Difference between revisions of "Voxelotor (Oxbryta)"
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(Created page with "==Mechanism of action== hemoglobin S polymerization inhibitor ==Diseases for which it is used== *Sickle cell anemia ==History of changes in FDA indication== *11/25/2019:...") |
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| − | == | + | ==General information== |
| − | hemoglobin S polymerization inhibitor | + | Class/mechanism: hemoglobin S (HbS) polymerization inhibitor. Voxelotor inhibits hemoglobin S polymerization and red blood cell sickling by increasing the affinity of hemoglobin for oxygen.<ref name="insert">[https://www.oxbryta.com/pdf/prescribing-information.pdf Voxelotor (Oxbryta) package insert]</ref><ref>[[:File:Voxelotor.pdf | Voxelotor (Oxbryta) package insert (locally hosted backup)]]</ref><ref>[https://www.oxbryta.com/ Oxbryta manufacturer's website]</ref> |
| + | <br>Route: PO | ||
| + | <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 Micromedex, UpToDate Lexidrug, Medscape, or the prescribing information.<ref name="insert"></ref> | ||
==Diseases for which it is used== | ==Diseases for which it is used== | ||
*[[Sickle cell anemia]] | *[[Sickle cell anemia]] | ||
| + | |||
| + | ==Patient drug information== | ||
| + | *[https://www.oxbryta.com/pdf/prescribing-information.pdf Voxelotor (Oxbryta) package insert]<ref name="insert"></ref> | ||
| + | *[https://www.uptodate.com/contents/voxelotor-patient-drug-information Voxelotor (Oxbryta) patient drug information (UpToDate)]<ref>[https://www.uptodate.com/contents/voxelotor-patient-drug-information Voxelotor (Oxbryta) patient drug information (UpToDate)]</ref> | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *11 | + | *2019-11-25: Granted [https://www.fda.gov/news-events/press-announcements/fda-approves-novel-treatment-target-abnormality-sickle-cell-disease FDA accelerated approval] "for the treatment of [[Sickle cell anemia|sickle cell disease (SCD)]] in adults and pediatric patients 12 years of age and older." in adults and pediatric patients 12 years of age and older. |
| + | *2021-12-17: Granted [https://www.fda.gov/drugs/news-events-human-drugs/fda-approves-drug-treat-sickle-cell-disease-patients-aged-4-11-years FDA accelerated approval] "to treat sickle cell disease in pediatric patients aged four up to 11 years" in addition to previous accelerated approval for Oxbryta for patients aged 12 years and older with sickle cell disease. | ||
| + | |||
| + | ==History of changes in EMA indication== | ||
| + | *2022-02-14: Initial EMA authorization | ||
| + | |||
| + | ==Also known as== | ||
| + | *'''Code names:''' GBT-440, GTx-011 | ||
| + | *'''Brand name:''' Oxbryta | ||
| + | |||
| + | ==References== | ||
| + | <references/> | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
| + | [[Category:Oral medications]] | ||
| + | [[Category:Hemoglobin S polymerization inhibitors]] | ||
| + | |||
[[Category:Sickle cell anemia medications]] | [[Category:Sickle cell anemia medications]] | ||
| + | [[Category:EMA approved in 2022]] | ||
[[Category:FDA approved in 2019]] | [[Category:FDA approved in 2019]] | ||
| − | |||
Latest revision as of 21:33, 19 July 2024
General information
Class/mechanism: hemoglobin S (HbS) polymerization inhibitor. Voxelotor inhibits hemoglobin S polymerization and red blood cell sickling by increasing the affinity of hemoglobin for oxygen.[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, UpToDate Lexidrug, Medscape, or the prescribing information.[1]
Diseases for which it is used
Patient drug information
History of changes in FDA indication
- 2019-11-25: Granted FDA accelerated approval "for the treatment of sickle cell disease (SCD) in adults and pediatric patients 12 years of age and older." in adults and pediatric patients 12 years of age and older.
- 2021-12-17: Granted FDA accelerated approval "to treat sickle cell disease in pediatric patients aged four up to 11 years" in addition to previous accelerated approval for Oxbryta for patients aged 12 years and older with sickle cell disease.
History of changes in EMA indication
- 2022-02-14: Initial EMA authorization
Also known as
- Code names: GBT-440, GTx-011
- Brand name: Oxbryta