Difference between revisions of "Thalidomide (Thalomid)"

From HemOnc.org - A Hematology Oncology Wiki
Jump to navigation Jump to search
m
m
(26 intermediate revisions by 2 users not shown)
Line 6: Line 6:
 
<br>Route: PO
 
<br>Route: PO
 
<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 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>
 +
 +
==Toxicity management==
 
*[http://www.thalomid.com/steps_program.aspx S.T.E.P.S. System for Thalidomide Education and Prescribing Safety]<ref>[http://www.thalomid.com/steps_program.aspx S.T.E.P.S. System for Thalidomide Education and Prescribing Safety]</ref>
 
*[http://www.thalomid.com/steps_program.aspx S.T.E.P.S. System for Thalidomide Education and Prescribing Safety]<ref>[http://www.thalomid.com/steps_program.aspx S.T.E.P.S. System for Thalidomide Education and Prescribing Safety]</ref>
−
*Prescription of this drug requires participation in the '''[http://www.thalomidrems.com/ Thalomid REMS program]'''
+
*Prescription of this drug requires participation in the '''[https://www.bmsremspatientsafety.com Thalomid REMS program]'''
  
−
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>
+
==Diseases for which it is established ''(work in progress)''==
 +
*[[Multiple myeloma]]
  
 
==Diseases for which it is used==
 
==Diseases for which it is used==
 +
*[[Castleman disease]]
 
*[[Light-chain (AL) amyloidosis]]
 
*[[Light-chain (AL) amyloidosis]]
 
*[[Mantle cell lymphoma]]
 
*[[Mantle cell lymphoma]]
−
*[[Multiple myeloma]]
+
*[[Neuroendocrine tumor]]
−
*[[Neuroendocrine tumors]]
+
*[[Pancreatic NET]]
−
*[[Waldenström macroglobulinemia]]
+
*[[Peripheral T-cell lymphoma]]
 +
*[[Polycythemia vera]]
 +
*[[Smoldering multiple myeloma]]
 +
*[[Waldenström macroglobulinemia]]‎
 +
 
 +
==Preliminary data for emesis prevention==
 +
* Zhang L, Qu X, Teng Y, Shi J, Yu P, Sun T, Wang J, Zhu Z, Zhang X, Zhao M, Liu J, Jin B, Luo Y, Teng Z, Dong Y, Wen F, An Y, Yuan C, Chen T, Zhou L, Chen Y, Zhang J, Wang Z, Qu J, Jin F, Zhang J, Jin X, Xie X, Wang J, Man L, Fu L, Liu Y. Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study). J Clin Oncol. 2017 Nov 1;35(31):3558-3565. Epub 2017 Aug 30. [https://doi.org/10.1200/JCO.2017.72.2538 link to original article] [https://pubmed.ncbi.nlm.nih.gov/28854065/ PubMed]
  
 
==Patient drug information==
 
==Patient drug information==
Line 25: Line 37:
 
==History of changes in FDA indication==
 
==History of changes in FDA indication==
 
* ''Note: thalidomide was introduced in 1957 but never FDA approved during that time period. It was taken off the global market in November 1961 due to birth defects, and was not FDA approved until 1998, at that time for a non-cancer indication (erythema nodosum leprosum).''
 
* ''Note: thalidomide was introduced in 1957 but never FDA approved during that time period. It was taken off the global market in November 1961 due to birth defects, and was not FDA approved until 1998, at that time for a non-cancer indication (erythema nodosum leprosum).''
−
* 5/25/2006: First cancer-specific FDA indication: "in combination with [[Dexamethasone (Decadron) | dexamethasone]] is indicated for the treatment of patients with newly diagnosed [[Multiple myeloma | multiple myeloma]]."
+
* 2006-05-25: First cancer-specific FDA indication: Accelerated approval in combination with [[Dexamethasone (Decadron) | dexamethasone]] for the treatment of patients with newly diagnosed [[Multiple myeloma | multiple myeloma]]. ''(Based on ECOG E1A00 & THAL-MM-003)''
−
+
**2014-06-19: Converted to regular approval. ''(No supporting studies are cited)''
 +
==History of changes in EMA indication==
 +
*2008-04-16: EURD
 +
==History of changes in Health Canada indication==
 +
*2010-08-04: Initial notice of compliance
 +
==History of changes in PMDA indication==
 +
*2008-10-16: Initial approval for the treatment of relapsed or refractory [[multiple myeloma]].
 +
==Also known as==
 +
*'''Brand names:''' Contergan, Distaval, Kevadon, Neurosedyn, Pantosediv, Pantosediv, Sedalis, Sedoval K17, Softenon, Synovir, Talimol, Thaangio, Thalide, Thalido, Thalimide, Thalitero, Thalix, Thaloma, Thalomid, Zuvimide
 +
 
