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Latest & Greatest
New Restrictions
on Vicodin and Other
Pain Medicines
Effective October 6, 2014, the U.S. Food
and Drug Administration rescheduled hydrocodone combination products (HCPs)
from schedule III to schedule II controlled
substances. This action means that HCPs,
such as vicodin, will have tighter restrictions on access. Patients must present a
written prescription to receive the drug; in
most instances, doctors will no longer be
able to call in a prescription to the pharmacy. Prescription refills are prohibited, but
at his or her discretion, a doctor can issue
multiple prescriptions that would provide
up to a 90-day supply. Many patients take
HCPs to manage pain associated with
chronic disease, including cancer.
Source: U.S. DEA Federal Register. 2014;79:49661-82.
FDA Approves First
Oral Treatment for
Gaucher Disease
Eliglustat (Cerdelga™) was recently approved
for the long-term treatment of patients with
the Type 1 form of Gaucher disease, a rare
genetic disorder with multiple hematologic
manifestations. Eliglustat is taken orally, in
capsule form. The drug works by slowing
down the production of the fatty materials
that collect in the spleen, liver, and bone
marrow of patients with Gaucher disease.
The safety and effectiveness of eliglustat
were evaluated in two clinical trials: one
examined patients who had not previously
received enzyme replacement therapy, and
the other compared eliglustat and enzyme
replacement therapy in previously treated
patients. In the first study, treatment with
eliglustat resulted in a greater reduction in
T:7”
REVLIMID® [lenalidomide] capsules, for oral use
The following is a Brief Summary for mantle cell lymphoma; refer to full
Prescribing Information for complete product information
WARNING: EMBRYO-FETAL TOXICITY, HEMATOLOGIC TOXICITY, and
VENOUS and ARTERIAL THROMBOEMBOLISM
Embryo-Fetal Toxicity
Do not use REVLIMID during pregnancy. Lenalidomide, a thalidomide
analogue, caused limb abnormalities in a developmental monkey study.
Thalidomide is a known human teratogen that causes severe lifethreatening human birth defects. If lenalidomide is used during pregnancy,
it may cause birth defects or embryo-fetal death. In females of reproductive
potential, obtain 2 negative pregnancy tests before starting REVLIMID®
treatment. Females of reproductive potential must use 2 forms of
contraception or continuously abstain from heterosexual sex during and
for 4 weeks after REVLIMID treatment [see Warnings and Precautions
(5.1), and Medication Guide (17)]. To avoid embryo-fetal exposure
to lenalidomide, REVLIMID is only available through a restricted
distribution program, the REVLIMID REMS™ program (formerly known
as the “RevAssist®” program) (5.2).
Information about the REVLIMID REMS™ program is available at
www.celgeneriskmanagement.com or by calling the manufacturer’s
toll-free number 1-888-423-5436.
Platelet counts
Thrombocytopenia during treatment in MCL
When