CLINICAL NEWS
Continued from page 85
that this one-on-one format will encour-
age trainees to ask focused, high-quality
questions.
What sessions are you most excited about?
Dr. Boucher: Wellness will be a big focus
of ASH-a-Palooza – it’s a topic that mem-
bers of the Trainee Council pushed for.
Several of the Blood Drops speakers will
be covering this through talks like “Medi-
cine and Parenthood,” and our last ASH
Talk covers resiliency and self-care.
Dr. Isenalumhe: The scope of these ses-
sions is broader than previous years, but I
think that this new format will give us the
opportunity to focus deeply on each topic.
Whether you’re a medical student, a resi-
dent, a first-, second-, or third-year fellow,
there’s something for you. Trainee Day was
already amazing, but I’m happy we have this
opportunity to continue to grow and evolve.
REVLIMID [lenalidomide] capsules, for oral use
The following is a Brief Summary; 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 life-
threatening 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)]. To avoid embryo-fetal exposure to lenalidomide,
REVLIMID is only available through a restricted distribution program,
the REVLIMID REMS ® 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.
Hematologic Toxicity (Neutropenia and Thrombocytopenia)
REVLIMID can cause significant neutropenia and thrombocytopenia.
Eighty percent of patients with del 5q myelodysplastic syndromes had to
have a dose delay/reduction during the major study. Thirty-four percent
of patients had to have a second dose delay/reduction. Grade 3 or 4
hematologic toxicity was seen in 80% of patients enrolled in the study.
Patients on therapy for del 5q myelodysplastic syndromes should have
their complete blood counts monitored weekly for the first 8 weeks of
therapy and at least monthly thereafter. Patients may require dose
interruption and/or reduction. Patients may require use of blood product
support and/or growth factors [see Dosage and Administration (2.1)].
Venous and Arterial Thromboembolism
REVLIMID has demonstrated a significantly increased risk of deep vein
thrombosis (DVT) and pulmonary embolism (PE), as well as risk of
myocardial infarction and stroke in patients with multiple myeloma who
were treated with REVLIMID and dexamethasone therapy. Monitor for
and advise patients about signs and symptoms of thromboembolism.
Advise patients to seek immediate medical care if they develop
symptoms such as shortness of breath, chest pain, or arm or leg
swelling. Thromboprophylaxis is recommended and the choice of
regimen should be based on an assessment of the patient’s underlying
risks [see Warnings and Precautions (5.4)].
1 INDICATIONS AND USAGE
1.1 Multiple Myeloma
REVLIMID is indicated as maintenance therapy in patients with MM
following autologous hematopoietic stem cell transplantation (auto-HSCT).
1.4 Limitations of Use:
REVLIMID is not indicated and is not recommended for the treatment of
patients with CLL outside of controlled clinical trials [see Warnings and
Precautions (5.5)].
2 DOSAGE AND ADMINISTRATION
REVLIMID should be taken orally at about the same time each day, either
with or without food. REVLIMID capsules should be swallowed whole
with water. The capsules should not be opened, broken, or chewed.
2.1 Multiple Myeloma
REVLIMID Maintenance Therapy Following Auto-HSCT
Following auto-HSCT, initiate REVLIMID maintenance therapy after
adequate hematologic recovery (ANC ≥ 1000/mcL and/or platelet counts
≥75,000/mcL). The recommended starting dose of REVLIMID is 10 mg
once daily continuously (Days 1-28 of repeated 28-day cycles) until
disease progression or unacceptable toxicity. After 3 cycles of maintenance
therapy, the dose can be increased to 15 mg once daily if tolerated.
Dose Adjustments for Hematologic Toxicities During MM Treatment
Dose modification guidelines, as summarized in Table 2 below, are
recommended to manage Grade 3 or 4 neutropenia or thrombocytopenia
or other Grade 3 or 4 toxicity judged to be related to REVLIMID.
Dr. Boucher: ASH-a-Palooza is a big
experiment in building a new experience
for trainees and continued capacity for
excitement, but we also need to know
what’s working so we can keep improving.
I encourage attendees to tell us what they
think and what we can do to make ASH-a-
Palooza even better next year.
