Important Safety Information (continued)
Embryo-Fetal Toxicity: See Boxed WARNINGS (continued)
• Blood Donation: Patients must not donate blood during treatment with REVLIMID and for 4 weeks
following discontinuation of the drug because the blood might be given to a pregnant female patient
whose fetus must not be exposed to REVLIMID
REVLIMID REMS ® Program: See Boxed WARNINGS: Prescribers and pharmacies must be certifi ed with
the REVLIMID REMS program by enrolling and complying with the REMS requirements; pharmacies must
only dispense to patients who are authorized to receive REVLIMID. Patients must sign a Patient-Physician
Agreement Form and comply with REMS requirements; female patients of reproductive potential who are
not pregnant must comply with the pregnancy testing and contraception requirements and males must
comply with contraception requirements
Hematologic Toxicity: REVLIMID can cause signifi cant neutropenia and thrombocytopenia. Monitor
patients with neutropenia for signs of infection. Advise patients to observe for bleeding or bruising,
especially with use of concomitant medications that may increase risk of bleeding. MM: Patients taking
REVLIMID/dex or REVLIMID as maintenance therapy should have their complete blood counts (CBC)
assessed every 7 days for the fi rst 2 cycles, on days 1 and 15 of cycle 3, and every 28 days thereafter
Venous and Arterial Thromboembolism: See Boxed WARNINGS: Venous thromboembolic events (DVT
and PE) and arterial thromboses (MI and CVA) are increased in patients treated with REVLIMID. Patients
with known risk factors, including prior thrombosis, may be at greater risk and actions should be taken to
try to minimize all modifi able factors (e.g., hyperlipidemia, hypertension, smoking). Thromboprophylaxis
is recommended and the regimen should be based on patient’s underlying risks. ESAs and estrogens may
further increase the risk of thrombosis and their use should be based on a benefi t-risk decision
Increased Mortality in Patients with CLL: In a clinical trial in the fi rst-line treatment of patients with CLL,
single agent REVLIMID therapy increased the risk of death as compared to single agent chlorambucil.
Serious adverse cardiovascular reactions, including atrial fi brillation, myocardial infarction, and cardiac
failure, occurred more frequently in the REVLIMID arm. REVLIMID is not indicated and not recommended
for use in CLL outside of controlled clinical trials
Second Primary Malignancies (SPM): In clinical trials in patients with MM receiving REVLIMID, an increase
of hematologic plus solid tumor SPM, notably AML and MDS, have been observed. Monitor patients for
the development of SPM. Take into account both the potential benefi t of REVLIMID and risk of SPM when
considering treatment
Increased Mortality with Pembrolizumab: In clinical trials in patients with multiple myeloma, the addition
of pembrolizumab to a thalidomide analogue plus dexamethasone resulted in increased mortality.
Treatment of patients with multiple myeloma with a PD-1 or PD-L1 blocking antibody in combination with
a thalidomide analogue plus dexamethasone is not recommended outside of controlled clinical trials
Hepatotoxicity: Hepatic failure, including fatal cases, has occurred in patients treated with REVLIMID/dex.
Pre-existing viral liver disease, elevated baseline liver enzymes, and concomitant medications may be risk
factors. Monitor liver enzymes periodically. Stop REVLIMID upon elevation of liver enzymes. After return to
baseline values, treatment at a lower dose may be considered
Severe Cutaneous Reactions Including Hypersensitivity Reactions: Angioedema and severe cutaneous
reactions including Stevens-Johnson syndrome (SJS), toxic epidermal necrolysis (TEN), and drug reaction
with eosinophilia and systemic symptoms (DRESS) have been reported. These events can be fatal.
Patients with a prior history of Grade 4 rash associated with thalidomide treatment should not receive
REVLIMID. REVLIMID interruption or discontinuation should be considered for Grade 2-3 skin rash.
REVLIMID must be discontinued for angioedema, Grade 4 rash, exfoliative or bullous rash, or if SJS, TEN,
or DRESS is suspected and should not be resumed following discontinuation for these reactions
Tumor Lysis Syndrome (TLS): Fatal instances of TLS have been reported during treatment with
lenalidomide. The patients at risk of TLS are those with high tumor burden prior to treatment. These
patients should be monitored closely and appropriate precautions taken
Tumor Flare Reaction (TFR): TFR has occurred during investigational use of lenalidomide for CLL and
lymphoma. Monitoring and evaluation for TFR is recommended in patients with MCL. Tumor fl are may
mimic the progression of disease (PD). In patients with Grade 3 or 4 TFR, it is recommended to withhold
treatment with REVLIMID until TFR resolves to ≤Grade 1. REVLIMID may be continued in patients with
Grade 1 and 2 TFR without interruption or modifi cation, at the physician’s discretion
Impaired Stem Cell Mobilization: A decrease in the number of CD34+ cells collected after treatment
(>4 cycles) with REVLIMID has been reported. Consider early referral to transplant center to optimize
timing of the stem cell collection
Thyroid Disorders: Both hypothyroidism and hyperthyroidism have been
reported. Measure thyroid function before start of REVLIMID treatment and
during therapy