Cablivi

caplacizumab

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An overview of Cablivi and why it is authorised in the EU

Cablivi is a medicine used for treating adults who have an episode of acquired thrombotic thrombocytopenic purpura (aTTP), a blood clotting disorder. During an episode of aTTP, blood clots form in small blood vessels and the patient has a low count of platelets (components that help the blood to clot).

Cablivi is used together with plasma exchange (in which certain antibodies are removed from the blood) and treatments to reduce the activity of the immune system (the body’s defences).

Cablivi contains the active substance caplacizumab.

aTTP is rare, and Cablivi was designated an ‘orphan medicine’ (a medicine used in rare diseases) on 30 April 2009. Further information on the orphan designation can be found here: ema.europa.eu/Find medicine/Human medicines/Rare disease designation

How is Cablivi used?

Cablivi can only be obtained with a prescription. Treatment should be started and supervised by doctors experienced in managing patients who have clotting disorders affecting small blood vessels.

Cablivi is started with a dose of 10 mg given by injection into a vein before plasma exchange. Treatment is continued with 10 mg daily given by injection under the skin in the belly after daily plasma exchange and continued for 30 days after daily plasma exchange is stopped. Treatment with Cablivi may continue for longer if necessary. Patients also receive treatments to reduce the immune system’s activity.

Patients or their carers may be able to inject Cablivi themselves after appropriate training.

For more information about using Cablivi, see the package leaflet or contact your doctor or pharmacist.

How does Cablivi work?

In patients with aTTP, levels of a substance called von Willebrand factor are increased. von Willebrand factor acts on platelets to cause them to stick together and form blood clots. Caplacizumab, the active substance in Cablivi, is a nanobody (a small antibody) which has been designed to attach to von Willebrand factor in a way that stops it acting on platelets. This reduces platelets sticking together and forming clots in blood vessels and, as a result, platelet levels in the blood rise because they are no longer taken up to form clots.

What benefits of Cablivi have been shown in studies?

Two main studies have investigated the effectiveness of Cablivi in patients with aTTP who required plasma exchange to treat their condition. All patients were receiving standard treatment.

In the first study, involving 75 patients, platelet counts returned to the normal range after 3 days on average in patients treated with Cablivi, compared with nearly 5 days in those receiving placebo (a dummy treatment).

The second study, involving 145 patients, measured how long it took for the platelet count to return to the normal range and for sufficient improvement in the condition to allow daily plasma exchange to be stopped within 5 days. The study found that platelet count was likely to return to the normal range more quickly in patients treated with Cablivi compared with those receiving placebo.

What are the risks associated with Cablivi?

The most common side effects with Cablivi (which may affect more than 1 in 10 people) are nosebleeds, headache and bleeding from gums. For the full list of side effects and restrictions with Cablivi, see the package leaflet.

Why is Cablivi authorised in the EU?

The European Medicines Agency decided that Cablivi’s benefits are greater than its risks and it can be authorised for use in the EU. The Agency considered that, in patients with aTTP, Cablivi combined with plasma exchange and immunosuppression can reduce the time it takes for platelet counts to return to the normal range, which is associated with shorter duration of plasma exchange treatment and shorter stay in intensive care facility. The most important side effect of treatment is bleeding but it is considered manageable. The company is expected to provide results of a study on Cablivi’s safety and effectiveness over a longer period.

What measures are being taken to ensure the safe and effective use of Cablivi?

The company that markets Cablivi will provide materials, including a patient alert card, on the risk of serious bleeding and how the risk should be managed.

Recommendations and precautions to be followed by healthcare professionals and patients for the safe and effective use of Cablivi have also been included in the summary of product characteristics and the package leaflet.

As for all medicines, data on the use of Cablivi are continuously monitored. Side effects reported with Cablivi are carefully evaluated and any necessary action taken to protect patients.

Other information about Cablivi

Cablivi received a marketing authorisation valid throughout the EU on 31 August 2018.

