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Also known as: 191732-72-6, Revlimid, Revimid, 3-(4-amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione, Cc-5013, Lenalidomide (cc-5013)
Molecular Formula
C13H13N3O3
Molecular Weight
259.26  g/mol
InChI Key
GOTYRUGSSMKFNF-UHFFFAOYSA-N
FDA UNII
F0P408N6V4

Lenalidomide
A phthalimide and piperidone derivative that has immunomodulatory and antiangiogenic properties. It is used for the treatment of transfusion-dependent anemia in MYELODYSPLASTIC SYNDROMES, and for the treatment of MULTIPLE MYELOMA, and relapsed or refractory MANTLE CELL LYMPHOMA.
Lenalidomide is a Thalidomide Analog.
1 2D Structure

Lenalidomide

2 Identification
2.1 Computed Descriptors
2.1.1 IUPAC Name
3-(7-amino-3-oxo-1H-isoindol-2-yl)piperidine-2,6-dione
2.1.2 InChI
InChI=1S/C13H13N3O3/c14-9-3-1-2-7-8(9)6-16(13(7)19)10-4-5-11(17)15-12(10)18/h1-3,10H,4-6,14H2,(H,15,17,18)
2.1.3 InChI Key
GOTYRUGSSMKFNF-UHFFFAOYSA-N
2.1.4 Canonical SMILES
C1CC(=O)NC(=O)C1N2CC3=C(C2=O)C=CC=C3N
2.2 Other Identifiers
2.2.1 UNII
F0P408N6V4
2.3 Synonyms
2.3.1 MeSH Synonyms

1. 2,6-piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2h- Isoindol-2-yl)-

2. 3-(4-amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione

3. Cc 5013

4. Cc-5013

5. Cc5013

6. Imid3 Cpd

7. Revimid

8. Revlimid

2.3.2 Depositor-Supplied Synonyms

1. 191732-72-6

2. Revlimid

3. Revimid

4. 3-(4-amino-1-oxoisoindolin-2-yl)piperidine-2,6-dione

5. Cc-5013

6. Lenalidomide (cc-5013)

7. Cdc 501

8. Cdc-501

9. Imid3

10. 3-(4-amino-1-oxo-1,3-dihydro-2h-isoindol-2-yl)piperidine-2,6-dione

11. 3-(7-amino-3-oxo-1h-isoindol-2-yl)piperidine-2,6-dione

12. Cc 5013

13. Lenadoamide

14. 2,6-piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2h-isoindol-2-yl)-

