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.^[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

S.T.E.P.S. System for Thalidomide Education and Prescribing Safety^[4]
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

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

[insert-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)

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