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Caplacizumab

Chemical compound

Chemical compound

FieldValue
typemab
mab_typesdAb
sourcezu
targetvon Willebrand factor (VWF)
tradenameCablivi
Drugs.com
MedlinePlusa619030
DailyMedIDCaplacizumab
pregnancy_AUB1
routes_of_administrationIntravenous, subcutaneous
ATC_prefixB01
ATC_suffixAX07
legal_AUS4
legal_BR
legal_CARx-only
legal_CA_comment/ Schedule D
legal_DE
legal_NZ
legal_UKPOM
legal_UK_comment
legal_USRx-only
legal_US_comment
legal_EURx-only
legal_EU_comment
legal_UN
legal_status
CAS_number915810-67-2
DrugBankDB06081
ChemSpiderIDnone
UNII2R27AB6766
KEGGD11160
synonymsALX-0081, caplacizumab-yhdp
C1213H=1891N=357O=380S=10

| Drugs.com =

Caplacizumab, sold under the brand name Cablivi, is a monoclonal antibody used for the treatment of thrombotic thrombocytopenic purpura. It is a von Willebrand factor-directed antibody fragment. It is given via intravenous injection followed by subcutaneous injection. Caplacizumab was developed by Ablynx NV.

Caplacizumab was authorized for medical use in the European Union in August 2018, and approved for medical use in the United States in February 2019. The US Food and Drug Administration considers it to be a first-in-class medication.

Medical uses

Caplacizumab is indicated for the treatment of acquired thrombotic thrombocytopenic purpura, in combination with plasma exchange and immunosuppressive therapy.

Side effects

Common adverse effects include injection site reactions, reported in 3–6% of patients in the HERCULES and TITAN trials.

Society and culture

Caplacizumab was authorized for medical use in the European Union in August 2018, and approved for medical use in the United States in February 2019.

Economics

The cost-effectiveness has been questioned.

Names

Caplacizumab is the international nonproprietary name and the United States Adopted Name.

Research

Use of caplacizumab without plasmapheresis has been reported. The MAYARI study was designed to evaluate the effectiveness of this option.

References

References

  1. (25 April 2012). "Cablivi Product information".
  2. (23 October 2014). "Summary Basis of Decision (SBD) for Cablivi".
  3. (22 June 2020). "Cablivi 10 mg powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)".
  4. (4 November 2024). "Cablivi- caplacizumab kit".
  5. (November 2020). "A critical evaluation of caplacizumab for the treatment of acquired thrombotic thrombocytopenic purpura". Expert Review of Hematology.
  6. (June 2019). "Caplacizumab to treat immune-mediated thrombotic thrombocytopenic purpura". Drugs of Today.
  7. (10 September 2018). "Cablivi EPAR".
  8. (6 February 2019). "FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder".
  9. (11 February 2019). "Drug Trials Snapshots: Cablivi".
  10. (31 December 2019). "New Drug Therapy Approvals 2019".
  11. (5 January 2026). "FDA approves therapy for rare blood disorder in pediatric patients 12 years and older".
  12. {{Drugs.com. pro. cablivi
  13. (February 2021). "Cost effectiveness of caplacizumab in acquired thrombotic thrombocytopenic purpura". Blood.
  14. [[World Health Organization]] (WHO). (2011). "International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 106". WHO Drug Information.
  15. "Statement On A Nonproprietary Name Adopted By The USAN Council - Caplacizumab". [[American Medical Association]].
  16. (November 2020). "Treatment of acquired thrombotic thrombocytopenic purpura without plasma exchange in selected patients under caplacizumab". J Thromb Haemost.
  17. {{ClinicalTrialsGov. NCT05468320. Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (MAYARI)
Info: Wikipedia Source

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