Hizentra

human normal immunoglobulin (SCIg)

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This is a summary of the European public assessment report (EPAR) for Hizentra. It explains how the Committee for Medicinal Products for Human Use (CHMP) assessed the medicine to reach its opinion in favour of granting a marketing authorisation and its recommendations on the conditions of use for Hizentra.

What is Hizentra?

Hizentra is a solution for injection under the skin. It contains the active substance human normal immunoglobulin (200 mg/ml).

What is Hizentra used for?

Hizentra is used in patients whose blood does not contain enough antibodies (proteins that help the body to fight infections and other diseases), also known as immunoglobulins. It is used to treat the following conditions:

  • primary immunodeficiency syndromes (PID, when people are born with an inability to produce enough antibodies);
  • low levels of antibodies in the blood in patients with chronic lymphocytic leukaemia (a cancer of a type of white blood cell) or myeloma (a cancer of another type of white blood cell) and who have frequent infections.

The medicine can only be obtained with a prescription.

How is Hizentra used?

Treatment with Hizentra should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems, but patients (or their carers) may administer it themselves once they have been trained and initially monitored. Hizentra is given as a subcutaneous infusion (very slow injection under the skin) in an area such as the abdomen, thigh, upper arm or hip. The injection is normally given on a weekly basis, to provide a total monthly dose of around 2 to 4 ml per kilogram body weight, but the dose and frequency of injection depend on the patient’s body weight and may be adjusted according to their response. At the start of treatment the doctor may decide to give an initial loading dose of 1 to 2.5 ml/kg.

How does Hizentra work?

The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from human plasma (part of the blood). It contains immunoglobulin G (IgG), which is a type of antibody. IgG has been used as a medicine since the 1980s and has a wide range of activity against organisms that can cause infection. Hizentra works by restoring abnormally low IgG levels to their normal range in the patient’s blood.

How has Hizentra been studied?

As human normal immunoglobulin has been used to treat these diseases for some time, and in accordance with current guidelines, Hizentra was investigated in one main study involving 51 PID patients who had already received human immunoglobulin treatment for at least six months. The patients received Hizentra every week for 28 weeks. The main measure of effectiveness was how the lowest IgG levels (called ‘trough levels’) seen during Hizentra treatment compared with the lowest levels seen during previous immunoglobulin treatment.

What benefit has Hizentra shown during the studies?

The lowest IgG levels seen during treatment with Hizentra (average trough level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment.

What is the risk associated with Hizentra?

Adverse reactions such as chills, headache, fever, vomiting, allergic reactions, nausea, arthralgia (joint pain), low blood pressure and moderate to low back pain may occur occasionally. For the full list of all side effects reported with Hizentra, see the package leaflet.

Hizentra should not be used in patients who may be allergic to normal human immunoglobulin or any of the other ingredients. It must not be used in patients with hyperprolinaemia (a genetic disorder causing high levels of the amino acid proline in the blood). It must not be injected into a blood vessel such as a vein or an artery.

Why has Hizentra been approved?

The CHMP noted that Hizentra can prevent serious bacterial infections in PID patients through weekly injections which may be given at home, while the side effects are not frequent or severe. It decided that Hizentra’s benefits are greater than its risks and recommended that it be given marketing authorisation.

Other information about Hizentra

The European Commission granted a marketing authorisation valid throughout the European Union for Hizentra to CSL Behring GmbH on 14 April 2011. The marketing authorisation is valid for five years, after which it can be renewed.

For more information about treatment with Hizentra, read the package leaflet (also part of the EPAR) or contact your doctor or pharmacist.

Name Language First published Last updated
Hizentra : EPAR - Summary for the public BG = bălgarski 06/06/2011  
Hizentra : EPAR - Summary for the public ES = español 06/06/2011  
Hizentra : EPAR - Summary for the public CS = čeština 06/06/2011  
Hizentra : EPAR - Summary for the public DA = dansk 06/06/2011  
Hizentra : EPAR - Summary for the public DE = Deutsch 06/06/2011  
Hizentra : EPAR - Summary for the public ET = eesti keel 06/06/2011  
Hizentra : EPAR - Summary for the public EL = elliniká 06/06/2011  
Hizentra : EPAR - Summary for the public EN = English 06/06/2011  
Hizentra : EPAR - Summary for the public FR = français 06/06/2011  
Hizentra : EPAR - Summary for the public IT = italiano 06/06/2011  
Hizentra : EPAR - Summary for the public LV = latviešu valoda 06/06/2011  
Hizentra : EPAR - Summary for the public LT = lietuvių kalba 06/06/2011  
Hizentra : EPAR - Summary for the public HU = magyar 06/06/2011  
Hizentra : EPAR - Summary for the public MT = Malti 06/06/2011  
Hizentra : EPAR - Summary for the public NL = Nederlands 06/06/2011  
Hizentra : EPAR - Summary for the public PL = polski 06/06/2011  
Hizentra : EPAR - Summary for the public PT = português 06/06/2011  
Hizentra : EPAR - Summary for the public RO = română 06/06/2011  
Hizentra : EPAR - Summary for the public SK = slovenčina 06/06/2011  
Hizentra : EPAR - Summary for the public SL = slovenščina 06/06/2011  
Hizentra : EPAR - Summary for the public FI = suomi 06/06/2011  
Hizentra : EPAR - Summary for the public SV = svenska 06/06/2011  

This EPAR was last updated on 04/02/2014 .

Authorisation details

Product details

Product details for Hizentra
NameHizentra
Agency product numberEMEA/H/C/002127
Active substance

human normal immunoglobulin (SCIg)

International non-proprietary name (INN) or common name

human normal immunoglobulin (SCIg)

Therapeutic area Immunologic Deficiency Syndromes
Anatomical therapeutic chemical (ATC) code J06BA01
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 Hizentra
Marketing-authorisation holder

CSL Behring GmbH

Revision8
Date of issue of marketing authorisation valid throughout the European Union14/04/2011

Contact address:

CSL Behring GmbH
Emil-von-Behring-Strasse 76
D-35041 Marburg
Germany

Product information

Product information

18/12/2013  Hizentra -EMEA/H/C/002127 -II/0027/G

Name Language First published Last updated
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014
Hizentra : EPAR - Product Information SV = svenska 06/06/2011 04/02/2014

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
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013
Hizentra : EPAR - All Authorised presentations SV = svenska 06/06/2011 20/08/2013

Pharmacotherapeutic group

Immune sera and immunoglobulins

Therapeutic indication

Replacement therapy in adults and children in primary immunodeficiency syndromes such as:

  • congenital agammaglobulinaemia and hypogammaglobulinaemia;
  • common variable immunodeficiency;
  • severe combined immunodeficiency;
  • immunoglobulin-G-subclass deficiencies with recurrent infections;
  • replacement therapy in myeloma or chronic lymphocytic leukaemia with severe secondary hypogammaglobulinaemia and recurrent infections.

Assessment History

Changes since initial authorisation of medicine

Name Language First published Last updated
Hizentra : EPAR - Procedural steps taken and scientific information after authorisation SV = svenska 08/12/2011 04/02/2014
Hizentra-H-C-2127-P46-12 : EPAR - Assessment Report SV = svenska 15/03/2013  

Initial marketing-authorisation documents

Name Language First published Last updated
Hizentra : EPAR - Public assessment report SV = svenska 06/06/2011  
CHMP summary of positive opinion for Hizentra SV = svenska 18/02/2011  

Authorised

This medicine is approved for use in the European Union