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.
Dose modifications for adverse events during
Maintenance Therapy.
Neutropenia, rash, fatigue, and diarrhea were among the most frequently reported (≥20%) in clinical trials of REVLIMID maintenance therapy post auto-HSCT. Dose modifications are recommended in patients with these adverse events.1
For a complete list of most frequently reported adverse events, please click here.
Neutropenia
Changes in dosing for neutropenia during REVLIMID Maintenance Therapy are based on decreases in absolute neutrophil count (ANC).
Neutropenia: How to Dose Modify REVLIMID
in MM post auto-HSCTNo dose adjustments required for ANC ≥500/mcL1
Find out about Dose Modification of
REVLIMID in NSCT NDMM.REVLIMID dose modifications for Grade 3/4 hematologic toxicities in patients with MM post auto-HSCT1* When ANC <500/mcL Interrupt REVLIMID treatment, follow CBC weekly Return to ANC ≥500/mcL Resume REVLIMID at next lower dose continuously
for Days 1–28 of repeated 28-day cyclesIf at the 5 mg daily dose, for a
subsequent drop to ANC <500/mcLInterrupt REVLIMID treatment
Do not dose below 5 mg daily for Days 1–21 of 28-day cyclesReturn to ANC ≥500/mcL Resume REVLIMID at 5 mg daily for Days 1–21 of repeated 28-day cycles
Do not dose below 5 mg daily for Days 1–21 of 28-day cyclesREVLIMID dose modifications for Grade 3/4 hematologic toxicities in patients with MM post auto-HSCT1* When ANC <500/mcL Interrupt REVLIMID treatment, follow CBC weekly Return to ANC ≥500/mcL Resume REVLIMID at next lower dose continuously for Days 1–28 of repeated 28-day cycles If at the 5 mg daily dose, for a subsequent drop to ANC <500/mcL Interrupt REVLIMID treatment
Do not dose below 5 mg daily for Days 1–21 of 28-day cyclesReturn to ANC ≥500/mcL Resume REVLIMID at 5 mg daily for Days 1–21 of repeated 28-day cycles
Do not dose below 5 mg daily for Days 1–21 of 28-day cyclesRash
Interruption or discontinuation of REVLIMID is recommended in the presence of Grade 3 rash.
For Grade 4 rash, permanently discontinue treatment with REVLIMID.Rash: How to Dose Modify REVLIMID
Dose modifications for non-hematologic adverse events
REVLIMID dose modifications based on rash grade in patients with MM1 Grade 1 No dose adjustment required Grade 2 Grade 3 Hold treatment and restart at the physician’s discretion at next lower dose when toxicity
has resolved to Grade 2 or belowGrade 4 Permanently discontinue REVLIMID REVLIMID dose modifications based on rash grade in patients with MM1 Grade 1 No dose adjustment required Grade 2 No dose adjustment required Grade 3 Hold treatment and restart at the physician’s discretion at next lower dose when toxicity has resolved to Grade 2 or below Grade 4 Permanently discontinue REVLIMID Downloads
†For more information, please refer to the American Cancer Society website.
Fatigue
Hold treatment and restart at next lower dose for Grade 3/4 fatigue.
Fatigue: How to Dose Modify REVLIMID
Dose modifications for non-hematologic adverse events
REVLIMID dose modifications based on fatigue grade in patients with MM1,3 Grade 1: Mild fatigue over baseline No dose adjustment required Grade 2: Moderate or causing difficulty
performing some ADLGrade 3: Severe fatigue interfering with ADL Hold treatment and restart at the physician's discretion at next lower dose
when toxicity has resolved to Grade 2 or belowGrade 4: Disabling REVLIMID dose modifications based on fatigue grade in patients with MM1,3 Grade 1: Mild fatigue over baseline No dose adjustment required Grade 2: Moderate or causing difficulty
performing some ADLNo dose adjustment required Grade 3: Severe fatigue interfering with ADL Hold treatment and restart at the physician's discretion at next lower dose
when toxicity has resolved to Grade 2 or belowGrade 4: Disabling Hold treatment and restart at the physician's discretion at next lower dose
when toxicity has resolved to Grade 2 or belowThe severity of AEs was graded by CTCAE v3.0 in the FIRST Trial and Maintenance Study 1. Maintenance Study 2 used the WHO toxicity criteria to grade adverse events.*†
Downloads
For patients who are auto-HSCT eligible, hematopoietic stem cell mobilization should occur within 4 cycles of receiving REVLIMID-containing therapy.
