Lenalidomide (Revlimid)

==General information==
Class/mechanism: Second-generation immunomodulatory drug (IMiD) similar to Thalidomide (Thalomid); mechanism not fully understood. Lenalidomide's mechanism may involve immunomodulatory, antiinflammatory, and antiangiogenic effects and suppression of tumor necrosis factor-alpha (TNF-α) from peripheral blood mononuclear cells. It has been observed to inhibit cells with the 5q deletion in myelodysplastic syndromes. It has also been seen in vitro to inhibit cyclooxygenase-2 (COX-2) expression, but not COX-1.Lenalidomide (Revlimid) package insertLenalidomide (Revlimid) package insert (locally hosted backup)Revlimid manufacturer's siteRevlimid REMS program
Route: PO
Extravasation: n/a
For conciseness and simplicity, HemOnc.org currently will focus on treatment regimens and not list information such as: renal/hepatic dose adjustments, metabolism (including CYP450), excretion, monitoring parameters (although this will be considered for checklists), or manufacturer. Instead, for the most current information, please refer to your preferred pharmacopeias or the prescribing information. 
==Toxicity management==
*Use of Lenalidomide (Revlimid) requires participation the Revlimid REMS program.
===Thrombosis===
*2006 (two simultaneously published NEJM letters to the editor): link to original article EuroPMC link to letter #1 EuroPMC link to letter #2
*2011: Larocca A, Cavallo F, Bringhen S, Di Raimondo F, Falanga A, Evangelista A, Cavalli M, Stanevsky A, Corradini P, Pezzatti S, Patriarca F, Cavo M, Peccatori J, Catalano L, Carella AM, Cafro AM, Siniscalchi A, Crippa C, Petrucci MT, Yehuda DB, Beggiato E, Di Toritto TC, Boccadoro M, Nagler A, Palumbo A. Aspirin or enoxaparin thromboprophylaxis for patients with newly diagnosed multiple myeloma treated with lenalidomide. Blood. 2012 Jan 26;119(4):933-9. Epub 2011 Aug 11. link to original article EuroPMC
===Lenalidomide Dose Adjustments for Renal Impairment===
Lenalidomide dosage should be adjusted based on the patient's renal function, particularly their creatinine clearance (CrCl). The following are the recommended dose adjustments:
====Multiple Myeloma (MM) and Mantle Cell Lymphoma (MCL)====
* CrCl ≥60 mL/min: No adjustment required.
* CrCl 30–59 mL/min: 10 mg daily.
* CrCl <30 mL/min (not on dialysis): 15 mg every other day.
* CrCl <30 mL/min (requiring dialysis): 5 mg daily (post-dialysis on dialysis days).
====Myelodysplastic Syndromes (MDS) and Maintenance Therapy Following Autologous Stem Cell Transplant for Multiple Myeloma====
* CrCl ≥60 mL/min: No adjustment required.
* CrCl 30–59 mL/min: 5 mg daily.
* CrCl <30 mL/min (not on dialysis): 2.5 mg daily
* CrCl <30 mL/min (requiring dialysis): 2.5 mg daily; on dialysis days, following hemodialysis
Note: These guidelines are based on the latest prescribing information and should be used as a reference. For personalized and detailed dosage adjustments, it is essential to consult the full prescribing information and a healthcare professional.
