Hizentra

human normal immunoglobulin (SCIg)

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About

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

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;
  • low levels of antibodies in the blood in patients before or after allogeneic haematopoietic stem cell transplantation (a procedure where the patient's bone marrow is cleared of cells and replaced by stem cells from a donor);
  • chronic inflammatory demyelinating polyneuropathy (CIDP). In this rare disease, the immune system (the body’s defence system) works abnormally and destroys the protective covering over the nerves.

Hizentra contains the active substance human normal immunoglobulin.

How is Hizentra used?

Hizentra can only be obtained with a prescription and treatment should be started by a doctor or nurse who is experienced in the treatment of patients with weakened immune systems or CIDP.

Hizentra is available as a solution for injection. It is given by subcutaneous infusion (very slow injection under the skin) through a device that controls the speed of infusion. It is given in the abdomen (belly), thigh, upper arm or hip. Patients (or their carers) may inject Hizentra at home once they have been trained.

The dose and how often Hizentra infusion is given depend on the disease being treated. The dose may need to be adjusted depending on how well the medicine is working.

For more information about using Hizentra, see the package leaflet or contact a doctor or pharmacist.

How does Hizentra work?

The active substance in Hizentra, human normal immunoglobulin, is a highly purified protein extracted from donated human blood. It contains mainly immunoglobulin G (IgG), which is composed of a range of antibodies involved in fighting organisms that can cause infection. Hizentra works by restoring abnormally low IgG levels to their normal range in the patient’s blood. It can also help to control the immune system when it is working abnormally such as in CIDP. Normal immunoglobulin has been used as a medicine since the 1980s.

What benefits of Hizentra have been shown in studies?

As human normal immunoglobulin has been used to treat these diseases for many years, in accordance with current guidelines, two small studies were needed to establish the effectiveness and safety of Hizentra in patients.

In the first study, Hizentra was investigated in 51 PID patients who had already received human immunoglobulin into a vein for at least six months. The patients received Hizentra for 28 weeks and the lowest IgG levels during treatment with Hizentra (average level of 8.1 g per litre) were comparable to those seen during previous immunoglobulin treatment. IN addition, no infections occurred during the study period.

In the second study Hizentra was studied in 172 patients with CIDP who had previously received human immunoglobulin treatment by injection into a vein. Patients received Hizentra or placebo (a dummy treatment) for 13 weeks and the study measured the proportion of patients in whom the disease came back within 13 weeks. For patients on placebo, the disease came back in about 63% of patients, for patients on Hizentra, the disease came back in 33 and 39% of patients; depending on the dose used.

What are the risks associated with Hizentra?

The most common side effects with Hizentra (which may affect more than 1 in 10 people) are headache, rash, muscle and joint pain (including muscle spasm and weakness), reactions around the injection area (swelling, soreness, redness, pitting, warmth, itching, bruising and rash) and flu-like illness. Rarely patients may have a sudden drop in blood pressure or an anaphylactic shock (sudden, severe allergic reaction).

Hizentra must not be used in patients with hyperprolinaemia (a genetic disorder causing hgh levels of the amino acid proline in the blood). It must not be injected into a blood vessel.

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

Why is Hizentra authorised in the EU?

The European Medicines Agency decided that Hizentra’s benefits are greater than its risks and it can be authorised for use in the EU. Hizentra was shown to prevent serious bacterial infections in PID patients and reduce the chance of CIDP coming back. It may be given at home, while the side effects are manageable.

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

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

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

Other information about Hizentra

Hizentra received a marketing authorisation valid throughout the EU on 14 April 2011.

Name Language First published Last updated
Hizentra : EPAR - Summary for the public BG = bălgarski 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public ES = español 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public CS = čeština 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public DA = dansk 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public DE = Deutsch 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public ET = eesti keel 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public EL = elliniká 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public EN = English 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public FR = français 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public IT = italiano 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public LV = latviešu valoda 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public LT = lietuvių kalba 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public HU = magyar 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public MT = Malti 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public NL = Nederlands 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public PL = polski 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public PT = português 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public RO = română 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public SK = slovenčina 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public SL = slovenščina 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public FI = suomi 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public SV = svenska 2011-06-06 2018-04-30
Hizentra : EPAR - Summary for the public HR = Hrvatski 2011-06-06 2018-04-30

This EPAR was last updated on 30/04/2018 .

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

Publication details

Publication details for Hizentra
Marketing-authorisation holder

CSL Behring GmbH

Revision16
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

05/03/2018  Hizentra -EMEA/H/C/002127 -II/0087

Name Language First published Last updated
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30
Hizentra : EPAR - Product Information HR = Hrvatski 2011-06-06 2018-04-30

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 HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16
Hizentra : EPAR - All Authorised presentations HR = Hrvatski 2011-06-06 2017-10-16

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

Initial marketing-authorisation documents

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

Authorised

This medicine is approved for use in the European Union