Difference between revisions of "Vismodegib (Erivedge)"
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Warner-admin (talk | contribs) m (Text replacement - "Basal cell carcinoma (BCC)" to "Cutaneous basal cell carcinoma") |
Warner-admin (talk | contribs) m (Text replacement - "[http://www.utdol.com/online/content/search.do UpToDate (courtesy of Lexicomp)], or" to "or") |
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==General information== | ==General information== | ||
| − | Class/mechanism: Hedgehog pathway inhibitor. Vismodegib 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. Vismodegib 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.gene.com/gene/products/information/erivedge/pdf/erivedge_prescribing.pdf Vismodegib (Erivedge) package insert]</ref><ref>[[:File:Vismodegib.pdf | Vismodegib (Erivedge) package insert (locally hosted backup)]]</ref><ref>[http://www.erivedge.com/ Erivedge manufacturer's website]</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. Instead, for the most current information, please refer to your preferred pharmacopeias such as | + | 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.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Cutaneous basal cell carcinoma]] | *[[Cutaneous basal cell carcinoma]] | ||
| − | *[[SMO or PTCH-1 (Hedgehog)|Hedgehog pathway-mutated tumors (tissue-agnostic)]] | + | *[[Malignant solid neoplasm, SMO-mutated or PTCH-1-mutated (Hedgehog)|Hedgehog pathway-mutated tumors (tissue-agnostic)]] |
==Patient drug information== | ==Patient drug information== | ||
| Line 15: | Line 15: | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | *2012-01-30: Initial FDA approval for the treatment of adults with metastatic [[Cutaneous basal cell carcinoma|basal cell carcinoma]]. ''(Based on ERIVANCE BCC)'' |
| + | *2012-01-30: Initial FDA approval for the treatment of adults with locally advanced [[Cutaneous basal cell carcinoma|basal cell carcinoma]] that has recurred following surgery. ''(Based on ERIVANCE BCC)'' | ||
| + | *2012-01-30: Initial FDA approval for the treatment of adults with locally advanced [[Cutaneous basal cell carcinoma|basal cell carcinoma]] who are not candidates for surgery, and who are not candidates for radiation. ''(Based on ERIVANCE BCC)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2013-04-26: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2013-07-12: Initial notice of compliance | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' GDC-0449 | *'''Code name:''' GDC-0449 | ||
| Line 31: | Line 37: | ||
[[Category:Cutaneous basal cell carcinoma medications]] | [[Category:Cutaneous basal cell carcinoma medications]] | ||
| − | [[Category:SMO or PTCH-1 (Hedgehog) medications]] | + | [[Category:Malignant solid neoplasm, SMO-mutated or PTCH-1-mutated (Hedgehog) medications]] |
[[Category:FDA approved in 2012]] | [[Category:FDA approved in 2012]] | ||
| + | [[Category:EMA approved in 2013]] | ||
| + | [[Category:Health Canada approved in 2013]] | ||
Latest revision as of 00:08, 6 July 2024
General information
Class/mechanism: Hedgehog pathway inhibitor. Vismodegib 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][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, or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Erivedge manufacturer side effect tips[4]
- Vismodegib (Erivedge) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 2012-01-30: Initial FDA approval for the treatment of adults with metastatic basal cell carcinoma. (Based on ERIVANCE BCC)
- 2012-01-30: Initial FDA approval for the treatment of adults with locally advanced basal cell carcinoma that has recurred following surgery. (Based on ERIVANCE BCC)
- 2012-01-30: Initial FDA approval for the treatment of adults with locally advanced basal cell carcinoma who are not candidates for surgery, and who are not candidates for radiation. (Based on ERIVANCE BCC)
History of changes in EMA indication
- 2013-04-26: Initial authorization
History of changes in Health Canada indication
- 2013-07-12: Initial notice of compliance
Also known as
- Code name: GDC-0449
- Brand name: Erivedge