Difference between revisions of "Methoxsalen (Uvadex)"
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==General information== | ==General information== | ||
| − | Class/mechanism: Psoralen/furocoumarin. Photoactive substance used for palliative photopheresis/extracorporeal phototherapy of cutaneous T-cell lymphoma (CTCL). Exact mechanism of action unknown, but photoactivation of methoxsalen is believed to result in its conjugation and formation of covalent bonds with DNA and possibly proteins. Additions to single strands of DNA and crosslinking of methoxsalen to two strands of DNA occur.<ref name="insert">[http://www.therakos.com/sites/default/files/pdf/us-package-insert.pdf Methoxsalen (Uvadex) package insert]</ref><ref>[ | + | Class/mechanism: Psoralen/furocoumarin. Photoactive substance used for palliative photopheresis/extracorporeal phototherapy of cutaneous T-cell lymphoma (CTCL). Exact mechanism of action unknown, but photoactivation of methoxsalen is believed to result in its conjugation and formation of covalent bonds with DNA and possibly proteins. Additions to single strands of DNA and crosslinking of methoxsalen to two strands of DNA occur.<ref name="insert">[http://www.therakos.com/sites/default/files/pdf/us-package-insert.pdf Methoxsalen (Uvadex) package insert]</ref><ref>[https://hemonc.org/docs/packageinsert/methoxsalen.pdf Methoxsalen (Uvadex) package insert (locally hosted backup)]</ref><ref>[http://www.therakos.com/healthcare-professionals Therakos manufacturer's website]</ref> |
Route: IV (other formulations of methoxsalen also available in PO & topical forms) | Route: IV (other formulations of methoxsalen also available in PO & topical forms) | ||
<br>Extravasation: no information | <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 | + | 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 or the prescribing information.<ref name="insert"></ref> |
==Diseases for which it is used== | ==Diseases for which it is used== | ||
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==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | * | + | * 1999-02-25: Initial FDA approval for extracorporeal administration with the UVAR Photopheresis System in the palliative treatment of the skin manifestations of [[cutaneous T-cell lymphoma | cutaneous T-cell lymphoma (CTCL)]] that is unresponsive to other forms of treatment. ''(Based on Edelson et al. 1987)'' |
| − | * 10 | + | * 2013-10-31: Indication revised for extracorporeal administration with the UVAR<sup>TM</sup> XTS<sup>TM</sup> or THERAKOS<sup>TM</sup> CELLEX<sup>TM</sup> Photopheresis System in the palliative treatment of the skin manifestations of [[cutaneous T-cell lymphoma | cutaneous T-cell lymphoma (CTCL)]] that is unresponsive to other forms of treatment. ''(No supporting studies are cited)'' |
| − | + | ==History of changes in EMA indication== | |
| + | *1958-03-31: EURD | ||
==Also known as== | ==Also known as== | ||
Photopheresis systems that methoxsalen is used with may be called UVAR XTS, Therakos, or Therakos Cellex. | Photopheresis systems that methoxsalen is used with may be called UVAR XTS, Therakos, or Therakos Cellex. | ||
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[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| + | [[Category:Furanocoumarins]] | ||
[[Category:Cutaneous T-cell lymphoma medications]] | [[Category:Cutaneous T-cell lymphoma medications]] | ||
[[Category:FDA approved in 1999]] | [[Category:FDA approved in 1999]] | ||
| + | [[Category:EMA approved in 1958]] | ||
Latest revision as of 00:59, 29 June 2024
General information
Class/mechanism: Psoralen/furocoumarin. Photoactive substance used for palliative photopheresis/extracorporeal phototherapy of cutaneous T-cell lymphoma (CTCL). Exact mechanism of action unknown, but photoactivation of methoxsalen is believed to result in its conjugation and formation of covalent bonds with DNA and possibly proteins. Additions to single strands of DNA and crosslinking of methoxsalen to two strands of DNA occur.[1][2][3]
Route: IV (other formulations of methoxsalen also available in PO & topical forms)
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 or the prescribing information.[1]
Diseases for which it is used
Patient drug information
- Patient information about Therakos photopheresis[4]
- Methoxsalen (Uvadex) patient drug information (UpToDate)[5]
History of changes in FDA indication
- 1999-02-25: Initial FDA approval for extracorporeal administration with the UVAR Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. (Based on Edelson et al. 1987)
- 2013-10-31: Indication revised for extracorporeal administration with the UVARTM XTSTM or THERAKOSTM CELLEXTM Photopheresis System in the palliative treatment of the skin manifestations of cutaneous T-cell lymphoma (CTCL) that is unresponsive to other forms of treatment. (No supporting studies are cited)
History of changes in EMA indication
- 1958-03-31: EURD
Also known as
Photopheresis systems that methoxsalen is used with may be called UVAR XTS, Therakos, or Therakos Cellex.
- Generic names: 8-MOP, methoxypsoralen
- Brand names: Ammoidin, Oxsoralen, Oxsoralen-Ultra, Uvadex, Xanthotoxin, Deltasoralen, Dermox, Geralen, Geroxalen, Meladinina, Meladinine, Metoxaleno, Mopsoralen, Puvasoralen, Ultramop