Hemlibra

emicizumab

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

Hemlibra is a medicine used to prevent or reduce bleeding in patients with haemophilia A (an inherited bleeding disorder caused by lack of factor VIII). It is used in patients who have developed factor VIII inhibitors, which are antibodies in the blood that act against factor VIII medicines and prevent them from working properly.

Hemlibra contains the active substance emicizumab.

How is Hemlibra used?

Hemlibra can only be obtained with a prescription and treatment should be started by a doctor experienced in the treatment of haemophilia or bleeding disorders.

Hemlibra is available as a solution for injection under the skin in the belly, thigh or upper arm. Patients or their carers may be able to inject Hemlibra at home once they have been trained appropriately. The arm injection should only be given by a caregiver or healthcare professional.

The day before starting Hemlibra treatment, patients should stop treatment with bypassing agents (medicines used to prevent bleeding in patients with factor VIII inhibitors, such as activated prothrombin complex concentrate or recombinant factor VIIa). The dose of Hemlibra depends on the patient’s bodyweight. The recommended dose is 3 mg per kg of bodyweight once every week for the first 4 weeks and then 1.5 mg per kg of bodyweight once every week. Hemlibra is intended for long-term use.

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

How does Hemlibra work?

Patients with haemophilia A lack factor VIII, a substance in the body that helps the blood to clot. The active substance in Hemlibra, emicizumab, is a monoclonal antibody which has been designed to do the work that factor VIII normally does – bringing together 2 clotting factors (IXa and X) as part of a chain of reactions needed for blood to clot.

Because emicizumab has a different structure to factor VIII, it is not affected by factor VIII inhibitors.

What benefits of Hemlibra have been shown in studies?

A study in 109 patients showed that Hemlibra is effective at preventing bleeding in haemophilia A patients who have factor VIII inhibitors.

In this study, patients given Hemlibra for prevention had fewer bleeds that needed to be treated (equivalent to 3 per year) than patients who received no preventive treatment (equivalent to 23 per year).

The study also enrolled patients who were already taking preventive treatment with medicines known as bypassing agents. When these patients were switched to Hemlibra, the number of treated bleeds per patient fell from the equivalent of around 16 bleeds per year before the switch to the equivalent of around 3 bleeds per year afterwards.

Patients receiving Hemlibra also had better quality of life scores than those who were not given Hemlibra.

What are the risks associated with Hemlibra?

The most common side effects with Hemlibra (which may affect 1 in 10 people or more) are redness, itching or pain at the place where it is injected, headache and joint pain.

The most serious side effects are thrombotic microangiopathy (clots in small blood vessels, which may affect between 1 in 10 and 1 in 100 people). Abnormal clotting, affecting between 1 and 10 in 1,000 people, may also occur and includes cavernous sinus thrombosis (clotting at the base of the brain) and superficial vein thrombosis (clotting in veins under the skin, usually in the arms or legs) with skin damage.

For the full list of side effects and restrictions with Hemlibra, see the package leaflet.

Why is Hemlibra authorised in the EU?

Only a few medicines, called bypassing agents, are suitable for patients with haemophilia A who have developed factor VIII inhibitors. Hemlibra reduces bleeding episodes in these patients and increases their quality of life. The side effects are tolerable and information on how to manage the risks of serious side effects is in the prescribing information and educational materials. The European Medicines Agency therefore decided that Hemlibra’s benefits are greater than its risks and it can be authorised for use in the EU.

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

The company that markets Hemlibra will issue educational materials for healthcare professionals, patients, carers and laboratory professionals about abnormal clotting side effects, the risk of taking Hemlibra at the same time as bypassing agents and how laboratory tests should be carried out for these patients. Materials will include product information, guides, and a patient alert card.

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

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

Other information about Hemlibra

Hemlibra received a marketing authorisation valid throughout the EU on 23 February 2018.

Name Language First published Last updated
Hemlibra : EPAR - Medicine overview BG = bălgarski 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview ES = español 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview CS = čeština 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview DA = dansk 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview DE = Deutsch 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview ET = eesti keel 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview EL = elliniká 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview EN = English 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview FR = français 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview IT = italiano 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview LV = latviešu valoda 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview LT = lietuvių kalba 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview HU = magyar 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview MT = Malti 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview NL = Nederlands 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview PL = polski 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview PT = português 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview RO = română 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview SK = slovenčina 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview SL = slovenščina 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview FI = suomi 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview SV = svenska 2018-03-01 2018-03-13
Hemlibra : EPAR - Medicine overview HR = Hrvatski 2018-03-01 2018-03-13
Name Language First published Last updated
Hemlibra : EPAR - Risk-management-plan summary (English only) 2018-03-01  

This EPAR was last updated on 07/05/2018 .

Authorisation details

Product details

Product details for Hemlibra
NameHemlibra
Agency product numberEMEA/H/C/004406
Active substance

emicizumab

International non-proprietary name (INN) or common name

emicizumab

Therapeutic area Hemophilia A
Anatomical therapeutic chemical (ATC) code B02BX
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.

Publication details

Publication details for Hemlibra
Marketing-authorisation holder

Roche Registration Limited

Revision1
Date of issue of marketing authorisation valid throughout the European Union23/02/2018

Contact address:

Roche Registration Limited
6 Falcon Way, Shire Park
Welwyn Garden City
AL7 1TW
United Kingdom

Product information

Product information

30/04/2018  Hemlibra -EMEA/H/C/004406 -T/0001

Name Language First published Last updated
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07
Hemlibra : EPAR - Product Information EN = English 2018-03-01 2018-05-07

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
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  
Hemlibra : EPAR - All Authorised presentations EN = English 2018-03-01  

Pharmacotherapeutic group

Antihemorrhagics

Therapeutic indication

Hemlibra is indicated for routine prophylaxis of bleeding episodes in patients with haemophilia A with factor VIII inhibitors.

Hemlibra can be used in all age groups.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Hemlibra : EPAR - Procedural steps taken and scientific information after authorisation EN = English 2018-05-07  

Initial marketing-authorisation documents

Name Language First published Last updated
Hemlibra : EPAR - Public assessment report EN = English 2018-03-01  
CHMP summary of positive opinion for Hemlibra EN = English 2018-01-26