Difference between revisions of "Lenalidomide (Revlimid)"

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m (Text replacement - "please refer to your preferred pharmacopeias such as [http://www.thomsonhc.com/home/dispatch Micromedex], [https://online.lexi.com/lco/action/login UpToDate Lexidrug], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information" to "please refer to your preferred pharmacopeias or the prescribing information")
 
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==General information==
 
==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.<ref name="insert">[http://www.celgene.com/content/uploads/revlimid-pi.pdf Lenalidomide (Revlimid) package insert]</ref><ref>[[Media:Lenalidomide.pdf|Lenalidomide (Revlimid) package insert (locally hosted backup)]]</ref><ref>[http://revlimid.com/ Revlimid manufacturer's site]</ref><ref name="revassist">[https://www.celgeneriskmanagement.com/REMSPortal/rems/portal/REMSPortal.portal Revlimid REMS program]</ref>
+
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.<ref name="insert">[http://www.celgene.com/content/uploads/revlimid-pi.pdf Lenalidomide (Revlimid) package insert]</ref><ref>[[:File:Lenalidomide.pdf|Lenalidomide (Revlimid) package insert (locally hosted backup)]]</ref><ref>[http://revlimid.com/ Revlimid manufacturer's site]</ref><ref name="revassist">[https://www.celgeneriskmanagement.com/REMSPortal/rems/portal/REMSPortal.portal Revlimid REMS program]</ref>
 
<br>Route: PO
 
<br>Route: PO
 
<br>Extravasation: n/a
 
<br>Extravasation: n/a
−
*Use of Lenalidomide (Revlimid) requires participation the [https://www.celgeneriskmanagement.com/REMSPortal/rems/portal/REMSPortal.portal Revlimid REMS program].<ref name="revassist"></ref>
 
  
−
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 [http://www.thomsonhc.com/home/dispatch Micromedex], [http://online.lexi.com/ Lexicomp], [http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or the prescribing information.<ref name="insert"></ref>
+
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.<ref name="insert"></ref>
 +
 
 +
==Toxicity management==
 +
*Use of Lenalidomide (Revlimid) requires participation the [https://www.bmsremspatientsafety.com Revlimid REMS program].<ref name="revassist"></ref>
 +
 
 +
===Thrombosis===
 +
*2006 (''two simultaneously published NEJM letters to the editor''): [https://doi.org/10.1056/NEJMc053530 link to original article] [https://pubmed.ncbi.nlm.nih.gov/16687729/ PubMed link to letter #1] [https://pubmed.ncbi.nlm.nih.gov/16696148/ 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. [https://doi.org/10.1182/blood-2011-03-344333 link to original article] [https://pubmed.ncbi.nlm.nih.gov/21835953/ PubMed]
 +
 
 +
===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===
 +
* [https://www.fda.gov/drugs/resources-information-approved-drugs/lenalidomide-revlimid FDA's page on Lenalidomide (Revlimid)]
 +
* [https://www.drugs.com/pro/lenalidomide.html Drugs.com Lenalidomide Information]
 +
* [https://packageinserts.bms.com/pi/pi_revlimid.pdf]
 +
 
 +
==Diseases for which it is established ''(work in progress)''==
 +
*[[Multiple myeloma]]
 +
*[[Myelodysplastic syndrome]]
 +
*Non-Hodgkin lymphoma
 +
**[[Follicular lymphoma]]
 +
**[[Mantle cell lymphoma]]
 +
**[[Marginal zone lymphoma]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 
<div style="column-count:3;-moz-column-count:3;-webkit-column-count:3">
 
<div style="column-count:3;-moz-column-count:3;-webkit-column-count:3">
−
*[[Adult T-cell leukemia/lymphoma]]
+
*[[Adult T-cell leukemia-lymphoma]]
 +
*[[B-cell lymphoma of mucosa-associated lymphoid tissue]]
 
*[[Chronic lymphocytic leukemia]]
 
*[[Chronic lymphocytic leukemia]]
 
*[[Chronic myelomonocytic leukemia]]
 
*[[Chronic myelomonocytic leukemia]]
 
