Synopsis
Synopsis
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CEP/COS
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VMF
DRUG PRODUCT COMPOSITIONS
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Weekly News Recap #Phispers
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
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
1. Lenalidomide Hcl
2. 1243329-97-6
3. Lenalidomide Hydrochloride
Molecular Weight | 259.26 g/mol |
---|---|
Molecular Formula | C13H13N3O3 |
XLogP3 | -0.5 |
Hydrogen Bond Donor Count | 2 |
Hydrogen Bond Acceptor Count | 4 |
Rotatable Bond Count | 1 |
Exact Mass | 259.09569129 g/mol |
Monoisotopic Mass | 259.09569129 g/mol |
Topological Polar Surface Area | 92.5 Ų |
Heavy Atom Count | 19 |
Formal Charge | 0 |
Complexity | 437 |
Isotope Atom Count | 0 |
Defined Atom Stereocenter Count | 0 |
Undefined Atom Stereocenter Count | 1 |
Defined Bond Stereocenter Count | 0 |
Undefined Bond Stereocenter Count | 0 |
Covalently Bonded Unit Count | 1 |
1 of 2 | |
---|---|
Drug Name | Revlimid |
PubMed Health | Lenalidomide (By mouth) |
Drug Classes | Immune Modulator |
Drug Label | REVLIMID, 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 Ingredient | Lenalidomide |
Dosage Form | Capsule |
Route | Oral |
Strength | 2.5mg; 25mg; 15mg; 5mg; 10mg; 20mg |
Market Status | Prescription |
Company | Celgene |
2 of 2 | |
---|---|
Drug Name | Revlimid |
PubMed Health | Lenalidomide (By mouth) |
Drug Classes | Immune Modulator |
Drug Label | REVLIMID, 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 Ingredient | Lenalidomide |
Dosage Form | Capsule |
Route | Oral |
Strength | 2.5mg; 25mg; 15mg; 5mg; 10mg; 20mg |
Market Status | Prescription |
Company | Celgene |
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.
/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.
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).
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.
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.)
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
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