15. Revlimid (tn)

16. Nsc-747972

17. Chebi:63791

18. C13h13n3o3

19. F0p408n6v4

20. Syp-1512

21. Mfcd07772307

22. 1-oxo-2-(2,6-dioxopiperidin-3-yl)-4-aminoisoindoline

23. Ncgc00167491-01

24. Lenalidomide [usan]

25. 3-(4-amino-1-oxo-2,3-dihydro-1h-isoindol-2-yl)piperidine-2,6-dione

26. Dsstox_cid_26664

27. Dsstox_rid_81806

28. Dsstox_gsid_46664

29. Revlimid (lenalidomide)

30. 3-(4-amino-1-oxo-1,3-dihydro-isoindol-2-yl)-piperidine-2,6-dione

31. Cas-191732-72-6

32. (3s)-3-(4-amino-1-oxo-1,3-dihydro-2h-isoindol-2-yl)piperidine-2,6-dione

33. Lenalidomide (usan/inn)

34. Unii-f0p408n6v4

35. Lenalidomide [usan:inn:ban]

36. Enmd 0997

37. Enmd-0997

38. Hsdb 8220

39. Imid-5013

40. Cdc-5013

41. Albb-015321

42. Lenalidomide [mi]

43. Lenalidomide [inn]

44. Lenalidomide [jan]

45. Chembl848

46. Revlimid (tn) (celgene)

47. Lenalidomide [vandf]

48. Schembl32978

49. Lenalidomide [mart.]

50. Mls003899194

51. Lenalidomide [who-dd]

52. Gtpl7331

53. Schembl1980410

54. Lenalidomide [ema Epar]

55. 3-(4-amino-1-oxo-2-isoindolinyl)piperidine-2,6-dione

56. Dtxsid8046664

57. Bdbm65454

58. 3-(7-amino-3-oxo-1h-isoindol-2-yl)-piperidine-2,6-dione

59. Bcpp000186

60. Hms3654g07

61. Hms3674c05

62. Lenalidomide [orange Book]

63. Bcp01390

64. Hy-a0003

65. Revlimid, Lenalidomide, Cc-5013

66. Tox21_112492

67. Ac-914

68. Nsc747972

69. S1029

70. Stk639603

71. 2,6-piperidinedione, 3-(4-amino-1,3-dihydro-1-oxo-2h- Isoindol-2-yl)-

72. Akos005146276

73. Akos005174869

74. Tox21_112492_1

75. Bcp9000847

76. Ccg-264781

77. Cs-0125

78. Db00480

79. Ks-1207

80. Nsc 747972

81. Sb66166

82. Ncgc00167491-02

83. Ncgc00167491-03

84. Ncgc00167491-04

85. 443912-14-9

86. Bl164614

87. Bp-27972

88. Smr002529986

89. Sy047646

90. Am20050439

91. Ft-0659651

92. Ft-0670758

93. Ft-0670759

94. Sw218084-2

95. Ec-000.2340

96. D04687

97. Ab01273975-01

98. Ab01273975-02

99. Ab01273975_03

100. 732l726

101. Q425681

102. Sr-01000883999

103. Q-101410

104. Sr-01000883999-1

105. Z1741976709

106. 2, 3-(4-amino-1,3-dihydro-1-oxo-2h-isoindol-2-yl)-

107. 3-(4-amino-1,3-dihydro-1-oxo-2h-isoindol-2-yl)-2,6-piperidinedione

108. 3-(4-amino-1-oxo-1,3-dihydro-2h-isoindol-2-yl)-2,6-dioxopiperidine

109. 3-(4-amino-1-oxo-1,3-dihydro-2h-isoindol-2-yl)-2,6-piperidinedione

110. 4-amino-2-(6-hydroxy-2-oxo-2,3,4,5-tetrahydropyridin-3-yl)-2,3-dihydro-1h-isoindol-1-one

2.3.3 Other Synonyms

1. Lenalidomide Hcl

2. 1243329-97-6

3. Lenalidomide Hydrochloride

2.4 Create Date
2005-08-09
3 Chemical and Physical Properties
Molecular Weight 259.26 g/mol
Molecular Formula C13H13N3O3
XLogP3-0.5
Hydrogen Bond Donor Count2
Hydrogen Bond Acceptor Count4
Rotatable Bond Count1
Exact Mass259.09569129 g/mol
Monoisotopic Mass259.09569129 g/mol
Topological Polar Surface Area92.5 Ų
Heavy Atom Count19
Formal Charge0
Complexity437
Isotope Atom Count0
Defined Atom Stereocenter Count0
Undefined Atom Stereocenter Count1
Defined Bond Stereocenter Count0
Undefined Bond Stereocenter Count0
Covalently Bonded Unit Count1
4 Drug and Medication Information
4.1 Drug Information
1 of 2  
Drug NameRevlimid
PubMed HealthLenalidomide (By mouth)
Drug ClassesImmune Modulator
Drug LabelREVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-...
Active IngredientLenalidomide
Dosage FormCapsule
RouteOral
Strength2.5mg; 25mg; 15mg; 5mg; 10mg; 20mg
Market StatusPrescription
CompanyCelgene

2 of 2  
Drug NameRevlimid
PubMed HealthLenalidomide (By mouth)
Drug ClassesImmune Modulator
Drug LabelREVLIMID, a thalidomide analogue, is an immunomodulatory agent with antiangiogenic and antineoplastic properties. The chemical name is 3-(4-amino-1-oxo 1,3-dihydro-2H-isoindol-2-yl) piperidine-2,6-dione and it has the following chemical structure: 3-...
Active IngredientLenalidomide
Dosage FormCapsule
RouteOral
Strength2.5mg; 25mg; 15mg; 5mg; 10mg; 20mg
Market StatusPrescription
CompanyCelgene

