36
Written in Blood
Continued from page 31
With regard to the links between
treatment and fitness, patients with
higher cumulative doses of asparaginase
(≥120,000 IU/m2) had lower average
performance on a sit-and-reach test
(p=0.001), as well as less dorsiflexion
range of motion (p=0.03) and
quadriceps and dorsiflexion strength
(p=0.002; p<0.001) compared with
those exposed to lower cumulative
doses of the drug. The researchers also
reported that cumulative exposure to
glucocorticoid steroids was linked to
decreased hand strength.
In an interview with ASH Clinical
News, Dr. Ness recommended referring
patients with these impairments to a
physical therapist or other rehabilitation
specialist. “I think that physical therapy
screening and appropriate intervention
during and immediately following
treatment is important to address the
needs of children with ALL,” Dr. Ness
explained. “Physical therapists will work
referrals for lifestyle interventions.”
It is important to note that this study
had some limitations. Not all eligible
subjects from the St Jude Lifetime
Cohort opted to take part in the study. If
those non-participatory survivors were
healthier, then the study’s estimates
may be biased away from the null, the
researchers explained. Also, some of the
lifestyle measures, such as smoking status
and diet, were based on self-report and
may not be entirely accurate.
with the child and his or her family to
regain function, teach compensatory
strategies for recreation and sport
participation when an impairment
is present, and help children choose
activities they can be successful doing.”
In this study, Dr. Ness and
colleagues concluded that “clinicians
who treat ALL survivors should
monitor them for [impaired flexibility,
muscle weakness, and poor exercise
tolerance] and make appropriate
T:7”
REVLIMID [lenalidomide] capsules, for oral use
Table 1: Dose Adjustments for Hematologic Toxicities for MM
The following is a Brief Summary; refer to full Prescribing Information for
complete product information.
Platelet counts
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.
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 (2.2)].
1 INDICATIONS AND USAGE
1.1 Multiple Myeloma
REVLIMID in combination with dexamethasone is indicated for the
treatment of patients with multiple myeloma (MM).
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
Multiple Myeloma
The recommended starting dose of REVLIMID is 25 mg orally once daily
on Days 1-21 of repeated 28-day cycles in combination with dexamethasone.
Refer to Section 14.1 for specific dexamethasone dosing. For patients
> 75 years old, the starting dose of dexamethasone may be reduced.
Treatment should be continued until disease progression or unacceptable
toxicity.
In patients who are not eligible for autologous stem cell transplantation
(ASCT), treatment should continue until disease progression or unacceptable
toxicity. For patients who are ASCT-eligible, hematopoietic stem cell
mobilization should occur within 4 cycles of a REVLIMID-containing
therapy [see Warnings and Precautions (5.11)].
Dose Adjustments for Hematologic Toxicities During Multiple Myeloma
Treatment
Dose modification guidelines, as summarized in Table 1 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.
When Platelets
Recommended Course
Fall to <30,000/mcL
Interrupt REVLIMID treatment, follow
CBC weekly
Resume REVLIMID at next lower dose.
Do not dose below 2.5 mg daily
Return to ≥30,000/mcL
For each subsequent drop
<30,0