†For more information, please refer to the American Cancer Society website.Diarrhea
Hold treatment and restart at next lower dose for Grade 3/4 diarrhea.
Diarrhea: How to Dose Modify REVLIMID
Dose modifications for non-hematologic adverse events
REVLIMID dose modifications based on diarrhea grade in patients with MM1,5 Grade 1: Increase of <4 stools per day over baseline; mild increase in
ostomy output compared to baselineNo dose adjustment required Grade 2: Increase of 4-6 stools per day over baseline; IV fluids
indicated <24 hours; moderate increase in ostomy output compared
to baseline; not interfering with ADLGrade 3: Increase of ≥7 stools per day over baseline; incontinence;
IV fluids ≥24 hours; hospitalization; severe increase in ostomy output
compared to baseline; interfering with ADLHold treatment and restart at the physician’s discretion at next
lower dose when toxicity has resolved to Grade 2 or belowGrade 4: Life-threatening consequences (eg, hemodynamic collapse) REVLIMID dose modifications based on diarrhea grade in patients with MM1,5 Grade 1: Increase of <4 stools per day over baseline; mild increase in ostomy output compared to baseline No dose adjustment required Grade 2: Increase of 4-6 stools per day over baseline; IV fluids indicated <24 hours; moderate increase in ostomy output compared to baseline; not interfering with ADL No dose adjustment required Grade 3: Increase of ≥7 stools per day over baseline; incontinence; IV fluids ≥24 hours; hospitalization; severe increase in ostomy output compared to baseline; interfering with ADL Hold treatment and restart at the physician’s discretion at next lower dose when toxicity has resolved to Grade 2 or below Grade 4: Life-threatening consequences (eg, hemodynamic collapse) Hold treatment and restart at the physician’s discretion at next lower dose when toxicity has resolved to Grade 2 or below The severity of AEs was graded by CTCAE v3.0 in the FIRST Trial and Maintenance Study 1. Maintenance Study 2 used the WHO toxicity criteria to grade adverse events.*†
Downloads
†For more information, please refer to the American Cancer Society website.
ADL, activities of daily living; AE, adverse event; ANC, absolute neutrophil count; auto-HSCT, autologous hematopoietic stem cell transplantation; CBC, complete blood count; CTCAE, Common Terminology Criteria for Adverse Events; FIRST, Frontline Investigation of REVLIMID + dexamethasone versus Standard Thalidomide; MM, multiple myeloma; NDMM, newly diagnosed multiple myeloma; NSCT, non-stem cell transplant; WHO, World Health Organization.
References: 1. REVLIMID [package insert]. Summit, NJ: Celgene Corp. 2. Miceli T, Colson K, Gavino M, Lilleby K; IMF Nurse Leadership Board. Myelosuppression associated with novel therapies in patients with multiple myeloma: consensus statement of the IMF Nurse Leadership Board. J Clin Oncol Nurs. 2008;12(suppl 3):13-20. 3. Targeted Therapy Side Effects: Skin Problems. American Cancer Society Website. https://www.cancer.org/treatment/treatments-and-side-effects/treatment-types/targeted-therapy/side-effects.html. Revised December 27, 2019. Accessed September 16, 2020. 4. Managing Cancer-related Fatigue. American Cancer Society website. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/fatigue/managing-cancer-related-fatigue.html. Revised October 22, 2018. Accessed September 16, 2020. 5. US Department of Health and Human Services. National Cancer Institute. Common Terminology Criteria for Adverse Events (CTCAE), Version 3.0. 6. Diarrhea. American Cancer Society website. https://www.cancer.org/treatment/treatments-and-side-effects/physical-side-effects/stool-or-urine-changes/diarrhea.html. Revised July 29, 2019. Accessed September 16, 2020.