WARNINGS AND PRECAUTIONS ( continued )
Allergic Reactions : Angioedema and serious dermatologic reactions including Stevens-Johnson syndrome ( SJS ) and toxic epidermal necrolysis ( TEN ) 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 or TEN is suspected and should not be resumed following discontinuation for these reactions . REVLIMID capsules contain lactose ; risk-benefit of treatment should be evaluated in patients with lactose intolerance
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 of TFR is recommended in patients with MCL . Tumor flare 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 modification , 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
ADVERSE REACTIONS Multiple Myeloma
• In newly diagnosed : The most frequently reported Grade 3 or 4 reactions included neutropenia , anemia , thrombocytopenia , pneumonia , asthenia , fatigue , back pain , hypokalemia , rash , cataract , lymphopenia , dyspnea , DVT , hyperglycemia , and leukopenia . The highest frequency of infections occurred in Arm Rd Continuous ( 75 %) compared to Arm MPT ( 56 %). There were more grade 3 and 4 and serious adverse reactions of infection in Arm Rd Continuous than either Arm MPT or Rd18
• The most common adverse reactions reported in ≥20 % ( Arm Rd Continuous ): diarrhea ( 46 %), anemia ( 44 %), neutropenia ( 35 %), fatigue ( 33 %), back pain ( 32 %), asthenia ( 28 %), insomnia ( 28 %), rash ( 26 %), decreased appetite ( 23 %), cough ( 23 %), dyspnea ( 22 %), pyrexia ( 21 %), abdominal pain ( 21 %), muscle spasms ( 20 %), and thrombocytopenia ( 20 %)
• After at least one prior therapy the most common adverse reactions reported in ≥20 % ( REVLIMID / dex vs dex / placebo ): fatigue ( 44 % vs 42 %), neutropenia ( 42 % vs 6 %), constipation ( 41 % vs 21 %), diarrhea ( 39 % vs 27 %), muscle cramp ( 33 % vs 21 %), anemia ( 31 % vs 24 %), pyrexia ( 28 % vs 23 %), peripheral edema ( 26 % vs 21 %), nausea ( 26 % vs 21 %), back pain ( 26 % vs 19 %), upper respiratory tract infection ( 25 % vs 16 %), dyspnea ( 24 % vs 17 %), dizziness ( 23 % vs 17 %), thrombocytopenia ( 22 % vs 11 %), rash ( 21 % vs 9 %), tremor ( 21 % vs 7 %), and weight decreased ( 20 % vs 15 %)
DRUG INTERACTIONS
Periodic monitoring of digoxin plasma levels is recommended due to increased Cmax and AUC with concomitant REVLIMID therapy . Patients taking concomitant therapies such as erythropoietin stimulating agents or estrogen containing therapies may have an increased risk of thrombosis . It is not known whether there is an interaction between dex and warfarin . Close monitoring of PT and INR is recommended in MM patients taking concomitant warfarin
NURSING MOTHERS
Discontinue drug or nursing taking into consideration the importance of the drug to the mother
PEDIATRIC USE
Safety and effectiveness in patients below the age of 18 have not been established
RENAL IMPAIRMENT
REVLIMID is primarily excreted unchanged by the kidneys ; adjustments to the starting dose are recommended to provide appropriate drug exposure in patients with moderate or severe renal impairment and in patients on dialysis
Please see brief summary of full Prescribing Information , including Boxed WARNINGS , on the following pages .
REVLIMID is only available through a restricted distribution program , REVLIMID REMS ® .
REVLIMID ® and REVLIMID REMS ® are registered trademarks of Celgene Corporation . © 2016 Celgene Corporation 09 / 16 US-REV160104a