4.2 Therapeutic Uses

Angiogenesis Inhibitors; Immunologic Factors

National Library of Medicine's Medical Subject Headings. Lenalidomide. Online file (MeSH, 2014). Available from, as of December 18, 2014: https://www.nlm.nih.gov/mesh/2014/mesh_browser/MBrowser.html


Revlimid in combination with dexamethasone is indicated for the treatment of patients with multiple myeloma (MM) who have received at least one prior therapy. /Included in US product label/

NIH; DailyMed. Current Medication Information for Revlimid (Lenalidomide) Capsule (Revised: September 2014). Available from, as of February 23, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fa97bf5-28a2-48f1-8955-f56012d296be


Revlimid is indicated for the treatment of patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. /Included in US product label/

NIH; DailyMed. Current Medication Information for Revlimid (Lenalidomide) Capsule (Revised: September 2014). Available from, as of December 31, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fa97bf5-28a2-48f1-8955-f56012d296be


Revlimid is indicated for the treatment of patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. /Included in US product label/

NIH; DailyMed. Current Medication Information for Revlimid (Lenalidomide) Capsule (Revised: September 2014). Available from, as of December 31, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fa97bf5-28a2-48f1-8955-f56012d296be


For more Therapeutic Uses (Complete) data for Lenalidomide (7 total), please visit the HSDB record page.


4.3 Drug Warning

/BOXED WARNING/ WARNING: EMBRYO-FETAL TOXICITY. Do not use Revlimid during pregnancy. Lenalidomide, a thalidomide analogue, caused limb abnormalities in a developmental monkey study. Thalidomide is a known human teratogen that causes severe life-threatening human birth defects. If lenalidomide is used during pregnancy, it may cause birth defects or embryo-fetal death. In females of reproductive potential, obtain 2 negative pregnancy tests before starting Revlimid treatment. Females of reproductive potential must use 2 forms of contraception or continuously abstain from heterosexual sex during and for 4 weeks after Revlimid treatment. To avoid embryo-fetal exposure to lenalidomide, Revlimid is only available through a restricted distribution program, the Revlimid REMS program (formerly known as the RevAssist program).

NIH; DailyMed. Current Medication Information for Revlimid (Lenalidomide) Capsule (Revised: September 2014). Available from, as of December 31, 2014: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fa97bf5-28a2-48f1-8955-f56012d296be


/BOXED WARNING/ WARNING: HEMATOLOGIC TOXICITY. Revlimid can cause significant neutropenia and thrombocytopenia. Eighty percent of patients with del 5q myelodysplastic syndromes had to have a dose delay/reduction during the major study. Thirty-four percent of patients had to have a second dose delay/reduction. Grade 3 or 4 hematologic toxicity was seen in 80% of patients enrolled in the study. Patients on therapy for del 5q myelodysplastic syndromes should have their complete blood counts monitored weekly for the first 8 weeks of therapy and at least monthly thereafter. Patients may require dose interruption and/or reduction. Patients may require use of blood product support and/or growth factors

NIH; DailyMed. Current Medication Information for Revlimid (Lenalidomide) Capsule (Revised: September 2014). Available from, as of February 27, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fa97bf5-28a2-48f1-8955-f56012d296be


/BOXED WARNING/ WARNING: VENOUS AND ARTERIAL THROMBOEMBOLISM. Revlimid has demonstrated a significantly increased risk of deep vein thrombosis (DVT) and pulmonary embolism (PE), as well as risk of myocardial infarction and stroke in patients with multiple myeloma who were treated with Revlimid and dexamethasone therapy. Monitor for and advise patients about signs and symptoms of thromboembolism. Advise patients to seek immediate medical care if they develop symptoms such as shortness of breath, chest pain, or arm or leg swelling. Thromboprophylaxis is recommended and the choice of regimen should be based on an assessment of the patient's underlying risks.

