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Caplacizumab

Caplacizumab, sold under the brand name Cablivi, is a monoclonal antibody used for the treatment of thrombotic thrombocytopenic purpura.[4][5][6] It is a von Willebrand factor-directed antibody fragment.[4] It is given via intravenous injection followed by subcutaneous injection.[4] Caplacizumab was developed by Ablynx NV.

Caplacizumab was authorized for medical use in the European Union in August 2018,[7] and approved for medical use in the United States in February 2019.[8][9] The US Food and Drug Administration considers it to be a first-in-class medication.[10]

Medical uses

Caplacizumab is indicated for the treatment of acquired thrombotic thrombocytopenic purpura, in combination with plasma exchange and immunosuppressive therapy.[4][7][11]

Side effects

Common adverse effects include injection site reactions, reported in 3–6% of patients in the HERCULES and TITAN trials.[12]

Society and culture

Legal status

Caplacizumab was authorized for medical use in the European Union in August 2018,[7] and approved for medical use in the United States in February 2019.[8][11]

Economics

The cost-effectiveness has been questioned.[13]

Names

Caplacizumab is the international nonproprietary name[14] and the United States Adopted Name.[15]

Research

Use of caplacizumab without plasmapheresis has been reported.[16] The MAYARI study was designed to evaluate the effectiveness of this option.[17]

External links

References

  1. Cablivi Product information Health Canada, 25 April 2012, retrieved 29 May 2022^
  2. Summary Basis of Decision (SBD) for Cablivi Health Canada, 23 October 2014, retrieved 29 May 2022^
  3. Cablivi 10 mg powder and solvent for solution for injection - Summary of Product Characteristics (SmPC) (emc), 22 June 2020, retrieved 22 August 2020^
  4. Cablivi- caplacizumab kit DailyMed, 4 November 2024, retrieved 9 January 2026^
  5. A critical evaluation of caplacizumab for the treatment of acquired thrombotic thrombocytopenic purpura Expert Review of Hematology, November 2020^
  6. Caplacizumab to treat immune-mediated thrombotic thrombocytopenic purpura Drugs of Today, June 2019^
  7. Cablivi EPAR European Medicines Agency (EMA), 10 September 2018, retrieved 7 September 2020^
  8. FDA approves first therapy for the treatment of adult patients with a rare blood clotting disorder U.S. Food and Drug Administration (FDA), 6 February 2019, retrieved 22 November 2019^
  9. Drug Trials Snapshots: Cablivi U.S. Food and Drug Administration (FDA), 11 February 2019, retrieved 22 November 2019^
  10. New Drug Therapy Approvals 2019 U.S. Food and Drug Administration, 31 December 2019, retrieved 15 September 2020^
  11. FDA approves therapy for rare blood disorder in pediatric patients 12 years and older U.S. Food and Drug Administration (FDA), 5 January 2026, retrieved 9 January 2026^
  12. {{Drugs.com|pro|cablivi}}^
  13. Cost effectiveness of caplacizumab in acquired thrombotic thrombocytopenic purpura Blood, February 2021^
  14. World Health Organization (WHO). International Nonproprietary Names for Pharmaceutical Substances (INN). Proposed INN: List 106 WHO Drug Information, 2011^
  15. Statement On A Nonproprietary Name Adopted By The USAN Council - Caplacizumab American Medical Association^
  16. Treatment of acquired thrombotic thrombocytopenic purpura without plasma exchange in selected patients under caplacizumab J Thromb Haemost, November 2020^
  17. {{ClinicalTrialsGov|NCT05468320|Caplacizumab and Immunosuppressive Therapy Without Firstline Therapeutic Plasma Exchange in Adults With Immune-mediated Thrombotic Thrombocytopenic Purpura (MAYARI)}}^