Difference between revisions of "Lenalidomide (Revlimid)"
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Warner-admin (talk | contribs) 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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<br>Extravasation: n/a | <br>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 | + | 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== | ==Toxicity management== | ||
| Line 10: | Line 10: | ||
===Thrombosis=== | ===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] | + | *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. [ | + | *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)''== | ==Diseases for which it is established ''(work in progress)''== | ||
| Line 29: | Line 52: | ||
*[[Cutaneous T-cell lymphoma]] | *[[Cutaneous T-cell lymphoma]] | ||
*[[Diffuse large B-cell lymphoma]] | *[[Diffuse large B-cell lymphoma]] | ||
| − | *[[Hodgkin lymphoma]] | + | *[[Classical Hodgkin lymphoma]] |
*[[Light-chain (AL) amyloidosis]] | *[[Light-chain (AL) amyloidosis]] | ||
*[[Myelofibrosis]] | *[[Myelofibrosis]] | ||
| Line 44: | Line 67: | ||
*[http://www.celgene.com/content/uploads/revlimid-pi.pdf 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> | ||
| − | *[https://chemocare.com/ | + | *[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> | ||
| Line 66: | Line 89: | ||
*2008-01-17: Initial notice of compliance with conditions | *2008-01-17: Initial notice of compliance with conditions | ||
*2013-06-06: Conditions were met | *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== | ||
| Line 86: | Line 115: | ||
[[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:MALT lymphoma medications]] | ||
| Line 106: | Line 135: | ||
[[Category:EMA approved in 2007]] | [[Category:EMA approved in 2007]] | ||
[[Category:Health Canada approved in 2008]] | [[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
- Use of Lenalidomide (Revlimid) requires participation the Revlimid REMS program.[4]
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)
- Multiple myeloma
- Myelodysplastic syndrome
- Non-Hodgkin lymphoma
Diseases for which it is used
- Adult T-cell leukemia-lymphoma
- 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[1]
- Lenalidomide (Revlimid) patient medication guide[5]
- Lenalidomide (Revlimid) patient drug information (Chemocare)[6]
- Lenalidomide (Revlimid) patient drug information (UpToDate)[7]
History of changes in FDA indication
Follicular lymphoma; Marginal zone 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.[1] (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.[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
- 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
- ↑ 1.0 1.1 1.2 1.3 1.4 Lenalidomide (Revlimid) package insert
- ↑ Lenalidomide (Revlimid) package insert (locally hosted backup)
- ↑ Revlimid manufacturer's site
- ↑ 4.0 4.1 Revlimid REMS program
- ↑ Lenalidomide (Revlimid) patient medication guide
- ↑ Lenalidomide (Revlimid) patient drug information (Chemocare)
- ↑ Lenalidomide (Revlimid) patient drug information (UpToDate)
Categories:
- Drugs
- Oral medications
- Mutation-specific medications
- Immunomodulatory drugs (IMiDs)
- Adult T-cell leukemia-lymphoma medications
- Chronic lymphocytic leukemia medications
- Chronic myelomonocytic leukemia medications
- Cutaneous T-cell lymphoma medications
- Diffuse large B-cell lymphoma medications
- Follicular lymphoma medications
- Classical Hodgkin lymphoma medications
- Light-chain (AL) amyloidosis medications
- MALT lymphoma medications
- Mantle cell lymphoma medications
- Marginal zone lymphoma medications
- Multiple myeloma medications
- Myelodysplastic syndrome medications
- Myelofibrosis medications
- Peripheral T-cell lymphoma medications
- Plasma cell leukemia medications
- POEMS syndrome medications
- Polycythemia vera medications
- Smoldering multiple myeloma medications
- Transformed lymphoma medications
- Waldenström macroglobulinemia medications
- REMS program
- FDA approved in 2005
- EMA approved in 2007
- Health Canada approved in 2008
- PMDA approved in 2010
- WHO Essential Cancer Medicine