Difference between revisions of "Etranacogene dezaparvovec (Hemgenix)"
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| + | ==General information== | ||
| + | Class/mechanism: adeno-associated virus vector-based gene therapy (adeno-associated virus serotype 5; AAV5) which delivers a gene encoding the Padua variant of human coagulation factor IX (hFIX-Padua) and results in the recipient producing circulating Factor IX.<ref name="insert">[https://labeling.cslbehring.com/PI/US/Hemgenix/EN/Hemgenix-Prescribing-Information.pdf Etranacogene dezaparvovec (Hemgenix) package insert]</ref><ref>[[:File:Etranacogenedezaparvovec.pdf | Etranacogene dezaparvovec (Hemgenix) package insert (locally hosted backup)]]</ref><ref>[https://www.hemgenix.com/ Hemgenix manufacturer's website]</ref> | ||
| + | <br>Route: IV | ||
| + | <br>Extravasation: no information | ||
| + | |||
| + | 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://reference.medscape.com/drug/zytiga-abiraterone-999651 Medscape], [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 used== | ||
| + | *Hemophilia B | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[https://labeling.cslbehring.com/PI/US/Hemgenix/EN/Hemgenix-Prescribing-Information.pdf Etranacogene dezaparvovec (Hemgenix) package insert]<ref name="insert"></ref> | ||
| + | *[https://www.uptodate.com/contents/etranacogene-dezaparvovec-patient-drug-information Etranacogene dezaparvovec (Hemgenix) patient drug information (UpToDate)]<ref>[https://www.uptodate.com/contents/etranacogene-dezaparvovec-patient-drug-information Etranacogene dezaparvovec (Hemgenix) patient drug information (UpToDate)]</ref> | ||
| + | |||
| + | ==History of changes in FDA indication== | ||
| + | *11/22/2022: [https://www.fda.gov/news-events/press-announcements/fda-approves-first-gene-therapy-treat-adults-hemophilia-b FDA approved] "for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use [[:Category:Coagulation factors|Factor IX]] prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes." | ||
| + | |||
==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2/20/2023: Granted conditional authorisation for the treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors. | *2/20/2023: Granted conditional authorisation for the treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors. | ||
| + | |||
| + | ==Also known as== | ||
| + | *'''Generic name:''' etranacogene dezaparvovec-drlb | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| + | [[Category:Intravenous medications]] | ||
[[Category:Stub]] | [[Category:Stub]] | ||
| + | [[Category:Inherited coagulopathy medications]] | ||
| + | [[Category:Coagulation factors]] | ||
[[Category:EMA approved in 2023]] | [[Category:EMA approved in 2023]] | ||
| + | [[Category:FDA approved in 2022]] | ||
| + | [[Category:Hematology medications]] | ||
Revision as of 03:13, 30 March 2023
General information
Class/mechanism: adeno-associated virus vector-based gene therapy (adeno-associated virus serotype 5; AAV5) which delivers a gene encoding the Padua variant of human coagulation factor IX (hFIX-Padua) and results in the recipient producing circulating Factor IX.[1][2][3]
Route: IV
Extravasation: no information
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, Medscape, UpToDate (courtesy of Lexicomp), or the prescribing information.[1]
Diseases for which it is used
- Hemophilia B
Patient drug information
- Etranacogene dezaparvovec (Hemgenix) package insert[1]
- Etranacogene dezaparvovec (Hemgenix) patient drug information (UpToDate)[4]
History of changes in FDA indication
- 11/22/2022: FDA approved "for the treatment of adults with Hemophilia B (congenital Factor IX deficiency) who currently use Factor IX prophylaxis therapy, or have current or historical life-threatening hemorrhage, or have repeated, serious spontaneous bleeding episodes."
History of changes in EMA indication
- 2/20/2023: Granted conditional authorisation for the treatment of severe and moderately severe Haemophilia B (congenital Factor IX deficiency) in adult patients without a history of Factor IX inhibitors.
Also known as
- Generic name: etranacogene dezaparvovec-drlb