CLINICAL NEWS
the cost of the drug will be accounted for
under the hospital accounting systems.
The final rule covering payments for
inpatient hospital stays for Medicare
patients for fiscal year 2016 was published in the Federal Register on August
17, and noted that blinatumomab “is
not substantially similar” to other drugs
available for this patient population
and “represents a substantial clinical
improvement over existing treatment
options.”
Source: The New York Times, “Medicare, reversing itself, will pay more
for an expensive new cancer drug.” August 8, 2015.
NIH Issues Requests
for Applications
Regarding Sickle Cell
Disease
The U.S. Department of Health and
adults with SCD in the United
States through the development of
multimodal, multisector interventions aimed at improving the
rate at which patients with SCD
receive routine primary care.
»»Design: In the initial phase 1, the
clinical sites will use the methodologies of implementation
research to (1) conduct a needsbased community assessment of
the barriers to care for subjects
Human Services (HHS) has submitted
two new National Institutes of Health
requests for applications regarding sickle
cell disease (SCD).
• Sickle cell disease implementation
consortium (SCDIC): Using implementation science to optimize care
of adolescents and adults with SCD
(U01); HHS (RFA-HL-16-010)
»»Purpose: Improve the health and
well-being of adolescents and
T:7”
4.2 Allergic Reactions
REVLIMID is contraindicated in patients who have demonstrated
hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic
epidermal necrolysis) to lenalidomide [see Warnings and Precautions
(5.8)].
5.2 REVLIMID REMS™ Program
Because of the embryo-fetal risk [see Warnings and Precautions (5.1)],
REVLIMID is available only through a restricted program under a Risk
Evaluation and Mitigation Strategy (REMS), the REVLIMID REMS™
program (formerly known as the “RevAssist®” program).
Required components of the REVLIMID REMS™ program include the
following:
• Prescribers must be certified with the REVLIMID REMS™ program by
enrolling and complying with the REMS requirements.
• Patients must sign a Patient-Physician agreement form and comply
with the REMS requirements. In particular, female patients of
reproductive potential who are not pregnant must comply with the
pregnancy testing and contraception requirements [see Use in Specific
Populations (8.6)] and males must comply with contraception
requirements [see Use in Specific Populations (8.6)].
• Pharmacies must be certified with the REVLIMID REMS™ program,
must only dispense to patients who are authorized to receive REVLIMID
and comply with REMS requirements.
Further information about the REVLIMID REMS™ program is available at
www.celgeneriskmanagement.com or by telephone at 1-888-423-5436.
5.3 Hematologic Toxicity
REVLIMID can cause significant neutropenia and thrombocytopenia.
Monitor patients with neutropenia for signs of infection. Advise patients to
observe for bleeding or bruising, especially with use of concomitant
medication that may increase risk of bleeding. Patients taking REVLIMID
should have their complete blood counts assessed periodically as
described below [see Dosage and Administration (2.1, 2.2, 2.3)].
Patients taking REVLIMID in combination with dexamethasone for MM
should have their complete blood counts (CBC) assessed every 7 days
(weekly) for the first 2 cycles, on Days 1 and 15 of Cycle 3, and every
Patients taking REVLIMID for MDS should have their complete blood counts
monitored weekly for the first 8 weeks and at least monthly thereafter.
Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled
in the MDS study. In the 48% of patients who developed Grade 3 or 4
neutropenia, the median time to onset was 42 days (range, 14-411 days),
and the median time to documented recovery was 17 days (range, 2-170 days).
In the 54% of patients who developed Grade 3 or 4 thrombocytopenia, the
median time to onset was 28 days (range, 8-290 days), and the median
time to documented recovery was 22 days (range, 5-224 days) [see
Boxed Warning and Dosage and Administration (2.2)].
Patients taking REVLIMID for MCL should have their complete blood
counts monitored weekly for the first cycle (28 days), every 2 weeks during
cycles 2-4, and then monthly thereafter. Patients may require dose
interruption and/or dose reduction. In the MCL trial, Grade 3 or 4 neutropenia
was reported in 43% of the patients. Grade 3 or 4 thrombocytopenia was
reported in 28% of the patients.
5.4 Venous and Arterial Thromboembolism
Venous thromboembolic events (deep venous thrombosis and pulmonary
embolism) and arterial thromboses are increased in patients treated with
REVLIMID. A significantly increased risk of DVT (7.4%) and of PE (3.7%)
occurred in patients with multiple myeloma after at least one prior therapy
who were treated with REVLIMID and dexamethasone therapy compared
to patients treated in the placebo and dexamethasone group (3.1% and
0.9%) in clinical trials with varying use of anticoagulant therapies. In the
newly diagnosed multiple myeloma (NDMM) study in which nearly all
patients received antithrombotic prophylaxis, DVT was reported as a
serious adverse reaction (3.6%, 2.0%, and 1.7%) in the Rd Continuous,
Rd18, and MPT Arms, respectively. The fre