REVLIMID® (lenalidomide) in combination with a rituximab product is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL). REVLIMID in combination with a rituximab product is indicated for the treatment of adult patients with previously treated marginal zone lymphoma (MZL). REVLIMID is not indicated and is not recommended for the treatment of patients with chronic lymphocytic leukemia (CLL) outside of controlled clinical trials.

FOLLICULAR LYMPHOMA POPULATION

Established safety profile

SAFETY POPULATION (N=356)

All grade ARs (≥20% of patients).1

R2 + rituximab Adverse Reactions Table
Full Adverse Reactions Table
  • Grade 3/4 neutropenia was reported in 50% of patients in the R² arm and in 13% of patients in the rituximab arm1
    • All incidences of Grade 3/4 neutropenia in the R² arm recovered to Grade 1 or less, with a median time of 9 days18
  • Patients receiving R² had an incidence of febrile neutropenia of 3% vs <1% receiving rituximab1

Note: ARs are coded to body system/AR using
MedDRA 21. A patient with multiple
occurrences of an AR is counted only once
under the applicable body system/AR.


1All treatment-emergent AEs in at least 5% of patients in the REVLIMID + rituximab group and at least 1% higher frequency (%) than the rituximab + placebo group (control arm).

2All grade 3 or 4 treatment-emergent AEs in at least 1% of patients in the REVLIMID + rituximab group and at least 1% higher frequency (%) than the rituximab + placebo group (control arm).

3All serious treatment-emergent AEs in at least 1% of patients in the REVLIMID + rituximab group and at least 1% higher frequency (%) than the rituximab + placebo group (control arm).

$Serious ADR reported.

@ - AR in which at least one resulted in a fatal outcome.

% - AR in which at least one was considered to be life threatening (if the outcome of the reaction was death, it is included with death cases).

*AR for combined ADR terms (based on relevant TEAE PTs [per MedDRA version 21.0]):

a“Thromboembolic events” combined term includes the following PTs: pulmonary embolism, deep vein thrombosis, cerebrovascular accident, embolism, and thrombosis.

b“Cough” combined AE term includes the following PTs: cough and productive cough.

c“Abdominal pain” combined AE term includes the following PTs: abdominal pain and abdominal pain upper.

d“Rash” combined AE term includes the following PTs: rash maculo-papular, rash erythematous, rash macular, rash papular, rash pruritic, and rash generalized.

e“Pruritus” combined AE term includes the following PTs: pruritus, pruritus generalized, rash pruritic, and pruritus allergic.


ADR, adverse drug reaction; AR, adverse reaction; PT, preferred term; TEAE, treatment-emergent adverse event; WBC, white blood cell.

See full reference list.


R2 is administered for a fixed duration.1

Explore Dosing