Difference between revisions of "Caplacizumab (Cablivi)"
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==History of changes in EMA indication== | ==History of changes in EMA indication== | ||
*2018-08-30: Initial authorization | *2018-08-30: Initial authorization | ||
| − | + | ==History of changes in PMDA indication== | |
| + | *2022-09-26: A drug with a new active ingredient indicated for the treatment of [[Thrombotic thrombocytopenic purpura|acquired thrombotic thrombocytopenic purpura]]. | ||
== Patient Drug Information== | == Patient Drug Information== | ||
*[https://products.sanofi.us/Cablivi/Cablivi.pdf Caplacizumab (Cablivi) Package Insert]<ref>[https://products.sanofi.us/Cablivi/Cablivi.pdf Caplacizumab (Cablivi) Package Insert]</ref><ref>[[:File:Cablivi.pdf | Caplacizumab (Cablivi) package insert (locally hosted backup)]]</ref> | *[https://products.sanofi.us/Cablivi/Cablivi.pdf Caplacizumab (Cablivi) Package Insert]<ref>[https://products.sanofi.us/Cablivi/Cablivi.pdf Caplacizumab (Cablivi) Package Insert]</ref><ref>[[:File:Cablivi.pdf | Caplacizumab (Cablivi) package insert (locally hosted backup)]]</ref> | ||
Revision as of 16:33, 6 June 2023
Mechanism of action
A single domain antibody directed against the A1 domain of von Willebrand factor (vWF).
Diseases for which it is used
History of changes in FDA indication
- 2019-02-06: Initial approval for adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.
History of changes in EMA indication
- 2018-08-30: Initial authorization
History of changes in PMDA indication
- 2022-09-26: A drug with a new active ingredient indicated for the treatment of acquired thrombotic thrombocytopenic purpura.
Patient Drug Information
Also known as
- Code name: ALX-0081
- Generic name: caplacizumab-yhdp
- Brand name: Cablivi