Table 2: Dose Adjustments for Hematologic Toxicities for MM
Platelet counts
Thrombocytopenia in MM
When Platelets Recommended Course
Fall to <30,000/mcL Return to ≥30,000/mcL Interrupt REVLIMID treatment, follow
CBC weekly
Resume REVLIMID at next lower dose,
continuously for Days 1-28 of
repeated 28-day cycle
If at the 5 mg daily dose,
For a subsequent drop
<30,000/mcL Interrupt REVLIMID treatment. Do not
dose below 5 mg daily for Day 1 to 21
of 28 day cycle
Return to ≥30,000/mcL Resume REVLIMID at 5 mg daily for
Days 1 to 21of 28-day cycle. Do not
dose below 5 mg daily for Day 1 to 21
of 28 day cycle
Absolute Neutrophil counts (ANC)
Neutropenia in MM
When Neutrophils Recommended Course
Fall to <500/mcL Interrupt REVLIMID treatment, follow
CBC weekly
Resume REVLIMID at next lower dose,
continuously for Days 1-28 of repeated
28-day cycle
Return to ≥500/mcL
If at 5 mg daily dose,
For a subsequent drop <500/mcL Interrupt REVLIMID treatment. Do not
dose below 5 mg daily for Days 1 to
21 of 28-day cycle
Return to >500/mcL Resume REVLIMID at 5 mg daily for
Days 1 to 21 of 28-day cycle. Do not
dose below 5 mg daily for Days 1 to
21 of 28-day cycle
Other Toxicities in MM
For other Grade 3/4 toxicities judged to be related to REVLIMID, hold
treatment and restart at the physician’s discretion at next lower dose level
when toxicity has resolved to ≤ Grade 2.
Starting Dose Adjustment for Renal Impairment in MM:
[See Dosage and Administration (2.4)].
2.2 Starting Dose for Renal Impairment in MM
The recommendations for starting doses for patients with renal impairment
are shown in the following table
Table 3: Starting Dose Adjustments for Patients with Renal Impairment
Renal Function
Dose in REVLIMID
Dose in REVLIMID
(Cockcroft-Gault)
Combination Therapy for Maintenance Therapy
MM
Following Auto-HSCT for
MM
CLcr 30 to 60 mL/min 10 mg once daily
5 mg once daily
CLcr < 30 mL/min
15 mg every other day
2.5 mg once daily
(not requiring dialysis)
CLcr < 30 mL/min
5 mg once daily. On
2.5 mg once daily. On
(requiring dialysis)
dialysis days, administer dialysis days, administer
the dose following dialysis. the dose following dialysis.
REVLIMID Maintenance Therapy Following Auto-HSCT for MM: Base
subsequent REVLIMID dose increase or decrease on individual patient
treatment tolerance [see Dosage and Administration (2.1)].
4 CONTRAINDICATIONS
4.1 Pregnancy
REVLIMID can cause fetal harm when administered to a pregnant female.
Limb abnormalities were seen in the offspring of monkeys that were
dosed with lenalidomide during organogenesis. This effect was seen at all
doses tested. Due to the results of this developmental monkey study, and
lenalidomide’s structural similarities to thalidomide, a known human
teratogen, lenalidomide is contraindicated in females who are pregnant
[see Boxed Warning]. If this drug is used during pregnancy or if the
patient becomes pregnant while taking this drug, the patient should be
apprised of the potential hazard to the fetus [see Warnings and
Precautions (5.1, 5.2), Use in Special Populations (8.1, 8.3)].
4.2 Severe Hypersensitivity Reactions
REVLIMID is contraindicated in patients who have demonstrated severe
hypersensitivity (e.g., angioedema, Stevens-Johnson syndrome, toxic
epidermal necrolysis) to lenalidomide [see Warnings and Precautions
(5.8)].
ASH-a-Palooza
Time and Date: Friday, November 30, 12 to 5 p.m.
Location: Petco Park, home of the San Diego Padres
While you must have an ASH Trainee badge for
admittance, there is no fee to attend, and separate
registration is not required; however, attendance
will be limited and access to the event will be on a
first-come, first-served basis.