Difference between revisions of "Glasdegib (Daurismo)"
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<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 | + | 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. |
| − | ==Diseases for which it is | + | ==Diseases for which it is established== |
*[[Acute myeloid leukemia]] | *[[Acute myeloid leukemia]] | ||
==History of changes in FDA indication== | ==History of changes in FDA indication== | ||
| − | *11 | + | *2018-11-21: Initial FDA approval for use in combination with low-dose [[Cytarabine (Ara-C)|cytarabine]] (LDAC), for newly-diagnosed [[Acute myeloid leukemia|acute myeloid leukemia (AML)]] in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy. ''(Based on BRIGHT AML 1003)'' |
| + | ==History of changes in EMA indication== | ||
| + | *2020-06-26: Initial authorization | ||
| + | *Uncertain date: Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary [[Acute myeloid leukemia|acute myeloid leukaemia (AML)]] in adult patients who are not candidates for standard induction chemotherapy. | ||
| + | |||
| + | == Patient Drug Information== | ||
| + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210656s000lbl.pdf Glasdegib (Daurismo) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2018/210656s000lbl.pdf Glasdegib (Daurismo) Package Insert]</ref> | ||
==Also known as== | ==Also known as== | ||
*'''Code name:''' PF-04449913 | *'''Code name:''' PF-04449913 | ||
*'''Brand name:''' Daurismo | *'''Brand name:''' Daurismo | ||
| + | |||
| + | ==References== | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
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[[Category:FDA approved in 2018]] | [[Category:FDA approved in 2018]] | ||
| + | [[Category:EMA approved in 2020]] | ||
Latest revision as of 01:05, 29 June 2024
General information
Class/mechanism from the NCI Drug Dictionary: An orally bioavailable small-molecule inhibitor of the Hedgehog (Hh) signaling pathway with potential antineoplastic activity. Glasdegib appears to inhibit Hh pathway signaling.
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 or the prescribing information.
Diseases for which it is established
History of changes in FDA indication
- 2018-11-21: Initial FDA approval for use in combination with low-dose cytarabine (LDAC), for newly-diagnosed acute myeloid leukemia (AML) in patients who are 75 years old or older or who have comorbidities that preclude intensive induction chemotherapy. (Based on BRIGHT AML 1003)
History of changes in EMA indication
- 2020-06-26: Initial authorization
- Uncertain date: Daurismo is indicated, in combination with low-dose cytarabine, for the treatment of newly diagnosed de novo or secondary acute myeloid leukaemia (AML) in adult patients who are not candidates for standard induction chemotherapy.
Patient Drug Information
Also known as
- Code name: PF-04449913
- Brand name: Daurismo