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
- S.T.E.P.S. System for Thalidomide Education and Prescribing Safety[4]
- Prescription of this drug requires participation in the 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 Micromedex, Lexicomp, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
- Light-chain (AL) amyloidosis
- Mantle cell lymphoma
- Multiple myeloma
- Neuroendocrine tumors
- Pancreatic NET
- Peripheral T-cell lymphoma
- Polycythemia vera
- 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 PubMed
Patient drug information
- Thalidomide (Thalomid) package insert PDF pages 6-7[1]
- Thalidomide (Thalomid) patient drug information (Chemocare)[5]
- Thalidomide (Thalomid) patient drug information (UpToDate)[6]
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).
- 5/25/2006: First cancer-specific FDA indication: "in combination with dexamethasone is indicated for the treatment of patients with newly diagnosed multiple myeloma."
Also known as
- Brand name: Thaangio, Thalide, Thalix, Thalomid, Zuvimide
References
- ↑ 1.0 1.1 1.2 Thalidomide (Thalomid) package insert
- ↑ Thalidomide (Thalomid) package insert (locally hosted backup)
- ↑ Thalomid manufacturer's website
- ↑ S.T.E.P.S. System for Thalidomide Education and Prescribing Safety
- ↑ Thalidomide (Thalomid) patient drug information (Chemocare)
- ↑ Thalidomide (Thalomid) patient drug information (UpToDate)
- Drugs
- Oral medications
- Emesis prevention
- Immunotherapy
- Immunomodulatory drugs (IMiDs)
- Light-chain (AL) amyloidosis medications
- Mantle cell lymphoma medications
- Multiple myeloma medications
- Neuroendocrine tumor medications
- Pancreatic NET medications
- Peripheral T-cell lymphoma medications
- Polycythemia vera medications
- Waldenström macroglobulinemia medications
- REMS program
- Drugs FDA approved in 1998