Difference between revisions of "Isatuximab (Sarclisa)"
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<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. |
| − | == | + | ==Diseases for which it is used== |
| − | + | *[[Multiple myeloma]] | |
| − | + | ||
| − | + | ==History of changes in FDA indication== | |
| + | *2020-03-02: Approved in combination with pomalidomide and dexamethasone for adult patients with [[multiple myeloma]] who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. ''(Based on ICARIA-MM)'' | ||
| + | *2021-03-31: Approved in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory [[multiple myeloma]] who have received one to three prior lines of therapy. ''(Based on IKEMA)'' | ||
| + | ==History of changes in EMA indication== | ||
| + | *2020-05-30: Initial authorization | ||
| + | ==History of changes in Health Canada indication== | ||
| + | *2020-04-29: Initial notice of compliance | ||
| + | ==History of changes in PMDA indication== | ||
| + | *2020-06-29: Newly indicated for the treatment of relapsed or refractory [[multiple myeloma]]. | ||
| + | == Patient Drug Information== | ||
| + | *[https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf Isatuximab (Sarclisa) Package Insert]<ref>[https://www.accessdata.fda.gov/drugsatfda_docs/label/2020/761113s000lbl.pdf Isatuximab (Sarclisa) Package Insert]</ref> | ||
| + | |||
| + | ==Also known as== | ||
| + | *'''Code name:''' SAR-650984 | ||
| + | *'''Generic name:''' isatuximab-irfc | ||
| + | *'''Brand name:''' Sarclisa | ||
| + | |||
| + | ==References== | ||
[[Category:Drugs]] | [[Category:Drugs]] | ||
[[Category:Intravenous medications]] | [[Category:Intravenous medications]] | ||
| − | |||
[[Category:Anti-CD38 antibodies]] | [[Category:Anti-CD38 antibodies]] | ||
[[Category:Multiple myeloma medications]] | [[Category:Multiple myeloma medications]] | ||
| − | [[Category: | + | [[Category:EMA approved in 2020]] |
| + | [[Category:FDA approved in 2020]] | ||
| + | [[Category:Health Canada approved in 2020]] | ||
| + | [[Category:PMDA approved in 2020]] | ||
Latest revision as of 01:02, 29 June 2024
General information
Class/mechanism from NCI Drug Dictionary: A humanized IgG1 monoclonal antibody directed against the cell surface glycoprotein CD-38 with potential antineoplastic activity. Isatuximab specifically binds to CD38 on CD38-positive tumor cells.
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 or the prescribing information.
Diseases for which it is used
History of changes in FDA indication
- 2020-03-02: Approved in combination with pomalidomide and dexamethasone for adult patients with multiple myeloma who have received at least two prior therapies including lenalidomide and a proteasome inhibitor. (Based on ICARIA-MM)
- 2021-03-31: Approved in combination with carfilzomib and dexamethasone, for the treatment of adult patients with relapsed or refractory multiple myeloma who have received one to three prior lines of therapy. (Based on IKEMA)
History of changes in EMA indication
- 2020-05-30: Initial authorization
History of changes in Health Canada indication
- 2020-04-29: Initial notice of compliance
History of changes in PMDA indication
- 2020-06-29: Newly indicated for the treatment of relapsed or refractory multiple myeloma.
Patient Drug Information
Also known as
- Code name: SAR-650984
- Generic name: isatuximab-irfc
- Brand name: Sarclisa