 
==References==
 
==References==
 
<references/>
 
<references/>
  
−
[[Category:Drug index]]
+
[[Category:Drugs]]
−
[[Category:Chemotherapy]]
+
[[Category:Oral medications]]
−
[[Category:Oral chemotherapy]]
+
 
 +
[[Category:Emesis prevention]]
  
−
[[Category:Immunotherapy]]
 
 
[[Category:Immunomodulatory drugs (IMiDs)]]
 
[[Category:Immunomodulatory drugs (IMiDs)]]
  
 +
[[Category:Castleman disease medications]]
 
[[Category:Light-chain (AL) amyloidosis medications]]
 
[[Category:Light-chain (AL) amyloidosis medications]]
 
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Mantle cell lymphoma medications]]
 
[[Category:Multiple myeloma medications]]
 
[[Category:Multiple myeloma medications]]
 
[[Category:Neuroendocrine tumor medications]]
 
[[Category:Neuroendocrine tumor medications]]
 +
[[Category:Pancreatic NET medications]]
 +
[[Category:Peripheral T-cell lymphoma medications]]
 +
[[Category:Polycythemia vera medications]]
 +
[[Category:Smoldering multiple myeloma medications]]
 
[[Category:Waldenström macroglobulinemia medications]]
 
[[Category:Waldenström macroglobulinemia medications]]
  
 
[[Category:REMS program]]
 
[[Category:REMS program]]
−
[[Category:Drugs FDA approved in 1998]]
+
[[Category:FDA approved in 1998]]
 +
[[Category:EMA approved in 2008]]
 +
[[Category:Health Canada approved in 2010]]
 +
[[Category:PMDA approved in 2008]]
 +
[[Category:WHO Essential Cancer Medicine]]

Revision as of 01:19, 7 November 2023

General information

Class/mechanism: Immunomodulatory drug (IMiD); mechanism not fully understood.

Thalidomide's mechanism may involve immunomodulatory, antiinflammatory, and antiangiogenic effects and suppression of tumor necrosis factor-alpha (TNF-α) from peripheral blood mononuclear cells. Thalidomide has been observed to inhibit angiogenesis in a human umbilical artery explant model in vitro.[1][2][3]
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

Diseases for which it is established (work in progress)

Diseases for which it is used

Preliminary data for emesis prevention

  • Zhang L, Qu X, Teng Y, Shi J, Yu P, Sun T, Wang J, Zhu Z, Zhang X, Zhao M, Liu J, Jin B, Luo Y, Teng Z, Dong Y, Wen F, An Y, Yuan C, Chen T, Zhou L, Chen Y, Zhang J, Wang Z, Qu J, Jin F, Zhang J, Jin X, Xie X, Wang J, Man L, Fu L, Liu Y. Efficacy of Thalidomide in Preventing Delayed Nausea and Vomiting Induced by Highly Emetogenic Chemotherapy: A Randomized, Multicenter, Double-Blind, Placebo-Controlled Phase III Trial (CLOG1302 study). J Clin Oncol. 2017 Nov 1;35(31):3558-3565. Epub 2017 Aug 30. link to original article PubMed

Patient drug information

History of changes in FDA indication

  • Note: thalidomide was introduced in 1957 but never FDA approved during that time period. It was taken off the global market in November 1961 due to birth defects, and was not FDA approved until 1998, at that time for a non-cancer indication (erythema nodosum leprosum).
  • 2006-05-25: First cancer-specific FDA indication: Accelerated approval in combination with dexamethasone for the treatment of patients with newly diagnosed multiple myeloma. (Based on ECOG E1A00 & THAL-MM-003)
    • 2014-06-19: Converted to regular approval. (No supporting studies are cited)

History of changes in EMA indication

  • 2008-04-16: EURD

History of changes in Health Canada indication

  • 2010-08-04: Initial notice of compliance

History of changes in PMDA indication

  • 2008-10-16: Initial approval for the treatment of relapsed or refractory multiple myeloma.

Also known as

  • Brand names: Contergan, Distaval, Kevadon, Neurosedyn, Pantosediv, Pantosediv, Sedalis, Sedoval K17, Softenon, Synovir, Talimol, Thaangio, Thalide, Thalido, Thalimide, Thalitero, Thalix, Thaloma, Thalomid, Zuvimide

References

  1. ↑ 1.0 1.1 1.2 Thalidomide (Thalomid) package insert
  2. ↑ Thalidomide (Thalomid) package insert (locally hosted backup)
  3. ↑ Thalomid manufacturer's website
  4. ↑ S.T.E.P.S. System for Thalidomide Education and Prescribing Safety
  5. ↑ Thalidomide (Thalomid) patient drug information (Chemocare)
  6. ↑ Thalidomide (Thalomid) patient drug information (UpToDate)
Retrieved from "https://hemonc.org/w/index.php?title=Thalidomide_(Thalomid)&oldid=80528"