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What is Cablivi (caplacizumab)?

Cablivi (caplacizumab) is the first medicine approved for the treatment of adult patients with acquired thrombotic thrombocytopenic purpura (aTTP)^[1,2]. It is available in powder form or solution for injection, to be used in combination with plasma exchange and immunosuppressive therapy^[1,2].

How does Cablivi (caplacizumab) work?

Acquired TTP is a rare, autoimmune-based blood clotting disorder characterised by extensive clot (thrombi) formation in small blood vessels within the body, which cause low platelet count (thrombocytopenia), small areas of bleeding under the skin (purpura), low red blood cell count and haemolytic anaemia^[3,4].

In patients with aTTP, levels of the blood protein called von Willebrand factor (vWF) are increased^[5]. vWF protein contains domains that bind to the platelets, which leads them to stick together and form blood clots^[5]. The active ingredient in Cablivi, caplacizumab, is an anti-vWF antibody which targets vWF to inhibit its interaction with platelets and reduces formation of clots^[5].

Where has Cablivi (caplacizumab) been approved?

Cablivi (caplacizumab) was approved by:

• Food and Drug Administration (FDA), USA, February 6, 2019^[1]
• European Medical Agency (EMA), European Union, August 30, 2018^[2]
• Therapeutic Goods Administration (TGA), Australia, February 5, 2020^[8]

for the treatment of patients with acquired thrombotic thrombocytopenic purpura (aTTP)^[1,2].

The European Medicines Agency, Europe (2009); the Food and Drug Administration, United States (2009); Swissmedic, Switzerland (2017); Japanese Pharmaceuticals and Medical Devices Agency, Japan (2018) granted caplacizumab orphan drug designation4. Orphan drug designation is a process designed to facilitate and expedite the development of a medicine to treat serious conditions and fill an unmet medical need^[6].

Please note that this medicine may have also been approved in other regions than the ones we’ve listed. If you have a question about its approval in a specific country feel free to contact our support team.

How is Cablivi (caplacizumab) taken?

The standard dosage recommended by:

• The EMA^[2]:
  • First dose: intravenous injection of 10 mg of caplacizumab prior to plasma exchange
  • Subsequent doses: daily subcutaneous administration of 10 mg of caplacizumab after completion of each plasma exchange for the duration of daily plasma exchange treatment, followed by daily subcutaneous injection of 10 mg of caplacizumab for 30 days after stopping daily plasma exchange treatment.

• The FDA^[1]:
  • First day of treatment: 11 mg bolus intravenous injection at least 15 minutes prior to plasma exchange followed by an 11 mg subcutaneous injection after completion of plasma exchange on day 1.
  • Subsequent days of treatment during daily plasma exchange: 11 mg subcutaneous injection once daily following plasma exchange.
  • Treatment after plasma exchange period: 11 mg subcutaneous injection once daily continuing for 30 days following the last daily plasma exchange.

Warning: Treatment with Cablivi (caplacizumab) should be initiated and supervised by physicians experienced in the management of patients with thrombotic microangiopathies^[1,2].

Complete information about Cablivi (caplacizumab) dosage and administration can be found in the official prescribing information listed in our resources section.

Note: Please consult with your treating doctor for personalised dosing and potential drug interactions.

Are there any known side effects or adverse reactions of Cablivi (caplacizumab)?

The most common adverse reactions listed in the prescribing information include^[1,2]:

• headache
• nosebleed
• gingival bleeding
• urticaria
• fatigue.

Cablivi (caplacizumab) can be fatal for a foetus, it is advised to avoid pregnancies and breastfeeding.

For a comprehensive list of side effects and adverse reactions please refer to the official prescribing information^[1,2].

References

1. Summary of Product Characteristics [FDA]: Cablivi (caplacizumab)[PDF] Ablynx, February 2019.
2. Summary of Product Characteristics [EMA]: Cablivi (caplacizumab)[PDF] Ablynx, August 2018.
3. National Institute of Health,Thrombotic thrombocytopenic purpura, acquired, cited on 20/02/2019.
4. Sanofi Press Release,Cablivi™ (caplacizumab) approved in Europe for adults with acquired thrombotic thrombocytopenic purpura (aTTP), cited on 20/02/2019.
5. EMA Human Medicines: Cablivi (caplacizumab)
   10/09/2018 (last update: 04/12/2018), cited on: 21/02/2019.
6. EMA, Orphan Medicine, cited on 20/02/ 2019.
7. National Library of Medicine,von Willebrand factor gene, cited on 21/02/2019.
8. Product Detail [TGA]: Cablivi (caplacizumab)[PDF] Sanofi-Aventis, February 2020.