Thalidomide (Thalomid)

==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.Thalidomide (Thalomid) package insertThalidomide (Thalomid) package insert (locally hosted backup)Thalomid manufacturer's website
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, or the prescribing information. 
==Toxicity management==
*S.T.E.P.S. System for Thalidomide Education and Prescribing SafetyS.T.E.P.S. System for Thalidomide Education and Prescribing Safety
*Prescription of this drug requires participation in the Thalomid REMS program
==Diseases for which it is established (work in progress)==
*Multiple myeloma
==Diseases for which it is used==
*Castleman disease
*Light-chain (AL) amyloidosis
*Mantle cell lymphoma
*Neuroendocrine tumor
*Pancreatic NET
*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. link to original article EuroPMC
==Patient drug information==
*Thalidomide (Thalomid) package insert PDF pages 6-7
*Thalidomide (Thalomid) patient drug information (Chemocare)Thalidomide (Thalomid) patient drug information (Chemocare)
*Thalidomide (Thalomid) patient drug information (UpToDate)Thalidomide (Thalomid) patient drug information (UpToDate)
==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==
Category:Drugs
Category:Oral medications
Category:Emesis prevention
Category:Immunomodulatory drugs (IMiDs)
Category:Castleman disease medications
Category:Light-chain (AL) amyloidosis medications
Category:Mantle cell lymphoma medications
Category:Multiple myeloma 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:REMS program
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