Difference between revisions of "Sonidegib (Odomzo)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Hedgehog pathway inhibitor. Sonidegib binds to and inhibits the transmembrane protein Smoothened (SMO), which is part of the Hedgehog signal transduction pathway that is clinically relevant in diseases such as basal cell cancer.<ref name="insert">[ | + | Class/mechanism: Hedgehog pathway inhibitor. Sonidegib binds to and inhibits the transmembrane protein Smoothened (SMO), which is part of the Hedgehog signal transduction pathway that is clinically relevant in diseases such as basal cell cancer.<ref name="insert">[https://www.odomzo.com/themes/custom/odomzo/global/pdfs/pi.pdf Sonidegib (Odomzo) package insert]</ref><ref>[[:File:Sonidegib.pdf | Sonidegib (Odomzo) package insert (locally hosted backup)]]</ref> |
<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. | + | 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 | + | ==Diseases for which it is established== |
| − | *[[ | + | *[[Cutaneous basal cell carcinoma]] |
==Patient drug information== | ==Patient drug information== | ||
| Line 13: | Line 13: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2015-07-24: Initial approval for the treatment of patients with locally advanced [[Cutaneous basal cell carcinoma|basal cell carcinoma (BCC)]] that has recurred following surgery or radiation therapy. ''(Based on BOLT)'' |
| − | + | *2015-07-24: Initial approval for the treatment of patients with locally advanced [[Cutaneous basal cell carcinoma|basal cell carcinoma (BCC)]] who are not candidates for surgery or radiation therapy. ''(Based on BOLT)'' | |
| + | ==History of changes in EMA indication== | ||
| + | *2015-08-14: Initial authorization | ||
| + | *Uncertain date: Odomzo is indicated for the treatment of adult patients with locally advanced [[Cutaneous basal cell carcinoma|basal cell carcinoma (BCC)]] who are not amenable to curative surgery or radiation therapy. | ||
==Also known as== | ==Also known as== | ||
| − | *'''Code name:''' | + | *'''Code name:''' LDE-225 |
*'''Generic name:''' erismodegib | *'''Generic name:''' erismodegib | ||
*'''Brand name:''' Odomzo | *'''Brand name:''' Odomzo | ||
| Line 23: | Line 26: | ||
<references/> | <references/> | ||
| − | [[Category: | + | [[Category:Drugs]] |
[[Category:Oral medications]] | [[Category:Oral medications]] | ||
| Line 29: | Line 32: | ||
[[Category:SMO inhibitors]] | [[Category:SMO inhibitors]] | ||
| − | [[Category: | + | [[Category:Cutaneous basal cell carcinoma medications]] |
| − | [[Category: | + | [[Category:EMA approved in 2015]] |
| + | [[Category:FDA approved in 2015]] | ||
Latest revision as of 23:29, 17 August 2023
General information
Class/mechanism: Hedgehog pathway inhibitor. Sonidegib binds to and inhibits the transmembrane protein Smoothened (SMO), which is part of the Hedgehog signal transduction pathway that is clinically relevant in diseases such as basal cell cancer.[1][2]
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]
Diseases for which it is established
Patient drug information
History of changes in FDA indication
- 2015-07-24: Initial approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) that has recurred following surgery or radiation therapy. (Based on BOLT)
- 2015-07-24: Initial approval for the treatment of patients with locally advanced basal cell carcinoma (BCC) who are not candidates for surgery or radiation therapy. (Based on BOLT)
History of changes in EMA indication
- 2015-08-14: Initial authorization
- Uncertain date: Odomzo is indicated for the treatment of adult patients with locally advanced basal cell carcinoma (BCC) who are not amenable to curative surgery or radiation therapy.
Also known as
- Code name: LDE-225
- Generic name: erismodegib
- Brand name: Odomzo