Name Language First published Last updated
Cablivi : EPAR - Summary for the public BG = bălgarski 2018-09-10  
Cablivi : EPAR - Summary for the public ES = español 2018-09-10  
Cablivi : EPAR - Summary for the public CS = čeština 2018-09-10  
Cablivi : EPAR - Summary for the public DA = dansk 2018-09-10  
Cablivi : EPAR - Summary for the public DE = Deutsch 2018-09-10  
Cablivi : EPAR - Summary for the public ET = eesti keel 2018-09-10  
Cablivi : EPAR - Summary for the public EL = elliniká 2018-09-10  
Cablivi : EPAR - Summary for the public EN = English 2018-09-10  
Cablivi : EPAR - Summary for the public FR = français 2018-09-10  
Cablivi : EPAR - Summary for the public IT = italiano 2018-09-10  
Cablivi : EPAR - Summary for the public LV = latviešu valoda 2018-09-10  
Cablivi : EPAR - Summary for the public LT = lietuvių kalba 2018-09-10  
Cablivi : EPAR - Summary for the public HU = magyar 2018-09-10  
Cablivi : EPAR - Summary for the public MT = Malti 2018-09-10  
Cablivi : EPAR - Summary for the public NL = Nederlands 2018-09-10  
Cablivi : EPAR - Summary for the public PL = polski 2018-09-10  
Cablivi : EPAR - Summary for the public PT = português 2018-09-10  
Cablivi : EPAR - Summary for the public RO = română 2018-09-10  
Cablivi : EPAR - Summary for the public SK = slovenčina 2018-09-10  
Cablivi : EPAR - Summary for the public SL = slovenščina 2018-09-10  
Cablivi : EPAR - Summary for the public FI = suomi 2018-09-10  
Cablivi : EPAR - Summary for the public SV = svenska 2018-09-10  
Cablivi : EPAR - Summary for the public HR = Hrvatski 2018-09-10  
Name Language First published Last updated
Cablivi : EPAR - Risk-management-plan summary (English only) 2018-09-10  

This EPAR was last updated on 10/09/2018 .

Authorisation details

Product details

Product details for Cablivi
NameCablivi
Agency product numberEMEA/H/C/004426
Active substance

caplacizumab

International non-proprietary name (INN) or common name

caplacizumab

Therapeutic area Purpura, Thrombotic Thrombocytopenic
Anatomical therapeutic chemical (ATC) code B01A
Additional monitoring

This medicine is under additional monitoring. This means that it is being monitored even more intensively than other medicines. For more information, see medicines under additional monitoring.

Treatment of rare diseases

This medicine has an "orphan designation" which means that it is used to treat life-threatening or chronically debilitating conditions that affect no more than five in 10,000 people in the European Union, or are medicines which, for economic reasons, would be unlikely to be developed without incentives.

Publication details

Publication details for Cablivi
Marketing-authorisation holder

Ablynx NV

Revision0
Date of issue of marketing authorisation valid throughout the European Union31/08/2018

Contact address:

Ablynx NV
Technologiepark 21
9052 Zwijnaarde
Belgium

Product information

Product information

31/08/2018  Cablivi -EMEA/H/C/004426 --

Name Language First published Last updated
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  
Cablivi : EPAR - Product Information EN = English 2018-09-10  

Contents

  • Annex I - Summary of product characteristics
  • Annex IIA - Manufacturing-authorisation holder responsible for batch release
  • Annex IIB - Conditions of the marketing authorisation
  • Annex IIIA - Labelling
  • Annex IIIB - Package leaflet

Please note that the size of the above document can exceed 50 pages.

You are therefore advised to be selective about which sections or pages you wish to print.


Name Language First published Last updated
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  
Cablivi : EPAR - All Authorised presentations EN = English 2018-09-10  

Pharmacotherapeutic group

Antithrombotic agents

Therapeutic indication

Cablivi is indicated for the treatment of adults experiencing an episode of acquired thrombotic thrombocytopenic purpura (aTTP), in conjunction with plasma exchange and immunosuppression.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated

Initial marketing-authorisation documents

Name Language First published Last updated
Cablivi : Orphan maintenance assessment report EN = English 2018-09-10  
Cablivi : EPAR - Public assessment report EN = English 2018-09-10  
CHMP summary of positive opinion for Cablivi EN = English 2018-06-29  

Authorised

This medicine is approved for use in the European Union

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