Lenalidomide (Revlimid)

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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 such as Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), 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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