*[[Cutaneous T-cell lymphoma]]
 
*[[Cutaneous T-cell lymphoma]]
 
*[[Diffuse large B-cell lymphoma]]
 
*[[Diffuse large B-cell lymphoma]]
−
*[[Follicular lymphoma]]
+
*[[Classical Hodgkin lymphoma]]
−
*[[Hodgkin lymphoma]]
 
 
*[[Light-chain (AL) amyloidosis]]
 
*[[Light-chain (AL) amyloidosis]]
−
*[[Mantle cell lymphoma]]
 
−
*[[Marginal zone lymphoma]]
 
−
*[[Multiple myeloma]]
 
−
*[[Myelodysplastic syndrome]]
 
 
*[[Myelofibrosis]]
 
*[[Myelofibrosis]]
 
*[[Peripheral T-cell lymphoma]]
 
*[[Peripheral T-cell lymphoma]]
Line 26: Line 59:
 
*[[POEMS syndrome]]
 
*[[POEMS syndrome]]
 
*[[Polycythemia vera]]
 
*[[Polycythemia vera]]
 +
*[[Smoldering multiple myeloma]]
 
*[[Transformed lymphoma]]
 
*[[Transformed lymphoma]]
 
*[[Waldenström macroglobulinemia]]
 
*[[Waldenström macroglobulinemia]]
 
</div>
 
</div>
−
 
−
==Significant side effects==
 
−
===Thrombosis===
 
−
*2006 (''two simultaneously published NEJM letters to the editor''): [https://www.nejm.org/doi/full/10.1056/NEJMc053530 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/16687729 PubMed link to letter #1] [https://www.ncbi.nlm.nih.gov/pubmed/16696148 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. [http://www.bloodjournal.org/content/119/4/933.long link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/21835953 PubMed]
 
  
 
==Patient drug information==
 
==Patient drug information==
−
*[https://hemonc.org/wiki/Lenalidomide_(Revlimid) Lenalidomide (Revlimid) package insert]<ref name="insert"></ref>
+
*[http://www.celgene.com/content/uploads/revlimid-pi.pdf Lenalidomide (Revlimid) package insert]<ref name="insert"></ref>
 
*[http://www.revlimid.com/wp-content/uploads/medication-guide.pdf Lenalidomide (Revlimid) patient medication guide]<ref>[http://www.revlimid.com/wp-content/uploads/medication-guide.pdf Lenalidomide (Revlimid) patient medication guide]</ref>
 
*[http://www.revlimid.com/wp-content/uploads/medication-guide.pdf Lenalidomide (Revlimid) patient medication guide]<ref>[http://www.revlimid.com/wp-content/uploads/medication-guide.pdf Lenalidomide (Revlimid) patient medication guide]</ref>
−
*[http://chemocare.com/chemotherapy/drug-info/Lenalidomide.aspx Lenalidomide (Revlimid) patient drug information (Chemocare)]<ref>[http://chemocare.com/chemotherapy/drug-info/Lenalidomide.aspx Lenalidomide (Revlimid) patient drug information (Chemocare)]</ref>
+
*[https://chemocare.com/druginfo/Lenalidomide.aspx Lenalidomide (Revlimid) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/Lenalidomide.aspx Lenalidomide (Revlimid) patient drug information (Chemocare)]</ref>
 
*[http://www.uptodate.com/contents/lenalidomide-patient-drug-information Lenalidomide (Revlimid) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/lenalidomide-patient-drug-information Lenalidomide (Revlimid) patient drug information (UpToDate)]</ref>
 
*[http://www.uptodate.com/contents/lenalidomide-patient-drug-information Lenalidomide (Revlimid) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/lenalidomide-patient-drug-information Lenalidomide (Revlimid) patient drug information (UpToDate)]</ref>
  
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
 
===[[Follicular lymphoma]]; [[Marginal zone lymphoma]]===
 
===[[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)''
+
*2019-05-28: 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]]===
 
===[[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)''
+
*2013-06-05: [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)''
 +
 
