Caplacizumab

Caplacizumab
Monoclonal antibody
TypeSingle domain antibody
SourceHumanized
Targetvon Willebrand factor (VWF)
Names
Trade namesCablivi
Other namesALX-0081, caplacizumab-yhdp
Clinical data
Main usesThrombotic thrombocytopenic purpura (TTP)[1]
Side effectsNosebleeding, headaches, bleeding gums[2]
WHO AWaReUnlinkedWikibase error: ⧼unlinkedwikibase-error-statements-entity-not-set⧽
Pregnancy
category
  • AU: B1
  • US: N (Not classified yet)
    Routes of
    use    		Intravenous, subcutaneous
    External links
    AHFS/Drugs.comMonograph
    MedlinePlusa619030
    Legal
    License data
    Legal status
    • AU: S4 (Prescription only)
    • UK: POM (Prescription only) [3]
    • US: ℞-only
    • EU: Rx-only
    Chemical and physical data
    FormulaC1213H1891N357O380S10
    Molar mass27876.19 g·mol−1

    Caplacizumab, sold under the brand name Cablivi, is a medication used to treat thrombotic thrombocytopenic purpura (TTP).[1] It is used with plasma exchange and immunosuppressive therapy.[1] It is given by injection into a vein or under the skin.[2]

    Common side effects include nosebleeding, headaches, and bleeding gums.[2] Use in pregnancy may increase the risk of bleeding in the baby.[1] It is a small antibody that attaches to and inactivates von Willebrand factor.[2]

    Caplacizumab was approved for medical use in Europe in 2018 and the United States in 2019.[2][1] In the United Kingdom a month of treatment costs about £125,000 as of 2021.[4] This amount in the United States costs about 230,000 USD.[5]

    Medical uses

    Dosage

    It is given at a dose of 10 mg into a vein followed by 10 mg under the skin for at least 30 days.[2]

    Mechanism of action

    It is an anti-von Willebrand factor humanized immunoglobulin.[6] It acts by blocking platelet aggregation to reduce organ injury due to ischemia.[6]

    Chemistry

    It is a bivalent single-domain antibody (VHH).

    History

    The U.S. Food and Drug Administration (FDA) considers it to be a first-in-class medication.[7]

    References

    1. 1 2 3 4 5 "Caplacizumab-yhdp Monograph for Professionals". Drugs.com. Retrieved 29 December 2021.
    2. 1 2 3 4 5 6 "Cablivi EPAR". European Medicines Agency (EMA). Archived from the original on 7 June 2020. Retrieved 7 September 2020.
    3. ↑ "Cablivi 10 mg powder and solvent for solution for injection - Summary of Product Characteristics (SmPC)". (emc). 22 June 2020. Archived from the original on 12 August 2021. Retrieved 22 August 2020.
    4. ↑ BNF 81: March-September 2021. BMJ Group and the Pharmaceutical Press. 2021. p. 1081. ISBN 978-0857114105.
    5. ↑ "Cablivi Prices, Coupons & Patient Assistance Programs". Drugs.com. Retrieved 29 December 2021.
    6. 1 2 "Immune Drug Tackles Microvascular Thrombosis Disorder. February 2016". Archived from the original on 16 January 2021. Retrieved 3 July 2021.
    7. ↑ "New Drug Therapy Approvals 2019". U.S. Food and Drug Administration. 31 December 2019. Archived from the original on 16 September 2020. Retrieved 15 September 2020.
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