===References===
* FDA's page on Lenalidomide (Revlimid)
* Drugs.com Lenalidomide Information
* 
==Diseases for which it is established (work in progress)==
*Adult T-cell leukemia-lymphoma (PMDA)
*Indolent lymphoma
**Follicular lymphoma (FDA, PMDA)
**Marginal zone lymphoma (FDA, PMDA)
*Mantle cell lymphoma (FDA)
*Multiple myeloma (FDA, PMDA)
*Myelodysplastic syndrome (FDA, PMDA)
==Diseases for which it is used==
*B-cell lymphoma of mucosa-associated lymphoid tissue
*Chronic lymphocytic leukemia
*Chronic myelomonocytic leukemia
*Cutaneous T-cell lymphoma
*Diffuse large B-cell lymphoma
*Classical Hodgkin lymphoma
*Light-chain (AL) amyloidosis
*Myelofibrosis
*Peripheral T-cell lymphoma
*Plasma cell leukemia
*POEMS syndrome
*Polycythemia vera
*Smoldering multiple myeloma
*Transformed lymphoma
*Waldenström macroglobulinemia
==Patient drug information==
*Lenalidomide (Revlimid) package insert
*Lenalidomide (Revlimid) patient medication guideLenalidomide (Revlimid) patient medication guide
*Lenalidomide (Revlimid) patient drug information (Chemocare)Lenalidomide (Revlimid) patient drug information (Chemocare)
*Lenalidomide (Revlimid) patient drug information (UpToDate)Lenalidomide (Revlimid) patient drug information (UpToDate)
==History of changes in FDA indication==
===Indolent lymphoma===
*2019-05-28: Approved in combination with a rituximab product for previously treated follicular lymphoma (FL) and previously treated marginal zone lymphoma (MZL). (New disease entity; based on AUGMENT and MAGNIFY)
===Mantle cell lymphoma===
*2013-06-05: Approved for patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. (New disease entity; based on EMERGE)
===Multiple myeloma===
*2006-06-29: Approved for treatment of patients with multiple myeloma (MM), in combination with dexamethasone, in patients who have received at least one prior therapy.] (New disease entity; based on MM-009 and MM-010)
*2015-02-17: Approved for multiple myeloma (MM), in combination with dexamethasone. (Prior treatment requirement removed; based on FIRSTMM)
*2017-02-22: Approval expanded as maintenance therapy for patients with multiple myeloma following autologous stem cell transplant. (Approval expanded to maintenance therapy after upfront treatment; based on CALGB 100104 and IFM 2005-02)
===Myelodysplastic syndrome===
*2005-12-28: Approved for patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities. (Initial approval; based on CC-5013-MDS-003)
==History of changes in EMA indication==
*2007-06-14: Initial authorization
==History of changes in Health Canada indication==
*2008-01-17: Initial notice of compliance with conditions
*2013-06-06: Conditions were met
==History of changes in PMDA indication==
*2010-06-25: Initial approval for the treatment of relapsed or refractory multiple myeloma.
*2010-08-20: New additional indication and a new dosage for the treatment of myelodysplastic syndrome associated with a deletion 5q cytogenetic abnormality.
*2015-12-21: revised indication for the treatment of multiple myeloma.
*2017-03-02: New additional indication and a new dosage for the treatment of relapsed or refractory adult T-cell leukemia/lymphoma.
*2020-02-21: New indications and a new dosage for the treatment of relapsed or refractory follicular lymphoma and marginal zone lymphoma.
==Also known as==
*Code names: CC-5013, IMiD-1, NSC-703813
*Brand names: Adlinod, Immunomide, Kabillon, Lenalid, Lenalidomid, Lenangio, Lenmid, Lenome, Lenomust, Lenzest, Lidmed, Linamide, Lynide, MyeloSar, Revlimid
==References==
Category:Drugs
Category:Oral medications
Category:Mutation-specific medications
Category:Immunomodulatory drugs (IMiDs)
Category:Adult T-cell leukemia-lymphoma medications
Category:Chronic lymphocytic leukemia medications
Category:Chronic myelomonocytic leukemia medications
Category:Classical Hodgkin lymphoma medications
Category:Cutaneous T-cell lymphoma ‎medications
Category:Diffuse large B-cell lymphoma ‎medications
Category:Follicular lymphoma medications
Category:Indolent lymphoma medications
Category:Light-chain (AL) amyloidosis medications
Category:MALT lymphoma medications
Category:Mantle cell lymphoma medications
Category:Marginal zone lymphoma medications
Category:Multiple myeloma medications
Category:Myelodysplastic syndrome medications
Category:Myelofibrosis medications
Category:Peripheral T-cell lymphoma medications
Category:Plasma cell leukemia medications
Category:POEMS syndrome medications
Category:Polycythemia vera medications
Category:Smoldering multiple myeloma medications
Category:Transformed lymphoma ‎medications
Category:Waldenström macroglobulinemia medications
Category:REMS program
Category:FDA approved in 2005
Category:EMA approved in 2007
Category:Health Canada approved in 2008
Category:PMDA approved in 2010
Category:WHO Essential Cancer Medicine