 +
===[[Multiple myeloma]]===
 +
*2006-06-29: [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)''
 +
*2015-02-17: Approved for [[Multiple myeloma |multiple myeloma (MM)]], in combination with dexamethasone. ''(Prior treatment requirement removed; based on FIRST<sub>MM</sub>)''
 +
*2017-02-22: [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)''
  
 
===[[Myelodysplastic syndrome]]===
 
===[[Myelodysplastic syndrome]]===
−
*12/28/2005: [http://www.fda.gov/NewsEvents/Newsroom/PressAnnouncements/2005/ucm108546.htm Approved] for patients with transfusion-dependent anemia due to [[Myelodysplastic syndrome | low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q abnormality with or without additional cytogenetic abnormalities]].<ref name="insert"></ref> ''(Initial approval)''
+
*2005-12-28: [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)''
−
 
+
==History of changes in EMA indication==
−
===[[Multiple myeloma]]===
+
*2007-06-14: Initial authorization
−
*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)''
+
==History of changes in Health Canada indication==
−
*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)''
+
*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|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==
 
==Also known as==
 
*'''Code names:''' CC-5013, IMiD-1, NSC-703813
 
*'''Code names:''' CC-5013, IMiD-1, NSC-703813
−
*'''Brand names:''' Kabillon, Lenalid, Lenangio, Lenmid, Lenome, Lenzest, MyeloSar, Revlimid
+
*'''Brand names:''' Adlinod, Immunomide, Kabillon, Lenalid, Lenalidomid, Lenangio, Lenmid, Lenome, Lenomust, Lenzest, Lidmed, Linamide, Lynide, MyeloSar, Revlimid
  
 
==References==
 
==References==
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[[Category:Drugs]]
 
[[Category:Drugs]]
 
[[Category:Oral medications]]
 
[[Category:Oral medications]]
 +
[[Category:Mutation-specific medications]]
  
 
[[Category:Immunomodulatory drugs (IMiDs)]]
 
[[Category:Immunomodulatory drugs (IMiDs)]]
  
−
[[Category:Adult T-cell leukemia/lymphoma medications]]
+
[[Category:Adult T-cell leukemia-lymphoma medications]]
 
[[Category:Chronic lymphocytic leukemia medications]]
 
[[Category:Chronic lymphocytic leukemia medications]]
 
[[Category:Chronic myelomonocytic leukemia medications]]
 
[[Category:Chronic myelomonocytic leukemia medications]]
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[[Category:Diffuse large B-cell lymphoma ‎medications]]
 
[[Category:Diffuse large B-cell lymphoma ‎medications]]
 
[[Category:Follicular lymphoma medications]]
 
[[Category:Follicular lymphoma medications]]
−
[[Category:Hodgkin lymphoma medications]]
+
[[Category:Classical Hodgkin lymphoma medications]]
 
[[Category:Light-chain (AL) amyloidosis medications]]
 
[[Category:Light-chain (AL) amyloidosis medications]]
 +
[[Category:MALT lymphoma medications]]
 
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Marginal zone lymphoma medications]]
 
[[Category:Marginal zone lymphoma medications]]
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[[Category:POEMS syndrome medications]]
 
[[Category:POEMS syndrome medications]]
 
[[Category:Polycythemia vera medications]]
 
[[Category:Polycythemia vera medications]]
 +
[[Category:Smoldering multiple myeloma medications]]
 
[[Category:Transformed lymphoma ‎medications]]
 
[[Category:Transformed lymphoma ‎medications]]
 
[[Category:Waldenström macroglobulinemia medications]]
 
[[Category:Waldenström macroglobulinemia medications]]
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[[Category:REMS program]]
 
[[Category:REMS program]]
 
[[Category:FDA approved in 2005]]
 
[[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]]
 
[[Category:WHO Essential Cancer Medicine]]

Latest revision as of 01:00, 29 June 2024

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

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.[1]

Toxicity management

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

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

Diseases for which it is established (work in progress)

Diseases for which it is used

Patient drug information

History of changes in FDA indication

Follicular lymphoma; Marginal zone lymphoma

Mantle cell lymphoma

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.[1] (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

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

  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
  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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