NIH; DailyMed. Current Medication Information for Revlimid (Lenalidomide) Capsule (Revised: September 2014). Available from, as of February 27, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fa97bf5-28a2-48f1-8955-f56012d296be


Patients with multiple myeloma treated with lenalidomide in studies including melphalan and stem cell transplantation had a higher incidence of second primary malignancies, particularly acute myelogenous leukemia (AML) and Hodgkin lymphoma, compared to patients in the control arms who received similar therapy but did not receive lenalidomide. Monitor patients for the development of second malignancies. Take into account both the potential benefit of lenalidomide and the risk of second primary malignancies when considering treatment with lenalidomide.

NIH; DailyMed. Current Medication Information for Revlimid (Lenalidomide) Capsule (Revised: September 2014). Available from, as of February 27, 2015: https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=5fa97bf5-28a2-48f1-8955-f56012d296be


For more Drug Warnings (Complete) data for Lenalidomide (19 total), please visit the HSDB record page.


4.4 Drug Indication

Lenalidomide is indicated for the treatment of adult patients with multiple myeloma (MM) in combination with dexamethasone. It is also indicated as maintenance therapy in multiple myeloma following autologous hematopoietic stem cell transplantation (auto-HSCT). It is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes (MDS) associated with a deletion 5q cytogenetic abnormality with or without additional cytogenetic abnormalities. Lenalidomide is indicated for the treatment of adult patients with mantle cell lymphoma (MCL) whose disease has relapsed or progressed after two prior therapies, one of which included bortezomib. In combination with a rituximab product, lenalidomide is indicated for the treatment of adult patients with previously treated follicular lymphoma (FL) or previously treated marginal zone lymphoma (MZL).


FDA Label


* Multiple myeloma:

Revlimid as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Revlimid as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Revlimid in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

* Myelodysplastic syndromes:

Revlimid as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

* Mantle cell lymphoma:

Revlimid as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma.

* Follicular lymphoma:

Revlimid in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 3a).


* Multiple myeloma:

Lenalidomide Accord as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Lenalidomide Accord as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Lenalidomide Accord in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

* Follicular lymphoma:

Lenalidomide Accord in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 3a).


Treatment of mature B-cell neoplasms


Treatment of diffuse large B-cell lymphoma


Myelodysplastic Syndrome


* Multiple myeloma:

Lenalidomide Mylan as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Lenalidomide Mylan as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Lenalidomide Mylan in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

* Follicular lymphoma:

Lenalidomide Mylan in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1-3a).


* Multiple myeloma:

Lenalidomide krka d. d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Lenalidomide krka d. d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Lenalidomide krka d. d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

* Follicular lymphoma:

Lenalidomide krka d. d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 3a).

* Multiple myeloma:

Lenalidomide krka d. d. Novo mesto as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Lenalidomide krka d. d. Novo mesto as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Lenalidomide krka d. d. Novo mesto in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

* Follicular lymphoma:

Lenalidomide krka d. d. Novo mesto in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 3a).


* Multiple myeloma:

Lenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

* Myelodysplastic syndromes:

Lenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

Mantle cell lymphoma

Lenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 and 5. 1).

* Follicular lymphoma:

Lenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 3a).

* Multiple myeloma:

Lenalidomide Krka as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Lenalidomide Krka as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Lenalidomide Krka in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

* Myelodysplastic syndromes:

Lenalidomide Krka as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

* Mantle cell lymphoma:

Lenalidomide Krka as monotherapy is indicated for the treatment of adult patients with relapsed or refractory mantle cell lymphoma (see sections 4. 4 and 5. 1).

* Follicular lymphoma:

Lenalidomide Krka in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 3a).


* Multiple myeloma:

Lenalidomide Krka d. d. as monotherapy is indicated for the maintenance treatment of adult patients with newly diagnosed multiple myeloma who have undergone autologous stem cell transplantation.

Lenalidomide Krka d. d. as combination therapy with dexamethasone, or bortezomib and dexamethasone, or melphalan and prednisone (see section 4. 2) is indicated for the treatment of adult patients with previously untreated multiple myeloma who are not eligible for transplant.

Lenalidomide Krka d. d. in combination with dexamethasone is indicated for the treatment of multiple myeloma in adult patients who have received at least one prior therapy.

* Myelodysplastic syndromes:

Lenalidomide Krka d. d. as monotherapy is indicated for the treatment of adult patients with transfusion-dependent anemia due to low- or intermediate-1-risk myelodysplastic syndromes associated with an isolated deletion 5q cytogenetic abnormality when other therapeutic options are insufficient or inadequate.

