaukee, noted
—SAMIR K. BALLAS, MD
Patients included in the study were
enrolled continuously in Medicaid and
had at least one sickle cell pain–related
ED visit. The researchers defined EDR for
pain as the proportion of ED visits among
all ambulatory visits (calculated by divid-
ing the number of ED visits for pain by
the number of all hospital visits). Exces-
sive ED use was defined as an EDR ≥0.33.
Participants were categorized into four
age groups:
• children (0-18 years; n=248)
• transition group (those who turned
19 years old during the 5-year study
period; n=54)
• young adults (19-30 years; n=170)
• adults (31-45 years; n=137)
Results from a linear mixed model
(adjusted for age group and hydroxyurea
adherence) demonstrated that the overall
January 2018