Difference between revisions of "Caplacizumab (Cablivi)"

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=Mechanism of action=
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==Mechanism of action==
 
A [https://en.wikipedia.org/wiki/Single-domain_antibody single domain antibody] directed against the A1 domain of von Willebrand factor (vWF).
 
A [https://en.wikipedia.org/wiki/Single-domain_antibody single domain antibody] directed against the A1 domain of von Willebrand factor (vWF).
  
=Preliminary data=
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==Diseases for which it is used==
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*[[Acquired thrombotic thrombocytopenic purpura]]
  
==[[Thrombotic thrombocytopenic purpura]]==
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==History of changes in FDA indication==
# Peyvandi F, Scully M, Kremer Hovinga JA, Cataland S, Knöbl P, Wu H, Artoni A, Westwood JP, Mansouri Taleghani M, Jilma B, Callewaert F, Ulrichts H, Duby C, Tersago D; TITAN Investigators. Caplacizumab for Acquired Thrombotic Thrombocytopenic Purpura. N Engl J Med. 2016 Feb 11;374(6):511-522. [https://www.nejm.org/doi/full/10.1056/NEJMoa1505533 link to original article] [https://www.ncbi.nlm.nih.gov/pubmed/26863353 PubMed]
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* 2019-02-06: Initial approval for adult patients with [[Acquired thrombotic thrombocytopenic purpura|acquired thrombotic thrombocytopenic purpura (aTTP)]], in combination with plasma exchange and immunosuppressive therapy.
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==History of changes in EMA indication==
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*2018-08-30: Initial authorization
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==History of changes in PMDA indication==
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*2022-09-26: A drug with a new active ingredient indicated for the treatment of [[Acquired thrombotic thrombocytopenic purpura|acquired thrombotic thrombocytopenic purpura]].
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== Patient Drug Information==
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*[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>
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==Also known as==
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*'''Code name:''' ALX-0081
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*'''Generic name:''' caplacizumab-yhdp
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*'''Brand name:''' Cablivi
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==References==
  
 
[[Category:Drugs]]
 
[[Category:Drugs]]
[[Category:Antibody medications]]
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[[Category:Intravenous medications]]
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[[Category:Subcutaneous medications]]
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[[Category:Anti-vWF medications]]
 
[[Category:Anti-vWF medications]]
  
 
[[Category:Hematology medications]]
 
[[Category:Hematology medications]]
[[Category:Thrombotic thrombocytopenic purpura medications]]
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[[Category:Acquired thrombotic thrombocytopenic purpura medications]]
  
[[Category:Investigational drugs]]
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[[Category:EMA approved in 2019]]
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[[Category:FDA approved in 2019]]

Latest revision as of 13:21, 7 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

History of changes in EMA indication

  • 2018-08-30: Initial authorization

History of changes in PMDA indication

Patient Drug Information

Also known as

  • Code name: ALX-0081
  • Generic name: caplacizumab-yhdp
  • Brand name: Cablivi

References