REVLIMID® (lenalidomide) in combination with dexamethasone (dex) is indicated for the treatment of adult patients with multiple myeloma (MM). REVLIMID is indicated as maintenance therapy in adult patients with MM following autologous hematopoietic stem cell transplantation (auto-HSCT). REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

A well-established safety profile.1


REVLIMID® + dexamethasone Safety Data
  • Adverse reactions in which at least 1 was considered to be life-threatening (if the outcome of the reaction was death, it is included with death cases).
  • Serious treatment-emergent adverse reactions in at least 1.0% of subjects in the Rd Continuous or Rd18 arms and at least a 1.0% higher frequency (%) in either the Rd Continuous or Rd18 arms compared with the MPT arm.
Full Adverse Reactions Table
  • The most frequently reported Grade 3 or 4 reactions included neutropenia, anemia, thrombocytopenia, pneumonia, asthenia, fatigue, back pain, hypokalemia, rash, cataracts, lymphopenia, dyspnea, DVT, hyperglycemia, and leukopenia
  • The highest frequency of infections occurred in the Rd Continuous arm (75%), compared to MPT (56%)

Common adverse reactions decreased over time in the Rd Continuous arm.2

REVLIMID® + dexamethasone adverse events
  • The frequency of adverse reactions was generally highest in the first 6 months in both Rd arms and decreased or remained stable over time, except for cataracts
  • The frequency of onset of cataracts increased over time, with 0.7% during the first 6 months and up to 9.6% by the second year of treatment with Rd Continuous
  • Most frequently reported adverse reactions were comparable in the Rd arms
  • The most frequently reported adverse reactions included diarrhea, anemia, constipation, peripheral edema, neutropenia, fatigue, back pain, nausea, asthenia, and insomnia
  • There were more Grade 3 and 4 serious adverse reactions of infection in the Rd Continuous arm than in either the MPT or Rd18 arms

Consider the potential benefit of REVLIMID and risk of SPM.1

  • Monitor patients for the development of SPM
  • In clinical trials in patients with multiple myeloma receiving REVLIMID, an increase of hematologic plus solid-tumor SPM, notably AML and MDS, has been observed


  • The frequency of AML and MDS cases in patients with NDMM treated with REVLIMID + low-dose dex without melphalan was 0.4%

Patients in the FIRST Trial who received REVLIMID until disease progression did not show a higher incidence of invasive SPM than those in the fixed-duration, REVLIMID-containing arm.1

  • AML, acute myeloid leukemia; DVT, deep vein thrombosis; MDS, myelodysplastic syndromes; MPT, melphalan + prednisone + thalidomide; NDMM, newly diagnosed multiple myeloma; Rd, REVLIMID + dexamethasone; SPM, second primary malignancies.

References: 1. REVLIMID [package insert]. Summit, NJ: Celgene Corp. 2. Data on file. Celgene Corp; 2018.

Help patients stay on therapy with dose modifications.*

*Until disease progression or unacceptable toxicity.

View Dosing