Difference between revisions of "Lenalidomide (Revlimid)"

Revision as of 01:27, 4 May 2021

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.^[1]^[2]^[3]^[4]
Route: PO
Extravasation: n/a

Use of Lenalidomide (Revlimid) requires participation the Revlimid REMS program.^[4]

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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.^[1]

Diseases for which it is used

Significant side effects

Thrombosis

2006 (two simultaneously published NEJM letters to the editor): link to original article PubMed link to letter #1 PubMed 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 PubMed

Patient drug information

History of changes in FDA indication

Follicular lymphoma; Marginal zone lymphoma

5/28/2019: 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

6/5/2013: Approved for patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib.^[1] (New disease entity; based on EMERGE)

Myelodysplastic syndrome

12/28/2005: 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.^[1] (Initial approval; based on CC-5013-MDS-003)

Multiple myeloma

6/29/2006: 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)
2/17/2015: Approved for multiple myeloma (MM), in combination with dexamethasone. (Prior treatment requirement removed; based on FIRST)
2/22/2017: 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)

Also known as

Code names: CC-5013, IMiD-1, NSC-703813
Brand names: Kabillon, Lenalid, Lenangio, Lenmid, Lenome, Lenzest, MyeloSar, Revlimid

References

[insert-1] 1.0 ^1.1 ^1.2 ^1.3 ^1.4 Lenalidomide (Revlimid) package insert

[2] Lenalidomide (Revlimid) package insert (locally hosted backup)

[3] Revlimid manufacturer's site

[revassist-4] 4.0 ^4.1 Revlimid REMS program

[5] Lenalidomide (Revlimid) patient medication guide

[6] Lenalidomide (Revlimid) patient drug information (Chemocare)

[7] Lenalidomide (Revlimid) patient drug information (UpToDate)

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 ==History of changes in FDA indication==
 ===[[Follicular lymphoma]]; [[Marginal zone lymphoma]]===
-*5/28/2019: Approved in combination with a rituximab product for previously treated [[Follicular lymphoma|follicular lymphoma (FL)]] and previously treated [[marginal zone lymphoma|marginal zone lymphoma (MZL)]]. ''(New disease entity)''
+*5/28/2019: Approved in combination with a rituximab product for previously treated [[Follicular lymphoma|follicular lymphoma (FL)]] and previously treated [[marginal zone lymphoma|marginal zone lymphoma (MZL)]]. ''(New disease entity; based on AUGMENT and MAGNIFY)''
 ===[[Mantle cell lymphoma]]===
-*6/5/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm355438.htm Approved] for patients with [[Mantle cell lymphoma |mantle cell lymphoma (MCL)]] whose disease has relapsed or progressed after two prior therapies, one of which included [[Bortezomib (Velcade) | bortezomib]].<ref name="insert"></ref> ''(New disease entity)''
+*6/5/2013: [http://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm355438.htm Approved] for patients with [[Mantle cell lymphoma |mantle cell lymphoma (MCL)]] whose disease has relapsed or progressed after two prior therapies, one of which included [[Bortezomib (Velcade) | bortezomib]].<ref name="insert"></ref> ''(New disease entity; based on EMERGE)''
 ===[[Myelodysplastic syndrome]]===
-*12/28/2005: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108546.htm Approved] for patients with transfusion-dependent anemia due to low- or intermediate-1-risk [[Myelodysplastic syndrome | myelodysplastic syndromes (MDS)]] associated with a [[Biomarkers#Deletion|deletion]] [[Biomarkers#5q|5q]] abnormality with or without additional cytogenetic abnormalities.<ref name="insert"></ref> ''(Initial approval)''
+*12/28/2005: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108546.htm Approved] for patients with transfusion-dependent anemia due to low- or intermediate-1-risk [[Myelodysplastic syndrome | myelodysplastic syndromes (MDS)]] associated with a [[Biomarkers#Deletion|deletion]] [[Biomarkers#5q|5q]] abnormality with or without additional cytogenetic abnormalities.<ref name="insert"></ref> ''(Initial approval; based on CC-5013-MDS-003)''
 ===[[Multiple myeloma]]===
-*6/29/2006: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm095626.htm Approved] for treatment of patients with "[[Multiple myeloma |multiple myeloma (MM)]], in combination with [[Dexamethasone (Decadron) | dexamethasone]], in patients who have received at least one prior therapy.]<ref name="insert"></ref> ''(New disease entity; based on FIRST)''
+*6/29/2006: [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CDER/ucm095626.htm Approved] for treatment of patients with [[Multiple myeloma |multiple myeloma (MM)]], in combination with [[Dexamethasone (Decadron) | dexamethasone]], in patients who have received at least one prior therapy.] ''(New disease entity; based on MM-009 and MM-010)''
+*2/17/2015: Approved for [[Multiple myeloma |multiple myeloma (MM)]], in combination with dexamethasone. ''(Prior treatment requirement removed; based on FIRST)''
 *2/22/2017: [https://www.fda.gov/Drugs/InformationOnDrugs/ApprovedDrugs/ucm542791.htm 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)''