WARNINGS AND PRECAUTIONS (continued)
treatment arm. REVLIMID is not indicated and not recommended for use in CLL
outside of controlled clinical trials
Second Primary Malignancies: In clinical trials in patients with MM receiving
REVLIMID, an increase of invasive second primary malignancies (SPM) notably
AML and MDS have been observed. The increase of AML and MDS occurred
predominantly in NDMM patients receiving REVLIMID in combination with oral
melphalan (5.3%) or immediately following high dose intravenous melphalan and
ASCT (up to 5.2%). The frequency of AML and MDS cases in the REVLIMID/dex
arms was observed to be 0.4%. Cases of B-cell malignancies (including Hodgkin’s
Lymphomas) were observed in clinical trials where patients received REVLIMID in the
post-ASCT setting. Patients who received REVLIMID-containing therapy until disease
progression did not show a higher incidence of invasive SPM than patients treated in
the fixed duration REVLIMID-containing arms. Monitor patients for the development
of second primary malignancies. Take into account both the potential benefit of
REVLIMID and risk of second primary malignancies when considering treatment
Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients
treated with REVLIMID in combination with dex. The mechanism of drug-induced
hepatotoxicity is unknown. Pre-existing viral liver disease, elevated baseline liv \