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REVLIMID is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.
Adverse reactions reported in the MCL clinical trial
Adverse reactions reported in ≥10% of patients or Grade 3/4 AEs in ≥2 patients, regardless of relationship to REVLIMID.1
aMCL clinical trial AEs – All treatment-emergent AEs with ≥10% of subjects.
bMCL clinical trial Grade 3/4 AEs – All treatment-emergent Grade 3/4 AEs in 2 or more subjects.
cMCL clinical trial Serious AEs – All treatment-emergent SAEs in 2 or more subjects.
dAEs where at least one resulted in a fatal outcome.
eAEs where at least one was considered to be Life Threatening (if the outcome of the event was death, it is included with death cases).
fAll adverse reactions under Body System of Infections except for rare infections of Public Health interest will be considered listed.
gAll adverse reactions under HLT of Rash will be considered listed.
Dose modifications may help patients stay on therapy.1*
*Until disease progression or unacceptable toxicity.
View Dosing
