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Cablivi FDA Approval History

Last updated by Judith Stewart, BPharm on Feb 24, 2019.

FDA Approved: Yes (First approved February 6, 2019)
Brand name: Cablivi
Generic name: caplacizumab-yhdp
Dosage form: Injection
Company: Ablynx NV
Treatment for: Acquired Thrombotic Thrombocytopenic Purpura

Cablivi (caplacizumab-yhdp) is a von Willebrand factor (vWF)-directed antibody fragment indicated for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP), in combination with plasma exchange and immunosuppressive therapy.

Administration of Cablivi

  • The first dose of Cablivi is injected via intravenous injection by a healthcare provider at least 15 minutes before the first plasma exchange.
  • Treatment is continued with a subcutaneous injection after daily plasma exchange and for 30 days after daily plasma exchange is stopped.

Important Safety Information

  • Contraindications Cablivi should not be used in patients who have had a previous severe hypersensitivity reaction to caplacizumab-yhdp or any of the other ingredients. Hypersensitivity reactions have included urticaria.
  • Warnings and Precautions Cablivi increases the risk of bleeding.
    • The risk of bleeding is increased in patients who have a bleeding disorder, and in patients who take other medicines that increase the risk of bleeding, such as anticoagulants. Patients should be advised that bruising and bleeding may occur more easily, that nose bleeds and bleeding of gums may occur, and that it may take them longer than usual to stop bleeding. Patients should contact their healthcare provider immediately if excessive bleeding or bruising occurs.
    • Patients should inform their healthcare provider before scheduling any elective surgery, dental procedure or other invasive interventions. Cablivi should be withheld for 7 days prior to these procedures. If emergency surgery is needed, the use of von Willebrand factor concentrate may be considered to correct hemostasis.
  • Adverse Reactions The most common adverse reactions (incidence >15%) were epistaxis, headache, and gingival bleeding.

Development timeline for Cablivi

Feb  6, 2019Approval FDA Approves Cablivi (caplacizumab-yhdp) for Acquired Thrombotic Thrombocytopenic Purpura (aTTP) in Adults
Jan 15, 2019New England Journal of Medicine Publishes Positive Results of the Pivotal Trial of Cablivi (caplacizumab) for Rare Blood Clotting Disorder

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.