Difference between revisions of "Carmustine wafer, polifeprosan 20 (Gliadel wafer)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Biodegradable copolymer matrix (polifeprosan 20) embedded with carmustine, a nitrosourea which alkylates DNA and RNA and inhibits several key enzymatic processes by carbamoylation of amino acids in proteins. | + | Class/mechanism: Biodegradable copolymer matrix (polifeprosan 20) embedded with carmustine, a nitrosourea which alkylates DNA and RNA and inhibits several key enzymatic processes by carbamoylation of amino acids in proteins. Each Gliadel wafer is 1.45 cm in diameter and 1 mm thick and contains 192.3 mg copolymer and 7.7 mg carmustine. Exposure to the surgical resection cavity results in hydrolyzation of anhydride bonds of the copolymer, which releases carmustine.<ref name="insert">[https://gliadel.com/hcp/media/_pdfs/prescribing-information-gliadel.pdf Carmustine wafer, polifeprosan 20 (Gliadel) package insert]</ref><ref>[[:File:Carmustinewafer.pdf | Carmustine wafer, polifeprosan 20 (Gliadel) package insert (locally hosted backup)]]</ref><ref>[http://www.gliadel.com/ Gliadel manufacturer's website]</ref> |
<br>Route: implanted wafer | <br>Route: implanted wafer | ||
<br>Extravasation: n/a | <br>Extravasation: n/a | ||
| Line 12: | Line 12: | ||
==Patient drug information== | ==Patient drug information== | ||
*[https://gliadel.com/hcp/media/_pdfs/prescribing-information-gliadel.pdf Carmustine wafer, polifeprosan 20 (Gliadel) package insert]<ref name="insert"></ref> | *[https://gliadel.com/hcp/media/_pdfs/prescribing-information-gliadel.pdf Carmustine wafer, polifeprosan 20 (Gliadel) package insert]<ref name="insert"></ref> | ||
| − | *[ | + | *[https://chemocare.com/druginfo/carmustine-wafer.aspx Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (Chemocare)]<ref>[https://chemocare.com/druginfo/carmustine-wafer.aspx Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (Chemocare)]</ref> |
*[http://www.uptodate.com/contents/carmustine-patient-drug-information Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/carmustine-patient-drug-information Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (UpToDate)]</ref> | *[http://www.uptodate.com/contents/carmustine-patient-drug-information Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (UpToDate)]<ref>[http://www.uptodate.com/contents/carmustine-patient-drug-information Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 1996-09-23: Initial FDA approval |
| − | * | + | * 2003-02-25 (oldest label available at Drugs @ FDA): indicated for newly diagnosed [[:Category:High-grade gliomas|high-grade malignant glioma]] patients as an adjunct to surgery and radiation |
| − | * | + | * 2003-02-25 (oldest label available at Drugs @ FDA): indicated for recurrent [[glioblastoma|glioblastoma multiforme]] patients as an adjunct to surgery |
| − | + | ==History of changes in EMA indication== | |
| + | *1996-09-23: EURD | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2012-09-28: Initial approval for the treatment of [[:Category:High-grade gliomas|malignant glioma]]. | ||
==Also known as== | ==Also known as== | ||
*'''Code names:''' NPC-08, NSC-409962, WR-139021 | *'''Code names:''' NPC-08, NSC-409962, WR-139021 | ||
| Line 30: | Line 33: | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intralesional medications]] | [[Category:Intralesional medications]] | ||
| + | [[Category:Locally delivered therapies]] | ||
| + | |||
[[Category:Nitrosoureas]] | [[Category:Nitrosoureas]] | ||
[[Category:Alkylating agents]] | [[Category:Alkylating agents]] | ||
| Line 36: | Line 41: | ||
[[Category:FDA approved in 1996]] | [[Category:FDA approved in 1996]] | ||
| + | [[Category:EMA approved in 1996]] | ||
| + | [[Category:PMDA approved in 2012]] | ||
Latest revision as of 17:31, 26 November 2023
General information
Class/mechanism: Biodegradable copolymer matrix (polifeprosan 20) embedded with carmustine, a nitrosourea which alkylates DNA and RNA and inhibits several key enzymatic processes by carbamoylation of amino acids in proteins. Each Gliadel wafer is 1.45 cm in diameter and 1 mm thick and contains 192.3 mg copolymer and 7.7 mg carmustine. Exposure to the surgical resection cavity results in hydrolyzation of anhydride bonds of the copolymer, which releases carmustine.[1][2][3]
Route: implanted wafer
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 used
Patient drug information
- Carmustine wafer, polifeprosan 20 (Gliadel) package insert[1]
- Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (Chemocare)[4]
- Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 1996-09-23: Initial FDA approval
- 2003-02-25 (oldest label available at Drugs @ FDA): indicated for newly diagnosed high-grade malignant glioma patients as an adjunct to surgery and radiation
- 2003-02-25 (oldest label available at Drugs @ FDA): indicated for recurrent glioblastoma multiforme patients as an adjunct to surgery
History of changes in EMA indication
- 1996-09-23: EURD
History of changes in PMDA indication
- 2012-09-28: Initial approval for the treatment of malignant glioma.
Also known as
- Code names: NPC-08, NSC-409962, WR-139021
- Generic name: polifeprosan 20 with carmustine implant
- Brand names: Biodel, Gliadel wafer
References
- ↑ 1.0 1.1 1.2 Carmustine wafer, polifeprosan 20 (Gliadel) package insert
- ↑ Carmustine wafer, polifeprosan 20 (Gliadel) package insert (locally hosted backup)
- ↑ Gliadel manufacturer's website
- ↑ Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (Chemocare)
- ↑ Carmustine wafer, polifeprosan 20 (Gliadel) patient drug information (UpToDate)