WARNING: EMBRYO-FETAL TOXICITY,
HEMATOLOGIC TOXICITY, and VENOUS
See full prescribing information for
complete boxed warning.
• Lenalidomide, a thalidomide analogue,
caused limb abnormalities in a
developmental monkey study similar to
birth defects caused by thalidomide in
humans. If lenalidomide is used during
pregnancy, it may cause birth defects
or embryo-fetal death.
• Pregnancy must be excluded before
start of treatment. Prevent pregnancy
during treatment by the use of two
reliable methods of contraception.
REVLIMID is available only through a
restricted distribution program called the
REVLIMID REMS™ program (formerly
known as the “RevAssist® program”).
HEMATOLOGIC TOXICITY. REVLIMID
can cause significant neutropenia and
• For patients with del 5q myelodysplastic
syndromes, monitor complete blood
counts weekly for the first 8 weeks
and monthly thereafter.
• Significantly increased risk of deep
vein thrombosis (DVT) and pulmonary
embolism (PE) in patients with multiple
myeloma receiving REVLIMID
• In a multicenter, single-arm, open-label study
• This major study enrolled 148 patients who had RBC transfusion dependent
anemia† with a del 5q cytogenetic abnormality
• Patients received REVLIMID 10 mg once daily or 10 mg once daily for 21 days
every 28 days. Sequential dose reductions to 5 mg daily and 5 mg every
other day, as well as dose delays, were allowed for toxicity
• 80% of patients in the trial had at least one dose interruption or reduction,
and 34% underwent a second dose interruption
• G-CSF was permitted for patients who developed neutropenia or fever
associated with neutropenia
67%* of patients achieved RBC transfusion independence with REVLIMID in the MDS clinical trial. (99/148; 95% CI, 59-74).
CLINICAL TRIAL RESULTS
*Frequency of RBC transfusion independence was assessed using criteria modified from
the International Working Group (IWG) response criteria.
Study not designed or powered to prospectively compare efficacy of 2 dosing regimens.
For more information, please visit www.REVLIMID.com.
REVLIMID is only available through a restricted distribution program, REVLIMID REMS™.
Please see Important Safety Information, including Boxed WARNINGS, and Brief Summary
of full Prescribing Information, on the following pages.
REVLIMID® (lenalidomide) is indicated for the treatment of patients with transfusion-dependent
anemia due to low- or intermediate-1–risk myelodysplastic syndromes (MDS) associated with
a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities.
REVLIMID is not indicated and not recommended for the treatment of patients with chronic
lymphocytic leukemia (CLL) outside of controlled clinical trials.
HELPING YOU SHAPE
in patients with del 5q MDS
REVLIMID® is a registered trademark of Celgene Corporation.
REVLIMID REMSTM is a trademark of Celgene Corporation.
© 2014 Celgene Corporation 05/14 US-REV140013
†RBC transfusion dependence was defined as having received ≥ 2 units of RBCs within
8 weeks prior to study treatment.