* Follicular lymphoma:

Lenalidomide Krka d. d. in combination with rituximab (anti-CD20 antibody) is indicated for the treatment of adult patients with previously treated follicular lymphoma (Grade 1 3a).


5 Pharmacology and Biochemistry
5.1 Pharmacology

In hematological malignancies, the immune system is deregulated in the form of altered cytokine networks in the tumour microenvironment, defective T cell regulation of host-tumour immune interactions, and diminished NK cell activity. Lenalidomide is an immunomodulatory agent with antineoplastic, antiangiogenic, and anti-inflammatory properties. Lenalidomide exerts direct cytotoxicity by increasing apoptosis and inhibiting the proliferation of hematopoietic malignant cells. It delays tumour growth in nonclinical hematopoietic tumour models _in vivo_, including multiple myeloma. Lenalidomide also works to limit the invasion or metastasis of tumour cells and inhibits angiogenesis. Lenalidomide also mediates indirect antitumour effects via its immunomodulatory actions: it inhibits the production of pro-inflammatory cytokines, which are implicated in various hematologic malignancies. Lenalidomide enhances the host immunity by stimulating T cell proliferation and enhancing the activity of natural killer (NK) cells. Lenalidomide is about 1001000 times more potent in stimulating T cell proliferation than [thalidomide]. _In vitro_, it enhances antibody-dependent cell-mediated cytotoxicity (ADCC), which is even more pronounced when used in combination with rituximab. Due to its anti-inflammatory properties, lenalidomide has been investigated in the context of inflammatory and autoimmune diseases, such as amyotrophic lateral sclerosis.


5.2 MeSH Pharmacological Classification

Immunologic Factors

Biologically active substances whose activities affect or play a role in the functioning of the immune system. (See all compounds classified as Immunologic Factors.)


Angiogenesis Inhibitors

Agents and endogenous substances that antagonize or inhibit the development of new blood vessels. (See all compounds classified as Angiogenesis Inhibitors.)


5.3 FDA Pharmacological Classification
5.3.1 Active Moiety
LENALIDOMIDE
5.3.2 FDA UNII
F0P408N6V4
5.3.3 Pharmacological Classes
Thalidomide Analog [EPC]
5.4 ATC Code

L04AX04


L04AX04


L04AX07


L04AX04


L04AX04


L04AX04


L04AX04

S76 | LUXPHARMA | Pharmaceuticals Marketed in Luxembourg | Pharmaceuticals marketed in Luxembourg, as published by d'Gesondheetskeess (CNS, la caisse nationale de sante, www.cns.lu), mapped by name to structures using CompTox by R. Singh et al. (in prep.). List downloaded from https://cns.public.lu/en/legislations/textes-coordonnes/liste-med-comm.html. Dataset DOI:10.5281/zenodo.4587355


L - Antineoplastic and immunomodulating agents

L04 - Immunosuppressants

L04A - Immunosuppressants

L04AX - Other immunosuppressants

L04AX04 - Lenalidomide


5.5 Absorption, Distribution and Excretion

Absorption

Following oral administration, lenalidomide is rapidly absorbed with high bioavailability. It has a Tmax ranging from 0.5 to six hours. Lenalidomide exhibits a linear pharmacokinetic profile, with its AUC and Cmax increasing proportionally with dose. Multiple dosing does not result in drug accumulation. In healthy male subjects, the Cmax was 413 77 ng/ml and the AUCinfinity was 1319 162 h x ng/ml.


Route of Elimination

Lenalidomide is eliminated predominantly via urinary excretion in the unchanged form. Following oral administration of 25 mg of radiolabeled lenalidomide in healthy subjects, about 90% of the dose (4.59% as metabolites) was eliminated in urine and 4% of the dose (1.83% as metabolites) was eliminated in feces within ten days post-dose. Approximately 85% of the dose was excreted as lenalidomide in the urine within 24 hours.


Volume of Distribution

In healthy male subjects, the apparent volume of distribution was 75.8 7.3 L.


Clearance

The ren