feature
“ aving collaborative care,
H
including that delivered
by individuals other than
hematologists, is critical
for all SCD patients.”
on consensus opinion when there
was scant published literature to
back these up.
Once we had a working draft of
the recommendations, that’s when
the “fine-tuning” process started.
I’m proud of the final document
that we produced, but it does
have imperfections, so critique
and opinions from ASH and
other societies will again be very
important.
Looking forward, what areas
will need more attention?
It is clear that we need much
more research in SCD. We found
knowledge gaps in almost every
area, and a serious deficiency of
RCTs. But I think there is some
light at the end of the tunnel
already; NHLBI and other
institutes within NIH realize
the need to provide additional
funding for high-quality research
T:7”
POMALYST REMS Program
Because of the risk of embryo-fetal toxicity,
POMALYST is only available through a restricted
program called POMALYST REMS [see Warnings
and Precautions (5.2)].
• Patients must sign a Patient-Prescriber
agreement form and comply with the
requirements to receive POMALYST. In
particular, females of reproductive potential
must comply with the pregnancy testing,
contraception requirements, and participate in
monthly telephone surveys. Males must comply
with the contraception requirements [see Use in
Specific Populations (8.6)].
• POMALYST is available only from pharmacies
that are certified in POMALYST REMS. Provide
patients with the telephone number and Web
site for information on how to obtain the
product.
Venous Thromboembolism
Inform patients of the potential risk of developing
venous thromboembolic events and discuss the
need for appropriate prophylactic treatment [see
Venous Thromboembolism (5.3)].
Hematologic Toxicities
Inform patients on the risks of developing
neutropenia, thrombocytopenia, and anemia and
the need to report signs and symptoms associated
with these events to their healthcare provider for
further evaluation [see Hematologic Toxicities
(5.4)].
Hypersensitivity
Inform patients of the potential for a severe
hypersensitivity reaction to POMALYST if they
have had such a reaction in the past to either
THALOMID® or REVLIMID® [see Hypersensitivity
Reaction (5.5)].
Dizziness and Confusional State
Inform patients of the potential risk of dizziness and
confusional state with the drug, to avoid situations
where dizziness or confusional state may be a
problem, and not to take other medications that
may cause dizziness or confusional state without
adequate medical advice [see Dizziness and
Confusional State (5.6)].
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 Neuropathy (5.7)].
Second Primary Malignancies
Inform the patient that the potential risk of
developing acute myelogenous leukemia during
treatment with POMALYST is unknown [see Risk of
Second Primary Malignancies (5.8)].
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 Warning and
Precautions (5.9)].
Dosing Instructions
Inform patients on how to take POMALYST [see
Dosage and Administration (2.1)]
• POMALYST